(202 days)
GraftPatch® Rapi-Seal™ Patch, Biosynthetic Surgical Mesh, Peri-Guard® family of products, Glycar Tissue Repair Patch
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen patch, with no mention of AI or ML.
Yes
The device is intended for the surgical repair of damaged or ruptured soft tissue membranes and is used in various soft tissue repair procedures, indicating a therapeutic purpose.
No
The device, Permacol™, is described as a soft tissue patch intended for repair and reinforcement of soft tissue, not for diagnosing conditions.
No
The device description clearly states that Permacol™ is a "sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin," indicating it is a physical 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 clearly describes a surgical patch used to reinforce soft tissue and repair damaged membranes. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical patch made of biological material (porcine dermal collagen and elastin).
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are used for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and clinical outcomes related to the surgical repair, not on diagnostic accuracy or analytical performance.
In summary, Permacol™ is a surgical implant used for structural repair, not a device used to perform tests on biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling.
Product codes
FTL
Device Description
Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal, inquinal, diaphragmatic, femoral, scrotal, umbilical, incisional, colon, rectal, urethral, vaginal, pelvic floor
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)
Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1. The product passed all of the following tests: Hemolysis Cytotoxicity - elution method Acute Systemic Toxicity Implantation/Subchronic Toxicity Genotoxicity - Ames Mutagenesis Genotoxicity - Bone Marrow Micronucleus Genotoxicity - Mouse Lymphoma Mutagenesis Sensitization-Magnusson and Kligman Pyrogenicity. In addition to standard biocompatibility testing, a histological evaluation of the material after implantation in rats for 6 months demonstrated that Permacol™ is safe and well tolerated. Clinical experience in several hundred patients in Europe also has demonstrated that Permacol™ is safe and well tolerated. Case histories for 60 patients undergoing a variety of soft tissue repair procedures demonstrate that Permacol™ is easy to handle, and successful clinical outcomes were achieved in nearly all cases. No product-related adverse effects were noted in any of the procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GraftPatch® Rapi-Seal™ Patch Biosynthetic Surgical Mesh Peri-Guard® family of products Glycar Tissue Repair Patch
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission
FEB 1 7 2000
510(k) Summary
Sponsor: Tissue Science Laboratories, PLC Grevholme House Victoria Road Aldershot Hants GU11 1SJ United Kingdom
Contact Person:
Dr. Allison F. Wren The Wren Group 7124 La Jolla Blvd La Jolla CA 92037 Tel: (619) 454-6260 Fax: (619) 454-2508 E-mail: TheWrenGrp@aol.com
or
Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: (202) 637-5813 Fax: (202) 637-5910 E-mail: hmholstein@hhlaw.com
- Submission July 31, 1999 Date:
- Device Name: Permacol™
- Classification: Polymeric Surgical Mesh
Predicate Devices:
GraftPatch® Rapi-Seal™ Patch Biosynthetic Surgical Mesh Peri-Guard® family of products Glycar Tissue Repair Patch
1
Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission
Device Description: Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin Intended Use: Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling. Substantial Equivalence: Permacol™ is substantially equivalent to the predicate devices in terms of its intended use, specific indications, and performance. There are minor differences in the technological characteristics, but laboratory and animal testing as well as clinical experience have shown that these do not raise any new concerns of either safety or effectiveness. Safetv Evaluation: Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1. The product passed all of the following tests: Hemolysis Cytotoxicity - elution method Acute Systemic Toxicity Implantation/Subchronic Toxicity Genotoxicity - Ames Mutagenesis Genotoxicity - Bone Marrow Micronucleus Genotoxicity - Mouse Lymphoma Mutagenesis Sensitization-Magnusson and Kligman Pyrogenicity
2
2
| | Permacol™ Porcine Collagen Surgical Mesh
510(k) Premarket Notification Submission |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In addition to standard biocompatibility testing, a histological
evaluation of the material after implantation in rats for 6
months demonstrated that Permacol™ is safe and well
tolerated. |
| Clinical
Evaluation: | Clinical experience in several hundred patients in Europe
also has demonstrated that Permacol™ is safe and well
tolerated. Case histories for 60 patients undergoing a
variety of soft tissue repair procedures demonstrate that
Permacol™ is easy to handle, and successful clinical
outcomes were achieved in nearly all cases. No
product-related adverse effects were noted in any of the
procedures. |
| Conclusions
Drawn: | Permacol™ is biocompatible, safe and effective for its |
intended use.
\\DC - 59177/1 - 0790126.01
The Wren Group on Behalf of Tissue Science Laboratories, PLC Aldershot, UK
:
.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping lines that form a shape similar to a bird in flight or a stylized human figure.
Public Health Service
FEB 1 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tissue Science Laboratories, PLC c/o Mr. Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, D.C. 20004
K992556 Re: Trade Name: Permacol™ Regulatory Class: II Product Code: FTL Dated: December 22, 1999 Received: December 22, 1999
Dear Mr. Holstein:
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.
4
Page 2 - Mr. Howard M. Holstein, Esq.
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) 594-4595. 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,
Neil K.R. Ogden
ದ್ದಾಗಿ 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
5
| 510(k) Number (if known): | K992556 |
|---|---|
| Device Name: | Permacol™ |
Indications for Use:
Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.
| NRO for JZD | |
|---|---|
| (Division Sign-Off | |
| Division of General Devices | |
| 510(k) Number | K992556 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
| Prescription Use | |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
Over-The-Counter
(Optional Format 1 - 2.96) (Form prepared by The Wren Group)