(47 days)
Not Found
No
The summary describes a mechanical implant and a wound retractor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The Virtue Male Sling System is indicated for the treatment of male stress urinary incontinence (SUI), which means it is used to manage a medical condition.
No
The provided text describes devices (Virtue Male Sling System and Alexis Wound Retractor) that are used for treatment and surgical access/protection, not for diagnosing conditions.
No
The device description clearly outlines physical components like polypropylene mesh, sleeves, sutures, a stainless steel wireform introducer, and a cylindrical membrane sheath with plastic rings. These are all hardware components, not software.
Based on the provided information, neither the Virtue Male Sling System nor the Applied Alexis Wound Retractor are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The descriptions of both devices clearly indicate they are surgical implants and instruments used directly on or within the patient's body during surgical procedures.
- The Virtue Male Sling System is an implantable support sling.
- The Alexis Wound Retractor is a device used to retract tissue and protect wounds during surgery.
Their intended uses and mechanisms of action are entirely focused on surgical intervention and support, not on analyzing biological samples.
N/A
Intended Use / Indications for 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:
- Scal 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.
Product codes
OTM, GAD, KKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k). There are no changes to the sterilization method, SAL, or sterilization parameters for the Virtue System or Alexis Wound Retractor and neither device will be subjected to additional sterilization cycles as a result of being offered for sale in the same package. Thus, additional sterilization validation is not necessary to support this Special 510(k). Evaluation of the packaging configuration for the Virtue Male Sling System with Alexis Wound Retractor demonstrates that the convenience kit packaging is substantially equivalent to the predicate devices' packaging; therefore, no additional design verification or validation testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG 1 7 2011
| 510(k) Owner/Submitter | Coloplast A/S; Division: Coloplast Corp
Holtedam 1
Humlebaek 3050 - Denmark |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Contact | Janell A. Colley
Coloplast Corp
1601 West River Road North
Minneapolis, 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: K101297;
Alexis: K041711 |
| Device Descriptions | |
| 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 atraumatically-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 Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k). There are no changes to the sterilization method, SAL, or sterilization parameters for the Virtue System or Alexis Wound Retractor and neither device will be subjected to additional sterilization cycles as a result of being offered for sale in the same package. Thus, additional sterilization validation is not necessary to support this Special 510(k). Evaluation of the packaging configuration for the Virtue Male Sling System with Alexis Wound Retractor demonstrates that the convenience kit packaging is substantially equivalent to the predicate devices' packaging; therefore, no additional design verification or validation testing was conducted. | |
| 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. | |
3 510(k) Summary
:
Confidential
.
1
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 or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
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 Coloplast Corporation 1601 West River Road North MINNEAPOLIS MN 55411
OCT 12 2012
K11881 Re:
Trade/Device Name: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTM, GAD, KKX Dated: June 30, 2011 Received: July 1, 2011
Dear Ms. Colley:
This letter corrects our substantially equivalent letter of August 17, 2011.
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
2
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/CDRH0ffices/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
3
2 Statement of Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
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:
- . Scal 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
(Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
A. A. Turner
Concurrence of CDRH, Office of Device Evaluation (ODE) - Sign-
of Reproductive. Gastro-Renal, and 0(k) Niimhe
Confidential