(61 days)
IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.
This document, a 510(k) Summary for the IDSS SLC device, does not contain a study proving the device meets acceptance criteria as typically understood for AI/ML medical devices.
The IDSS SLC is described as an additional function of an integrated operating room system that controls surgical lighting, video displays, observation cameras, audio/video equipment, and teleconferencing. Its primary function is to allow control of surgical lighting during a procedure from a centralized interface.
Instead of a typical performance study with acceptance criteria for an AI/ML diagnostic or prognostic device, this document describes a summary of nonclinical testing focused on the device's functional integrity, safety, and equivalence to predicate devices.
Here's a breakdown of the information that can be extracted, and what is not applicable (N/A) given the nature of this device and document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (implicit from nonclinical testing) | Reported Device Performance |
|---|---|
| Functional Requirements (Interfaces, Features) | Validation testing performed on interfaces and feature functional requirements. (Indicates conformance to specified functions) |
| Non-functional Reliability | Validation testing performed on non-functional reliability. (Indicates stable and consistent operation) |
| Electrical Safety (Patient/User Protection) | Conforms to EN 60601-1, EN 60601-1-2:2007, and CAN/CSA-C22.2 NO. 601.1. (Passed electrical safety standards) |
| Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2:2007. (Passed EMC standards to prevent interference) |
| User Needs (Overall System) | Testing and evaluation indicate that the system meets the needs of the users. |
| No New Safety/Efficacy Issues vs. Predicate | Testing and evaluation indicate that the system does not raise any new safety and efficacy issues compared to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document describes nonclinical engineering and safety testing of a control system, not a study involving patient data or a test set in the traditional sense for AI/ML performance evaluation. The "test set" would be the device itself and its components undergoing various engineering validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for clinical interpretation or diagnostic accuracy is not relevant here. The "ground truth" for this device's performance would be whether it accurately implements its programmed controls, adheres to safety standards, and functions reliably. This would be established by qualified engineers and testers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting clinical data. This is not relevant for the type of testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. The IDSS SLC is a control system for surgical lights and other OR equipment. It is not an AI-assisted diagnostic or interpretative device that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not an AI algorithm in the context of clinical interpretation. The "standalone" performance would refer to the IDSS SLC system's ability to operate its functions as designed, which is covered by the validation testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is its conformance to engineering specifications, functional requirements, and established safety standards (e.g., EN 60601-1). This ground truth is based on predefined technical standards and the expected behavior of a physical control system.
8. The sample size for the training set
- N/A. This device does not use a training set for machine learning. The "training" for such a system would involve software development, component testing, and integration testing, which are distinct from AI model training.
9. How the ground truth for the training set was established
- N/A. As there is no training set mentioned in the context of AI/ML, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Black Diamond Video. The logo consists of the letters "BDV" in a bold, sans-serif font, with the words "BLACK DIAMOND VIDEO" printed in a smaller font underneath. To the left of the letters is a diamond shape made up of smaller diamonds. The logo is black and white.
- 510(K) Summary
Date Prepared: 10/17/2013
K133413 Page 1 of 2 JAN - 7 2014
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| 510K Owner: | Black Diamond Video |
|---|---|
| 503 Canal Blvd | |
| Richmond, CA94804 | |
| Contact: | Ragunath Muniandy |
| Regulatory Affairs Specialist |
| Trade Name: | IDSS SLC |
|---|---|
| Common Name: | Surgical Light Control |
| Classification Name: | Light, Surgical Accessories |
| Classification Panel: | General and Plastic Surgery |
| CFR section: | 21 CFR 878.4580 |
| Class: | 2 |
| Product Code: | FTA |
| Predicate Device: | Easy Suite Surgical Light Control (K102791)OASYS Surgical Light Controller (K112133) |
| Device Description: | IDSS SLC is an additional function of the IDSS, which is anintegrated operating room system that controls video displays,observation cameras, audio video equipment, teleconferencingand the routing of videos and images from multiple sources tomultiple destination via touch screen interface. |
… 2017/06/2017 11:00:00 PM 11/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017 11:00 10/08/2017
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Image /page/1/Picture/0 description: The image shows the logo for Black Diamond Video, which includes a diamond shape made up of smaller diamonds on the left side of the image. To the right of the diamond shape, the letters "BDV" are written in a bold, sans-serif font. Below the letters, the words "BLACK DIAMOND VIDEO" are written in a smaller, sans-serif font. The logo is black and white.
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Indications for use: IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
Substantial Equivalence
(SE) Rational: The IDSS SLC is substantially equivalent to predicate devices since intended use, operational principle, basic technology and design are similar. The minor differences between the IDSS SLC and predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended of use of the device. Therefore based on the applicable testing and the equivalence information presented in this submission, Black Diamond Video believes that IDSS SLC does not raise any new safety or efficacy issues.
Summary of Nonclinical
Testing:
- Validation testing performed on interfaces, feature functional requirements, and non-function reliability. - Electrical safety testing per EN 60601-1 and EN 60601-1-2:2007
| Summary of Safetyand Effectiveness: | Testing and evaluation indicate that the system meets the needsof the users of the device and does not raise any new safety andefficacy of the predicate device. The IDSS conforms to theEN 60601-1 “Medical Electrical Equipment- Part 1-2 Generalrequirement for safety.EN 60601-1-2:2007 “Medical Electrical Equipment- Part 1-2General requirement for safety- Collateral Standard:Electromagnetic compatibility- requirement and test.CAN/CSA-C22.2 NO. 601.1 -Medical Electrical EquipmentPart 1, General Requirements for Safety, Adopted IEC601-12ed(90) |
|---|---|
| ----------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and appears to be the heading of a document or official communication. The font is a sans-serif typeface, and the text is black against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Black Diamond Video Incorporated Ragunath Muniandy Regulatory Affairs Specialist 503 Canal Boulevard Richmond, California 94804
January 7, 2014
Re: K133413
Trade/Device Name: IDSS SLC Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTA Dated: October 17, 2013 Received: November 7, 2013
Dear Muniandy:
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 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
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Page 2 - Ragunath Muniandy
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K1333413
Device Name: IDSS SLC
Indications For Use:
IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
Over-The-Counter Use Prescription Use __ × AND/OR (Part 21 CFR 801 Subpart D) (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)
| DSD-DIVISION SIGN-OFF | |
|---|---|
| Division of Surgical Devices | |
| 510(k) Number: | K133413 |
| Long H. Chen -A | |
| Digitally signed by Long H. Chen -AO=U.S. Government,OU=HHS, OU=FDA, OU=People,CN=Long H. Chen -A0.9.2342.19200300.100.1.1=1300369Date: 2014.01.02 14:40:06 -05'00' |
Page __ of _
4-1
§ 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.