(78 days)
Not Found
No
The device description focuses on the material properties and biological processing of the patch, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance study is an animal study evaluating biocompatibility, not algorithmic performance.
Yes
The device is intended for "repair of carotid endarterectomy and vascular patch grafting," which is a medical treatment for a disease or injury.
No
The device is described as a patch for repair, which is a therapeutic function, not a diagnostic one. It is implanted to address a condition rather than to identify or characterize it.
No
The device description clearly states it is made of glutaraldehyde fixed bovine pericardium, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For repair of carotid endarterectomy and vascular patch grafting." This describes a surgical procedure performed in vivo (within the living body) to repair blood vessels.
- Device Description: The device is a physical patch made of bovine pericardium, designed to be implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health or condition. This device does not perform any such analysis.
The device described is a surgical implant used for vascular repair, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
For repair of carotid endarterectomy and vascular patch grafting.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher evel of biocompatibility.
The non clinical /Animal testing data showed that the Shelhigh No-React® VascuPatch™. has higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The VascuPatch™ is identical to the Shelhigh No-React® pericardial patch, thus is substantially equivalent to the predicate device.
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
OCT 28 1998
Class II 510(K) Summary Shelhigh No-React® VASCUPATCH™
This summary of the 510(k) information is being submitted as required by section 807.92(a).
Proprietary and Common Name: 1.
Shelhigh No-React® VascuPatch™ Proprietary name:
Common name: Cardiovascular patch
II. Regulatory Class:
Class II device
III. Intended Use
For repair of carotid endarterectomy and vascular patch grafting.
Product Description IV.
The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
V. Substantial Equivalence
The Shelhigh No-React® VascuPatch™ is equivalent to the Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496 and identical to the Shelhigh No-React® pericardial patch K974914 currently manufactured by Shelhigh Inc.
VI. Comparison with Predicate Device
The Shelhigh No-React® VascuPatch™, like the Shelhigh No-React® pericardial patch is a glutaraldehyde cross-linked bovine pericardium membrane which
1
exhibits substantially equivalent physical/mechnical properties as measured by suture retention, tensile strength, and shrink temperature. They both have identical flexibility, wall thickness and both are stored in bezyle alcohol.
VII.Nonclinical / Animal Tests
An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher evel of biocompatibility.
VIII. Conclusions
l
The non clinical /Animal testing data showed that the Shelhigh No-React® VascuPatch™. has higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The VascuPatch™ is identical to the Shelhigh No-React® pericardial patch, thus is substantially equivalent to the predicate device.
Page 2 of 2 of Summary
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of a human figure. The figure is composed of three curved lines that form the shape of a person in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
OCT 28 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shlomo Gabbay, M.D. Chief Scientific Advisor Shelhigh, Inc. P.O. Box 884 Millburn, NJ 07041
Re : K982810 Shelhigh No-React® VASCUPATCH™ Regulatory Class: II Product Code: DXZ Dated: July 15, 1998 Received: August 11, 1998
Dear Dr. Gabbay:
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 legally marketed predicate 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. All references to the No-React® treatment or to animal studies regarding said treatment in the labeling or promotional materials/advertisements must be immediately followed by a statement that no clinical data are available which evaluate the long term impact of the detoxification treatment in humans.
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Shlomo Gabbay, M.D.
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.
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of of 1 _
510(k) Number (if known): 长982810
Device Name: Shelhigh No-React® VASCUPATCH™ Indications For Use:
For repair of carotid endarterectomy and vascular patch grafting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) V2
Selli Camper le (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ ≤ 98 28 1(2
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)