(23 days)
Not Found
No
The summary describes a surgical implant made of collagen and focuses on its biocompatibility and mechanical properties. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
No.
The device is described as a surgical implant intended to support/reinforce soft tissue, which is a structural or restorative function rather than a therapeutic one (i.e., treating a disease or condition).
No
The device is a surgical implant intended to support/reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states it is a "Surgical Implant" and describes physical characteristics and performance studies related to materials and design, indicating it is a physical medical 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 is to "support/reinforce soft tissue in surgical procedures." This describes a device used in vivo (within the body) during surgery, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples for diagnostic purposes.
- Device Description: The description focuses on the material (porcine dermal collagen) and shape for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests of specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is structural support during surgery.
N/A
Intended Use / Indications for Use
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.
Product codes
PAI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Biocompatibility and bench studies have been completed and support the safety and effectiveness of Permacol® Surgical Implant for its intended use, therefore data supporting the biocompatibility of Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece is incorporated by reference.
The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece will meet the established specification necessary for consistent performance during their intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
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MAR 9 - 105
K050355
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510(k) SUMMARY
Tissue Science Laboratories PLC, Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Victoria Taylor Tissue Science Laboratories PLC 1141 Clark Street Suite D Covington, Georgia 30014 USA Tel. (678) 342 - 7808 Fax: (678) 342 - 7844 Email: vtsylor@tissuescience.com
Contact Person: Victoria Taylor
Date Prepared: 11th February 2005
Name of Device and Name/Address of Sponsor
Tissue Science Laboratories PLC 7th Floor, Victoria House Victoria Road Aldreshot Hampshire GU11 1 EJ United Kingdom
Trade Name
Permacol® Surgical Implant T-piece Permacol® Surgical Implant Rectocele-piece
Common or Usual Name
Surgical Mesh
Classification Name
Surgical Mesh
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Predicate Devices
Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (K992556) and Permacola Surgical Implant (K043366)
Intended Use
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocclc-picces are shaped for use in rectocele repair.
Technological Characteristics and Substantial Equivalence
Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.
Performance Data
Biocompatibility and bench studies have been completed and support the safety and effectiveness of Permacol® Surgical Implant for its intended use, therefore data supporting the biocompatibility of Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece is 111corporated by reference.
The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing Permacole Surgical Implant T-piece and Permacolo Surgical Implant Rectocele-piece will meet the established specification necessary for consistent performance during their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Victoria Taylor Associate Director of Regulatory Affairs Tissue Science Laboratories, PLC 1141 Clark Street, Suite D COVINGTON GA 30014
SEP 2 8 2012
Re: K050355 Trade/Device Name: Permacol® Surgical Implant T-piece Permacol® Surgical Implant Rectocele-piece Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAI Dated: February 11, 2005 Received: February 14, 2005
Dear Ms. Taylor:
This letter corrects our substantially equivalent letter of March 9, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 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 approval of a premarket approval (PMA). 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 (PMA), it may be subject to 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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOTOBIT
Indications for Use
510(k) Number (if known): K050355
Permacol® Surgical Implant T-piece Device Name: Permacol® Surgical Implant Rectocele-piece
Indications for Use:
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical remator - Bargious miles and Implant T-pieces are shaped for use in rectal intussusception procedures - I waical of Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINF-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Divisic Sign-Off) Division of General, Restorative, and Newslogical Dollees
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510(k) Number. Ko 50355