The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Device Description

The Pentax Confocal Laser System (software controlled device) is intended for use as a required accessory with Pentax video endoscope system that are equipped with confocal imaging module. The confocal laser system includes a laser light source, system computer. A video endoscope equipped with a confocal imaging module is connected to a conventional video endoscope system that will present the video endoscopic image. The endoscope is connected to the confocal system laser light source. The endoscope confocal imaging module contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitry to transmit/ receive the light signals the endoscope confocal imaging module. The detected signal is sent to the system computer processes the confocal image information for display on the system monitor, controls the laser light source, and acts as an image storage device for still frame images.

AI/ML Overview

The provided text describes the Pentax Confocal Laser System and its 510(k) submission, not a study involving acceptance criteria and device performance data. Therefore, I cannot extract the requested information.

The document states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that no performance study was conducted to establish acceptance criteria or demonstrate device performance as per your request.

The information provided only covers:

Submitting company and device name
Classification and predicate device information
Device description
Intended use
A letter from the FDA indicating substantial equivalence based on the provided information, but explicitly stating it was not based on clinical performance data.

Summary

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510(k )Summary Pentax Confocal Laser System

Submitter Information:

Pentax Medical Company 102 Chestnut Ridge Road Montvale, New Jersey 07645-1856 Tel: (201)-391-0932

Name Of Device:

Trade Name:	Pentax Confocal Laser System
Classification Name:	Endoscope and Accessories (78KOG) {876.1500} [Class II]

Predicated Device(s) Information:

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Device Description:

The Pentax Confocal Laser System (software controlled device) is intended for use as a required accessory with Pentax video endoscope system that are equipped with confocal imaging module. The confocal laser system includes a laser light source, system computer. A video endoscope equipped with a confocal imaging module is connected to a conventional video endoscope system that will present the video endoscopic image. The endoscope is connected to the confocal system laser light source. The endoscope confocal imaging module contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitry to transmit/ receive the light signals the endoscope confocal imaging module. The detected signal is sent to the system computer processes the confocalimage information for display on the system monitor, controls the laser light source, and acts as an image storage device for still frame images.

Intended Use:

Comparison To Predicated Device(s):

The submission for substantial equivalence included Pentax Confocal laser system literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.

Prepared By:

Paul Silva

Paul Silva, Regulatory Affairs Coordinator

Control Number: PS-726.ConfocalSys.510KS page 1 of 1

09-09-2004

Date

Revision: a

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Pentax Medical Company c/o Mr. Tamas Borsai Division Manager, Medical Division, and Program Manager, Third Party Review Program TÜV Rheinland of North America 12 Commerce Road Newtown, Connecticut 06470

Re: K042740

Trade/Device Name: ISC-1000 Confocal Laser System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, KOG Dated: September 30, 2004 Received: October 4, 2004

Dear Mr. Borsai:

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 - Mr. Tamas Borsai

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

for Miriam C. Provost

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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Intended Use Statement:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost
(Division Sign Off)

(Divi Division of General, Restorative, and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number K642740

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.