MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.

MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)

Device Description

The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.

The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. This device, the MainStream® OR Surgical Light Control (MSLC), is a surgical light accessory that enables control of surgical lights from an integrated operating room system's touch panel. The submission primarily focuses on establishing substantial equivalence to a predicate device (SCB/Steris OR-Light Interface Box) based on functional similarities and safety principles rather than performance metrics.

The document states that the MSLC does not perform calculations and that the safety features and controls of the surgical light system take precedence over the MSLC. This implies that the MSLC's function is primarily an interface and control mechanism, and its safety is intrinsically linked to the underlying surgical lighting system it controls.

Therefore, I cannot provide a table of acceptance criteria or details about a study as requested. The available information describes the device's function and its classification, but not specific performance testing or clinical studies.

Summary

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K081698

JUL 80 2008

510(k) Summary

Date prepared May 30, 2008

510(k) Owner Image Stream Medical, Inc. One Monarch Drive Littleton, MA 01460

Phone: (978) 486-8494 Fax: (978) 428-2694 Contact Mona Pinette, Chief Operating Officer

MainStream® OR Surgical Light Control Trade name

Common name Surgical Light Accessory

Classificationname	Classification Name:	Light, Surgical, Accessories
	Classification Panel:	General & Plastic Surgery
	CFR Section:	21 CFR 878.4580
	Class:	2
	Product Code:	FTA

Predicate SCB/Steris OR-Light Interface Box, which was cleared to market in device 510(k) # K051505.

Device The MainStream® OR Surgical Light Control (MSLC) is an description optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.

The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.

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Intended use

Comparison to

the predicate device

	MSLC	SCB/Steris OR-Light Interface Box
Function	Control of surgical lights from a convenientintegrated operating room system.
Primary control ofsurgical lights	The surgical light controls from the surgicallight system manufacturer take precedenceover the integrated system.
Calculationsperformed	None
Primary purpose ofintegrated operatingroom system.	MainStream® OR isa primarily medicalvideo image routingand communicationsystem, which alsocontrols functionssuch as ambientlighting.	The SCB (StorzCommunicationBus) system is thebackbone for anintegrated operatingroom system thatadditionallyinterfaces withendoscopes.
Sterile field	No components are used in the sterile field.

Conclusion

The MSLC is substantially equivalent to the SCB/Steris OR-Light Interface Box, which was cleared to market in 510(k) K051505.

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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 features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image Stream Medical, Inc. % Chas Burr Q/R Services, Inc. Mr. Chas Burr 11 Mystic Avenue Winchester, Massachusetts 01890-2920

JUL 3 0 2008

Re: K081698 Trade/Device Name: MainStream® OR Surgical Light Control Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTA Dated: May 30, 2008 Received: June 17, 2008

Dear Mr. Burr:

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. Chas Burr

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 yours.

Mark N. Mullan

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): KOB1698

Device Name: MainStream® OR Surgical Light Control

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

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.