(24 days)
The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The modified Coloplast Virtue Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.
This document describes the 510(k) summary for the Coloplast Virtue™ Ventral Urethral Elevation Sling System. The submission claims substantial equivalence to previously cleared devices (K082640 and K091152).
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria or detailed reported device performance in a quantitative manner. The submission relies on demonstrating substantial equivalence through "bench testing compared to the predicate device and existing specifications." This implies that the 'acceptance criteria' were met if the bench test results for the modified device were comparable to the predicate and fell within established specifications, but these specifics are not provided in the summary.
Since no specific performance metrics are provided in the document, a table cannot be constructed with performance data.
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "bench testing." It does not specify a sample size for the test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. Bench testing typically refers to laboratory-based evaluations, not human or observational data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since only "bench testing" is mentioned and there are no clinical studies or human-involved test sets described, there is no information provided regarding experts establishing ground truth or their qualifications.
4. Adjudication Method for the Test Set
As there are no clinical studies or human-involved test sets described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "nonclinical tests" and "bench testing." It does not mention any multi-reader multi-case comparative effectiveness study or any studies involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a surgical sling system, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The "device performance" would refer to the mechanical and biological performance of the sling itself.
7. The Type of Ground Truth Used
For the "bench testing," the ground truth would be established by engineering and material specifications – i.e., whether the physical properties and performance characteristics (e.g., tensile strength, pore size, biocompatibility) of the modified device meet predefined engineering standards and are comparable to the predicate device. The document does not provide details on these specific ground truths.
8. The Sample Size for the Training Set
This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" with a sample size for machine learning is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" for this type of device is not applicable.
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K101297
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2010
510(k) Summary
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 13050 Humlebaek, DenmarkEstablishment Registration: 9610694Owner/Operator: 8010144 |
| Name of Contact Person: | Angela BylandSenior Regulatory Affairs Manager |
| Phone and Fax Numbers: | Phone: (612) 287-4236Fax: (612) 287-4138Email: usaby@coloplast.com |
| Submission Date: | May 7, 2010 |
| Trade Name: | Virtue™ Ventral Urethral Elevation Sling System |
| Common or Usual Name: | Sub-Urethral Sling System; Surgical Mesh |
| Classification Name: | Surgical Mesh, polymeric |
Legally Marketed Device to Which Your Firm is Claiming Equivalence:
The modified Coloplast Virtue Ventral Urethral Elevation Sling System is substantially equivalent in performance, indications, design and materials to the currently marketed Virtue Ventral Urethral Elevation Sling System, which was cleared under K082640 and K091152.
Description of the Device:
The modified Coloplast Virtue Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.
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K101297
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Intended Use Of The Device:
?
The Coloplast Virtue Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
Technological Characteristics Compared To Predicate Device:
Coloplast believes the proposed Coloplast Virtue Ventral Urethral Elevation Sling System is substantially equivalent in form and function to Coloplast's VIRTUE Ventral Urethral Elevation Sling System, which was cleared under 510(k) K082640 and K091152. i
Summary and Conclusions of the Nonclinical Tests Submitted:
Substantial equivalency is supported by bench testing compared to the predicate device and existing specifications.
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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 features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S % Coloplast Corporation Ms. Angela Byland Senior Regulatory Affairs Manager 1601 West River Road North MINNEAPOLIS MN 55411
OCT 1 2 2012
Re: K101297
Trade/Device Name: VIRTUE Ventral Urethral Elevation Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM Dated: May 7, 2010 Received: May 10, 2010
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of June 3, 2010.
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. Fuchs
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VIRTUE Ventral Urethral Elevation Sling System
Indications for Use:
The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress . urinary incontinence (SUI).
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 OF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page __ of __ |
(Posted November 13, 2000(k) Number K101297
Confidential
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§ 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.