(70 days)
Not Found
No
The device description focuses on the material properties and biological processing of the tissue repair patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a tissue repair patch used for surgical repair of various soft tissue deficiencies, which directly addresses disease or injury by repairing or replacing tissue.
No
The device is a tissue repair patch used for surgical repair of deficiencies, not for diagnosing conditions.
No
The device description clearly states it is a "Tissue repair patch" made of "glutaraldehyde fixed bovine pericardium," indicating it is a physical implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical repair of soft tissue deficiencies. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a tissue repair patch made of bovine pericardium. This is a physical implant used for structural support and repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are designed to perform tests on biological samples to provide diagnostic information. This device is a surgical implant used for physical repair.
N/A
Intended Use / Indications for Use
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inquinal, lumbar, and umbilical hernia.
Product codes
FTM
Device Description
The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine 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
abdominal wall, thoracic wall, gastric, rectal, vaginal, urethra, pelvic floor, diaphragm, femoral, incisional, inquinal, lumbar, umbilical
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-Reac® patch shows higher evel of biocompatibility. The non clinical /Animal testing data showed that the Shelhigh No-React®Tissue repair patch/ UroPatch™. has higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The UroPatch™ is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Class II 510(K) Summary Shelhigh No-React® UROPATCH™
This summary of the 510(k) information is being submitted as required by section 807.92(a).
1. Proprietary and Common Name:
Shelhigh No-React® Tissue repair patch; Proprietary name:
UroPatch™
Mesh , surgical Common name:
II. Regulatory Class:
Class II device
III. Intended Use
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inquinal, lumbar, and umbilical hernia.
IV. Product_Description
The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine 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® Tissue repair patch/UroPatch™ is equivalent to the Shelhigh No-React® pericardial patch K974914, and K981756 currently manufactured by Shelhigh Inc.
1
VI. Comparison with Predicate Device
The Shelhigh No-React® Tissue repair patch/UroPatch™. like the Shelhigh No-React® pericardial patch is a glutaraldehyde cross-linked bovine pericardium membrane which 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-Reac® patch shows higher evel of biocompatibility.
VIII. Conclusions
The non clinical /Animal testing data showed that the Shelhigh No-React®Tissue repair patch/ UroPatch™. has higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The UroPatch™ is substantially equivalent to the predicate device.
Page 2 of 2 of Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines extending from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Shlomo Gabbay, M.D. Chief Scientific Advisor Shelhigh, Inc. 67 E. Willow Street Millburn, New Jersey 07041
K991567 Re:
Trade Name: No-React® Tissue Repair Patch/UroPatch Regulatory Class: II Product Code: FTM Dated: May 3, 1999 Received: May 5, 1999
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 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 requirement, 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 assumptions. Failure to comply with the GMP regulation may result in regulatory 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 - Shlomo Gabbay, M.D.
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 vour 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) 594-4595. 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,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _1_of 1__1
510(k) Number (if known): _ (99156 7
Device Name: Shelhigh No-React® Tissue repair patch/UROPATCH™ Indications For Use:
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Re
| 510(k) Number | K971567 |
|---|---|
| --------------- | --------- |
| Prescription Use
21CFR 801.109) | X | OR | Over-The-Counter Use (Per
(Optional Format 1-2-96)) |
| ------------------------------------ | -------------- | ---- | -------------------------------------------------------- |
|---|