(336 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a bovine pericardial patch, with no mention of AI or ML technology.
No.
The device is a patch material used for repair and buttressing of tissues, not for treating a disease or condition itself.
No
The device is described as a "patch for intracardiac, great vessel, valve repair and suture line buttressing," indicating it is used for treatment and repair, not diagnosis.
No
The device description explicitly states that CV Peri-Guard™ is composed of bovine pericardium, which is a physical material, not software. The intended use also describes a physical patch for surgical repair.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a patch for surgical repair of various anatomical structures within the cardiovascular system (intracardiac, great vessels, valves, etc.). This is a surgical implant used directly on the patient's body.
- Device Description: The description confirms it's a physical patch made of bovine pericardium.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is a surgical implant, not a diagnostic tool used on patient samples.
N/A
Intended Use / Indications for Use
CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress).
CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac, great vessel, valve, atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft, ventricular septal defect (VSD), ventricular aneurysm, aortic graft, septal defect and annulus.
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Calcification Studies: Peri-Guard has been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode. Peri-Guard and Supple Peri-Guard have demonstrated clinical insignificant calcification and significantly less calcification that either a glutaraldehyde-treated control or a competitor's bovine pericardial patch product. Additionally, Peri-Guard has been evaluated clinically in the mittal valve annulus position, and other intracardiac patch positions, and has demonstrated no calcification related to the Peri-Guard patch up to a mean of 17 months post-op.
Canine Studies: A Canine implant study show that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo.
Clinical Report: The clinical data, gathered under the Peri-Guard Retrospective study protocol, demonstrated that our bovine material performed safe and effectively, and in a substantially equivalent fashion to alternative intracardiac and great vessel patch materials.
History of Safety and Effectiveness: Peri-Guard (and thus CV Peri-Guard) processed bovine pericardium has been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications.
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.
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.
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
K91726
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant Name & Address: Bio-Vascular, Inc., 2575 University Ave.,St. Paul, MN 55114-1024 | |
---|---|
Contact: | Barbara Atzenhoefer, Regulatory Affairs Manager |
Date Prepared: | May 7, 1997 |
Common or Usual Name: | Cardiovascular patch |
Device Classification Name: | Intracardiac and Great Vessel Repair |
Substantial Equivilance: | Gore-Tex Cardiovascular Patch, Peri-Guard and Vascu-Guard |
Device Description:
CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.
Statement of Intended Use:
CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress).
Summary/Comparison of Technological Characteristics:
We maintain that CV Peri-Guard™ is substantially equivalent to the predicate devices and that the extended indication for use in intracardiac and great vessel repair does not pose new questions of safety and effectiveness. This claim of substantial equivalence is based upon the following elements.
1.Configuration
The additional sizes of CV Peri-Guard are configured for intracardiac and great vessel repair and are substantially equivalent to those sold by the predicate device.
2.Extension of Indications (Labeling)
Processed bovine pericardium and the material used in the predicate device have a history of being used in similar prosthetic applications. The material used in CV Peri-Guard is already indicated for pericardial closure and repair of soft tissue deficiencies. As summarized below and discussed earlier, we have shown that extension of these indications to include intracardiac and great vessel repair does not pose new questions of safety and effectiveness.
3.Physical/Mechanical Properties
The physical and mechanical properties critical for performance as an intracardiac and great vessel patch are substantially equivalent between CV Peri-Guard and the predicate device.
1
4. Biocompatibility
Processed bovine pericardium has a long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems. The biocompatibility testing summarized herein is consistent with this clinical experience and the nonhemolytic nature of CV Peri-Guard is especially relevant to the intracardiac and great vessel repair indication under consideration in this premarket notification.
5.Calcification Studies
Peri-Guard has been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode. Peri-Guard and Supple Peri-Guard have demonstrated clinical insignificant calcification and significantly less calcification that either a glutaraldehyde-treated control or a competitor's bovine pericardial patch product. Additionally, Peri-Guard has been evaluated clinically in the mittal valve annulus position, and other intracardiac patch positions, and has demonstrated no calcification related to the Peri-Guard patch up to a mean of 17 months post-op.
6.Canine Studies
A Canine implant study show that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo.
7.Clinical Report
The clinical data, gathered under the Peri-Guard Retrospective study protocol, demonstrated that our bovine material performed safe and effectively, and in a substantially equivalent fashion to alternative intracardiac and great vessel patch materials.
8.History of Safety and Effectiveness
Peri-Guard (and thus CV Peri-Guard) processed bovine pericardium has been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Atzenhoefer Regulatory Affairs Manager Bio-Vascular, Inc. 2575 University Avenue Saint Paul, MN 55114-1024
APR 1 0 1998
Re: K971726 CV Peri-Guard - Cardiovascular Patch Regulatory Class: II (Two) Product Code: DXZ Dated: February 11, 1998 March 23, 1998 Received:
Dear Ms. Atzenhoefer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: . General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Barbara Atzenhoefer
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 _of_1
510(k) Number (if known):_K971726
Device Name:_CV Peri-Guard™
Indications For Use: CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bale L. Simperle
(Division Sign-Off) ------Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)