(9 days)
Not Found
No
The summary describes a surgical implant made of porcine dermal collagen mesh and does not mention any AI or ML components or functionalities.
No
The device is a surgical implant intended to reinforce soft tissue, which is a structural or supportive function rather than a therapeutic one (i.e., treating a disease or condition).
No
This device is a surgical implant designed to reinforce soft tissue, not to diagnose a condition. Its function is to repair, not to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a "Crosslinked Porcine Dermal Collagen Mesh," which is a physical implant, 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 to "reinforce soft tissue where weakness exists or ruptured soft tissue membranes," specifically for "repair of abdominal wall defects and hernias." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The device is described as a "Crosslinked Porcine Dermal Collagen Mesh," which is a material used for surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples outside the body.
Therefore, Permacol® Surgical Implant is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce Permiacol® Surgical implant is intensed or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias. Permacol® is intended of use as a soft tissue patch to reinforce soft tissue where weakness exists Pennacol® is intended of ass a box or ruptured soft tissue membranes. It is specifically alld for the surgical repair of damages wall defects and hernias, including but not limited to parastomal hernias.
Product codes
FTL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Permacol® Surgical Implant for its intended use. The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues manufacture of the device are non toxic and new teen tresults demonstrate that the materials materials consistent with then michded use. Laboratory termacol® Surgical Implant will meet chosen and the design unfized in manufacturing i critation of tormance during their intended use.
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
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
K043366$_{Pi/2}$
510(k) SUMMARY
DEC 17 2004
Tissue Science Laboratories, plc's Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Victoria Taylor Tissue Science Laboratories, plc 1141 Clark Street, Suite D Covington, GA 30014 Phone: (678) 342-7808 (678) 342-7844 Fax: Email: vtaylor@tissuescience.com
Contact Person: Victoria Taylor
December 06, 2004 Date Prepared:
Name of Device and Name/Address of Sponsor
Tissue Science Laboratories, plc 7th Floor, Victoria House Victoria Road Aldershot Hampshire GU111 1EJ United Kingdom
Common or Usual Name
Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
Permacol® Crosslinked Porcine Dermal Coilagen Surgical Mesh (K992556), BioSugar Sungers (19), Cross 110), Box 1002162), Cook Biotech 1 V ascular Inc S Supple Felf-Guard® (11705163).
SurgiSIS™ (K980431) and Bard's® CK Parastomal Hernia Patch (K042026).
Intended Use
Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce Permiacol® Surgical implant is intensed or ruptured soft tissue
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P2/2
membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
Technological Characteristics and Substantial Equivalence
Permacol® is substantially equivalent to its predicates because it has the same intended use and very similary equivalent with to tax to the soft tiseve intended use and very simmal teenge of surgical procedures for soft tissues and are intended for use in a broad fange of saige of saige of Sarge of Service, includes include repairremforcement. Permacol® and Burd 50 Corrent wall defects and hernias, including parastomal hernias.
The technological characteristics of Permacol® are very similar to its predicate The technological characteristics of I climits on I cimensions, technological characteristics, and thickness.
Performance Data
Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Permacol® Surgical Implant for its intended use.
The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues manufacture of the device are non toxic and new teen tresults demonstrate that the materials materials consistent with then michded use. Laboratory termacol® Surgical Implant will meet chosen and the design unfized in manufacturing i critation of tormance during their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines above a wavy line.
Public Health Service
DEC 17 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Victoria Taylor Associate Director of Regulatory Affairs Tissue Science Laboratories plc North American Division 1141 Clark Street, Suite D Covington, Georgia 30014
Re: K043366
Trade/Device Name: Permacol® Surgical Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: December 6, 2004 Received: December 8, 2004
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave rowled above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 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) that do not require approval of a premarket approval application (PMA). and cosmetie fore, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Victoria Taylor
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with and my of substantial equivalence of your device 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Miriam C. Provost
( ol Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K043366
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Permacol® Surgical Implant Device Name:
Indications for Use:
Permacol® is intended of use as a soft tissue patch to reinforce soft tissue where weakness exists Pennacol® is intended of ass a box or ruptured soft tissue membranes. It is specifically alld for the surgical repair of damages wall defects and hernias, including but not limited to parastomal hernias.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K643366
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