This document is a 510(k) summary for a Xenon Light Source Model LS 6000 and the FDA's response. It is a declaration of substantial equivalence to already marketed devices, not a study proving the device meets specific acceptance criteria in the way a medical AI or diagnostic device would.

Therefore, many of the requested points are not applicable to this type of submission. This 510(k) relies on the existing safety and effectiveness of predicate devices rather than a new standalone study with performance metrics.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices:	The device is substantially equivalent to legally marketed devices such as the Richard Wolf Model 5141 (K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561), and the Linvatec Model 8430.
Design: Designed the same as predicate devices.	"Each Xenon Light Source is designed the same."
Specifications: Meets the same specifications as predicate devices.	"...meets the same specifications..."
Intended Use: Same indication as predicate devices.	"...and its indication is the same."
Technological Characteristics: No significant difference in technological characteristics compared to existing devices.	"There is no significant technological characteristics of the Model LS 6000 compared to existing, legally marketed devices..."
Lamp Wattage (Distinguishing Feature): Uses a 100-Watt Xenon lamp.	"The lamp utilized with the LS 6000 is a 100 Watt lamp." (This is noted as the only difference to predicates, implying meeting other criteria makes this acceptable.)

2. Sample Size Used for the Test Set and Data Provenance

Sample size: N/A. This is a 510(k) submission asserting substantial equivalence based on device characteristics, not a clinical study with a test set of data.
Data provenance: N/A.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. Ground truth establishment for a test set is not relevant for this 510(k) submission.

4. Adjudication Method for the Test Set

N/A.

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

N/A. This device is a light source for endoscopy, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an algorithm.

7. The type of ground truth used

N/A. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices through their prior 510(k) clearances or pre-amendments status.

8. The sample size for the training set

N/A. This is not a machine learning model.

9. How the ground truth for the training set was established

N/A.

Summary

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JUL 2 4 1998

K981804

P 101

CONTEC MEDICAL/Austin & Associates, Inc.

Phone 410/877-3269/Fax 410/877-0544 1109 Sturbridge Road Fallston, Maryland 21047

510(k) SUMMARY

The enclosed is a Summary of our 510(k) Submission of a Xenon Light Source which is substantially equivalent to many current and legally marketed devices.

TRADE NAME:

Xenon Light Source Model LS 6000

CLASSIFICATION NAME:

Light Source, Endoscope, Xenon Arc

EQUIVALENCE:

The Xenon Light Source Model LS 6000 is substantially equivalent to current and legally marketed devices. Examples are enclosed and include the Richard Wolf Model 5141(K944821), Model 5135 (K944607), the Karl Storz Model 201315-20 (K954561) and the Linvatec Model 8430 (enclosed brochure information).

Each Xenon Light Source is designed the same, meets the same specifications and its indication is the same. The only difference between each model is the Watt of the light source lamp.

DESCRIPTION:

The Model LS 6000 is an electronic light source using a 100Watt Xenon lamp, to provide light for endoscopic procedures.

INTENDED USE:

The Model LS 6000 Xenon Light Source is intended for use in endoscopic applications.

CHARACTERISTICS:

There is no significant technological characteristics of the Model LS 6000 compared to existing, legally marketed devices of which examples are listed (Equivalence Section above). The lamp utilized with the LS 6000 is a 100 Watt lamp.

Summary Prepared by:

Allan West

Summary Prepared On:

5/20/98

Albert Austin Manager/Sales and Quality Assurance CONTEC Medical/Austin & Associates, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 24 1998

Contec Medical Ltd. c/o Mr. Albert Austin Austin & Associates, Inc. 1109 Sturbridge Road Fallston, MD 21047

Re: K981804 Xenon Light Source Dated: May 20, 1998 Received: May 21, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 GCT and 78 FCW

Dear Mr. Austin:

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 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 (30) ) 594-4613. 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/dsmallsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Xenon Light Source, Model LS6000 Device Name:

ﮧ

Indications For Use:

The Xenon Light Source Model LS6000 is designed to supply light for endoscopic diagnostic observation and surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roler R. Ratting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1981804 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

. ミ

(Optional Format 1-2-96)

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.