The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.

AI/ML Overview

The provided text is a 510(k) summary for the ConMed Linvatec 300W Xenon Light Source. It does not contain any information about acceptance criteria, study data, or performance metrics for an AI/ML device or any device that would be subject to such detailed performance studies.

The document describes a conventional medical device (a light source for endoscopic procedures) and establishes its substantial equivalence to previously marketed devices (predicates). Therefore, I cannot fulfill the request to provide information about acceptance criteria, study details, and performance metrics as if it were an AI/ML device.

Here's why and what information is available in the document:

Why the requested information cannot be provided from this text:

Nature of the Device: The device is a "ConMed Linvatec 300W Xenon Light Source," which is a light-generating device used during endoscopic procedures. It is not an AI/ML diagnostic or prognostic tool.
Regulatory Pathway: The submission is a 510(k) for substantial equivalence to predicate devices, not a de novo or PMA submission that would typically require extensive clinical performance studies to establish safety and effectiveness for a novel AI/ML application.
Content: The document focuses on device description, intended use, and comparison to predicates based on design, technology, and intended use, rather than specific performance metrics against an established ground truth.

Information that is available (and relevant to the prompt, if it were an AI/ML device):

Acceptance Criteria and Reported Device Performance:
- NO INFORMATION PROVIDED. For a traditional medical device like a light source, acceptance criteria typically relate to functional performance (e.g., light intensity, color temperature, safety features, durability) based on internal testing and compliance with recognized standards, not clinical performance metrics like sensitivity or specificity. No such performance data or acceptance criteria are detailed in this 510(k) summary.
Sample sized used for the test set and the data provenance:
- NO INFORMATION PROVIDED. There's no test set described for evaluating performance in the context of AI/ML or even clinical performance. The focus is on substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- NO INFORMATION PROVIDED. Ground truth establishment is not relevant for this type of device and regulatory submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- NO INFORMATION PROVIDED. Not applicable.
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:
- NO INFORMATION PROVIDED. Not applicable. This device does not involve human readers interpreting data with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NO INFORMATION PROVIDED. Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- NO INFORMATION PROVIDED. Not applicable.
The sample size for the training set:
- NO INFORMATION PROVIDED. Not applicable. There's no AI/ML algorithm involved that would require a training set.
How the ground truth for the training set was established:
- NO INFORMATION PROVIDED. Not applicable.

Summary of Device in the Provided Text:

Device Name: ConMed Linvatec 300W Xenon Light Source
Intended Use: To be used with an endoscope to provide illumination during endoscopic procedures.
Regulatory Class: Class II
Predicate Devices:
- Linvatec Corporation Xenon 300W Light Source (K031994)
- Karl Storz Endoscopy Xenon 300W Light Source (K962595)
Substantial Equivalence: Claimed based on similar design, technology, and intended use to the predicate devices, with "minor differences" that "raise no new questions of safety and effectiveness."

In conclusion, the provided text describes a conventional medical device applying for 510(k) clearance via substantial equivalence, and therefore does not contain the detailed performance study information typically associated with AI/ML devices.

Summary

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AUG 2 0 2007

Device Name 510(k) # Ko 7 0376 Date Page 1 of 2

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 300W Xenon Light Source, 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Submitter A.

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

B. Company Contact

Elizabeth M. Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name: ConMed Linvatec 300W Xenon Light Source Light Source Common Name:

↓

Classification Name: Endoscope and accessories

Classification Number: 21 CFR 876.1500

Proposed Class: Class II

GCT Product Code:

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Summary of Safety and Effectiveness Device Name 510(k) # Ko703 76 Date Page 2 of 2

D. Predicate/Legally Marketed Devices

Linvatec Corporation Xenon 300W Light Source 510(k) #K031994

Karl Storz Endoscopy Xenon 300W Light Source 510(k) #K962595

ші Device Description

The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.

ட் Intended Use

The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

G. Substantial Equivalence

The ConMed Linvatec 300W Xenon Light Source described in this notification is similar in design, technology and intended use to the Linvatec Corporation 300 Xenon Light Source (K031994) and the Karl Storz Endoscopy Xenon 300W Light Source (K962595).

The differences between the ConMed Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, the Linvatec 300W Xenon Light Source is substantially equivalent to the predicate devices currently on the market.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, represented by three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 2 0 2007

Ms. Elizabeth M. Paul Manager, Regulatory Affairs ConMed™ Linvatec 11311 Concept Boulevard LARGO FL 33773-4908

Re: K070376

Trade/Device Name: ConMed Linvatec 300W Xenon Light Source Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: July 17, 2007 Received: July 19, 2007

Dear Ms. Paul:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, sans-serif font. There are three stars below the word "Centennial". The text around the circle reads "U.S. Department of Health and Human Services".

noting Public J

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I 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 CI It Fart 607), adomig (DS) regulation (21 CFR Part 820); and if applicable, the electronic for at the quality by ovisions (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) I mis letter with a son finding of substantial equivalence of your device to a legally prematicated predicated 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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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/cdrlv/industry/support/index.html.

Sincerely vours,

Nancy C Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K 670376 510(k) Number (if known):

ConMed Linvatec 300W Xenon Light Source Device Name:

Indications For Use:

The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart'C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign. ate)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number.

Page 1 of

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.