IDSS SLC

K133413 · Black Diamond Video · FTA · Jan 7, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133413
• Device Name: IDSS SLC
• Applicant: Black Diamond Video
• Product Code: FTA · General, Plastic Surgery
• Decision Date: Jan 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended 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.

Device Story

IDSS SLC is an add-on function for the Integrated Operating Room System (IDSS). It provides a centralized touch-screen interface for controlling surgical lighting alongside existing capabilities for routing video, audio, observation cameras, and teleconferencing. Used in the operating room by surgical staff; the device acts as a remote control interface for lighting systems. By consolidating lighting controls into the existing IDSS interface, it simplifies OR equipment management, potentially improving workflow efficiency for the surgical team during procedures.

Clinical Evidence

No clinical data. Bench testing only, including validation of interfaces, feature functional requirements, non-function reliability, and electrical safety testing per EN 60601-1 and EN 60601-1-2:2007.

Technological Characteristics

Centralized touch-screen interface for surgical light control. Integrated into the IDSS system. Electrical safety compliance per EN 60601-1, EN 60601-1-2:2007, and CAN/CSA-C22.2 NO. 601.1.

Indications for Use

Indicated for use in the operating room to control surgical lighting during surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Easy Suite Surgical Light Control (K102791)
• OASYS Surgical Light Controller (K112133)

Submission Summary (Full Text)

{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)<br>OASYS Surgical Light Controller (K112133) |
| Device Description: | IDSS SLC is an additional function of the IDSS, which is an<br>integrated operating room system that controls video displays,<br>observation cameras, audio video equipment, teleconferencing<br>and the routing of videos and images from multiple sources to<br>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.

K133413

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<br>and Effectiveness: | Testing and evaluation indicate that the system meets the needs<br>of the users of the device and does not raise any new safety and<br>efficacy of the predicate device. The IDSS conforms to the<br>EN 60601-1 “Medical Electrical Equipment- Part 1-2 General<br>requirement for safety.<br>EN 60601-1-2:2007 “Medical Electrical Equipment- Part 1-2<br>General requirement for safety- Collateral Standard:<br>Electromagnetic compatibility- requirement and test.<br>CAN/CSA-C22.2 NO. 601.1 -Medical Electrical Equipment<br>Part 1, General Requirements for Safety, Adopted IEC601-1<br>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 [phone] or [phone] 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 [phone] or [phone] 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<br>O=U.S. Government,<br>OU=HHS, OU=FDA, OU=People,<br>CN=Long H. Chen -A<br>0.9.2342.19200300.100.1.1=1300369<br>Date: 2014.01.02 14:40:06 -05'00' |

Page __ of _

4-1