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K Number
K992442
Device Name
V.T.S., INC. (V.T.-3)
Manufacturer
V.T.S.,INC.
Date Cleared
1999-10-05

(75 days)

Product Code
LKY
Regulation Number
876.5020
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter for the V.T.S., Inc. V.T.-3 device, which describes its indication for use (assisting men with erectile dysfunction to achieve an erection using a vacuum device).

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or details about the test set.
  3. Information on experts, ground truth establishment, or adjudication methods.
  4. Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect sizes.
  5. Results of a standalone algorithm performance study.
  6. The type of ground truth used.
  7. Sample size for the training set or how its ground truth was established.

This document merely grants clearance based on substantial equivalence to a predicate device, as opposed to providing detailed performance study results that would typically be found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

§ 876.5020 External penile rigidity devices.

(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.