(24 days)
Not Found
No
The description focuses on the physical components of a surgical implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the treatment of male stress urinary incontinence, which is a medical condition, meaning it is used for therapeutic purposes.
No
The device is described as an "implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI)," which suggests a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is an implantable sling system made of polypropylene mesh with arms and an introducer consisting of a handle and stainless steel wireform. 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 clearly states it's an "implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI)." This describes a surgical device used to treat a medical condition within the body.
- Device Description: The description details a physical implant (polypropylene mesh with arms) and an introducer for surgical placement. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (in a lab setting), or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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)
Substantial equivalency is supported by bench testing compared to the predicate device and existing specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K101297
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2010
510(k) Summary
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Establishment Registration: 9610694 | |
| Owner/Operator: 8010144 | |
| Name of Contact Person: | Angela Byland |
| Senior Regulatory Affairs Manager | |
| Phone and Fax Numbers: | Phone: (612) 287-4236 |
| Fax: (612) 287-4138 | |
| Email: 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.
2
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
4
. 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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