K Number
K012098
Device Name
PRECLUDE PERICARDIAL MEMBRANE
Date Cleared
2001-09-20

(77 days)

Product Code
Regulation Number
870.3470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For reconstruction and repair of the pericardium
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of < 1 µm. The device is in sheet configuration with a variety of width and length dimensions.
More Information

Not Found

No
The device description and performance studies focus on the material properties and clinical outcomes of ePTFE, with no mention of AI or ML.

No.
The device is a reconstructive material for the pericardium, indicated for physical repair rather than treating a disease or condition.

No
The device is described as an ePTFE material for reconstruction and repair of the pericardium, which is a therapeutic function, not a diagnostic one.

No

The device description clearly states it is a physical material (expanded polytetrafluoroethylene) in sheet configuration, indicating it is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "For reconstruction and repair of the pericardium." This describes a surgical implant used in vivo (within the body) to repair tissue.
  • Device Description: The device is a "Biocompatible, expanded polytetrafluoroethylene (ePTFE)" sheet. This is a material used for surgical implants.
  • Anatomical Site: The anatomical site is the "pericardium," which is a structure within the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to be used in vitro to analyze biological samples. This device is clearly intended for direct surgical implantation in vivo.

N/A

Intended Use / Indications for Use

For reconstruction and repair of the pericardium

Product codes

DXZ

Device Description

Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of

§ 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).

0

SEP 2 0 2001

Attachment 4

510 (k) Premarket Notification

PRECLUDE® Pericardial Membrane

Premarket Notification 510(k) Summary

  • A. Submitted By: W.L. Gore & Associates, Inc. P.O. Box 500 Flaqstaff, AZ 86002-0500
    Date Prepared: September 17, 2001

Contact : R. Larry Pratt

Phone: 928-779-2771

  • PRECLUDE® Pericardial Membrane Device Name: B.
  • c. Applicant Device Description:

Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of