(118 days)
The Arthrex NanoScope System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery.
For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.
The Arthrex NanoScope System provides real-time visible light illumination and imaging. The system includes a non-sterile reusable camera control unit (CCU) console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface.
The provided document describes the Arthrex NanoScope System, a medical device used for endoscopic video imaging. However, this document does not contain information about a study proving the device meets specific acceptance criteria related to a specific performance metric (e.g., accuracy, sensitivity, specificity) for an AI/ML algorithm that identifies or classifies something.
The performance data section (pages 5 and 6) outlines various non-clinical bench testing, including:
- Biocompatibility testing: Performed according to ISO 10993 standards.
- Electrical, Mechanical, and Thermal (EMT) safety testing: Performed according to ANSI/AAMI ES60601-1 and IEC 60601-2-18 standards.
- Electromagnetic Compatibility (EMC) testing: Performed according to IEC 60601-1-2 standards.
- Software testing: Performed according to FDA guidance and IEC 62304.
- Design verification testing: Included inspection, engineering analysis, and functional testing.
These tests confirm the device's conformance to safety, performance, and software quality standards relevant to an endoscopic imaging system, rather than demonstrating the performance of an AI model against specific clinical metrics like sensitivity or specificity. The submission aims to expand indications and report software and device modifications, relying on equivalence to predicate devices rather than a de novo clinical study proving AI performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML algorithm's performance, as the provided text does not describe such a study. The document explicitly states: "The Arthrex NanoScope System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This further indicates that no clinical performance study, particularly one involving AI/ML and human-in-the-loop or standalone performance, was conducted as part of this submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
January 22, 2025
Arthrex, Inc. Lai Saeteurn Senior Regulatory Affairs Specialist 1370 Creekside Blvd. Naples, Florida 34108
Re: K243008
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: December 23, 2024 Received: December 23, 2024
Dear Lai Saeteurn:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Digitally signed by Long H. Chen Long H. Chen-S Date: 2025.01.22 16:10:44 -05'00'
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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Indications for Use
Submission 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 to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery.
For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthonedic procedures
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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Image /page/4/Picture/0 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of surgical scissors. The scissors are positioned at an angle, with the blades open and the handles forming two circles.
510(k) Summary
| Date Prepared | September 26, 2024 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Name: Lai SaeteurnPhone: 239-643-5553Email: Lai.Saeteurn@Arthrex.com |
| Trade Name | Arthrex NanoScope System |
| Classification | 21 CFR 876.1500: Endoscope and accessories,21 CFR 892.1600: Angiographic x-ray systems |
| Product Code | GCJ, IZI |
| Common Name | Endoscopic Imaging System |
| Regulatory Class | Class II |
| PrimaryPredicate Device | K201134 Arthrex NanoScope System |
| AdditionalPredicate Device | K210088 Stryker AIM (Advanced Imaging Modality) System |
| Purpose ofSubmission | This Traditional 510(k) premarket notification is submitted to expand indicationsfor the Arthrex NanoScope System. Arthrex is also reporting software updates,device modifications, and additional device models made since clearance inK201134. |
| DeviceDescription | The Arthrex NanoScope System provides real-time visible light illumination andimaging. The system includes a non-sterile reusable camera control unit (CCU)console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management systeminto a single console with touchscreen interface. |
| Indications forUse | The Arthrex NanoScope System is intended to be used as an endoscopic videocamera to provide visible light imaging in a variety of endoscopic diagnostic andsurgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy,spine, and urology. The device is also intended to be used as an accessory formicroscopic surgery.For pediatric patients, the Arthrex NanoScope System is indicated for use inlaparoscopy and orthopedic procedures. |
| PerformanceData | Non-clinical bench testing was developed and performed on the ArthrexNanoScope System to confirm the device meets product requirements and devicespecifications. These tests included biocompatibility testing, design verification,electrical, mechanical, and thermal (EMT) safety testing, electromagneticcompatibility (EMC) testing, and software testing. The testing methods used andacceptance criteria are comparable to the primary predicate device.The biological testing was performed in accordance with ISO 10993-1:2018,Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process (FDA Recognition Number: 2-258); ISO 10993-5:2009,Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
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K243008
(FDA Recognition Number: 2-245); ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for skin sensitization (FDA Recognition Number: 2-174); ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (FDA Recognition Number: 2-255); ISO 10993-12:2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (FDA Recognition Number: 2-289); ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (FDA Recognition Number: 2-237); ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation (FDA Recognition Number: 2-291); ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals (FDA Recognition Number: 2-275); and ISO 11737-1, and Sterilization of health care products — Microbiological methods, Part 1: Determination of a population of microorganisms on products (FDA Recognition Number: 14-577).
The EMT and EMC testing was performed in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] (FDA Recognition Number: 19-46); IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (FDA Recognition Number: 9-114); IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA Recognition Number: 5-132); IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognition Number: 19-36); IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (FDA Recognition Number: 19-19).
Software testing was performed in accordance with recommendations in FDA guidance document "Content of Premarket Submissions for Device Software Functions" (issued June 2023) and IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes (FDA Recognition Number: 13-79).
Design verification testing included inspection, engineering analysis and functional testing of the subject device. The test results confirm the subject device met Arthrex product requirements and design specifications for the device. A technical rationale was used to support the safety and effectiveness of the Arthrex NanoScope System when used in the pediatric population.
Biological testing was conducted and the test results confirm the subject device is biocompatible for its intended use and indications for use.
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Image /page/6/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by an image of a surgical instrument. The surgical instrument appears to be a type of forceps or clamp, with a handle and a set of jaws. The logo is simple and professional, and it is likely used to represent the company's brand and identity.
| EMT and EMC testing was conducted on the subject device. The test resultsconfirm the subject device conforms with EMT safety and EMC standards. | |
|---|---|
| Software testing was conducted and documentation was provided in thissubmission. The test results confirm the Arthrex software updates met productrequirements and design specifications established for the device. | |
| TechnologicalComparison | The Arthrex NanoScope System and predicate devices have the same intendeduse and the same or similar indications for use and technological characteristics(i.e., principle of operation, accessories and system components, basic softwaredesign, cleaning and reprocessing requirements, wireless technology,electrical/thermal safety, and electromagnetic compatibility). |
| Conclusion | All verification activities were successfully completed to confirm the subjectdevice meets product requirements and design specifications established for thedevice. |
| The Arthrex NanoScope System did not require animal testing or human clinicalstudies to support the determination of substantial equivalence. | |
| Based on the same intended use and the same or similar indications for use andtechnological characteristics, and successful completion of non-clinical benchtesting and software testing, the Arthrex NanoScope System is as safe and aseffective as the legally marketed predicate devices. Any differences between thesubject device and predicate devices are considered minor and do not raisedifferent questions concerning safety and effectiveness. |
§ 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.