SCB/STERIS OR-LIGHT INTERFACE BOX by KARL STORZ ENDOSCOPY-AMERICA, INC.

The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STERIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.

Device Description

The Karl Storz SCB/STERIS OR-Light Interface Box connects the Storz Communication Bus computer to the STERIS Harmony OR-Light Control System. It enables the SCB computer to display and control the Harmony's functions.

AI/ML Overview

This document describes a 510(k) summary for the KARL STORZ Endoscopy - America, Inc. SCB/STERIS OR-Light Interface Box.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any specific acceptance criteria or performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions, where the main "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device.

The "reported device performance" is implicitly that it functions as intended by allowing the SCB computer to "control/monitor" the STERIS Harmony LA Surgical Lighting System, a room camera, and various ambient light settings. The key assertion is: "The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls."

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

The document does not describe any specific test set, sample size, or data provenance related to performance testing of the device. This is because the device's function is an interface for control, and its safety and effectiveness are established through substantial equivalence to a predicate device with similar functionalities, rather than through
a clinical or performance study with a test set.

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

Not applicable. No ground truth was established through expert consensus for this device notification as no specific performance study beyond substantial equivalence was provided.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is mentioned as there was no test set or study described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted or described. This type of study is more relevant for diagnostic or image-interpretation devices, not for an interface box that relays controls.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a hardware interface with software that relays controls; it is always "human-in-the-loop" as it is controlled by a surgeon via a monitor. The concept of "standalone algorithm performance" doesn't apply here.

7. Type of Ground Truth Used:

Not applicable. As no performance study requiring ground truth was described, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The "truth" for this submission is the established safety and effectiveness of the predicate device and the claim that the new device operates similarly and introduces no new safety or effectiveness concerns.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Document's Approach to Acceptance:

The submission relies entirely on Substantial Equivalence to establish the device's "acceptance."

Predicate Device: SCB/ValleyLabs Force FX Interface Box (K041912)
Argument for Equivalence: "The Karl Storz SCB/STERIS OR-Light Interface Box is substantially equivalent to the predicate device SCB/ValleyLabs Force FX Interface Box (K041912) since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/STERIS OR-Light Interface Unit and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

In essence, the "study" proving the device meets "acceptance criteria" is the comparison to the predicate device, demonstrating that the new device performs similarly for its intended use, without introducing new risks. This is a regulatory pathway, not a performance study in the traditional sense of medical device evaluation for diagnostic or therapeutic efficacy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopes. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ ENDOSCOPES" in a smaller font. The logo is simple and modern, and it is likely used to identify the company's products and services.

AUG 1 1 2005 KOSISOS 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500
Contact:	Paul S. Lee,Senior Regulatory Affairs Specialist

Remote Control: SCB/STERIS OR-Light Control Device Identification:

The Storz Communication Bus/STERIS OR-Light Interface device is Indication: an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System.

This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STERIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.

Device Description: The Karl Storz SCB/STERIS OR-Light Interface Box connects the Storz Communication Bus computer to the STERIS Harmony OR-Light Control System. It enables the SCB computer to display and control the Harmony's functions.

Substantial Equivalence: The Karl Storz SCB/STERIS OR-Light Interface Box is substantially equivalent to the predicate device SCB/ValleyLabs Force FX Interface Box (K041912) since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/STERIS OR-Light Interface Unit and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

Paul S. Lee Senior Regulatory Affairs Specialist

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AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, California 90230

Re: K051505

Trade/Device Name: SCB/STERIS OR-Light Interface Box Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTA Dated: June 3, 2005 Received: June 13, 2005

Dear Mr. Lee:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter with and my Jame FDA finding of substantial equivalence of your device to a legally prematics notineteem " 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 n you atence 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 other gollers, 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

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

KOSISOS 510(k) Number (if known):

Device Name: SCB/STERIS OR-Light Interface Box

Indications for Use: The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System.

Prescription Use: (Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Division of General, Restorative. and Neurological Devices

510(k) Number K 051505

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.