(107 days)
AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.
The provided text is a 510(k) summary statement and related FDA correspondence for a surgical mesh device. The document states that the device components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." However, it does not provide specific quantitative acceptance criteria or a detailed study description that proves the device meets those criteria.
Therefore, the requested information, which typically involves detailed performance metrics, sample sizes, expert involvement, and ground truth establishment, is not present in the provided text.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: The document states "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." It does not provide a table with specific criteria (e.g., tensile strength, pore size, elasticity) or the numerical results from these tests.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing described is for biocompatibility and performance, not involving human interpretation of medical data where experts would establish ground truth.
- Adjudication method for the test set: Not applicable for the type of testing described (biocompatibility and performance).
- 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 document is about a surgical mesh, not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
- The type of ground truth used: Not applicable in the context of the described physical device testing. The "ground truth" for material properties would be the established standards or values of the predicate device.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not a machine learning device.
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DEC 0 4 2008
510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)10700 Bren Road WestMinnetonka, MN 55343 |
|---|---|
| Contact Person: | Sarah PetersonPhone: 952.930.6431Fax: 952.930.5785 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Apogee and Perigee Systems with IntePro Lite andInteXen LP, Part of the AMS Pelvic Floor RepairSystem |
| Device Classification/Classification Name: | Class II, 21 CFR Part 878.3300Surgical Mesh, polymeric (OTP, PAI) |
| Predicate Device: | Apogee and Perigee Systems with IntePro Lite andInteXen LP (K051485), Part of the AMS PelvicFloor Repair System |
Indications for Use
AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Device Description
The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.
Summary of Testing
The components of the Apogee and Perigee Systems with IntePro Lite and InteXen LP have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems (AMS) %. Ms. Sarah Peterson 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K082387
Trade/Device Name: Apogee and Perigee Systems with IntePro Life and InteXen LP, Part of the AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: November 3, 2008 Received: November 4, 2008
Dear Ms. Anderson:
This letter corrects our substantially equivalent letter of December 4, 2008.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Perkins
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) | |
|---|---|
| Device Name: | Apogee and Perigee Systems with IntePro Lite and InteXen LP, Part of the AMS Pelvic Floor Repair System |
| Indications For Use: | AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nitho Dyln for man
08238
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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§ 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.