(17 days)
No
The description focuses on the physical components of a surgical implant and delivery system, with no mention of AI or ML terms or functionalities.
Yes
The device is an implantable suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI), which directly addresses a medical condition.
No
This device is an implantable surgical sling used for treatment, not for diagnosing a condition. Its function is to provide physical support, not to detect or analyze medical conditions.
No
The device description clearly states it is an implantable system consisting of polypropylene mesh, arms, sleeves, sutures, and a stainless steel wireform introducer. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of male stress urinary incontinence (SUI) by providing suburethral support. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable sling system. IVDs are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens.
Therefore, the Coloplast VIRTUE Ventral Urethral Elevation Sling System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
OTM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
2009 -
510(k) Summary
| 510(K) Owner's Name: | Coloplast A/S | MAY - 7 |
|---|---|---|
| Address: | Holtedam I | |
| 3050 Humlebaek, Denmark | ||
| Establishment Registration: 9610694 | ||
| Owner/Operator: 8010144 | ||
| Name of Contact Person: | Angela Byland | |
| Regulatory Affairs Manager | ||
| Phone and Fax Numbers: | Phone: (612) 287-4236 | |
| Fax: (612) 287-4138 | ||
| Email: usaby@coloplast.com | ||
| Submission Date: | April 17, 2009 | |
| 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 510(k) K082640.
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.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast Corporation % Ms. Angela Byland Manager, Regulatory Affairs 1601 West River Road North MINNEAPOLIS MN 55411
OCT 12 2012
Re: K091152 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: April 17, 2009 Received: April 20, 2009
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of May 7, 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
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/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/ReportalProblem/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/ResourcesforYou/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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Indications for Use
4041152
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 (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)
Daniel Krone for MKM
(Division Sign-Off) Division of Surgical, Orthopedic,
. Page
(Posted November 13, 300 gestorative Devices
.510(k) Number K091152