(81 days)
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The Applied Alexis Wound Retractor is indicated for use to:
Access the abdominal cavity during surgery through an atraumatically retracted incision.
Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to:
Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an alraumatically-retracted incision.
The Coloplast Virtue Male 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.
The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large.
The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.
The submission K113496 by Coloplast A/S for the "Virtue Male Sling System with Alexis Wound Retractor" describes non-clinical testing to demonstrate substantial equivalence to its predicate devices. This 510(k) summary does not include any clinical studies, and therefore, does not provide information on acceptance criteria for device performance based on human studies, nor details like sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for such studies. It also does not involve AI.
Here's an analysis of the provided information, focusing on the non-clinical tests mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established Design Specifications) | Reported Device Performance and Confirmation |
|---|---|
| Meet established design specifications for minor design modifications (decrease in mesh body, addition of suture knots). | Confirmed: Design verification testing and simulated use tests in a cadaveric laboratory confirmed that the modified Virtue System meets the established design specifications. |
| Biocompatibility requirements for the device materials. | Confirmed: Supported by previous biocompatibility testing for the original 510(k) (K041711) as there were no changes to materials. |
| Sterilization efficacy and sterility assurance level (SAL). | Confirmed: Existing sterilization validation supports the modified Virtue device as there were no changes to the sterilization method, SAL, or sterilization parameters. |
| Substantial equivalence to predicate devices (Virtue System K101297 and Alexis K041711) regarding intended use, design, materials, and scientific technology. | Confirmed: The non-clinical tests (design verification, simulated cadaveric use, previous biocompatibility, and sterilization validation) collectively support the conclusion that the Virtue Male Sling System with Alexis Wound Retractor is substantially equivalent to its predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The "simulated use tests in a cadaveric laboratory" imply a sample size of cadavers, but the specific number is not provided.
- Data Provenance: The cadaveric laboratory testing would be considered prospective for the purposes of evaluating the design modifications. The location of the cadaveric lab is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as no clinical study or expert-adjudicated ground truth for device performance in humans was conducted. The non-clinical tests relied on engineering and scientific assessments.
4. Adjudication method for the test set
This information is not provided as it pertains to expert consensus in clinical studies, which were not conducted.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical sling and wound retractor, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this device is not an algorithm or AI system. Its performance is evaluated through physical tests and material properties.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by engineering design specifications and objective measurements gathered from the design verification testing, simulated cadaveric use tests, and established material and sterilization standards.
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" for this type of medical device.
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Image /page/0/Picture/1 description: The image contains the word "Coloplast" in a bold, sans-serif font. To the left of the word is a circular logo with horizontal lines across it. The logo is black and white and appears to be a stylized representation of a globe or sphere.
FEB 1 4 2012
510(K) SUMMARY 3
| 510(k) Owner/Submitter | Coloplast A/S; Division: Coloplast CorpHoltedam 1Humlebaek 3050 - Denmark |
|---|---|
| Contact | Janell A. ColleyColoplast Corp1601 West River Road NorthMinneapolis, Minnesota 55411 USA |
| Date Prepared | 30 June 2011 |
| Common name/Classification | Virtue: Surgical Mesh: 21CFR 878.3300;Alexis: Surgical drape and drape accessories: 878.4370 |
| Proprietary Name | Virtue Male Sling System with Alexis Wound Retractor |
| Predicate Devices | Virtue: K101297Alexis: K041711 |
| Device Description | The Coloplast Virtue Male 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.The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large.The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box. |
| Intended Use | The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).The Applied Alexis Wound Retractor is indicated for use to:Access the abdominal cavity during surgery through an atraumatically retracted incision.Deliver maximum exposure of the abdominal cavity with minimum incision.Protect against wound contamination during laparoscopic and open surgery.The smaller two sizes of Alexis are also intended to be used to:Seal off the incision opening to permit insufflating the peritoneum.Convert the incision wound to an additional trocar port site.Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an alraumatically-retracted incision. |
| Technological Characteristics Compared to Predicate | The Virtue Male Sling System with Alexis Wound Retractor has the same intended use, design, materials and fundamental scientific technology as the predicates Virtue System K101297 and Alexis K041711. |
| Summary Of The Nonclinical Tests Submitted | The minor design modifications, including a decrease in the mesh body and addition of suture knots were evaluated via design verification testing and simulated use tests in a cadaveric laboratory. These tests confirmed that the Virtue System as modified meets the established design specifications and is substantially equivalent to the predicate. The Virtue System was subjected to biocompatibility testing to support the original 510k (K041711), and since there have been no changes to materials, the previous testing supports the modified Virtue device. In addition, since there were no changes to the sterilization method, SAL, or sterilization parameters, the existing sterilization validation supports the modified Virtue device. |
| Summary Of Clinical Tests Submitted (As Applicable) | Not applicable |
| Conclusions Drawn From The Nonclinical Tests | The Virtue Male Sling System with Alexis Wound Retractor is substantially equivalent to the predicates. |
Coloplast Virtue Male Sling Sytem Traditional 510(k) for Design Changes
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DSORD cleared surgical mesh indicated for pelvic organ prolapse and stress urinary incontinence (male and female) under 21 CFR 878.3300 (surgical mesh) and product codes FTL (surgical mesh, synthetic) and FTM (surgical mesh). DRGUD (carrecting the substantially equivalent letters for these devices to and P TM (Garglour moon). Do. At this time, the regulation number for these devices remains the same.
Cheryl R. Mackey, Program Analyst, DRCHD
Cheryl R. Mackey, Program Analyst, ORGUD
JCA B
John H. Baxley, Biomedical Engineer, ULDB
K. B. Bell
Glenn B. Bell, Branch Chief, ULDB
9/28/12
Date
Date
9/28/2012
Date
28 Sept 2012
Date
Date
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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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "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
Ms. Janell A. Colley Regulatory Affairs Manager Coloplast A/S 1601 West River Road North MINNEAPOLIS MN 55411
OCT 1 2 2012
Re: K113496
Trade/Device Name: Virtue Male Sling System with Alexis Wound Retractor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM, GAD Dated: January 18, 2012 Received: January 20, 2012
Dear Ms. Colley:
This letter corrects our substantially equivalent letter of February 14, 2012.
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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STATEMENT OF INDICATIONS FOR USE 2
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The Applied Alexis Wound Retractor is indicated for use to:
Access the abdominal cavity during surgery through an atraumatically retracted incision.
Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to:
Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.
Prescription Use X
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heulstemen
n Slan-Off Reproductive
§ 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.