(70 days)
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.
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.
The provided text describes a medical device, the Shelhigh No-React® UROPATCH™, and its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission highlights three key physical/mechanical properties used for comparison with the predicate device. These can be considered the de facto acceptance criteria addressed by the non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|
| Suture Retention | Substantially equivalent |
| Tensile Strength | Substantially equivalent |
| Shrink Temperature | Substantially equivalent |
| Flexibility | Identical |
| Wall Thickness | Identical |
| Biocompatibility (cytocompatibility) | Higher level (vs. conventional glutaraldehyde treated and storage) |
Missing Information:
- Specific quantitative thresholds for "substantially equivalent" or "higher level" for most criteria. The document states they are "substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" and the UroPatch™ has a "higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "animal study" to evaluate biocompatibility.
- Sample Size: Not specified.
- Data Provenance: Animal study. No country of origin is mentioned. Whether it was retrospective or prospective is not explicitly stated, but animal studies are typically prospective.
Missing Information:
- Specific number of animals used in the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the submission describes non-clinical/animal testing, not a study involving human experts establishing ground truth for diagnostic or interpretative tasks.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is an animal study evaluating physical and biological properties of a patch, not a diagnostic device requiring adjudication of human readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not provided and is not applicable to this type of device (a tissue repair patch). MRMC studies are typically for diagnostic imaging devices or AI tools that assist human interpretation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
This information is not provided and is not applicable to this type of device. The device is a physical tissue repair patch, not software or an algorithm.
7. The Type of Ground Truth Used
For the animal study:
- Ground Truth: "Higher level of biocompatibility" compared to a control group ("conventional glutaraldehyde treated patch"). This would likely involve histological assessment, cellular response markers, or other in-vivo biological endpoints. Specifics are not provided.
8. The Sample Size for the Training Set
This information is not applicable as the device is not a machine learning model or an algorithm that requires a training set. The "testing" involved non-clinical and animal studies to demonstrate physical properties and biocompatibility.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of physical/mechanical properties and an animal study for biocompatibility. It does not contain the detailed information typically found in submissions for AI/ML-driven diagnostic devices, which would include extensive data on human expert review, training sets, and specific performance metrics against clinical ground truth.
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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.
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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 Use21CFR 801.109) | X | OR | Over-The-Counter Use (Per(Optional Format 1-2-96)) |
|---|---|---|---|
| ------------------------------------ | -------------- | ---- | -------------------------------------------------------- |
§ 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.