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K Number
K061727
Device Name
GORE PRECLUDE VESSEL GUARD
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
2006-08-07

(49 days)

Product Code
MFX
Regulation Number
870.3470
Type
Traditional
Panel
CV
Reference & Predicate Devices
K984526
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GORE PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the GORE PRECLUDE® Vessel Guard. It outlines the product's classification, contact information, and its intended use. However, it explicitly states that "Performance standards do not currently exist for these devices." Additionally, the document is largely focused on the process of re-categorizing an existing device (GORE ACUSEAL Cardiovascular Patch) for a new indication rather than presenting a study demonstrating its performance against specific acceptance criteria.

Therefore, based on the provided text, I cannot describe acceptance criteria or a study proving the device meets them because:

  • No acceptance criteria are defined: The document clearly states that performance standards do not exist for these devices.
  • No performance study is presented: The submission is for a new indication for an already cleared device, not for a new device requiring a de novo performance study against acceptance criteria. The purpose of the submission is to propose a new indication for a previously cleared product, not to prove its performance through a study.

The document does not contain information related to:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets, data provenance, or study design.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

In summary, the provided content is a regulatory submission for a new indication for an existing medical device, not a performance study documenting acceptance criteria and their fulfillment.

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).