Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.

Device Description

Sovis Optique's endoscopic light cable consists of two metal end fittings connected by a glass fiber bundle and a silicone sheath covering. The sheath is reinforced with a stainless steel spring. The protruding optical end is made from an independent piece of glass bonded to a stainless steel support for ease of replacement.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (endoscopic light cable). It asserts substantial equivalence to a predicate device based on similar intended use, target population, environment of use, design, and materials.

However, the provided document does not contain information about:

Specific acceptance criteria, performance metrics, or a formal study proving the device meets those criteria.
Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
The type of ground truth used in such studies.
Sample size for training sets or how ground truth for training sets was established.

The summary discusses two minor differences between the proposed and predicate device:

Reinforced sheath: The summary claims the reinforcement is molded into the silicone and does not contact human tissues. It also states that "biocompatibility tests performed on the material, the silicone that may potentially contact patients poses no additional safety issues."
Independent glass rod at the source end: The summary states "The rod is made from the same components as CUDA or UFR product (i.e., glass, epoxy glue and stainless steel). There is thus no significant adverse effect on safety."

These statements suggest that some form of testing or evaluation was performed for biocompatibility, but details of these tests, their acceptance criteria, or their results are not explicitly provided in the text you've given.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving their fulfillment as the necessary information is not present in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence, not on detailed performance study results against specific acceptance criteria.

Summary

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ATTACHMENT 7

KO23633

DEC 31 2002

510(K) SUMMARY

(As required by 21 C.F.R. §§ 807.87(h), 807.92)

1. Manufacturer
  SOVIS OPTIQUE B.P. 1-77260 La Ferte-Sous 77640 Jouarre France
1. Contact Person
  Hugues Tariel Marketing Manager Saint-Gobain, parent company of Sovis Optique Phone: +33 (0)1 64 36 30 58 Fax: +33 (0)1 60 22 79 67 Mobile: +33 (0)6 80 99 93 42 hugues.tariel(@saint-gobain.com
1. Device
- 1. Trade or Proprietary Name: None
- 1. Common Name: Endoscopic light cable (accessory to endoscope)
- 1. Classification/Product Code: II FST
1. Intended Use

Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It is designed to be adjustable to major manufacturers' equipment.

న. Predicate Devices
Sovis Optique's endoscopic light cable is substantially equivalent to Universal Fiberoptic Repair's UFR Fiberoptic Light Cable (K972225).

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Device Description 6.

1. Summary of Technological Characteristics
  The SOVIS universal fiber optic cable is substantially equivalent to the predicate device for the following reasons:
They have the same intended use.
They have the same indicated target population.
트 They have the same environment of use.
트 They have the same or similar design.
They are made of similar materials.

The minor differences between SOVIS Optique cable and the UFR Cable are as follows:

The Sovis cable has a reinforced sheath. The reinforcement is molded into the silicone, and therefore has no chance to get into contact with human tissues. As demonstrated by the results of the biocompatibility tests performed on the material, the silicone that may potentially contact patients poses no additional safety issues.
미 The Sovis cable has an independent glass rod at the source end. The rod is made from the same components as CUDA or UFR product (i.e., glass, epoxy glue and stainless steel). There is thus no significant adverse effect on safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2002

Sovis Optique c/o Frances K. Wu Hyman, Phelps & McNamara 700 Thirteenth Street, NW, Suite 1200 Washington, D.C. 20005

Re: K023633

Trade/Device Name: Sovis Optique's Endoscopic Cable Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulation Class: II Product Code: FFS Dated: October 29, 2002 Received: October 29, 2002

Dear Ms. Wu:

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. 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 (PMA), 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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 -- Ms. Frances K. Wu

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Pierret

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

Enclosure

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ATTACHMENT 9

INDICATIONS FOR USE STATEMENT

510(k) Number: K_023633

Device Name: Endoscopic light cable

Indications for Use: Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Priest

ivision Sign-Off) Division of General, Restorative and Neurological Devices

Number KC23633

Prescription Use
(Per 21 C.F.R. § 801.109)

Over-the-Counter Use

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.