(199 days)
Not Found
No
The device description and intended use focus on a biological patch for surgical repair, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is a patch designed for arterial reconstruction and tissue repair following surgery. Its function is to directly treat or improve physiological function in a diseased or injured part of the body (blood vessels/arteries).
No
The PFA patch is a surgical implant used for reconstruction of blood vessels, not for diagnosing conditions.
No
The device description clearly states it is a physical patch made of bovine tissue, packaged in a vial with a solution, and intended for surgical implantation. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a patch and pledget for use in vivo (within the body) during surgical procedures on peripheral arteries and blood vessels. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device is a tissue patch intended for implantation. This is consistent with a surgical implant, not an IVD.
- Lack of Diagnostic Purpose: The intended use and description do not mention any diagnostic purpose or the analysis of biological samples for diagnostic information.
Therefore, the PFA patch is a surgical device intended for implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines. The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
Product codes
74 DXZ
Device Description
The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes: 0.8 cm x 3.0 cm, 1.0 cm x 8.0 cm, 2.0 cm x 9.0 cm. The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, blood vessels
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing for the following parameters: failure tension, stiffness, relax slope, suture pull out strength, extensibility, fatigue tension, and creep tests. In vivo animal testing comparing the bovine PFA patch to a commercially available arterial patch was conducted. PFA patches and control patches were implanted in canines. All vessels examined were patent with no evidence of stenosis. There was no evidence of aneurysm formation in any vessel and no difference between groups in inflammatory reaction. There was no neointimal hyperplasia or scarring in animals that received the PFA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | PFA Vascular Patch |
| Submitter | Peritec Biosciences LTD |
| 3291 Bremerton Road | |
| Cleveland, OH 44124 | |
| Tel: 216-595-9178 | |
| Contact | Robert M. Dickson |
| President & CEO |
Intended Use
The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines.
Predicate Devices
Vascu-Guard Peripheral Vascular Patch K942010 from Bio-Vascular, Inc.
Device Description
The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes:
0.8 cm x 3.0 cm 1.0 cm x 8.0 cm 2.0 cm x 9.0 cm
The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf
1
carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.
Materials
All materials used in the manufacture of the PFA Vascular Patch are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing for the following parameters: failure tension, stiffness, relax slope, suture pull out strength, extensibility, fatigue tension, and creep tests.
In vivo animal testing comparing the bovine PFA patch to a commercially available arterial patch was conducted. PFA patches and control patches were implanted in canines. All vessels examined were patent with no evidence of stenosis. There was no evidence of aneurysm formation in any vessel and no difference between groups in inflammatory reaction. There was no neointimal hyperplasia or scarring in animals that received the PFA.
Summary of Substantial Equivalence
The PFA Vascular Patch is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
JAN 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PeriTec Biosciences, Ltd. c/o Mr. Robert M. Dickson CEO 3291 Bremerton Road Pepper Pike, OH 44124
Re: K041736
PFA Patch - Vascular Patch (Cellular or Unwashed Version) Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: 74 DXZ Dated: December 12, 2004 Received: December 20, 2004
Dear Mr. Dickson:
We have reviewed your Section 510(k) premarket notification of intent to market the device w Charle forlowed your becement of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to rial 2011 devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controlo profices in the practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is exassinod tion as controls. Existing major regulations affecting your device can may or subject to back access to back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of act hour made a determination that your device complies with other requirements of the Act
3
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna R. Vochner
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) : K041736
Device Name : PFA Patch - Vascular Patch
·
Indications For Use: The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
Over-The-Counter Use AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Lochner
n Sign-Of Division of Cardiovascular Devices
510(k) Number Ko 41730