← Back to catalogue

IDSS SLC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133413

by Black Diamond Video, Inc.

Identifiers

510(k) Number
K133413 FDA 510(k)
FDA Product Code
FTA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4580 FDA 510(k)
Regulation Number
878.4580 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IDSS SLC is a Surgical Light, Accessory (OpenFDA classification: FTA) designed for integration into surgical environments. It serves as a component for remote control of surgical lighting systems, enabling precise illumination adjustments during procedures. The device supports high-resolution video routing when paired with compatible 4K hardware within the Integrated Digital Surgical Suite (IDSS) system.

This accessory is intended for use within an integrated surgical suite, facilitating remote control of surgical lights and supporting video routing functionalities. It is classified as a Class II device under FDA regulations (878.4580) and holds a 510(k) clearance (K133413) for substantial equivalence. The IDSS SLC is not described as single-use or sterile but is regulated under the FDA’s 510(k) pathway for traditional clearance in the advisory committee for General Plastic Surgery.

Frequently asked questions

What is the primary purpose of the IDSS SLC in a surgical setting?

The IDSS SLC is designed as a Surgical Light Accessory (FTA) to integrate with surgical lighting systems, enabling remote control of illumination adjustments during procedures. It also supports high-resolution video routing when paired with compatible 4K hardware within the Integrated Digital Surgical Suite (IDSS) system, enhancing surgical workflows by providing flexible lighting and video management.

Is the IDSS SLC intended for single-use or reusable applications?

The device description does not specify whether the IDSS SLC is single-use or reusable. Since it is not labeled as sterile or intended for single-use, it should be handled according to standard institutional protocols for reusable surgical accessories, which typically involve cleaning, disinfection, and sterilization as needed.

How is the IDSS SLC regulated by the FDA, and what does this mean for buyers?

The IDSS SLC holds a 510(k) clearance (K133413) under the FDA’s 510(k) pathway, demonstrating substantial equivalence to a predicate device. This means it has undergone FDA review and is classified as a Class II device under the product code FTA (Surgical Light, Accessories) and regulation 878.4580. Buyers can rely on this clearance as evidence of compliance with FDA requirements for safety and performance, though they should verify the latest regulatory status directly with the manufacturer or FDA records.

What types of surgical environments or specialties is the IDSS SLC intended for?

The IDSS SLC is designed for use within an integrated surgical suite and is associated with the General, Plastic Surgery advisory committee in its regulatory filing. While it is not explicitly limited to plastic surgery, its integration with surgical lighting systems and video routing capabilities makes it particularly useful in operating rooms where precise illumination and remote control are critical, such as in plastic surgery, general surgery, or other specialties requiring advanced lighting solutions.

How should the IDSS SLC be stored to maintain its functionality?

The device description does not provide specific storage instructions, but since it is not labeled as sterile or single-use, it should be stored in a clean, dry environment protected from physical damage, moisture, and extreme temperatures. Follow manufacturer guidelines or institutional protocols for reusable medical devices to ensure optimal performance and longevity, particularly if it is part of a larger surgical system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RevMed Marketplace | Connecting the Dots, Black Diamond Video - BDV Black Diamond Video - PDF ... - MedicalExpo, Na - Beudamed, Integrated operating room - IDSS - BDV Black Diamond Video

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Black Diamond Video, Inc.
FDA Applicant
Black Diamond Video

Sources (1)

  • FDA 510(k) K133413 24 fields · synced Sep 19, 2026