(42 days)
Not Found
No
The description focuses on the material properties and mechanical characteristics of a surgical mesh, with no mention of AI or ML.
Yes
The device is indicated for tissue reinforcement and stabilization of fascial structures in vaginal wall prolapse, which is a medical condition. This indicates a therapeutic intended use.
No
The device is described as a surgical mesh intended for tissue reinforcement and stabilization of fascial structures, indicating it is a therapeutic or reconstructive device rather than one used for diagnosing a condition.
No
The device description clearly states it is a "knitted mesh of polypropylene fibers," which is a physical, hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states the device is a "knitted mesh of polypropylene fibers" intended for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse." This is a physical implant used within the body during surgery.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely structural and supportive.
Therefore, based on the provided information, the AMS Large Pore Polypropylene Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Product codes (comma separated list FDA assigned to the subject device)
OTP, OTO
Device Description
The AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 AMS Large Pore Polypropylene Mesh has been demonstrated to be biocompatible. In addition, the AMS Large Pore Polypropylene Mesh has been tested for a in addition, the AMG Largo Ford : crypt a accord-ance with FDA's Guidance for the vanety of mechaniour characteristication for a Surgical Mesh and has r repuration of a vemaintent to the listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Gynemesh Prolene Soft Mesh - K013718, Ethicon Prolene Soft Mesh - K001122, AMS Sacral Colpopexy Sling - K010931
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
K033636 P/2
DEC 3 1 2003
510(k) Summary AMS Large Pore Polypropylene Mesh
510(k) Number _
Date of Summary Preparation: November 17, 2003
Submitter/Contact Person:
Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6000 Fax: (952) 930-6496
Device Name and Classification:
Trade Name: AMS Large Pore Polypropylene Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP, OTO Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
Gynemesh Prolene Soft Mesh - K013718 Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling - K010931
Indications for Use:
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Device Description:
The AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
Summary of Testing
The material used in the AMS Large Pore Polypropylene Mesh has been demonstrated to be biocompatible.
1
K033636
$\rho_{2/2}$
In addition, the AMS Large Pore Polypropylene Mesh has been tested for a in addition, the AMG Largo Ford : crypt a coordance with FDA's Guidance for the vanety of mechaniour characteristication for a Surgical Mesh and has r repuration of a vemaintent to the listed predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a bird, or possibly a bird in flight. The symbol is rendered in solid black, creating a strong contrast against the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road, West MINNETONKA MN 55343
SEP 2 8 2012
Re: K033636 Trade/Device Name: AMS Large Pore Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 17, 2003 Received: November 19, 2003
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of December 31, 2003.
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
3
Page 2 -
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
INDICATIONS FOR USE ENCLOSURE
510(k) Number:
AMS Large Pore Polypropylene Mesh Device Name:
Indications for Use: The AMS Large Pore Polypropylene Mesh is indicated for midications for Ose. The Ame Eargo volte , byt it is cial structures of the pelvic tissue relimordement and long thems withing surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Prescription Use مكو (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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
Page 1 of / __
510(k) Number K633636