(53 days)
Not Found
Not Found
No
The provided 510(k) summary describes a patch for cardiac and vascular repair and reconstruction. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the material and intended use of the patch itself.
Yes
The device is indicated for "cardiac and vascular reconstruction and repair," which are therapeutic interventions aimed at restoring function or structure.
No
The device, PeriPro™ Patch, is indicated for cardiac and vascular reconstruction and repair, which describes a therapeutic or reparative function, not a diagnostic one.
No
The summary describes a "PeriPro™ Patch," which is a physical device used for surgical reconstruction and repair. There is no mention of software as the primary or sole component.
Based on the provided information, the PeriPro™ Patch is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "cardiac and vascular reconstruction and repair." This describes a device used in vivo (within the body) for surgical procedures.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of IVD Activities: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the core function of an IVD.
- Anatomical Site: The anatomical sites are internal organs and blood vessels, consistent with an in vivo device.
- Intended User: The intended user is a physician, consistent with a surgical device.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PeriPro™ Patch's function is to physically repair or reconstruct tissues within the body, which is not the role of an IVD.
N/A
Intended Use / 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).
Product codes
DXZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cardiac, vascular (carotid, renal, iliac, femoral, profunda and tibial arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (or properly licensed practitioner)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
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
1
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
2
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