(72 days)
Not Found
No
The device description focuses on the material and mechanical properties of a surgical mesh implant and explicitly states that the principles of operation and fundamental scientific technology have not changed from the predicate. There is no mention of AI, ML, image processing, or data sets.
Yes
The device is indicated for the "treatment of female stress urinary incontinence" and provides "strong, stable support for the urethra," indicating a therapeutic purpose.
No
The device description indicates it is a permanent implant designed to provide physical support for the urethra in patients with stress urinary incontinence, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it includes a "sterile, single use permanent implant" made of "knitted, open porosity, monofilament, polypropylene mesh strip," which is a physical hardware component.
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 female stress urinary incontinence by providing physical support to the urethra. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a permanent implant made of polypropylene mesh. This is a surgical device designed to be placed within the body, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Align™ Urethral Support System does not fit this description.
N/A
Intended Use / Indications for Use
The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
The Align™ Urethral Support System includes a sterile, single use permanent implant that provides strong, stable support for the urethra in patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allows for macrophage penetration and tissue ingrowth to promote the creation of a permanent support for the urethra. The knitted polypropylene mesh is made from a small fiber diameter which creates a soft and pliable material.
Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.
The principles of operation and fundamental scientific technology have not changed from the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted.
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.
0
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.
- SUBMITTER INFORMATION: A.
| Submitter's Name: | C. R. Bard, Inc.
Bard Urological Division |
|------------------------------------|----------------------------------------------|
| Address: | 13183 Harland Dr.
Covington, GA 30014 |
| Contact Person: | Julie J. Bassett |
| Contact Person's Telephone Number: | 678-342-4921 |
| Contact Person's Fax: | 770-788-5517 |
| Date of Preparation: | March 9, 2006 |
B. DEVICE NAME:
| Trade Name(s): | Bard Align™ Urethral Support System |
|---|---|
| Common/Usual Name: | Urethral Sling; Surgical Mesh |
| Classification Names: | 79 OTN-Mesh, Surgical, Polymeric; CFR Reference: |
| 21 CFR 878.3300, Surgical mesh |
- PREDICATE DEVICE NAME: C.
- Uretex® TO Trans-Obturator Urethral Support System Trade Name(s):
- D. Device Description:
The Align™ Urethral Support System includes a sterile, single use permanent implant that provides strong, stable support for the urethra in patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allows for macrophage penetration and tissue ingrowth to promote the creation of a permanent support for the urethra. The knitted polypropylene mesh is made from a small fiber diameter which creates a soft and pliable material.
Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.
The principles of operation and fundamental scientific technology have not changed from the predicate.
1
E. Intended Use:
The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The intended use has not changed from the predicate (K041176).
TECHNOLOGICAL CHARACTERISTICS SUMMARY: F.
The subject device, the Align™ Urethral Support System, has the same intended use, general design and fundamental scientific technology as the predicate device (K041176).
G. PERFORMANCE DATA SUMMARY:
The appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
C.R. Bard, Inc. % Ms. Julie J. Bassett. RAC Regulatory Affairs Specialist 13183 Harland Drive COVINGTON GA 30014
Re: K070073 Trade/Device Name: Align™ Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 5, 2007 Received: January 8, 2007
Dear Ms. Bassett:
This letter corrects our substantially equivalent letter of March 21, 2007.
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
Page 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/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
C.R. Bard, Inc., Bard Urological Division Align™ Urethral Support System Premarket Notification {510(k)]
1.3 Indications for Use Statement
510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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 IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
(Recommended Format 11/13/2003)
(Division Sign-Off) Division of General, Restorative, and Neurological Device
510(k) Number L070073
3