(199 days)
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.
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.
The provided 510(k) summary for the PFA Vascular Patch (K041736) does not contain a typical acceptance criteria table and reported device performance in the manner often seen for diagnostic or AI-driven medical devices. Instead, the testing described relates to the physical and biological characteristics of the vascular patch itself, comparing it to a predicate device. This is a Class II medical device, and the evaluation focuses on substantial equivalence for safety and effectiveness based on material properties and in vivo performance, rather than algorithm-driven metrics.
Therefore, the requested information elements related to AI-driven device performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't present a formalized table of acceptance criteria with numerical targets. Instead, it describes general product specifications and reports on the results of testing designed to demonstrate conformance and equivalence to a predicate device.
| Test Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Conformance to product specification (not detailed numerically) | Tested for failure tension, stiffness, relax slope, suture pull out strength, extensibility, fatigue tension, and creep tests. (Results not explicitly quantified, but implied to be acceptable for substantial equivalence) |
| In Vivo Animal Testing | No significant adverse events, patency, no aneurysm, no difference in inflammatory reaction, no neointimal hyperplasia or scarring compared to control device. | All vessels patent, no stenosis, no aneurysm formation, no difference in inflammatory reaction between groups, no neointimal hyperplasia or scarring in animals with PFA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for In Vivo Study: "PFA patches and control patches were implanted in canines." The exact number of canines or patches implanted is not specified in the summary.
- Data Provenance: The in vivo study was conducted on canines, an animal model. This is a prospective animal study, not retrospective human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This concept is not applicable as the testing involves physical material properties and animal in-vivo response, not a diagnostic interpretation requiring expert consensus. The "ground truth" here would be the direct observation of mechanical properties and histological examination or patency assessments in the animal model. The qualifications of the individuals performing these assessments are not specified, but would typically be engineers (for mechanical tests) and veterinarians/pathologists (for animal studies).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or decision-making performance being evaluated that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device aims to assist or replace that interpretation. The PFA Vascular Patch is an implantable surgical patch, not a diagnostic device.
6. Standalone Performance Study (Algorithm Only)
No, a standalone performance study was not done. The PFA Vascular Patch is a physical implant, not an algorithm.
7. Type of Ground Truth Used
- Mechanical Strength: The ground truth for mechanical strength testing is derived from direct measurements of material properties under defined conditions.
- In Vivo Animal Testing: The ground truth for the in vivo animal study was established through direct observation and histological examination of the implanted vessels. This includes patency checks, assessment for stenosis, aneurysm formation, inflammation, neointimal hyperplasia, and scarring.
8. Sample Size for the Training Set
Not applicable. The PFA Vascular Patch is a physical medical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of Substantial Equivalence and Rationale for Clearance:
The PFA Vascular Patch received 510(k) clearance based on its substantial equivalence to the predicate device, Vascu-Guard Peripheral Vascular Patch (K942010). The rationale for this determination, as stated in the submission, is that the two devices share:
- Identical Indications for Use: Peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
- Basic Overall Function: Providing a patch for vessel repair or pledget/buttress for sutures.
- Methods of Manufacturing: Implied to be similar enough not to raise new safety/effectiveness concerns.
- Materials Used: "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." This implies the raw bovine tissue and cross-linking agents are similar or well-established in similar devices.
The testing performed (mechanical and in vivo animal studies) aimed to demonstrate that despite any minor differences, the PFA Vascular Patch performs equally safely and effectively for its intended use as the predicate device. The results reported (e.g., patency, no stenosis, no aneurysm, no inflammatory difference) supported this claim of substantial equivalence.
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510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | PFA Vascular Patch |
| Submitter | Peritec Biosciences LTD3291 Bremerton RoadCleveland, OH 44124Tel: 216-595-9178 |
| Contact | Robert M. DicksonPresident & 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
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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.
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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
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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
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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
§ 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).