(43 days)
Not Found
No
The document explicitly states the device "does not perform calculations" and describes it as a control interface for surgical lights, with no mention of AI or ML terms or concepts.
No
The device controls surgical lights and is part of an integrated operating room system. It does not directly interact with a patient or have a therapeutic effect.
No
The MSLC controls surgical lights and displays their status; it does not perform calculations or provide medical diagnoses based on patient data.
No
The device is described as an "optional function in the MainStream® OR integrated operating room system," which is explicitly stated to include hardware components like a touch panel user interface, audio management system, and interfaces for controlling various devices. The MSLC function is a software component within this larger hardware system, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The MainStream® OR Surgical Light Control (MSLC) is described as a system for controlling surgical lights and other operating room equipment (video routing, cameras, ambient lighting, audio). It interacts with physical devices and displays information about their status.
- Lack of biological sample analysis: There is no mention of the MSLC analyzing any biological samples or performing any diagnostic tests on patient specimens.
The device's function is related to controlling the environment and equipment within an operating room, not to performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
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.)
Product codes
FTA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
| Classification
| name | 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.
1
Intended use
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.)
Comparison to
the predicate device
| | MSLC | SCB/Steris OR-
Light Interface Box |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function | Control of surgical lights from a convenient
integrated operating room system. | |
| Primary control of
surgical lights | The surgical light controls from the surgical
light system manufacturer take precedence
over the integrated system. | |
| Calculations
performed | None | |
| Primary purpose of
integrated operating
room system. | MainStream® OR is
a primarily medical
video image routing
and communication
system, which also
controls functions
such as ambient
lighting. | The SCB (Storz
Communication
Bus) system is the
backbone for an
integrated operating
room system that
additionally
interfaces with
endoscopes. |
| 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.
2
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.
3
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
4
Indications for Use
510(k) Number (if known): KOB1698
Device Name: MainStream® OR Surgical Light Control
Indications for Use:
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.)
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