(114 days)
Not Found
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/test sets for algorithmic performance.
No.
The device is an endoscopic video camera system that provides image processing and digital documentation for various surgical procedures; it does not explicitly state that it treats or prevents a disease or condition.
No
The device is described as an endoscopic video camera for surgical procedures that provides image processing and digital documentation. Its intended use is to assist in viewing during surgical procedures, not to diagnose conditions.
No
The device description explicitly states that the system comprises a camera control unit (CCU) and a handpiece with a fiber optic bundle and camera sensor, indicating hardware components are included.
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 an endoscopic video camera for surgical procedures. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description focuses on capturing and processing images during surgery, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
The device is a surgical imaging system, not a diagnostic test performed on biological specimens.
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 surgical procedures, including but not limited to: orthopedic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
Product codes
GCJ
Device Description
The Arthrex NanoScope System provides image processing and digital documentation for endoscopic procedures. The system comprises a camera control unit (CCU) and a handpiece that 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
Not Found
Anatomical Site
Not Found
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)
Bench testing was performed to demonstrate equivalence to the predicate regarding environmental conditions, power requirements, image capture, and video output and resolution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K153218 – Arthrex Synergy UHD4 System
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 5, 2019
Arthrex Inc. Heli Chambi Infantas Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190645
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: May 24, 2019 Received: May 29, 2019
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.
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
1
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.
Jennifer R. Stevenson, MBE Acting 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
Indications for Use
510(k) Number (if known) K190645
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 surgical procedures, including but not limited to: orthopedic, urologic, sinuscopic, 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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3
510(k) Summary
| Date Prepared | March 12, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Heli F Chambi Infantas |
| Senior 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 |
| Classification Name | 21 CFR 876-1500: Endoscope and accessories |
| Regulatory Class | II |
| Predicate Device | K153218 – Arthrex Synergy UHD4 System |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex NanoScope System as a line extension to the Arthrex Synergy UHD4 System | |
| cleared under K153218. | |
| Device Description | The Arthrex NanoScope System provides image processing and digital documentation |
| for endoscopic procedures. The system comprises a camera control unit (CCU) and a | |
| handpiece that 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 surgical procedures, including but not limited to: | |
| orthopedic, 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 device in |
| which the basic design features and intended use are the same. Any differences | |
| between the Arthrex NanoScope System and the predicates are considered minor | |
| and do not raised questions concerning safety and effectiveness. | |
| There are no significant differences between the new device and predicate that raise | |
| issue of safety or effectiveness. Bench testing was performed to demonstrate | |
| equivalence to the predicate regarding environmental conditions, power | |
| requirements, image capture, and video output and resolution. | |
| Conclusion | 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. |