(15 days)
The Elevate Prolapse 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.
This document is a 510(k) summary for a medical device called the "Elevate Prolapse Repair System with PC Coated IntePro Lite". This is a regulatory submission for a surgical mesh, and as such, it does not describe a study in the way one would for an AI/ML device or diagnostic test.
Instead, the document details a comparison to a predicate device and performance testing to demonstrate substantial equivalence, which is the regulatory pathway for this type of device.
Here's an analysis of the provided text in the context of your request, highlighting where the information is present or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain existing performance parameters of the predicate device (Elevate Prolapse Repair System with IntePro Lite) post-modification. | "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised." |
| No new safety or efficacy issues introduced by the addition of the synthetic phosphorylcholine (PC) polymer coating. | "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised." |
| Functional equivalence to the predicate device in terms of intended use. | The device is "identical to the previous version with the exception of a synthetic phosphorylcholine (PC) polymer coating". Note: The "Supporting Information" section implies a comparison of performance parameters to ensure the modification (PC coating) does not negatively impact existing functions. Specific quantitative performance metrics are not provided in this summary but would have been part of the underlying testing documentation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this 510(k) summary. The summary refers to "testing" performed but does not quantify the sample sizes for any tests conducted.
- Data Provenance: Not specified. This would typically be internal testing conducted by the manufacturer, American Medical Systems. The nature of the device (surgical mesh) suggests bench testing and potentially in vitro/in vivo animal studies would be used rather than human clinical data in this type of submission for a modification. It is likely prospective testing on material samples or animal models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For a surgical mesh modification, "ground truth" as you'd define it for an AI/ML or diagnostic device (e.g., expert consensus on images) is not relevant. The "ground truth" here is the established safety and performance profile of the predicate device, against which the modified device's performance is compared through engineering and material testing. The experts involved would be engineers, material scientists, and regulatory specialists within the company assessing the test results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for clinical endpoints or image interpretations. For this device, the "adjudication" would involve internal review and approval of the test protocols, results, and conclusions by the manufacturer's R&D, quality, and regulatory departments, followed by FDA's review of the submission.
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 a physical medical device (surgical mesh), not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies are not relevant nor performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device, the "ground truth" (or more accurately, the comparator) is the established performance and safety profile of the legally marketed predicate device (Elevate Prolapse Repair System with IntePro Lite). The testing (e.g., mechanical properties, biocompatibility, coating adhesion) aims to demonstrate that the new device meets or exceeds these established parameters and introduces no new risks.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
Summary of the Study (as described in the 510(k) summary):
The "study" in this context is a Design Failure Mode Effects and Criticality Analysis (dFMECA) of the modification (adding a PC coating) to the predicate device. This analysis identified potential performance parameters that could be affected by the coating. Subsequently, performance testing was conducted to evaluate these identified parameters. The results of this testing formed the basis for demonstrating that the modified device is substantially equivalent to the predicate. The key finding reported is that: "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised."
In essence, this is a substantive equivalence demonstration based on engineering and performance testing rather than a clinical efficacy trial or an AI/ML performance study.
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APR - 2 2009
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| 2.6 | 510(k) Summary |
|---|---|
| Submitter: | American Medical Systems10700 Bren Road WestMinnetonka, MN 55343Phone: 952-933-4666Fax: 952-930-6496 |
| Contact Person: | Denise Thompson |
| Date Summary Prepared: | March 17, 2009 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Elevate Prolapse Repair System with PCCoated IntePro Lite |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | Elevate Prolapse Repair System with IntePro Lite |
Device Description
The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.
Indications for Use
The Elevate Prolapse 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Comparison to Predicate Devices
The Elevate System is identical to the previous version with the exception of a synthetic phosphorylcholine (PC) polymer coating being added to the center IntePro Lite section of the mesh assembly.
Supporting Information
A Design Failure Mode Effects and Criticality Analysis (dFMECA) was used to assess the impact of the modification. The performance parameters which were identified as potentially able to be affected by the modification were tested as mitigation. The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised.
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3. Labeling
- Draft Labeling and Instructions for Use for the Elevate System with PC coated . IntePro Lite are provided in Appendix A.
- A copy of the predicate Labeling and Instructions for Use for the Elevate System . with IntePro Lite are provided in Appendix B.
Special 510(k) - AMS Elevate with PC Coated ELPP
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems % Ms. Denise Thompson Sr. Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K090713 Trade/Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 17, 2009 Received: March 18, 2009
Dear Ms. Thompson:
This letter corrects our substantially equivalent letter of April 2, 2009.
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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Page 1 of 1.
INDICATIONS FOR USE STATEMENT
K090713 510(k) Number (if known):
Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite
Indications For Use:
The AMS Elevate Prolapse 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Prescription Use (Per 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) (Divisi: .. . gri-gii) Division of General, Restorative, Division of General, Restorative, and Neurological Devices and Neurological Devices
510(k) Number: K90115
Special 510(k) - AMS Elevate with PC Coal
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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.