(22 days)
PAG
Not Found
No
The summary describes a surgical implant and introducer device, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to treat stress urinary incontinence in women, which is a medical condition, making it a therapeutic device.
No
The device is described as a "soft tissue patch to reinforce soft tissue" and a "pubourethral sling" for surgical repair and treatment of stress urinary incontinence. Its function is to provide physical support and reinforcement, not to diagnose a condition.
No
The device description explicitly states it consists of a physical implant and an introducer device, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant and support system for treating stress urinary incontinence. This involves a physical intervention within the body.
- Device Description: The description details a surgical implant (soft tissue patch) and an introducer device for placement. This is a medical device used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue) in vitro (outside the body) to diagnose a condition. IVDs are typically tests or kits used for diagnostic purposes on biological samples.
The device is clearly intended for surgical repair and support in vivo (within the body), which is characteristic of a surgical medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
PAG
Device Description
The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases.
The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, pubourethral sling for the urethra
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 Bard® InnerLace" BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues.
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.
Permacol® Acellular Collagen Matrix
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.
0
MAY 1 5 2003
K031295/ppk
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
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:
Address:
Contact Person: Contact Person's Telephone Number: Contact Person's Fax: Date of Preparation:
C.R. Bard, Inc. Bard Urological Division 8195 Industrial Blvd. Covington, GA 30014 Frances E. Harrison, RAC 770-784-6257 770-784-6419 April 17, 2003
B. DEVICE NAME:
Trade Name: Bard® InnerLace™ BioUrethrai Support System Common / Usual Name: Surgical Mesh Polymeric Surgical Mesh Classification Name:
C. PREDICATE DEVICE NAME:
Trade Name: Permacol® Acellular Collagen Matrix
D. DEVICE DESCRIPTION:
The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases.
The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.
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Image /page/1/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K031295/P2/2". The characters are written in black ink on a white background. The writing style is cursive.
E. INTENDED USE:
The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The fundamental technology of processing the Bard® InnerLace™ System Pelvicol® Implant and the predicate device, Permacol® implant, are the same.
G. PERFORMANCE DATA SUMMARY:
The Bard® InnerLace" BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border 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 that suggest the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Frances E. Harrison, RAC Director, Regulatory Affairs C.R. Bard, Inc. Bard Urological Division 8195 Industrial Boulevard COVINGTON GA 30014
SEP 2 8 2012
Re: K031295 Trade/Device Name: Bard® InnerLace™ BioUrethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: April 16, 2003 Received: April 23, 2003
Dear Ms. Harrison:
This letter corrects our substantially equivalent letter of May 15, 2003.
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
3
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/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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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K031295 |
|---|---|
| Device Name: | Bard® InnerLace™ BioUrethral Support System |
Indications for Use:
The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
ﺮ Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use _____________
(Optional Format 1/2/96)