(73 days)
Not Found
No
The summary describes a biological tissue patch and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is used for soft tissue repair and reinforcement in plastic and reconstructive surgery, which directly addresses a medical condition or injury.
No
The device, Permacol™, is a soft tissue patch used for repair and reinforcement, not for diagnosing conditions.
No
The device description clearly states it is a physical sheet comprised of acellular crosslinked porcine dermal collagen and elastin, indicating it is a hardware device, 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 states that Permacol™ is for "soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a "sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin." This is a physical material intended for implantation.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Permacol™ is a surgical implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head.
Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue, as a dura mater substitute, or to repair damaged or ruptured soft tissue where weakness exists, such as in plastic and reconstructive surgery of the face and head.
Product codes
FTM
Device Description
Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.
To use Permacol™ for soft tissue repair, the surgeon first removes damaged or necrotic tissue. Permacol™ can be cut to the desired size and shape required to reinforce or repair the tissue. It is flexible and can conform to the complex surface shapes of human anatomy. Once the product is cut to the desired dimensions, it can be sutured in position if desired. Permacol™ provides sufficient mechanical strength to secure sutures to the surrounding healthy tissue until healing occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face and head
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992556, K002071, K000849, K973462, K011025, K973379
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
JAN 1 7 2002
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
- Tissue Sciences Laboratories PLC Submitter: 7th Floor, Victoria House Victoria Road Aldershot Hants GU11 1SJ United Kingdom Tel. (011) 44 125 233 3002 Fax (011) 44 125 233 3010
Submission Correspondent:
Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth St. N.W. Washington, DC 20004 Tel. (202) 637-5813 Fax (202) 637-5910
Date Prepared: October 26, 2001
Name of Device and Name/Address of Sponsor
Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh
Sponsor:
Tissue Sciences Laboratories PLC 7th Floor, Victoria House Victoria Road Aldershot Hants GU11 1SJ United Kingdom Tel. (011) 44 125 233 3002 Fax (011) 44 125 233 3010
Common or Usual Name
Permacol™
1
Classification Name
Surgical Mesh
Predicate Devices
-
- Tissue Science Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol")
-
- Organogenesis, Inc.'s Fortaflex Surgical Mesh (K011025) ("Fortaflex")
-
- S. Jackson, Inc.'s Sterile SupraFOIL Smooth Nylon Foil Sheets (K973379) ("SupraFOIL")
Intended Use
Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head.
Technological Characteristics
Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.
To use Permacol™ for soft tissue repair, the surgeon first removes damaged or necrotic tissue. Permacol™ can be cut to the desired
2
size and shape required to reinforce or repair the tissue. It is flexible and can conform to the complex surface shapes of human anatomy. Once the product is cut to the desired dimensions, it can be sutured in position if desired. Permacol™ provides sufficient mechanical strength to secure sutures to the surrounding healthy tissue until healing occurs. Similar procedures are used with other surgical mesh devices.
Summary Basis for the Finding of Substantial Equivalence
Permacol™ has the same intended use and substantially the same indications for use as the predicates, which have previously been cleared for use in the face and in reconstructive procedures in the head. Furthermore, the technological features of Permacol™ are substantially similar to the predicates. Although there are minor differences between the products, i.e., with respect to the dimensions and form, method of securement, and materials, these differences do not raise any new questions of safety or effectiveness, as confirmed by preclinical and clinical evaluation. Therefore, Permacol™ is substantially equivalent to the predicate devices.
3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping lines forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Tissue Science Laboratories, PLC c/o Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K013625
Trade/Device Name: Permacol Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: November 01, 2001 Received: November 05, 2001
Dear Mr. Holstein:
We have reviewed your Section 510(k) premarket notification of intent to market the We have fevenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices the increations for abo 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) that do not require with the provisions of the Posts. application (PMA). You may, therefore, market the approval or a promiser applicontrols provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions facturing 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 (Frid I), It may or san be found in the Code of Federal Regulations, Title 21, Parts arroomig your 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 I loase on that FDA has made a determination that your device complies with other not intoun that I DTP has or any Federal statutes and regulations administered by other requirements on the Free of any For all the Act's requirements, including, but not I carreral agencies: " or 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 - Mr. Howard M. Holstein, Esq
This letter will allow you to begin marketing your device as described in your Section Find four market 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milken
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Permacol™ Porcine Collagen Surgical Mesh
Indications For Use:
Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue r crimator - trebute is the surgical repair of damaged or ruptured soft where weakness calow and of the our plastic and reconstructive surgery of the face and head.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluati
e Evaluation (QPE)
Mark n millhuss
(Div on Sign-Off)
Divison of General, Restorative and +++rological Devices
Prescription Use_ X
OR
Over - The 510(to) telubber -(Per 21 CFR 801.109)
(Optional Format 1-2-96)
013625