The Harmony vLED Surgical Lighting System 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.

Device Description

The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.

The Harmony vLED Surgical Lighting System accessories are as follows:

STERIS ACT Interface o
o Camera Module
Dual or Single Flat Panel Monitors o
o 24VDC Battery Backup support
Remote Power Module Unit 0
Sterile Disposable Handle Covers o

AI/ML Overview

The provided text describes the STERIS® Harmony vLED Surgical Lighting System (K100395) and its performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific details required to complete your request for acceptance criteria and a study proving device conformance to those criteria.

The document states: "Performance testing was conducted to verify that the Harmony vLED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41." This indicates that the device's performance was evaluated against these safety and performance standards for medical electrical equipment. However, the specific acceptance criteria within these standards for this particular device and the results of that testing demonstrating the device meets those criteria are not provided in the given text.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, ground truth, expert involvement, or comparative effectiveness studies based on the information given.

To answer your request, I would need access to the actual performance testing report, which would detail the specific tests conducted, the acceptance limits for each test, and the actual measurements obtained from the Harmony vLED Surgical Lighting System.

Based on the provided text, the following information is available (though insufficient for your request):

1. A table of acceptance criteria and the reported device performance:

Cannot be provided as the specific acceptance criteria and detailed performance results are not included in the text. The text only states that the device meets the "general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment."

2. Sample sized used for the test set and the data provenance:

Not provided. The document does not specify the number of devices or components tested. Data provenance is also not mentioned beyond the manufacturer being STERIS Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. For a surgical light, "ground truth" and expert adjudication are typically not involved in performance testing for electrical and safety standards like CEI/IEC 60601-1 and IEC 60601-2-41. These standards involve objective measurements (e.g., light intensity, electrical leakage, temperature, etc.) against pre-defined limits.

4. Adjudication method for the test set:

Not applicable / Not provided. See point 3.

5. 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:

Not applicable. This device is a surgical light, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical light; there is no algorithm for standalone performance to evaluate in this context.

7. The type of ground truth used:

Not applicable. Performance testing for a surgical light against IEC standards relies on objective measurements against engineering specifications, not "ground truth" in the diagnostic sense (e.g., pathology, expert consensus).

8. The sample size for the training set:

Not applicable. There is no "training set" for a surgical light being tested against electrical and safety standards.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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STERIS®

MAR ] 7 2010

510(k) Summary

For
Harmony vLED Surgical Lighting System

K100395

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Contact:

Robert F. Sullivan Senior Director, Regulatory Affairs

440 392 7695 Telephone: 440 357 9198 Fax No:

Submission Date:

ﻪ ﻣﻦ ﻣﺎﻳﻮ

February 12, 2010

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	Harmony vLED 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 Device

Harmony LED-1 Surgical Lighting System (K072072)

3. Device Description

The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.

The Harmony vLED Surgical Lighting System accessories are as follows:

STERIS ACT Interface o
o Camera Module
Dual or Single Flat Panel Monitors o
o 24VDC Battery Backup support
Remote Power Module Unit 0
Sterile Disposable Handle Covers o

4. Intended Use

The proposed Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field

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and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The performance of the Harmony vLED 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.

Description of Safety and Substantial Equivalence 5.

The proposed Harmony vLED Surgical Lighting System, like its predicate device, is a variable pattern, variable intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide optional videovisual procedural support for the hospital staff during surgical procedures. The proposed device has the same function, intended use, components, technology, and performance as the predicate device, Harmony LED-1 Surgical Lighting System (K072072) manufactured and owned by STERIS Corporation.

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

Performance Testing 6.

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

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is inscribed along the border of the seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR 1 7 2010

STERIS Corporation % Mr. Robert F. Sullivan Senior Director. Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K100395

Trade/Device Name: Harmony vLED Surgical Lighting System Regulation Number: 21 CFR 878,4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: February 12, 2010 Received: February 16, 2010

Dear Mr. Sullivan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Robert F. Sullivan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 Division of Small Manufacturers, International 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

incerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K100395 510(k) Number (if known):

Device Name:

Harmony vLED Surgical Lighting System

Indications For Use:

The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to mgnide video-visual procedural support for the hospital staff during surgical procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. K100398

Page 1 of 1

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.