The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical procedures.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for a medical device, the KARL STORZ Power LED 175. It outlines the device description, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not explicitly contain a formal "acceptance criteria" table with corresponding "reported device performance" data in the manner typically found in a detailed clinical or performance study report.

Instead, the document states that "performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6" and that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." It also mentions software verification. These statements indicate that testing was performed to verify the device's functionality and safety, but the specifics of the acceptance criteria and the detailed results are not provided within this summary for public consumption. The "Comparative Bench Testing" enclosure would contain the detailed information.

Given the information available:

Table of acceptance criteria and the reported device performance:
The document does not explicitly provide a table titled "acceptance criteria" and "reported device performance" with specific numerical values for metrics like light intensity, color temperature stability, etc. It broadly states that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." The "Technological Characteristics" table compares the Power LED 175 to its predicate devices, showing:

Parameter Power LED 175 (Subject Device) LED NOVA 100 (Predicate Device) 300 Watt Xenon (Predicate Device)
Lamp Type LED LED Xenon
Color Temperature 6500 K 5600 K 6000 K

The implication is that the Power LED 175's performance (e.g., light output, color temperature) is deemed acceptable if it is comparable to or better than the predicate devices and meets design specifications. However, the specific quantitative acceptance criteria and the exact measured performance values are not detailed in this summary.
Sample size used for the test set and the data provenance:
The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Comparative Bench Testing" and "Design Verification Testing (DVT)," which are typically internal engineering and validation tests rather than clinical studies with human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The testing described is technical "performance testing" and "design verification testing" of a light source, not a diagnostic device requiring expert interpretation of results to establish ground truth.
Adjudication method for the test set:
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies where multiple human readers assess cases, typically for diagnostic accuracy. The testing described focuses on the device's technical performance.
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:
No MRMC study was done, and this information is not applicable. The device is a light source, not an AI-powered diagnostic tool, and the submission does not involve human-in-the-loop performance evaluation in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a medical light source, not a standalone algorithm.
The type of ground truth used:
For the "performance testing" and "design verification testing," the ground truth would be based on engineering specifications, established measurement standards, and comparison to the performance characteristics of the predicate devices. For example, light output would be measured against a specified lumen or candela output, and color temperature against a CCT (Correlated Color Temperature) value.
The sample size for the training set:
This information is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.
How the ground truth for the training set was established:
This information is not applicable as there is no training set mentioned.

Parameter	Power LED 175 (Subject Device)	LED NOVA 100 (Predicate Device)	300 Watt Xenon (Predicate Device)
Lamp Type	LED	LED	Xenon
Color Temperature	6500 K	5600 K	6000 K

Summary

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K123956

510(K) Summary of Safety and Effectiveness

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JAN 2 5 2013

Submitter:	KARL STORZ Endoscopy America Inc.
Date of Preparation:	January 16, 2013
Sponsor Company Name:	KARL STORZ Endoscopy America Inc. (KSEA)
Phone Number:	(424) 218 8322
Street Address:	2151 East Grand Avenue
Fax Number:	(424) 218 8519
City:	El Segundo
State:	California
Country:	USA
Zip Code:	90245
Contact Name:	Shiven Gandhi
Contact Tittle:	Regulatory Affairs Associate
Email Address:	shiven.gandhi@karlstorz.com

Manufacturing Company Name:	Karl Storz GmbH & Co. KG
Street Address:	Mittelstrasse 8
City:	Tuttlingen
State/Province:	Baden-Wurttemburg
Country:	Germany
Zip Code:	78532

Trade Name:	Power LED 175
Model Number:	20161420-1
Common Name:	LED Light source
Classification Name:	FCW - Light Source, Fiber Optic, RoutineNTN - LED Light Source

Information about devices to which Substantial Equivalence is claimed:

510 (K) Number	Trade/ Proprietary Name/Model Number	Manufacturer/
K091968	LED NOVA 100 Cold Light Fountain	Karl Storz GmbH & Co. KG
K962595	300 Watt Xenon Light Source	Karl Storz GmbH & Co. KG

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Introduction:

Device Trade Name: Common Name: Classification Name: Regulation Number: Product Code:

Power LED 175 Light source, Fiber Optic, Routine Endoscope and accessories 21 CFR 876.1500 FCW, NTN

Device Description:

Indication for Use

Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.

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Technological Characteristics:

Parameter	Power LED 175Cold Light Fountain(Subject Device)	LED NOVA 100Cold Light Fountain(Predicate Device)	300 Watt XenonLight Source(Predicate Device)
Applicant	KARL STORZEndoscopy AmericaInc.	KARL STORZEndoscopy AmericaInc.	KARL STORZEndoscopy AmericaInc.
510(k) number	K123956	K091968	K962595
Type of Device	Light Source	Light Source	Light Source
Intended Use	Cold light sources-are designed tosupply light forendoscopicdiagnostic andsurgical procedures.	Used as a light sourcein conjunction withrigid and flexibleendoscopes as well asother light providinginstruments toilluminate theoperating field duringminimally invasiveendoscopic surgicalprocedures	The device isdesigned to supplylight for endoscopicdiagnostic andsurgical procedures.
Lamp Type	LED	LED	Xenon
Color	6500 K	5600 K	6000 K
Temperature
Used With	Fluid Optic or FluidLight Cable, Rigidor FlexibleEndoscope	Fluid Optic or FluidLight Cable, Rigid orFlexible Endoscope	Fluid Optic or FluidLight Cable, Rigid orFlexible Endoscope

Performing Testing

The performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6. Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness. Software verification was done and is attached in Enclosure # 5.17 Performance standards under section 514 of the Codc of Federal Regulations Title 21 have not been developed for this device however the manufacturer complies with the following voluntary standards:

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IEC 60601-1 Medical Electrical Equipment, Part 1- General Safety Requirements 트
IEC 60601-1-2:2001 (CISPR 11 Class B) Electromagnetic Compatibility ●
IEC 60601-2-18 Medical Electrical Equipment, Part 2-18 Particular requirements for I the basic safety and essential performance of endoscopic equipment

Summary of Substantial Equivalence:

The Power LED 175 is substantially equivalent to the existing 510(k) cleared devices on the market i.e. KARL STORZ LED NOVA 100 Cold Light Fountain (K091968 cleared September 14, 2009) and KARL STORZ 300 Watt Xenon Light Source (K962595 cleared September 4, 1996). The indication for use of the Power LED 175 is identical to the predicate devices. The Power LED 175 does not incorporate any special technology or characteristics when compared to its predicate devices.

Conclusion:

The Karl Storz Power LED 175 is substantially equivalent to the predicate device(s) mentioned above and the non-clinical performance testing demonstrates that the device is as safe and effective and performs as well as or better than the legally marketed devices

Contact:

Shiven Gandhi

Shiven Gandhi KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 Phone: (424)-218-8322 Shiven Gandhi Regulatory Affairs Associate Email: shiven.gandhi@karlstorz.com

01/16/2013

Date:

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Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three lines forming a shape that could be interpreted as a person or a symbol of health.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

January 25, 2013

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

Karl Storz Endoscopy-America, Incorporated % Mr. Shiven Gandhi Regulatory Affairs Associate 2151 East Grand Avenue El Segundo, California 90245-5017

Re: K123956

Trade/Device Name: Power LED 175 Cold Light Fountain Regulation Number: 21 CFR 876.1500

· Regulation Name: Endoscope and accessories Regulatory Class: II

Product Code: FCW, NTN Dated: December 18, 2012 Received: December 12, 2012

Dear Mr. Gandhi:

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. Shiven Gandhi

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,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use:

510(k) Number: K123956

Device Name: Power LED 175 Cold Light Fountain

Indication for use: Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.

Prescription Use_ ✔___________________________________________________________________________________________________________________________________________________________ ´ AND/OR (Part 21 CFR 801.109 i.e. Subpart D)

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) Neil R Ogden 2013.01.29 17:01:25 -05′00′

(Division Sign-Off) for my my Division of Surgical Devices 510(k) Number K123956

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.