(129 days)
No
The summary mentions "image processing" but does not contain any keywords or descriptions indicative of AI/ML, such as "artificial intelligence," "machine learning," "deep learning," "neural network," or descriptions of training/testing data sets for algorithmic performance.
No
The device is described as an endoscopic video camera system for diagnostic and surgical procedures, providing image processing and documentation. It is not intended to directly treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "endoscopic diagnostic and surgical procedures," indicating its use in diagnosis.
No
The device description explicitly mentions a "handpiece" with a "fiber optic bundle surrounding a high-resolution camera sensor," indicating the presence of hardware components beyond just software.
Based on the provided information, the Arthrex NanoScope system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for endoscopic video in various surgical and diagnostic procedures. This involves visualizing internal structures in vivo (within the living body).
- Device Description: The description focuses on image processing and digital documentation of endoscopic procedures, again related to in vivo visualization.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The Arthrex NanoScope does not perform this function.
The Arthrex NanoScope is an endoscopic imaging system used during surgical and diagnostic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ, HRX
Device Description
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.
Mentions image processing
The Arthrex NanoScope System provides image processing and digital documentation for endoscopic procedures.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video camera
Anatomical Site
orthopedic, spine, laparoscopic, urologic, sinuscopic, and plastic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue.
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Prepared | September 4, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Heli F Chambi Infantas |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 71263 | |
| Heli.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 System |
| K180766 – Endiscope Cervical | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to add spine as an additional |
| anatomical location for the Arthrex NanoScope System indications for use. This 510K is | |
| also submitted to extend the shelf life of the product sterile component from 6 to 18 | |
| months and to present labeling changes for storage conditions. | |
| Device Description | 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. | |
| Indications for Use | 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. | |
| Substantial Equivalence | |
| Summary | The Arthrex NanoScope System is substantially equivalent to the predicate devices in |
| which the basic design features and intended users are the same. | |
| 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. |
| | Accordingly, Arthrex believes that the Arthrex NanoScope System is substantially
equivalent to its original K190645 clearance and to the Elliquence Endiscope Cervical
system cleared under K180299. |
| Conclusion | The proposed Arthrex NanoScope System is substantially equivalent to the predicate
device in which the basic design feature and intended use are the same. The visualization
for the intraoperative site during spinal endoscopic procedures and minimally invasive
surgery does not deviate from the current endoscopic visualization intended use and
application originally cleared under K190645.
Any differences between the proposed device and the predicate device are considered
minor and do not raise questions concerning safety or effectiveness.
Based on the indications for use, technological characteristics, and the summary of data
submitted, Arthrex Inc. has determined that the proposed device is substantially
equivalent to the currently marketed predicate device. |