(129 days)
The Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex NanoScope System provides image processing and digital documentation for endoscopic procedures. The system utilizes a handpiece which provides distal LED illumination to the surgical site using a fiber optic bundle surrounding a high-resolution camera sensor.
The provided text is a 510(k) premarket notification letter and summary for the Arthrex NanoScope System. It describes the device, its intended use, and arguments for substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.
This document specifically states that:
- "Nonclinical (bench) testing was performed to demonstrate substantial equivalence to the predicate regarding thermal safety, electrical safety, optical performance, environmental conditions, power requirements, image capture, and video output and resolution."
- "An engineering analysis was performed to address the substantial equivalence of the field of view and the working diameter compared to the predicate device."
This indicates that the substantial equivalence was established through bench testing and engineering analysis for hardware performance, not through clinical studies or AI/ML performance evaluations against specific acceptance criteria. The device is an endoscopic video camera system, and the submission is to expand its indications for use (adding spine procedures) and extend the shelf life of a sterile component, not for a new AI/ML-driven diagnostic or assistive feature.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from the provided text. The questions posed are highly relevant to AI/ML medical devices, but this document describes a traditional medical device submission (an endoscopic camera) where such metrics and studies are not typically required for regulatory clearance unless the device incorporates an AI/ML component with a diagnostic or assistive function.
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September 4, 2020
Arthrex, Inc. Heli Chambi Infantas Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K201134
Trade/Device Name: Arthrex NanoScope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 4. 2020 Received: August 5, 2020
Dear Heli Chambi Infantas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Arthrex NanoScope System
Indications for Use (Describe)
The Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | September 4, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Heli F Chambi InfantasRegulatory Affairs Associate1-239-643-5553, ext. 71263Heli.chambiinfantas@arthrex.com |
| Name of Device | Arthrex NanoScope System |
| Common Name | Endoscopic Video Camera System |
| Product Code | GCJ, HRX |
| Classification Name | 21 CFR 876-1500: Endoscope and accessories |
| Regulatory Class | II |
| Predicate Device | K190645 - Arthrex NanoScope SystemK180766 – Endiscope Cervical |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to add spine as an additionalanatomical location for the Arthrex NanoScope System indications for use. This 510K isalso submitted to extend the shelf life of the product sterile component from 6 to 18months and to present labeling changes for storage conditions. |
| Device Description | The Arthrex NanoScope System provides image processing and digital documentation forendoscopic procedures. The system utilizes a handpiece which provides distal LEDillumination to the surgical site using a fiber optic bundle surrounding a high-resolutioncamera sensor. |
| Indications for Use | The Arthrex NanoScope System is intended to be used as an endoscopic video camera in avariety of endoscopic diagnostic and surgical procedures, including but not limited to:orthopedic, spine, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. Thedevice is also intended to be used as an accessory for microscopic surgery. |
| Substantial EquivalenceSummary | The Arthrex NanoScope System is substantially equivalent to the predicate devices inwhich the basic design features and intended users are the same.Nonclinical (bench) testing was performed to demonstrate substantial equivalence to thepredicate regarding thermal safety, electrical safety, optical performance, environmentalconditions, power requirements, image capture, and video output and resolution.An engineering analysis was performed to address the substantial equivalence of the fieldof view and the working diameter compared to the predicate device. |
| Accordingly, Arthrex believes that the Arthrex NanoScope System is substantiallyequivalent to its original K190645 clearance and to the Elliquence Endiscope Cervicalsystem cleared under K180299. | |
| Conclusion | The proposed Arthrex NanoScope System is substantially equivalent to the predicatedevice in which the basic design feature and intended use are the same. The visualizationfor the intraoperative site during spinal endoscopic procedures and minimally invasivesurgery does not deviate from the current endoscopic visualization intended use andapplication originally cleared under K190645.Any differences between the proposed device and the predicate device are consideredminor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device. |
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.