The 5mm x 300mm Images Endoscope (REF. 7205XXX) is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Device Description

The Smith & Nephew Images 5mm x 300mm Endoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a series of optical lenses and prisms. The endoscope allows it to gain access to the surgical site.

AI/ML Overview

This is a 510(k) summary for an endoscope, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device's performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not applicable to this document.

The document describes a medical device, the Smith & Nephew Images 5mm x 300mm Endoscope, and asserts its substantial equivalence to a predicate device (Karl Storz Endoscopy Telescope). The basis for clearance is this substantial equivalence, not a performance study against specific acceptance criteria for AI algorithms.

However, I can extract the following information that is somewhat related to "acceptance criteria" in a general sense within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance (as defined by 510(k) substantial equivalence):

Acceptance Criteria (for 510(k))	Reported Device Performance (Smith & Nephew Images 5mm x 300mm Endoscope)
Substantial Equivalence in Design:	Substantially equivalent in design to the Karl Storz Endoscopy 5mm x 300mm Telescope.
Substantial Equivalence in Materials:	Substantially equivalent in materials to the Karl Storz Endoscopy 5mm x 300mm Telescope.
Substantial Equivalence in Function:	Substantially equivalent in function to the Karl Storz Endoscopy 5mm x 300mm Telescope. Transfers light and allows visualization of the surgical site.
Substantial Equivalence in Intended Use:	Substantially equivalent in intended use to the Karl Storz Endoscopy 5mm x 300mm Telescope. Indicated for endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization for decission, ligation, and harvesting of vessels.
Raises no new questions of safety and effectiveness:	Does not raise new questions of safety and effectiveness compared to the predicate.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device with a "test set" in the analytical sense for algorithm performance. Substantial equivalence is demonstrated through comparison of specifications and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an endoscope, not an AI assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used: For a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is generally established by comparison to an existing legally marketed predicate device's established safety and effectiveness profile, often through engineering specifications, material composition, functional tests (if applicable to the device type, e.g., sterility, biocompatibility), and clinical indications. The document mainly focuses on comparative characteristics rather than specific "ground truth" data for performance in a diagnostic sense.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

{0}------------------------------------------------

AUG 1 2 1997

11850

510(k) Summary

Smith & Nephew, Inc., Endoscopy Division Images 5mm x 300mm Endoscope

Substantial Equivalence:

The Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in design, materials, function, and intended use to the 5mm x 300mm telescope offered by Karl Storz Endoscopy as part of the KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities.

Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities.

Summary of Device Function:

Intended Use of Device:

The 5mm x 300mm Images Endoscope is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in materials, design and function to the Karl Storz Endoscopy 5mm x 300mm Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities and raises of safety and effectiveness.

Delores J. Conners

Deborah J. Connors Regulatory Affairs Specialist

Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599

Smith - Nephew

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah J. Connors Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810

AUG 1 2 1997

Re: K971850

Trade Name: Images Endoscopes and Accessories Regulatory Class: II Product Code: GCJ Dated: May 19, 1997 Received: May 20, 1997

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Deborah J. Connors

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number :

Device Name : Smith & Nephew, Inc., Endoscopy Division Images Endoscopes

Indications for Use :

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109)

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

lecoell
(Division Sign-Off)

(Division Sign-off)
Division or General Restorative Devices
510(k) Number K971850

Regulation Number and Section

§ 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.