(53 days)
The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach
The Supris Retropubic Sling System is a permanent, synthetic sub-urethral sling that is provided with disposable needles in the system. The Supris sling is made from knitted monofilament polypropylene and has low elasticity. This structure gives the Supris sling resistance to traction, allows for tissue colonization and facilitates positioning during surgery.
This document, K111233, is a 510(k) premarket notification for the Supris® Retropubic Sling System, a surgical mesh for treating female stress urinary incontinence.
Here's an analysis of the provided text in the context of acceptance criteria and a study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain any specific acceptance criteria or quantitative performance metrics for the device itself (e.g., success rates, complication rates, or objective measures of SUI improvement). The submission is a name change and labeling update (specifically adding a "bottom-up" surgical approach) to an already cleared device.
Instead, the submission states:
| Criterion | Reported Performance |
|---|---|
| Comparison of Surgical Approaches (top-down vs. bottom-up) | "The Supris Retropubic Sling System has not been evaluated in any clinical trial to compare the safety and effectiveness of the top-down vs. the bottom-up surgical approaches." "The safety and effectiveness of both the top-down and the bottom-up approaches were evaluated based on a review of published scientific literature on other tension-free retropubic female urinary incontinence slings." "The results of this review determined that both approaches are comparable in terms of risks and the occurrence of related adverse events." |
| Substantial Equivalence | "The changes cited in this submission do not affect substantial equivalence established in the original submission." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not refer to a "test set" in the context of device performance testing for this specific K111233 submission. This is because the device itself received its initial substantial equivalence in a previous 510(k) (K053296, the predicate device). This current submission is for a labeling update and name change.
The "study" mentioned for the comparison of surgical approaches is a review of published scientific literature on other tension-free retropubic female urinary incontinence slings. Therefore, there is no specific sample size from a primary study on the Supris device for this submission, and the data provenance is retrospective, derived from existing published literature, likely from various countries as it refers to "scientific literature" generally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since there was no primary test set or clinical trial conducted for this specific submission's labeling update, there were no experts explicitly used to establish ground truth in the way one would for a new device's performance evaluation.
The "review of published scientific literature" would implicitly rely on the expertise of the authors of those published papers, who are likely surgeons and researchers in the field of urology/gynecology. However, the submission does not specify the number or qualifications of individuals who performed this specific review of the literature.
4. Adjudication Method for the Test Set
As there was no primary test set for this K111233 submission, there was no adjudication method described. The conclusion about the comparability of surgical approaches was drawn directly from the literature review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No. This device is a surgical sling, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
For the purpose of this K111233 submission's justification for adding the "bottom-up" approach, the "ground truth" was established by "review of published scientific literature" on the safety and effectiveness of different surgical approaches for similar devices. This can be considered a form of expert consensus derived from the collective knowledge and findings reported in peer-reviewed medical literature.
8. The Sample Size for the Training Set
There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
In Summary:
The K111233 submission is primarily for a labeling change (addition of a "bottom-up" surgical approach) and a name change for an already cleared device. It explicitly states that no new clinical trials were conducted for the Supris Retropubic Sling System to compare the two surgical approaches. Instead, the justification for the equivalency of the two approaches relies on a retrospective review of published scientific literature pertaining to other tension-free retropubic female urinary incontinence slings. Therefore, the concepts of "acceptance criteria," "test set," "training set," "ground truth establishment with experts," or "AI performance studies" as typically applied to novel diagnostic or AI devices, are not directly relevant to this specific premarket notification. The FDA's decision to clear the device was based on the conclusion that the changes did not affect the substantial equivalence established in the original submission.
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K111233
510(k) Summary
JUN 2 4 25/11
| Submitter: | Coloplast A/S |
|---|---|
| Address | Holtedam 13050 Humlebaek, Denmark(612) 302-4922 |
| Company Contact: | Tim CrabtreeRegulatory Affairs Manager |
| Date Prepared: | June 14, 2011 |
| Device Name: | Supris® Retropubic Sling System |
| Common Name: | Surgical mesh |
| Classification Name: | Surgical mesh, polymeric |
| Classification: | 21 CFR §878.3300 |
| Product Code: | OTN, FTL |
| Predicate Devices: | Mentor Aris TM Suprapubic Surgical KitK053296 |
Description of Device: The Supris Retropubic Sling System is a permanent, synthetic sub-urethral sling that is provided with disposable needles in the system. The Supris sling is made from knitted monofilament polypropylene and has low elasticity. This structure gives the Supris sling resistance to traction, allows for tissue colonization and facilitates positioning during surgery.
Intended Use: The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach
Purpose of Submission: Name change and labeling update with the description of bottom-up approach surgical approach.
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Comparison of Surgical Approaches: The Supris Retropubic Sling System has not been evaluated in any clinical trial to compare the safety and effectiveness of the top-down vs. the bottom-up surgical approaches. The safety and effectiveness of both the top-down and the bottom-up approaches were evaluated based on a review of published scientific literature on other tension-free retropubic female urinary incontinence slings. The results of this review determined that both approaches are comparable in terms of risks and the occurrence of related adverse events. Additionally, the literature also cited that that either approach is used based on surgeon preference and medical specialty.
Substantial Equivalence: The changes cited in this submission do not affect substantial equivalence established in the original submission.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest the feathers and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20995-0002
Coloplast A/S Mr. Tim Crabtree Regulatory Affairs Manager c/o Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411
JUN 2 4 2011
Re: K111233
Trade Name: SUPRIS® Retropubic Sling System Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product code: OTN Dated: June 14, 2011 Received: June 15, 2011
Dear Mr. Crabtree:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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 of medical device-related
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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" (21CFR 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,
Huchal Lemur MD
erbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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510(k) Number (if known): ≤ | | 2 ≥ 3
Device Name: Supris® Sling System
Indications for Use: The Supris Retropubic Sling System is an implantable, suburethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is placed retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Offige of Derice Evaluation (ODE)-
Hecht Kemer
(Division Sign-om)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111233
§ 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.