(61 days)
Not Found
No
The summary describes a system for controlling surgical lighting and other operating room equipment via a centralized interface. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies focus on interface validation, functional requirements, and electrical safety, not on the performance of an AI/ML algorithm.
No
The device controls surgical lighting and other operating room equipment and does not directly treat or diagnose a medical condition.
No
The device controls surgical lighting and integrates audio/video, not performing any diagnostic functions like analyzing patient data or images to identify medical conditions.
No
The device description explicitly states that 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 indicates the device is part of a larger hardware system, not solely software. Furthermore, the performance studies include electrical safety testing per EN 60601-1 and EN 60601-1-2:2007, which are standards for medical electrical equipment, confirming the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to control surgical lighting during a surgical procedure. This is a direct interaction with the surgical environment and not with biological samples or specimens.
- Device Description: The device controls various aspects of an operating room environment (video displays, cameras, audio, teleconferencing, routing of video/images) and specifically mentions controlling surgical lighting. This is all related to the physical environment and workflow of a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on controlling equipment within the operating room during a surgical procedure.
N/A
Intended Use / 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.
Product codes
FTA
Device Description
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.
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
Operating room
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)
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. Testing and evaluation indicate that the system meets the needs of the users of the device and does not raise any new safety and efficacy of the predicate device. The IDSS conforms to the EN 60601-1 “Medical Electrical Equipment- Part 1-2 General requirement for safety. EN 60601-1-2:2007 “Medical Electrical Equipment- Part 1-2 General requirement for safety- Collateral Standard: Electromagnetic compatibility- requirement and test. CAN/CSA-C22.2 NO. 601.1 -Medical Electrical Equipment Part 1, General Requirements for Safety, Adopted IEC601-1 2ed(90).
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
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
, ''·
i
| 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 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. |
… 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
1
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.
Page 2 of 2
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 Safety
and Effectiveness: | Testing and evaluation indicate that the system meets the needs
of the users of the device and does not raise any new safety and
efficacy of the predicate device. The IDSS conforms to the
EN 60601-1 “Medical Electrical Equipment- Part 1-2 General
requirement for safety.
EN 60601-1-2:2007 “Medical Electrical Equipment- Part 1-2
General requirement for safety- Collateral Standard:
Electromagnetic compatibility- requirement and test.
CAN/CSA-C22.2 NO. 601.1 -Medical Electrical Equipment
Part 1, General Requirements for Safety, Adopted IEC601-1
2ed(90) |
| ----------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2
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
3
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
4
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 -A | |
| O=U.S. Government, | |
| OU=HHS, OU=FDA, OU=People, | |
| CN=Long H. Chen -A | |
| 0.9.2342.19200300.100.1.1=1300369 | |
| Date: 2014.01.02 14:40:06 -05'00' |
Page __ of _
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