(72 days)
P890045
No
The description focuses on the material properties and physical characteristics of a vascular patch, with no mention of AI/ML algorithms or data processing.
Yes.
The device is used for vascular patch grafting and intracardiac patching, which are medical treatments for disease or injury.
No
Explanation: The device is a surgical fabric used for patching in vascular and intracardiac procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical fabric patch made of knitted polyester and gelatin, intended for surgical implantation. It is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for vascular and intracardiac patching, which are surgical procedures performed in vivo (within the body). IVDs are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a fabric patch designed for implantation. This is consistent with a surgical implant, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological specimens.
Therefore, the Vascutek Cardiovascular Fabric is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vascutek Cardiovascular Fabric is indicated for vascular patch grafting and for intracardiac patching. The Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.
Product codes
Not Found
Device Description
The Vascutek Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each patch product line is gelatin-sealed, knitted polyester, with a base fabric porosity of 1460 ml/min/cm2, 2118 ml/min/cm2 and 3515 ml/min/cm² respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a family of cardiovascular patches that do not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. The gelatin has been shown to be safe and effective through the approval of the Vascutek Gelseal™ Vascular Graft, PMA# P890045 on January 11, 1993.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular, cardiac, carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comprehensive in-vitro performance testing has been performed on Vascutek Cardiovascular Fabric. In-vitro performance testing performed on the Vascutek Gelseal™, Gelsoft™, and Thin Wall Carotid patches and the Meadox Hemashield Microvel Double Velour Fabric, which included burst strength, suture retention, tensile strength and water porosity, provides evidence that Vascutek Cardiovascular Fabric is substantially equivalent to the predicate fabric. Previously accepted animal testing has demonstrated acceptable in-vivo performance for the Vascutek Cardiovascular Fabric gelatin-sealed polyester material.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
P890045
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
1 ARRINGSON (ASSESS VASCUTEK CARDIOVASCULAR FABRIC
K 9635011
Image /page/0/Picture/1 description: The image shows the logo for CarboMedics, a company of Sulzer Medica. The logo features a black hexagon shape on the left, followed by the company name in a bold, stylized font. Below the company name, in a smaller font, is the text "A company of SULZERmedica".
1300 EAST ANDERSON LANE, AUSTIN, TEXAS 78752-1793 T
The Vascutek Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each patch product line is gelatin-sealed, knitted polyester, with a base fabric porosity of 1460 ml/min/cm2, 2118 ml/min/cm2 and 3515 ml/min/cm² respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a family of cardiovascular patches that do not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. The gelatin has been shown to be safe and effective through the approval of the Vascutek Gelseal™ Vascular Graft, PMA# P890045 on January 11, 1993.
Vascutek Cardiovascular Fabric is indicated for vascular patch grafting and for intracardiac The Thin Wall Carotid Patch is, in addition, indicated for patch closure after patching. endarterectorny, particularly of the carotid arteries. Vascutek Cardiovascular Fabric is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. This polyester material and gelatin sealant have been thoroughly tested and characterized with regard to biocompatibility and suitability for their intended use. Vascutek Cardiovascular Fabric is supplied sterilization used is Ethylene Oxide. A shelf-life of 4 years has been established.
Comprehensive in-vitro performance testing has been performed on Vascutek Cardiovascular Fabric. In-vitro performance testing performed on the Vascutek Gelseal™, Gelsoft™, and Thin Wall Carotid patches and the Meadox Hemashield Microvel Double Velour Fabric, which included burst strength, suture retention, tensile strength and water porosity, provides evidence that Vascutek Cardiovascular Fabric is substantially equivalent to the predicate fabric. Previously accepted animal testing has demonstrated acceptable in-vivo performance for the Vascutek Cardiovascular Fabric gelatin-sealed polyester material.
CarboMedics considers Vascutek Cardiovascular Fabric safe, effective and substantially equivalent in intended use, material (polyester and sealant), and function to the Meadox Hemashield® Microvel® Double Velour Fabric which received marketing clearance on May 27, 1993 under 510(k) K931386.
| Common name of the device: | Cardiovascular Patch |
|---|---|
| Trade name of Proprietary name: | Vascutek Cardiovascular Fabric: |
| Vascutek Gelseal™ Patch | |
| Vascutek Gelsoft™ Patch | |
| Vascutek Thin Wall Carotid Patch | |
| Submitter and contact person: | Teena M. Augostino, Manager, Regulatory Affairs |
| 1300 E. Anderson Lane, Austin, TX 78752 | |
| Phone: (512) 435-3225 Fax: (512) 435-3350 | |
| Submission Submitted on: | September 6, 1996 |
NOV 21 1996