← Product Code [FTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA) · K102791 # EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (K102791) _Image Stream Medical, Inc. · FTA · Nov 23, 2010 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K102791 ## Device Facts - **Applicant:** Image Stream Medical, Inc. - **Product Code:** [FTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA.md) - **Decision Date:** Nov 23, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface. ## Device Story EasySuite™ Surgical Light Control (ESLC) is a software application integrated into the EasySuite™ operating room system; enables control of surgical lights from a centralized touch panel user interface. System manages surgical images, audio, room cameras, ambient lighting, and surgical lights; provides single point of entry for surgical charts and image archives. Operated by surgical staff in the operating room; provides convenience by allowing light intensity and on/off adjustments from the same interface used for video routing. Does not operate within the sterile field; surgical light system manufacturer controls take precedence over integrated system commands. Benefits include streamlined OR workflow and centralized device management. ## Clinical Evidence Bench testing only. Verification and validation testing performed by Image Stream personnel confirmed the ESLC application meets specified requirements. ## Technological Characteristics Software application running on Microsoft Windows Standard Embedded platform. Integrated into EasySuite™ OR system. Connectivity via touch panel user interface. No components used in the sterile field. No calculations performed. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - MainStream™ OR Surgical Light Control (MSLC) ([K081698](/device/K081698.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # Attachment 3 ## 510 (k) Summary K102791 | Date prepared | September 22, 2010 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner | Image Stream Medical, Inc.
One Monarch Drive
Littleton, MA
01460 | | | NOV 2 3 2010 | | | Phone: (978) 486-8494
Fax: (978) 428-2694 | | Contact | Beth Cyr, Director of Quality Assurance | | Trade name | EasySuite™ Surgical Light Control | | 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 device | MainStream™ OR Surgical Light Control (MSLC), which was cleared to
market in 510(k) # K081698. | | Device description | The EasySuite™ Surgical Light Control (ESLC) is an optional function in the
EasySuite™, 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. | ! ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ {1}------------------------------------------------ The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface. EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user Intended use interface. #### ESLC is an optional function in the EasySuite™ integrated operating room ESLC system. (The EasySuite™ system includes a touch panel user interface for Description 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. EasySuite™ also includes an audio management system and a single point of entry for querying surgical charts and image archives.) | Comparison to
the predicate
device | Control Platform | | |------------------------------------------|-----------------------------|--| | | Function | | | | Primary control of surgical | | | | | MSLC | ESLC | |--|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | | Control Platform | Crestron | Microsoft Windows
Standard Embedded | | | Function | Control of surgical lights from a convenient
integrated operating room system. Control is
defined by setting the light intensity or the lights on
or off. | | | | 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. | | The system is primarily medical video image
routing and communication system, which also
controls functions such as ambient lighting. | | | Sterile field | | No components are used in the sterile field. | Image Stream Medical EasySuite Special 510k {2}------------------------------------------------ The EasySuite™ Surgical Light Control (ESLC) is a software application. Verification Non-Clinical and validation testing was performed by Image Stream personnel. The verification and Tests validation confirmed that the ESLC application meets specified requirements. The ESLC is substantially equivalent to the MainStreamTM OR Surgical Light Conclusion Control (MSLC), which was cleared to market in 510(k) # K081698. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three vertical lines that form the staff and the snakes are represented by curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Image Stream Medical, Inc. % Ms. Beth Cyr Director of Quality Assurance One Monarch Drive Littleton, Massachusetts 01460 NOV 2 3 2010 Re: K102791 Trade/Device Name: EasySuite™ Surgical Light Control Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTA Dated: November 09, 2010 Received: November 10, 2010 #### Dear Ms. Cyr: 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. Ilsting 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 {4}------------------------------------------------ #### Page 2 - Ms. Beth Cyr 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); medical device 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/ReportalProblem/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 vours. Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Attachments | Attachment 1 | | |--------------|--| | | | | | | | | | | | | NOV 2 3 2010 ### Indications for Use Statement 10 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | 510(k) Number (if known) | # K102791 | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | EasySuite™ Surgical Light Control | | Indications for Use | EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface. | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801. 109) |
X
| OR | Over-The-Counter Use | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----|----------------------| | |

Neil R. Ogden for mxm

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

| | | | 510(k) Number | K102791 | | | ﺎ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K102791](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K102791) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com