The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.

Device Description

The Truphatek Tru-Cable™ endoscopic fiber optic cables are:

. Lengths of 10 feet (3.5m)
Diameters 3.5mm and 5.0mm .
The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods.
The cables are sold non-sterile. .
The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the Tru-Cable™ endoscopic fiber optic cables. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This device is a physical medical instrument (fiber optic cable), not an AI/software device. The 510(k) summary provided is for a traditional medical device submission, which typically focuses on bench testing, biocompatibility, sterilization validation, and comparison to legally marketed predicate devices, rather than performance metrics typically associated with AI/ML diagnostic or prognostic tools.

Summary

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510(k) Summary Non-Confidential Summary of Safety and Effectiveness

10-Jan-07

Truphatek International Ltd.Park Poleg-C, Sapir Industrial Zone	Tel - 011-972-9-885-1155
Netanya, 42504 ISRAEL	Fax - 011-972-9-885-1212
Official Contact:	David Grey, CEO
Proprietary or Trade Name:	Tru-Cable™ endoscopic fiber optic cables
Common/Usual Name:	Fiber optic cables for endoscopes
Classification Name:	Illuminator, fiberoptic for endoscopesEndoscope and / or accessories
Device:	Tru-Cable™
Predicate Devices:	Cogent - Micro Link - K001698Sovis Optique - K023633

Device Description:

The Truphatek Tru-Cable™ endoscopic fiber optic cables are:

. Lengths of 10 feet (3.5m)
Diameters 3.5mm and 5.0mm .
The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods.
The cables are sold non-sterile. .

The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.

Indications for Use --

Differences between Other Legally Marketed Predicate Devices

The Tru-Cable™ endoscopic fiber optic cables are viewed as substantially equivalent to the predicate devices - K001698 and K023633.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Truphatek International, Ltd. % Promedic, Inc. Mr. Paul E. Dryden President 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134-0354

JAN 1 2 2007

Re: K063309

Trade/Device Name: Tru-Cable™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FFS Dated: December 28, 2006 Received: December 29, 2006

Dear Mr. Dryden:

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

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Page 2 – Mr. Paul E. Dryden

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K063309 (To be assigned)

Device Name: Tru-Cable™

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign= Division of General, Restorative, and Neurological Devices

510(k) Number L063305

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.