The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.

Device Description

The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ENDOLIGHT LED Light Source. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study that proves the device meets specific performance thresholds in a clinical or AI-assisted context.

Therefore, many of the requested categories cannot be answered from the provided document. This document describes a medical device rather than an AI/ML powered device.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not present a table of specific quantitative acceptance criteria alongside reported performance data. Instead, it states that "Design verification testing demonstrates that the devices function as intended" and lists adherence to voluntary safety and performance standards.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Functionality	Device functions as intended.	"Design verification testing demonstrates that the devices function as intended..."
Safety - Electromagnetic Compatibility	Conforms to IEC 60601-1-2 Edition 3:2007-03.	"The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-1-2..."
Safety - General Requirements	Conforms to IEC 60601-1, Medical Electrical Equipment Part 1.	"The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-1..."
Safety - Endoscopic Equipment	Conforms to IEC 60601-2-18:1996, Amendment 1 2000.	"The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-2-18..."
Safety & Effectiveness (General)	No new issues of safety and effectiveness raised.	"...performance did not raise any new issues of safety and effectiveness..."
User Training	Formal user training not required.	"...formal user training is not required."

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

Not applicable. The document describes a traditional medical device (LED light source), not an AI/ML-powered device that would typically involve test sets of data for performance evaluation. The "testing" mentioned refers to design verification and adherence to electrical safety standards.

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

Not applicable. Ground truth and expert consensus are relevant for AI/ML-powered diagnostic or interpretive devices, which this is not. The "ground truth" for this device would be its physical properties and adherence to engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method as it relates to evaluating data for an AI/ML-powered device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI/ML algorithm. The device stands alone as a light source.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for its performance is established by engineering specifications, international safety standards (e.g., IEC standards for medical electrical equipment), and functional design verification tests. The document explicitly states "Design verification testing demonstrates that the devices function as intended" and lists conformity to specific IEC safety standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML-powered device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

In summary: The provided document is for a traditional medical device (an LED light source) and outlines its substantial equivalence to predicate devices based on technological characteristics and adherence to established safety standards. It does not involve AI/ML technology, and therefore, many of the requested categories related to AI/ML performance evaluation (such as test sets, ground truth establishment by experts, adjudication, and clinical effectiveness studies with AI) are not applicable.

Summary

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K12 / 72 4
Revision 08-21-2012

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510(k) Summary

Submitter:
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Division name (if applicable):	N.A.
Street address:	353 Corporate Woods Parkway
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
Contact name:	Mr. Ron Haselhorst
Contact title:	Quality Assurance / Regulatory Affairs Manager
Date of Preparation:	June 08, 2012
FDA establishment registration number:	14 184 79
Phone number (include area code):	( 847 ) 913 1113
FAX number (include area code):	( 847 ) 913 0924
ZIP / Postal Code:	60061
Parent Company:
Company / Institution name:	Richard Wolf GmbH
FDA establishment registration number:	96 111 02
Street address:	Pforzheimer Str. 32
City:	Knittlingen
State/Province:	Baden-Württemberg
Country:	Germany
ZIP / Postal Code:	75438
Product Information:
Trade name:	5160 ENDOLIGHT LED Light Source
Model numbers:	5160XXX
Common name:	LED Light Source
Classification name:	FCW - Light Source, Fiber Optic, RoutineNTN - LED Light Source
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K983628	1 Auto LP 5123 Xenon Light Projector (Product Code GCT)	1 Richard Wolf Medical Inst. Corp.
2 K082813	2 Stryker LED Light Source (Product Code FCW)	2 Stryker Endoscopy
3 K102167	3 LO-50 LED Light Source (Product Code FCW, NTN)	3 Fiberoptics Technology, Inc

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K12/724
Revision 08-21-2012

Device Description:

ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing.

ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices.

This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

Intended Use:

Technological Characteristics:

The ENDOLIGHT LED Light Sources 1.1 and 1.2 are technologically similar to predicate device found in this submission in that all/some of the devices:

Use fiber optic cables and scopes to transmit the light from the source to the site of the l medical procedure
Use an identical technology ie, an LED lamp to produce light while others use an equivalent | source such as a xenon or halogen lamp.
. I Utilize similar manual controls to set the light brightness
Have similar illumination and quality of light -
Operate within an equivalent temperature range -
Can utilize a number of commonly available fiber optic cables ー
ENDOLIGHT LED 1.2 has a light cable detection feature which shuts the unit off the LED l lamp when the fiber optic cable is detached reducing the chance of unit overheating.

The ENDOLIGHT LED Light Sources are technologically different to predicate devices found in this submission in that:

ENDOLIGHT LED 1.2 utilizes a "Safe Start"™ function which after a power interruption of more than five seconds and less then thirty seconds the LED lamp is shut off but retains nominal brightness setting. After thirty seconds the LED lamp is shut off and brightness is reset to 50%.

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Performance Data:

Design verification testing demonstrates that the devices function as intended, and the performance did not raise any new issues of safety and effectiveness, and that formal user training is not required.

Voluntary Safety and Performance Standards: The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards:

IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (General)
IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
IEC 60601-2-18:1996, Amendment 1 2000 Medical electrical equipment Part 2: Particular A requirements for the safety of endoscopic equipment. (Dental/ENT)

Testing was completed by Independent laboratories, certifications are on file.

Clinical Data:

No clinical tests performed.

Rational for Substantial Equivalence:

The Richard Wolf ENDOLIGHT LED Light Source shares the same general indications for use, has similar function features and technological characteristics as the predicate devices, the minor difference(s) do not raise new questions for safety or effectiveness.

The Richard Wolf ENDOLIGHT LED Light Sources were non-clinically tested to determine the safety and efficacy under the indications for use and meet aforementioned safety standards, same as the predicate devices.

For these reasons, the Richard Wolf ENDOLIGHT LED Light Source is substantially equivalent to the existing 510(k) cleared devices sold by: Richard Wolf Medical Instruments Corporation (K983628), Stryker Endoscopy (K082813), and Fiberoptics Technology, Inc (K102167).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ron Haselhorst
Quality Assurance / Regulatory Affairs Manager
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
VERNON HILLS IL 60061

Re: K121724

Trade/Device Name: ENDOLIGHT LED Light Source Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCW, NTN Dated: August 22, 2012 Received: August 27, 2012

Dear Mr. Haselhorst:

We have reviewed your Section 5.10(k) premarket notification of intent to market the indication We have reviewed your Section 3.10(x) promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans ment date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the enacifican with the provisions of the Federal Food. Drug, devices that have been reclasined in accerative approval of a premarket approval application (PMA).).).). and Cosment Act (Act) that to hot require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, buyer to many for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note. CDNT does not overaliate international and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (SCC above) in Exting major regulations affecting your device can be
it may be subject to additional controls. Extracts of an edition, FDA may it may be subject to additional controls. Externs mayor solo to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of I eactar resguinting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualite of a but device with other requirements of the Act
that FDA has made a determination that your device of the Force agencies. You must that FDA has made a decommancin as administered by other Federal agencies. You must or any Pederal Statutes and regulations and not limited to: registration and listing comply with an the Act s requirements, mortains, common
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical

SEP 2 0 2012

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse ovents) (21 CFR Part 820); and if applicable, the electronic form in the quality by selling (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice for your do need on our more offices/ucm115809.htm for go to intp://www.idd.gov/rtladiological Health's (CDRH's) Office of Compliance. Also, please the Center for Deviocs and Radiotoground by reference to premarket notification" (21CFR Part note the regulation onlined, "informations" - " - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may ovan other general mistmational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

K121724 510(k) Number (if known):

Device Name: ENDOLIGHT LED Light Source

Intended Use:

The ENDOLIGHT LED Light Source Projector is intended to be used to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.

Prescription use S (Part 21 CFR 801 Subpart D) and / or

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

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

Concurrence of CDHR office of Device Evaluation (ODE)

Aoy M. Whan

ductive, Gastro-R

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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.