(57 days)
Not Found
No
The description focuses on a control system for surgical lights via a touch panel interface, with no mention of AI or ML capabilities.
No
The device controls surgical lighting and operates room systems; it does not directly treat or diagnose a medical condition.
No
Explanation: The device description states that the EasySuite™ Surgical Light Control (ESLC) allows control of surgical lighting and is an optional function within an integrated operating room system for managing various room functionalities. There is no mention of the device being used to identify, detect, or monitor any medical conditions, diseases, or physiological states.
No
The device description explicitly states that the ESLC is an "optional function in the EasySuite™, which is an integrated operating room system". This indicates that the ESLC is part of a larger hardware system (the EasySuite™) and is not a standalone software-only device. The control is exercised through a "touch panel user interface", which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control surgical lighting during a surgical procedure. This is a function related to the physical environment of the operating room, not the analysis of biological samples from the human body.
- Device Description: The device is described as a function within an integrated operating room system for managing communication, audio, and control of devices like room lights and surgical lights. This aligns with controlling the surgical environment, not performing diagnostic tests on patient samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, conditions, or states of health, or providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The EasySuite™ Surgical Light Control (ESLC) does not fit this description.
N/A
Intended Use / 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.
Product codes
FTA
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.
The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.
ESLC is an optional function in the EasySuite™ integrated operating room ESLC system. (The EasySuite™ 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. EasySuite™ also includes an audio management system and a single point of entry for querying surgical charts and image archives.)
The EasySuite™ Surgical Light Control (ESLC) is a software application.
Mentions image processing
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Verification and validation testing was performed by Image Stream personnel. The verification and validation confirmed that the ESLC application meets specified requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Attachment 3
510 (k) Summary
| 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. |
!
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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 |
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