(23 days)
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.
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.
The provided text is for a 510(k) summary for a medical device (AMS Large Pore Polypropylene Mesh). It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested particulars related to a study that proves the device meets acceptance criteria.
The summary states: "The new device has been tested in accordance with FDA's 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh' and has been shown to be equivalent to the listed predicate device." This indicates that the regulatory requirements for showing substantial equivalence were met, but it doesn't provide the granular data requested.
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. It only states that the device was "shown to be equivalent to the listed predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Equivalent to predicate device (K033636) per FDA guidance. |
2. Sample sized used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "testing" was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified, as no human expert-based ground truth is mentioned for the testing of a surgical mesh's physical characteristics.
4. Adjudication method for the test set
Not applicable. The testing described appears to be physical/mechanical testing of the mesh, not a clinical assessment requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not explicitly stated. For a surgical mesh, "ground truth" would typically refer to physical and mechanical properties being measured against established standards or the properties of the predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable.
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K040521 Page '1/
MAR 2 4 2004
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. |
|---|---|
| Address: | 10700 Bren Road WestMinnetonka, MN 55343 |
| Tel: | 952-930-6000 |
| Fax: | 952-930-6157 |
| Contact Person: | Elsa A. Linke |
| Date of Summary Preparation: | February 27, 2004 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | AMS Large Pore Polypropylene Mesh |
| Device Classification Name: | Surgical Mesh, polymeric (21 CFR 878.3300)Classification: Class IIProduct Code: OTP, OTO |
| Predicate Device: | AMS Large Pore Polypropylene MeshK033636 |
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.
Indications for Use
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and longlasting 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.
Comparison to Predicate Device
The fundamental scientific technology of this device and the predicate device does not differ. The base material and mesh design remain the same.
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K040521 page 2/2
[510(k) Summary continued]
Summary of Testing
The new device has been tested in accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" and has been shown to be equivalent to the listed predicate device.
Conclusion
The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.
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: K040521 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: February 27, 2004 Received: March 1, 2004
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of March 24, 2004.
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 (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,
Sincerely yours,
Benjamin R. Weeks
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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K040521 |
|---|---|
| Device Name: | AMS Large Pore Polypropylene Mesh |
| Indications For Use: | The AMS Large Pore Polypropylene Mesh isindicated for tissue reinforcement and long-lastingstabilization of fascial structures of the pelvic floor invaginal wall prolapse where surgical treatment isintended, either as mechanical support or bridgingmaterial for the fascial defect. |
Prescription Use_ × (Per 21 CFR 801 Subpan 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.