(106 days)
The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.
The SIS Facial Implant is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration pre-attached to a trocar. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
The provided text is a 510(k) summary for the SIS Facial Implant. It describes the device, its intended use, predicate devices, and the conclusion of substantial equivalence based on testing. However, it does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against those criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility, viral inactivation, and mechanical testing, but the results of these tests in a quantifiable manner against specific criteria are not detailed in this summary.
{0}------------------------------------------------
9. 510(K) SUMMARY
| Submitted By: | Mark Bleyer, PresidentCook Biotech Incorporated1425 Innovation PlaceWest Lafayette, IN 47906(765) 497-3355May 6, 2005 |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
Names of Device:
Trade Name: Common/Usual Name: Proposed classification name:
SIS Facial Implant Surgical Mesh Surgical Mesh 21 CFR 878.3300 (FTM) Class II
Intended Use:
The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.
Predicate Devices:
The SIS Facial Implant is similar to predicate devices, including the SIS Plastic Surgery Matrix (K034039) and SURGISES Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated. Permacol (K013625) manufactured by Tissue Science Laboratories, PLC. and Advanta PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation.
Device Description:
The SIS Facial Implant is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration pre-attached to a trocar. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Substantial Equivalence:
The SIS Facial Implant is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through bench and biocompatibility testing.
Discussion of Tests and Test Results:
The material comprising the SIS Facial Implant was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient.
Conclusions Drawn from the Tests:
Outcomes from the evaluation of the SIS Facial Implant provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Mr. Mark Bleyer President Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906
Re: K050246
Trade/Device Name: SIS Facial Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 6, 2005 Received: May 9, 2005
Dear Mr.Bleyer:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainter instibution workers marketed in interstate referenced above and nave decembiled the arresed predicate devices marketed in interstate for use stated in the encrosule for legally manatinent date of the Medical Device Ameral Food. Drug commerce prior in May 28, 1970, the chance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision recept anningti devices that have been reclassince in acondance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual registe general controls provisions of the rectments required in the bromibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existing major regulations affecting your device. EDA it may be subject to such additional controls: "Links 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, was and reasonal Regi can be found in the Code of Pederal Regulations, wour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualies of a substition with other requirements of the Act
that FDA has made a determination that your device complies with other requires . Yo that FDA nas made a delemmation that your as roo be other Federal agencies. You must and listing or any Federal Statutes and regulations administered of registration and listing (21 comply with all the Act S requirements, measurements as and the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the destron CFR Part 807), labeling (21 CFR Part 801), god frances 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000), 1050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegn manieung your manitoung of your device to a legally premarket notification: "The sults 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 If you desire spocitie at novation at (240) 276-0115 . Also, please note the regulation entitled, Comacs the Office of Coursemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
K050246 510(k) Number (if known): SIS Facial Implant Device Name:
Indications for Use:
The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the repair of reinforcement is supplied sterile and is intended for onetime use.
Over-The-Counter Use Prescription Use x AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
050246
§ 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.