(53 days)
The PeriPro™ Patch is indicated for cardiac and vascular reconstruction and repair. This may include intra-cardiac patching and peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial arteries and arteriovenous access revisions.
Not Found
I am sorry, but the provided text from the FDA 510(k) K052416 document for the PeriPro™ Patch does not contain any information regarding the acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or study methodologies that you have requested.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It specifies the product's indications for use but does not detail the studies conducted to establish its safety and effectiveness or how specific performance criteria were met.
Therefore, I cannot provide the requested table and information based on the text provided.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hancock Jaffe Laboratories, Inc. c/o Ms. Sue Montoya Vice President of Operations and RA/QA 2807 McGaw Avenue Irvine. CA 92614
Re: K052416 PeriPro™ Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Made of Polypropylene, PETP, or PTFE Regulatory Class: Class II (Two) Product Code: DXZ Dated: August 31, 2005 Received: September 2, 2005
Dear Ms. Montoya:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced and ve and nave action legally marketed predicate devices marketed in interstate for use stated in the encrosare) to regions and the Medical Device Amendments, or 10 comineres province with the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act (Act that do not require approval application (PMA). and Cosmetic Act (71ct) that ac not request of the general controls provisions of the Act. The r ou may, merclore, maner of the Act include requirements for annual registration, listing of general control.s provisions of wactice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is elassined (600 as ofrols. Existing major regulations affecting your device can may be nabyee to suer as sueral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obao neements concerning your device in the Federal Register.
OCT 2 5 2005
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Page 2 - Ms. Sue Montoya
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act 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 sct 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) 276-0120. 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/industry/support/index.html.
Sincerely yours,
ivina R. Vihuri
- A 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): K052416
Device Name:
Indications for Use:
The PeriPro™ Patch is indicated for cardiac and vascular reconstruction and repair. This may include intra-cardiac patching and peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial arteries and arteriovenous access revisions.
PeriPro™ will be restricted to sale by or on the order of physician (or properly licensed practitioner).
Duna R. Richner
vision Sign-Off) ision of Cardiovascular Devices
َيَكَ الاَدَ جَ الاَ (k) Number
§ 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).