The Verde LED Surgical Light System, subjected in this submission is a variable pattern / intensity surgical light designed to provide illumination of the surgical field and patient during surgical and non-surgical procedures.

Device Description

The proposed Verde LED Surgical Light System is the next generation variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures.

AI/ML Overview

The provided text describes a 510(k) submission for the Verde LED Surgical Lighting System. This is a medical device for providing illumination during surgical procedures, not an AI or diagnostic device that would typically involve acceptance criteria related to accuracy, sensitivity, or specificity. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, ground truth types) are not applicable to the information provided.

However, based on the available text, here's an analysis of what can be extracted regarding acceptance criteria and performance for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Standard	Reported Device Performance	Reference in Text
Safety	General requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment.	The performance of the Verde LED 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 "Performance Testing" sections

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of this device (a surgical lighting system), as performance testing is typically done on the device itself, not on a dataset of patient cases.
Data Provenance: Not applicable. Performance testing for this type of device involves engineering and electrical safety tests, not data from specific countries or retrospective/prospective studies in the sense of clinical trials for diagnostic devices.

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

Not applicable. Ground truth, in the context of experts, usually pertains to diagnostic accuracy, which is not relevant for a surgical lighting system. The "ground truth" for safety standards is the standard itself (CEI/IEC 60601-1 and IEC 60601-2-41), not established by experts during testing of the device.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data, particularly in diagnostic studies. This is not relevant to performance testing of a surgical light.

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. An MRMC study is relevant for diagnostic devices (especially those involving AI assistance for human readers). This device is a lighting system; it does not involve human "readers" or AI assistance in this context.

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

Not applicable. This device is a physical product (a surgical light), not an algorithm or AI system.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" for this device's performance is compliance with established international safety and performance standards for medical electrical equipment, specifically CEI/IEC 60601-1 and IEC 60601-2-41. These are engineering and safety standards, not clinical outcomes, pathology reports, or expert consensus on diagnostic findings.

8. The sample size for the training set

Not applicable. This device is not an AI model, so there is no "training set."

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for NUVVO, INC. The logo is in a rectangular shape with rounded corners. The word "NUVVO" is written in a stylized font, with the letters split in half. Below the logo, the words "NUVVO, INC." are written in a smaller, simpler font.

JAN 2 8 2009

083323

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510 (k) SUMMARY

Submitter:

Nuvo Inc 5368 Kuhl Road Erie, PA 16407

Contact Person:

Curt Vander Schaaff

Trade Name:

Verde LED Surgical Lighting System

Light Surgical, Ceiling Mounted Common Name:

21 CFR 878.4580 Classification Number:

FSY Product Code:

Predicate Devices:

Aurora LED Series Surgical Light (Skytron) . K071698 dated July 6, 2007 510 (k): Product Code: FSY .
Harmony LED-1 Surgical Lighting System (Steris) . K072072 dated October 5, 2007 510 (k): Product Code FSY
iLED Surgical Lighting System (Trumpf Kreuzer Medizin) . K061317 dated June 22, 2006 510 (k): Product Code FSY

Device Description:

な

5368 KUHL ROAD • ERIE, PENNSYLVANIA 16510 • PHONE 814-899-4220 • FAX 814-899-1410

A member of the Medical Illumination International Group

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483323

Intended Use:

Description of Safety:

The performance of the Verde LED 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.

Substantial Equivalence:

The proposed Verde LED Surgical Light System is a variable pattern / intensity surgical I ght designed to provide visible illumination of the surgical field and the patient during surgical procedures. The Proposed Device is identical in function, intended use, components, technology and performance to the predicate devices: Aurora LED Series Surgical Light (Skytron) (K071698), Harmony LED-1 Surgical Lighting System (Steris) (K072072), and iLED Surgical Lighting System (Trumpf Kreuzer Medizin) (K061317).

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 efficiency

Performance Testing:

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

5368 KUHL ROAD ● ERIE, PENNSYLVANIA 16510 ● PHONE 814-899-4220 ● FAX 814-899-1410

A member of the Medical Illumination International Group

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NUVO, Inc. % Mr. Curt Vander Schaaff OA/RA Manager 5368 Kuhl Road Erie, Pennsylvania 16407

JAN 2 8 2009

Re: K083323

Trade/Device Name: The Verde LED Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: October 20, 2008 Received: December 2, 2008

Dear Mr. Schaaff:

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. Curt Vander Schaaff

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark N. Millman

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

K083323

510(k) Number: Unknown

Device Name:

Indications for Use:

Prescription Use (Per 21 CFR 801.109 X OR

Over- the- Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Delim Del De 1/29/4

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

: 510(k) Number K083323

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.