The OASYS Surgical Light Controller Software allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.

Device Description

The OASYS Surgical Light Controller allows the control of surgical lights from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light. It works with surgical lights from many vendors.

The OASYS Surgical Light Controller communicates with the target surgical light using serial or Ethernet communications. All communications include error and exception handling. The safety features and controls of the surgical light take precedence over these communications.

This software controlling the Surgical Light is written with C# and XML data structures that run on Windows Embedded 7. The software is an optional module to the OASYS View OR Control application. OASYS View is a medical control application that allows for simple and streamlined management of an operating room. The software allows users to:

Enable video routing from any source device to any destination device
Preview selected sources on-screen
Adjust image settings for video sources
Change picture-in-picture capabilities on supported displays
Control camera settings including:
Panning & tilting
Zooming
Focusing
Presets
Operate medical-grade video recorders
Select and listen to audio from an iPod or external audio device
Engage in video conference calls

The software communicates with the light over a serial connection (RS485). Parameters are passed over a socket. The software manages the send and receive buffers to ensure effective communications. Data transmission is verified through the use of checksums and status commands.

The software allows for the Surgical Light to be initialized at run time. Default settings, such as brightness, are initialised on the Surgical Light. During normal operation, commands are passed back and forth based upon operator interaction with the graphical user interface. There are no patient contacting components.

AI/ML Overview

The provided text describes functionality and technical specifications rather than diagnostic performance, therefore it does not fit the typical format for AI/ML device performance analysis. However, based on the provided text, I can infer the "acceptance criteria" relate to the functional operation of the OASYS Surgical Light Controller and the "study" is the performance testing conducted to confirm these functions.

Here's an adaptation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Ability to increase brightness	Tested and confirmed
Ability to decrease brightness	Tested and confirmed
Ability to power ON the surgical light	Tested and confirmed
Ability to power OFF the surgical light	Tested and confirmed
Ability to switch between surgical light mode(s)	Tested and confirmed
Ability to switch between surgical light feature(s)	Tested and confirmed
Ensure all communication happens within 5 seconds	Tested and confirmed
Test communications failure between the control system and surgical light controller	Tested and confirmed
Verify ability to connect Surgical Light Controller	Tested and confirmed
Verify Communications	Tested and confirmed
Verify all other system connections	Tested and confirmed
Verify the device reboots properly	Tested and confirmed

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

The document specifies "Performance Testing" was carried out, but it does not mention the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data). This is a software and hardware control system, not a diagnostic AI/ML device, so the concept of "data provenance" in the usual sense (e.g., patient data) does not apply. The testing would have involved the physical device and a surgical light.

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

The document does not mention using experts to establish ground truth. For a control system like this, the "ground truth" would be defined by the functional specifications (e.g., is the light brighter when the "increase brightness" button is pressed?). Testing would likely be performed by engineers or quality assurance personnel against these predefined functional requirements.

4. Adjudication method for the test set

The document does not mention an adjudication method. For functional testing of a control system, formal adjudication by experts is typically not performed in the same way it would be for a diagnostic AI/ML device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

Not applicable. This device is a surgical light controller, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant or described.

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

The performance testing described is inherently "standalone" in function, as it tests the capability of the software to control the surgical light as designed. The software itself is the "algorithm only" aspect, performing its control functions based on user input. The document describes the software communicating with the light and managing operations.

7. The type of ground truth used

The ground truth for this device would be defined by engineering specifications and user requirements for the control of a surgical light. For example, "increasing brightness" means the software sends the correct command and the light responds by becoming brighter. This is a functional truth rather than a clinical ground truth (like a pathology report).

8. The sample size for the training set

Not applicable. This is not an AI/ML device in the sense of requiring a training set for model development. The software is programmed with explicit logic and rules for controlling surgical lights, not "trained" on data.

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

Not applicable. As this is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply.

Summary

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KI12133

MAR - 1 2012

510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:	AJW Technology Consultants962 Allegro LaneApollo Beach, FL 33572Tanya O'Brientmobrien@ajwtech.com813-645-2855813-677-4787
Submitter of 510(k):	Oasys Healthcare191 Main Street NorthUxbridge, Ontario, L9P1C3, CanadaGary Schisslergschissler@oasyshealthcare.com
Date of Summary:	February 2, 2012
Trade/Proprietary Name:	OASYS Surgical Light Controller
K#:	K112133
Classification Name:	Class II
Product Code:	FTA

Indications for Use:

The OASYS Surgical Light Controller allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.

Device Description:

This software controlling the Surgical Light is written with C# and XML data structures that run on Windows Embedded 7. The software is an optional module

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to the OASYS View OR Control application. OASYS View is a medical control application that allows for simple and streamlined management of an operating room. The software allows users to:

. Enable video routing from any source device to any destination device
Preview selected sources on-screen .
Adjust image settings for video sources ●
. Change picture-in-picture capabilities on supported displays
Control camera settings including: .
. Panning & tilting
Zooming .
Focusing ●
Presets .
Operate medical-grade video recorders .
. Select and listen to audio from an iPod or external audio device
Engage in video conference calls .

Predicate Device:

EasySuite Surgical Light Control (K102791) software.

Substantial Equivalence:

The proposed OASYS Surgical Light Controller Software is substantially equivalent to Image Stream Medical - EasySuite Surgical Light Control (K102791). The proposed device has the same classification information, similar indications for use and function as compared to the predicate device.

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Comparison between Proposed Device and Predicate Devices

ComparisonElements	Applicant Device	Predicated Device
Device Name	OASYS Surgical Light ControllerSoftware K112133	EasySuite Surgical Light ControlSoftware K102791
ClassificationName	light, surgical, accessories
Product Code	FTA
Indications for Use	The OASYS Surgical Light Controller(software only) allows the control ofsurgical lights during a procedure fromthe OASYS View user interface touchpanel. It displays the status of the surgicallight and controls the operation of thesurgical light.	EasySuite Light Control (ESLC)allows the control of surgical lightingduring a surgical procedure from theEasySuite panel user interface
Level of Concern	Minor
Patient Interaction	None
Control Platform	Microsoft Windows 7 Embedded	Microsoft Windows StandardEmbedded
Access	Touch Screen
Function	Control of surgical lights from a convenient integrated operating room system.Control is defined by setting the light intensity or turning lights on and off.
CalculationsPerformed	None
Primary Control ofSurgical Lights	The surgical light controls from the manufacturer take precedence over the ORcontrol system.
Primary Purposeof OR ControlSystem	The OASYS OR Control System providescontrol of audio, video and environmentalsystems in the OR through a commonuser interface touch panel.	The system is primarily medical videoimage routing and communicationssystem, which also controls functionssuch as ambient lighting.
Sterile Field	No components used in the sterile field.
ComparisonStatement	The applicant device has similar label and labeling as the predicate device.
Comparison Analysis
The applicant device has the same classification information, similar indications for use, and the same
function, as the predicate device.

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Performance Testing:

Below is a summary of the performance testing was carried out on the OASYS Surgical Light Controller for integration of the user requirements and software requirements.

Ability to increase brightness .
Ability to decrease brightness ●
Ability to power ON the surgical light .
Ability to power OFF the surgical light. .
Ability to switch between surgical light mode(s) .
Ability to switch between surgical light feature(s) .
Ensure all communication happens within 5 seconds .
. Test communications failure between the control system and surgical light controller
. Verify ability to connect Surgical Light Controller.
Verify Communications .
Verify all other system connections ●
Verify the device reboots properly .

Conclusion Summary:

Comparison to the predicate devices listed shows nearly identical technical data, similar indications for use, and raises no new questions of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Oasys Healthcare % AJW Technology Consultants Ms. Tanya O'Brien 962 Allegro Lane Apollo Beach, Florida 33572

MAR - 1 2012

Re: K112133 -

Trade/Device Name: OASYS Surgical Light Controller Software Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTA Dated: February 23, 2012 Received: February 27, 2012

Dear Ms. O'Brien:

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. 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 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

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Page 2 - Ms. Tanya O'Brien

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/CDRH0ffices/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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112133

Device Name: OASYS Surgical Light Controller Software

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil be Ogden for mkr

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112133

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.