(40 days)
Not Found
No
The document describes a collagen-based implant for soft tissue reinforcement and repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on biocompatibility and integrity, not algorithmic performance.
Yes
The device is described as being used for "treatment of urinary incontinence" and for "reinforc[ing] and support[ing] soft tissue where weakness exists," which directly addresses a medical condition or weakness.
No
Explanation: The device is a surgical implant designed to reinforce and support soft tissue, not to diagnose medical conditions. Its intended use is therapeutic, involving repair and reconstruction.
No
The device description clearly states that FortaPerm consists of a multi-laminate sheet of porcine collagen, which 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 states that FortaPerm is for implantation to reinforce and support soft tissue within the body. This is a surgical procedure performed on a living patient.
- Device Description: The device is described as a "multi-laminate sheet predominantly of Type I porcine collagen" supplied in sheet form 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) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from a patient, not implanted within the patient. FortaPerm is an implantable medical device.
N/A
Intended Use / Indications for Use
FortaPerm is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.
Product codes
FTM
Device Description
Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, pubourethral, urethral, vaginal, rectal, colon, pelvic floor, bladder
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
FortaPerm was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests.
Key Metrics
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
K021107
MAY 1 5 2002
510(K) SUMMARY
Submitted by:
Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021
Contact
Michael L. Sabolinski Telephone: (781) 575-0775 Facsimile: (781) 575-0440
April 25, 2002 Date:
Device:
Trade Name: Common/Usual Name: Classification Name: Regulatory Class:
FortaPerm™ Surgical Mesh, Sling, Tissue Support Biomaterial Surgical Mesh (79FTM, 878.3300) Class II
Predicate Device:
The device is similar to predicate collagen-based surgical mesh and sling devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis Sling (K992159) manufactured by Cook Biotech, Incorporated.
Statement of Substantial Equivalence:
FortaPerm is substantially equivalent to the predicate devices, having similar intended use, technological characteristics, materials, physical construction and performance.
Intended Use:
FortaPerm is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.
Device Description:
Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.
Performance Data:
FortaPerm was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests.
Organogenesis Inc., Amendment to $10(k) Premarket Notification April 25, 2002
Page 15
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Mr. Michael L. Sabolinski, M.D. Executive Vice President Medical and Regulatory Affairs Organogenesis, Inc. 150 Dan Road Canton, MA 02021
Re: K021107
Trade/Device Name: FortaPerm™ Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: April 4, 2002 Received: April 5, 2002
Dear Dr. Sabolinski:
We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreases of the enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmeter For (110) and the device, subject to the general controls provisions of the Act. The I ou may) attests 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.
2
Page 2 - Mr. Michael L. Sabolinski, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) r market notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 O wier general missimal 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
for Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
Applicant: Organogenesis Inc.
or 1107 510(k) Number (if known):
Device Name: FortaPerm™
Indications For Use:
FortaPerm™ is intended for implantation to reinforce and support soft tissues where weakness exists, including but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolnosuspension, reconstructive procedures and tissue repair. By providing pubourethral support, the FortaPerm™ may be used for the treatment of Dy providing pacourounce resulting from urethral hypermobility or intrinsic sphincter deficiency.
The device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use (Per 21 CFR 801.109)
K021107 510(k) Number. Over The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Organogenesis Inc., Amendment to 510(k) Premarket Notification April 25, 2002
Page 2