(80 days)
GoreTex™ Reinforcement Patch, ProteGen™ Sling
Not Found
No
The device description and performance studies focus on the material properties and mechanical strength of a surgical sling, with no mention of AI or ML technologies.
Yes
The device is intended for the treatment of female urinary incontinence, which is a therapeutic purpose.
No
This device is a surgical sling intended to reinforce soft tissue, not to diagnose medical conditions.
No
The device description clearly states it is an implantable sling made of a physical material (polyether urea urethane elastomer) and comes in different sizes, 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 clearly describes a surgical implant used to reinforce soft tissue for the treatment of female urinary incontinence. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical sling made of a biocompatible material, designed to be implanted.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an implantable medical device used in vivo.
N/A
Intended Use / Indications for Use
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists in the urological and vastigal and vaginal tissue where weakless casis in the and bladder support, urethral and vaginal procedures: pubburential support and elsesses and sacro-colposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Product codes
FTL
Device Description
The Mentor SUSPEND™ Sling is rectangular in shape and will be made available in several sizes: 2 cm x 4 cm, 3 cm x 5 cm, and 4 cm x 7 cm to accomodate various patient profiles. An aperature matrix is incorporated throughout the device. The Mentor SUSPEND™ Sling is manufactured from a biocompatible, segmented polyether urea urethane elastomer. An anti-bacterial coating has been incorporated onto the surface of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological and vaginal tissue, pelvic floor
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)
The material used in the Mentor SUSPEND™ Sling has been tested for biocompatibility and passed all tests.
The Mentor SUSPEND™ Sling was tested for suture pull strength to determine the point at which the suture would "tear" the sling. The test results showed that the Mentor SUSPEND™ Sling met the design criteria for suture pull strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GoreTex™ Reinforcement Patch, ProteGen™ Sling
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
(805) 681-600
ني جي
Image /page/0/Picture/3 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol resembling a four-pointed star with arrows at the end of each point, followed by the word "MENTOR" in bold, sans-serif font. Below "MENTOR" is the word "CORPORATION" in a smaller, sans-serif font.
Executive Offices 5425 Hollister Avenue
Santa Barbara. CA 93111
APR 3 0 1998
510(k) SUMMARY MENTOR SUSPEND™ SLING
This 510(k) summary of safety and effectiveness information is being submitted in
This 510(k) summary of safety and effectiveness information is being submitted in
the format ummary of salety and encies. The encoments of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: _ K980483
Submitter/ Contact Person:
Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111
| Telephone: | (805) 681-6000 |
|---|---|
| FAX: | (805) 681-6004 |
April 21, 1998 Date Prepared:
Device Name and Classification
Proprietary Name: Common Name: Classification Name: Classification:
Mentor SUSPEND™ Sling Sling Surgical mesh, polymeric Class II per 21 CFR 878.3300
Manufacturer
Mentor Urology 601 West River Road North Minneapolis, MN 55411
Substantial Equivalence Claim
ntial Equivalence Claim
The Mentor SUSPEND™ Sling is substantially equivalent to the GoreTex™ The Meinforcement Patch and the ProteGen™ Sling.
Indications For Use
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft The Mentor SOSPEND - Sing is an mapsical anatomy inclusive of the following
tissue where weakness exists in the urological and vastigal and vaginal tissue where weakless casis in the and bladder support, urethral and vaginal procedures: pubburential support and elsesses and sacro-colposuspension. It is
prolapse repair, reconstruction of the pelvice as seculting from urethral prolapse repair, reconstruction of the partinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
1
Device Description
The Mentor SUSPEND™ Sling is rectangular in shape and will be made available in several sizes: 2 cm x 4 cm, 3 cm x 5 cm, and 4 cm x 7 cm to accomodate various patient profiles. An aperature matrix is incorporated throughout the device. The Mentor SUSPEND™ Sling is manufactured from a biocompatible, segmented polyether urea urethane elastomer. An anti-bacterial coating has been incorporated onto the surface of the device.
Summary of Testing
The material used in the Mentor SUSPEND™ Sling has been tested for biocompatibility and passed all tests.
The Mentor SUSPEND™ Sling was tested for suture pull strength to determine the point at which the suture would "tear" the sling. The test results showed that the Mentor SUSPEND™ Sling met the design criteria for suture pull strength.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation Executive Offices 5425 Hollister Avenue Santa Barbara, California 93111
Re: K980483 Mentor Suspend Sling Trade Name: Requlatory Class: II Product Code: - FTL Dated: February 6, 1998 Received: February 9, 1998
Dear Ms. Crawford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device; subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੋ substantially equivalent determination assumes compliance with ... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Crawford
This letter will allow you to begin marketing your device as described in your 510 (k) premarket 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
La M. Witten, JPh.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
980483 510(k) Number (if known):
Device Name: MENTOR SUSPEND™ Sling
Indications For Use:
(Per 21 CFR 801.109)
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists for the urological anatomy inclusive of the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, and sacro-culposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K980483
Prescription Use X OR Over-The Counter Use
(Optional Format 1-2-96)