(14 days)
K/DEN, Uretex™ TO
Not Found
No
The summary describes a surgical implant and its introducers, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for the surgical repair of damaged tissue and for the inhibition of stress urinary incontinence, which are therapeutic interventions.
No
Explanation: The device is described as an implant and introducers used for surgical repair and support, not for diagnosing conditions.
No
The device description explicitly states it consists of an implant and introducers, which are physical 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 for surgical repair of soft tissue and inhibition of stress urinary incontinence. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description confirms it's an implant and introducers used for surgical placement.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such analysis.
Therefore, the PelviLace™ Transobturator BioUrethral Support System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue membranes. It is specifically intended for use in the surgical repair of tissue resulting from damaged or ruptured soft tissue inbibition of stress urinary incontinence in women resulting from pubourethral ligament injury and/or intrinsic sphincter deficiency.
Product codes
PAG
Device Description
The Bard® PelviLace™ TO BioUrethral Support System consists of the PelviLace Pelvicol implant and introducers. The introducers are used to place the implant which provides a natural backboard for the urethra during abdominal pressure increases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra
Indicated Patient Age Range
women
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)
InnerLace™ BioUrethral Support System, Uretex™ TO Transobturator Urethrql Support System
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
K042949 1 of 1
C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
NOV - 9 2004
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and connected to each other. The word is black and the background is white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATIO
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. SUBMITTER INFORMATION:
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 8195 Industrial Blvd. |
| Covington, GA 30014 |
John C. Knorpp Contact Person: 770-784-6451 Contact Person's Telephone Number: 770-784-6419 Contact Person's Fax: October 25, 2004 Date of Preparation:
в. DEVICE NAME:
| Trade Name: | PelviLace™ TO BioUrethral Support System |
|---|---|
| Common/Usual Name: | Suburethral Sling |
| Classification Names: | PAG Mesh, Surgical, Polymeric |
C. PREDICATE DEVICE NAME:
Trade Names: InnerLace™ BioUrethral Support System and Uretex™ TO Transobturator Urethral Support System
D. Device Description:
The Bard® PelviLace™ TO BioUrethral Support System consists of the PelviLace Pelvicol implant and introducers. The introducers are used to place the implant which provides a natural backboard for the urethra during abdominal pressure increases.
E. INTENDED USE:
The PelviLace™ TO BioUrethral Support System is used for the treatment of stress urinary incontinence.
- F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject PelviLace™ TO BioUrethral Support System has the same intended use, design and fundamental scientific technology as the predicate devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John C. Knorpp Senior Regulatory Affairs Specialist C.R. Bard, Inc., Urological Division 8195 Industrial Boulevard COVINGTON GA 30014
SEP 2 8 2012
K042949 Trade/Device Name: PelviLace™ Transobturator BioUrethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: October 25, 2004 Received: November 1, 2004
Dear Mr. Knorpp:
Re:
This letter corrects our substantially equivalent letter of November 9, 2004.
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 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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Bard Urological Division, C.R. Bard, Inc. PelviLace™ TO System Premarket Notification [510(k)]
Indications for Use Statement 1.3
510(k) Number (if known): ___K042949
Device Name: ___PelviLace™ Transobturator BioUrethral Support System
Indications for Use:
The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft The PelvilLace™ Transolurator Dioorcanal Oupport of the surgical repair of tissue patch to remiorce soft tissue membranes. It is specifically in weap soculting from damaged or ruptured sont ussue incribition of stress urinary incontinence in women resulting from publumbling oling fity and/or intrinsic sphincter deficiency.
X 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 IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042949
(Recommended Format 11/13/2003)