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K Number
K982409
Device Name
VES 1501-M
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-08-21

(42 days)

Product Code
FWF
Regulation Number
878.4160
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "VES 1501-M Video Endoscopic System." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of new clinical efficacy or performance studies with acceptance criteria for the new device itself.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:

  1. A table of acceptance criteria and the reported device performance: The letter states the device is substantially equivalent to a predicate, not that it met specific performance criteria from a new study.
  2. Sample size used for the test set and the data provenance: No new test set data is discussed.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. The letter does not mention such a study.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a video endoscopic system, not an AI algorithm.
  7. The type of ground truth used: Not applicable as no new study data is presented.
  8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no new training data is mentioned.
  9. How the ground truth for the training set was established: Not applicable.

The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and intended use. It does not typically involve the presentation of new efficacy studies with defined acceptance criteria in the same way a Premarket Approval (PMA) application might.

§ 878.4160 Surgical camera and accessories.

(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.