The proposed Harmony LED-1 Surgical lighting System subjected in this submission is a variable pattern/ intensity surgical light designed to provide visible illumination of the surgical field and patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

Device Description

The proposed Harmony LED-1 Surgical Lighting System Lighthead is specifically designed to be the next generation lighthead which can be added to the existing center mounted suspension system supporting the horizontal arms, spring arms and yokes of the predicate device Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation). Like the predicate device the system operates via an electronic controller.

The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:

. Ambient Light System.
. IR remote control for camera module.
DeepSite Fiber Optic Light. .
Fiber Optic Video Enabled Video. ●
. STERIS ACT Interface.
Camera Module.
. Dual or Single Flat Panel Monitors.
. CRT.
. 24VDC Battery Backup support.
. Secondary Spindle Mount.
. Low Profile Wall Control Unit.
. Remote Power Module Unit.
. Sterile Disposable Handle Covers.

AI/ML Overview

Here's an analysis of the provided text regarding the STERIS Harmony LED-1 Surgical Lighting System, specifically addressing the requested information about acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document cites performance testing to verify compliance with safety standards, but does not explicitly list specific acceptance criteria or quantitative performance metrics (e.g., lux levels, color temperature, etc.) for the Harmony LED-1 Surgical Lighting System within the given text.

It makes a general statement: "Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41."

Therefore, based on the provided text, the table would look like this:

Acceptance Criteria	Reported Device Performance
Compliance with CEI/IEC 60601-1 (General Requirements for Safety of Medical Electrical Equipment)	The device "meet[s] the requirements" of CEI/IEC 60601-1.
Compliance with IEC 60601-2-41 (Particular Requirements for the Safety of Surgical Luminaires and Light for Diagnosis)	The device "meet[s] the requirements" of IEC 60601-2-41.

Important Note: To get actual numerical acceptance criteria (e.g., minimum illumination levels, maximum heat generation, color rendering index), one would need to refer to the specific clauses of the CEI/IEC 60601-1 and IEC 60601-2-41 standards, which are not detailed in this submission. This document focuses on demonstrating conformance to these standards rather than detailing the specific performance results against each criteria.

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

The provided text does not mention any specific sample size for a "test set" in the context of clinical or performance data. The performance testing described refers to verification against technical standards, which typically involves testing the device itself, not a sample of patient data.

Therefore, this information cannot be extracted from the given document.

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

This is not applicable to the type of safety and performance testing described in the document. The "ground truth" here is established by the international safety standards (CEI/IEC 60601-1 and IEC 60601-2-41), and the testing verifies the device's adherence to these engineering and electrical safety requirements, not clinical efficacy or diagnostic accuracy that would require human expert adjudication.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3. The "test set" here is the physical device and its electrical/mechanical performance, which is assessed against objective technical standards, not through human adjudication of data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. This type of study is typically used for diagnostic or screening devices to assess the impact of AI on human reader performance for interpretation of images or other data. The STERIS Harmony LED-1 Surgical Lighting System is an illumination device, not a diagnostic tool that relies on human interpretation of outputs aided by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a surgical light, not an algorithm. Therefore, there is no "standalone" algorithmic performance to report.

7. The Type of Ground Truth Used

The "ground truth" used for performance assessment is the technical requirements and specifications outlined in the international safety and performance standards CEI/IEC 60601-1 and IEC 60601-2-41. These standards define what constitutes a safe and functional surgical light. The device is tested to ensure it meets these engineering and electrical safety criteria.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical hardware product (surgical light), not an AI/ML algorithm that requires a "training set" of data.

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

This is not applicable for the reasons stated in point 8.

Summary

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION HARMONY LED-1 SURGICAL LIGHTING SYSTEM

1. Device Name

OCT 5 * 2007

Trade Name:	Harmony LED-1 Surgical Lighting System
Common Name:	Light, Surgical, Ceiling Mounted.
Classification Name:	Light, Surgical, Ceiling Mounted.
Classification Number:	21 CFR 878.4580
Product Code:	FSY

2. Predicate Devices

POWERLED™ Surgical Light System cleared for market on March 16, 2007 as ● K070442 (Getinge USA, Inc).
. iLED cleared for market on June 22, 2006 as K061317 (Trumpf Kreuzer Medizin).
. Amsco Harmony Surgical Lighting and Media System cleared for market on December 13, 2001 as K013242 (STERIS Corporation).

3. Device Description

The proposed Harmony LED-1 Surgical Lighting System accessories are as follows:

. Ambient Light System.
. IR remote control for camera module.
DeepSite Fiber Optic Light. .
Fiber Optic Video Enabled Video. ●
. STERIS ACT Interface.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION HARMONY LED-1 SURGICAL LIGHTING SYSTEM

Camera Module. �
. Dual or Single Flat Panel Monitors.
. CRT.
. 24VDC Battery Backup support.
. Secondary Spindle Mount.
. Low Profile Wall Control Unit.
. Remote Power Module Unit.
. Sterile Disposable Handle Covers.

4. Intended Use

The proposed Harmony LED-1 Surgical Lighting System subjected in this submission is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures. The performance of the Harmony LED-1 Surgical Lighting System meets the general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment.

5. Description of Safety and Substantial Equivalence

The proposed Harmony LED-1 Surgical Lighting System, like its predicate devices is a variable pattern, variable intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures. The Proposed device, is identical in function, intended use, components, technology, and performance to the predicate devices: AMSCO Harmony LA Surgical Light System (K013242) manufactured and owned by STERIS Corporation and the iLED (K061317) manufactured by Trumpf Kreuzer Medizin Systeme.

The differences between the proposed and predicate devices are limited to differences in design, material, and operational. These differences do not raise any new issues of safety and efficacy.

6. Performance Testing

Performance testing was conducted to verify that the proposed Harmony LED-1 Surgical Lighting System meet the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41.

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Image /page/2/Picture/1 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 an abstract symbol resembling three stylized human profiles or faces stacked on top of each other, creating a sense of depth and connection.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

STERIS Corporation % Mr. Jack Scoville Fellow, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834

OCT 5 *

Re: K072072

Trade/Device Name: Harmony LED 1 Surgical Lighting System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: September 24, 2007 Received: September 25, 2007

Dear Mr. Scoville:

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

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Page 2 - Mr. Jack Scoville

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,

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,
Mark A. Milken

Mark N. Melkerson 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

510(k) Number (if known): K072072

Device Name: Harmony LED 1 Surgical Lighting System

Indications For Use:

Mark A. Mulkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Prescription Use _

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CONFIDENTIAL

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.