(90 days)
Not Found
No
The description focuses on the material and physical characteristics of a surgical mesh and sling, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is intended for the treatment of urinary incontinence and for reinforcing soft tissues, which are therapeutic uses.
No
The device is an implantable surgical mesh intended for the treatment of urinary incontinence and reinforcement of soft tissues, not for diagnosing medical conditions.
No
The device description clearly states it is a "Silicone-Coated Sling and Surgical Mesh" made of polyester mesh and silicone elastomer, which are physical materials, 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 the device is an "implant that is intended for the treatment of urinary incontinence... and for implantation to reinforce soft tissues..." This describes a surgical implant used directly within the body for therapeutic purposes.
- Device Description: The description details a physical mesh made of polyester and silicone, available in various sizes. This is a physical device, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a person's health status.
IVD devices are used in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions by examining specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse publication and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.
Product codes
FTL
Device Description
The AMS Triangle™ Siliconc-Coated Sling and Surgical Mesh is made of a The AMS THangle - Omeone with a thin layer of solid silicone elastomer. The polyester mesil that is obverted the Sling and Surgical Mesh is available in sizes AMO Triangle - Binoo.144 cm2, including 2 cm x 5 cm, 2 cm x 4 cm, 2 cm x 10 cm, 2 cm x 7 cm, 2 cm x 20 cm, 6 cm x 6cm and 12 cm x 12cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral, urological, gynecological, gastroenterological anatomy, pubourethral, bladder, urethral, vaginal, colon, rectal, pelvic floor, sacral
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
The material used in the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been demonstrated to be biocompatible.
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been I ne Ario Trange of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K980482, K922916, K962530, K980483
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
NOV 2 9 2000
510(k) Summary AMS Triangle™ Silicone-Coated Sling and Surgical Mesh 510(k) Number K002721
Submitter/Contact Person:
Ginger Sackett Glaser Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6541 Fax: (952) 930-6496 Email: ginger glaser@visitams.com
Device Name and Classification:
Trade Name: AMS Triangle™ Silicone-Coated Sling and Surgical Mesh Common/Usual Name: Surgical Mesh, Sling, Urethral Sling Classification Name: Surgical Mesh, polymeric Product Code: FTL Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
TriAngleTM Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh Mentor SUSPEND™ Sling - K980483
Indications for Use:
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse publication and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.
1
Device Description:
The AMS Triangle™ Siliconc-Coated Sling and Surgical Mesh is made of a The AMS THangle - Omeone with a thin layer of solid silicone elastomer. The polyester mesil that is obverted the Sling and Surgical Mesh is available in sizes AMO Triangle - Binoo.144 cm2, including 2 cm x 5 cm, 2 cm x 4 cm, 2 cm x 10 cm, 2 cm x 7 cm, 2 cm x 20 cm, 6 cm x 6cm and 12 cm x 12cm.
Summary of Testing
The material used in the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been demonstrated to be biocompatible.
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been I ne Ario Trange of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2000
Ms. Ginger S. Glaser *Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West Minnetonka, Minnesota 55343
K002721 Re:
Trade Name: AMS Triangle Silicone-Coated Sling and Surgical Mesh
Regulatory Class: II Product Code: FTL Dated: August 24, 2000 Received: August 31, 2000
Dear Ms. Glaser:
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 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 (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. A 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 regulation may result in regulatory 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 obligation 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. Ginger S. Glaser
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow your to other substantial equivalence of your device to a premarket notification. - The PDF 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 -II you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 6091794-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. ad vertibing of your a regulation entitled, "Misbranding by reference to premarket Also, prease note togation of ther 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,
Sincerely yours,
Mark N Milliken
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
4
Image /page/4/Picture/0 description: The image shows a word written in a stylized, brushstroke-like font. The word appears to be "KOOZ21". The letters are thick and bold, with a rough, textured appearance, giving the impression of having been painted with a brush. The overall style is artistic and somewhat abstract.
Page 1 of 1
510(k) Number (if known):
Device Name:_AMS Triangle Silicone-Coated Sling and Surgical Mesh
Indications For Use:
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
to Mark N Milliner
(Division Sign-Off) Division of General Restorative Dev 510(k) Number.