(219 days)
Not Found
No
The description focuses on basic control functions, communication protocols, and user interface interactions. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML.
No
The device controls surgical lights and is not directly applied to a patient for diagnosis, treatment, or prevention of a disease or condition. Its function is to manage and operate an external therapeutic device (surgical lights), but it is not itself therapeutic.
No
The device is described as software that controls surgical lights and related operating room equipment. It is not used to gather or analyze medical information for diagnosis.
Yes
The device is described as "software controlling the Surgical Light" and is an "optional module to the OASYS View OR Control application." While it interacts with hardware (surgical lights and the OASYS View touch panel), the device itself is presented as a software component that controls existing hardware, not a piece of hardware itself. The description focuses on the software's functionality, communication protocols, and integration within a larger software system.
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 lights during a procedure and display their status. This is a functional control system for a piece of surgical equipment.
- Device Description: The description focuses on the software's ability to communicate with and control surgical lights, manage video routing, camera settings, and other operating room functions. It does not mention any interaction with biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document does not describe any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, urine, etc.)
- Providing diagnostic information about a patient's health or condition
- Detecting the presence of specific substances or markers
- Being used in a laboratory setting for diagnostic purposes
The software's function is to facilitate the operation of surgical equipment and manage the operating room environment, not to perform diagnostic tests on patient samples.
N/A
Intended Use / 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.
Product codes
FTA
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.
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)
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 .
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
KI12133
MAR - 1 2012
510(k) SUMMARY (as required by 807.92(c))
| Regulatory Correspondent: | AJW Technology Consultants
962 Allegro Lane
Apollo Beach, FL 33572
Tanya O'Brien
tmobrien@ajwtech.com
813-645-2855
813-677-4787 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Oasys Healthcare
191 Main Street North
Uxbridge, Ontario, L9P1C3, Canada
Gary Schissler
gschissler@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:
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
1
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.
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.
2
Comparison between Proposed Device and Predicate Devices
| Comparison
| Elements | Applicant Device | Predicated Device |
|---|---|---|
| Device Name | OASYS Surgical Light Controller | |
| Software K112133 | EasySuite Surgical Light Control | |
| Software K102791 | ||
| Classification | ||
| Name | light, surgical, accessories | |
| Product Code | FTA | |
| Indications for Use | The OASYS Surgical Light Controller | |
| (software only) 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. | EasySuite Light Control (ESLC) | |
| allows the control of surgical lighting | ||
| during a surgical procedure from the | ||
| EasySuite panel user interface | ||
| Level of Concern | Minor | |
| Patient Interaction | None | |
| Control Platform | Microsoft Windows 7 Embedded | Microsoft Windows Standard |
| Embedded | ||
| 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. | ||
| Calculations | ||
| Performed | None | |
| Primary Control of | ||
| Surgical Lights | The surgical light controls from the manufacturer take precedence over the OR | |
| control system. | ||
| Primary Purpose | ||
| of OR Control | ||
| System | The OASYS OR Control System provides | |
| control of audio, video and environmental | ||
| systems in the OR through a common | ||
| user interface touch panel. | The system is primarily medical video | |
| image routing and communications | ||
| system, which also controls functions | ||
| such as ambient lighting. | ||
| Sterile Field | No components used in the sterile field. | |
| Comparison | ||
| Statement | 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. |
,
.
3
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
5
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
6
Indications for Use
510(k) Number (if known): K112133
Device Name: OASYS Surgical Light Controller Software
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.
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
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112133