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WARNING LETTER
CMS# 664014

October 13, 2023

Dear Mr. Mansberger:

During an inspection of your firm located at 340 SW Columbia St., Bend, OR on May 15, 2023 through May 18, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a reprocessor and distributor of reprocessed single-use devices such as Electrosurgical Ablation Wands, Electrosurgical Ear, Nose, and Throat (ENT) Coblators, Trocars, ENT Burs, Drill Bits, and Surgical Saw Blades. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

We received a response(s) from Mary Vater, Deputy Quality Manager dated June 1, 2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations.

Our inspection revealed that the following devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g):

• ReNovo Inc (b)(4) Single Use Device (SUD) Model Numbers (b)(4) Ablation Electrodes;
• (b)(4) Ablation Electrodes;
• (b)(4) Ablation Electrodes;
• (b)(4) Coblators;
• (b)(4) Bipolar Sealers;
• (b)(4) Bipolar Sealers;
• (b)(4) Trochars/Cannulas;
• (b)(4) Trochars/Cannulas;
• (b)(4) Trochars/Cannulas;
• (b)(4) Ablation Electrodes;
• (b)(4) Ablation Electrodes;
• (b)(4) Ablation Electrodes;
• (b)(4) Trochars/Cannulas;
• (b)(4) Trochars/Cannulas and
• (b)(4) Trochars/Cannulas

The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Specifically, your firm added (b)(4) new models of (b)(4) by Letter to File that were not cleared K173741. For example,

• (b)(4) Ablation Electrodes (b)(4)
• (b)(4) Ablation Electrodes, (b)(4)
• (b)(4) Ablation Electrodes (b)(4)

These new models ((b)(4)) are (b)(4) versions of OEM models that were not included in K173741. The additional OEM models have smaller diameter shafts, smaller diameters lumens, and smaller tip elements than the OEM models included in K173741, and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in K173741. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new (b)(4) models.¹ These changes could significantly affect the safety or effectiveness of the (b)(4) devices and required the submission of a new 510(k). 21 CFR 807.81(a)(3)(i).

Your firm also added (b)(4) new models of (b)(4) by Letter to File in connection with clearance K173740. For example,

• (b)(4) Ablation (b)(4)
• (b)(4) Ablation (b)(4)
• (b)(4) Ablation (b)(4)

These new models ((b)(4)) are (b)(4) versions of OEM models that were not included in K173740. These additional OEM models have smaller diameter shafts, smaller diameters lumens, smaller tip elements, and/or longer shafts than then OEM models included in K173740, and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in K173740. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new (b)(4) models.¹ These changes could significantly affect the safety or effectiveness of the (b)(4) devices and required the submission of a new 510(k). 21 CFR 807.81(a)(3)(i).

Your firm also added (b)(4) new models of (b)(4) by Letter to File in connection with clearance K172647. For example,

• (b)(4) Coblators (b)(4)
• (b)(4) Coblators (b)(4)
• (b)(4) Coblators (b)(4)

These new models ((b)(4)) are (b)(4) versions of OEM models that were not included in K172647. The additional OEM models have smaller diameter shafts, smaller diameters lumens, smaller tip elements, and/or longer shafts than the OEM models included in K172647, and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in K172647. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new (b)(4) models.¹ These changes could significantly affect the safety or effectiveness of the (b)(4) devices and required submission of a new 510(k). 21 CFR 807.81(a)(3)(i).

Your firm also added (b)(4) new models of (b)(4) by Letter to File in connection with clearance K172097. For example,

• (b)(4) Trochars/Cannulas (b)(4)
• (b)(4)
• (b)(4) Trochars/ Cannulas (b)(4)
• (b)(4)
• (b)(4) Trochars/Cannulas (b)(4)

These new models ((b)(4)) are (b)(4) versions of OEM models that were not included in K172097. The additional OEM models have smaller constructional elements, and/or different design features than the OEM models included in K172097, and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in K172097. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new (b)(4) models.¹ These changes could significantly affect the safety or effectiveness of the (b)(4) devices and required the submission of a new 510(k). 21 CFR 807.81(a)(3)(i).

Your firm also added (b)(4) new models of (b)(4) by Letter to File in connection with clearance K172093. For example,

• (b)(4) Trochars/Cannulas (b)(4)
• (b)(4) Trochars/Cannulas (b)(4)
• (b)(4) Trochars/Cannulas (b)(4)

These new models ((b)(4)) are (b)(4) versions of OEM models that were not included in K172093. The additional OEM models have smaller constructional elements, and/or different design features than the OEM models included in K172093, and they present a more challenging scenario for cleaning and re-sterilization compared to the designs of the OEM models that were included in K172093. Your company did not evaluate how cleaning and re-sterilization of the additional OEM models with different designs could affect the performance specifications and reliability of your new (b)(4) models.¹ These changes could significantly affect the safety or effectiveness of the (b)(4) devices and required submission of a new 510(k). 21 CFR 807.81(a)(3)(i).

Our inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

These violations include, but are not limited to, the following:

1. Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically,

Your firm’s air compressor system is used for drying and operation of process equipment for manufacturing (b)(4) medical devices. (b)(4) air particulate testing, conducted on (b)(4), found the number of particles for particle sizes between 1.0μm and 5.0μm were above the specified limit, particles above (b)(4) were detected, and the test failed. Your firm did not initiate a non-conforming product report to assess if this nonconformance impacted product. Your firm initiated CAPA 22-003 to investigate why the air compressor failed the testing, however, this CAPA also did not assess if product may have been impacted by the failure.

We reviewed your firm’s response and your response to this observation appears to be adequate. Please provide a timeframe for completion of your corrective actions. A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.

2. Failure to adequately establish procedures to control environmental conditions, as required by 21 CFR 820.70(c). Specifically,

Your firm reprocesses medical devices in a controlled environment room, and your firm’s Controlled Environment Monitoring procedure, SOP-065, Version: A7, Effective: 08/10/2021, requires routine monitoring of air particulate measurements. This procedure states that (b)(4). Air particulate sampling began on (b)(4), however, as of (b)(4) your firm has not set acceptable levels for air particulate.

We reviewed your firm’s response and your response to this observation appears to be adequate. A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch, at [email protected]. Refer to CMS # 664014 when replying. If you have any questions about the contents of this letter, please contact: Shaquenta Y. Perkins, Compliance Officer at (619) 941-3763 or [email protected].

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Operations Division 3/West

/S/
Binita S. Ashar, MD, MBA, FACS Director
OHT 4: Office of Surgery and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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1 See FDA’s Guidance for Industry and Food and Drug Administration Staff on Deciding When to Submit a 510(k) for a Change to an Existing Device available at https://www.fda.gov/media/99812/download.