The Align® Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Align® Urethral Support System and Align® TO Urethral Support System (Align® System) include a sterile, single use permanent implant that provides support for the urethra in female patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip, which is self-anchoring. The open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra. The knitted polypropylene mesh is made from a small diameter fiber which creates a soft and pliable material. The mesh sling is encased in a removable, protective sheath assembly. The sheath assembly consists of a PTFE tube with a Peel-Away tab that is used to separate the two sections of the sheath for removal of the sheath assembly after the implant has been placed. At the ends of the sheath are flexible green polyurethane tubes to aid in placing the device and for easy visualization during cystoscopy. The sheath incorporates a stainless steel dilator that smoothes the transition from the green tubing to the protective sheath to aid in sheath removal. Push on polypropylene connectors at each end of the green tubes are used to connect the device to the introducers. Because of the different surgical approaches that may be used to place the device, the same implant is offered in several kit configurations depending on the surgical approach (retropybic, suprapubic, or transobturator) to be used for placement of the mesh implant.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Performed	Predetermined Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Material/Design Integrity	Dimensional Testing	Met specifications for dimensions.	Not explicitly detailed, but stated as "met the predetermined acceptance criteria."
	Tensile Strength Testing	Withstood required tensile forces.	Not explicitly detailed, but stated as "met the predetermined acceptance criteria."
Functional Performance	Insertion Force Testing	Met specifications for insertion force.	Not explicitly detailed, but stated as "met the predetermined acceptance criteria."
Surgical Handling & Removal	Cadaver Study	- Sheath glides easily through tissue. - Sheath removal is easy.	- Demonstrated ability of the sheath to easily glide through tissue during implantation. - Demonstrated ease of sheath removal.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The text mentions a "cadaver study" but does not specify the number of cadavers (i.e., the sample size) used for this test.
Data Provenance: The cadaver study is a type of prospective non-clinical study, as it involves physical testing performed specifically for the device evaluation. The country of origin is not specified, but given the submission is to the FDA, it is likely that the study was conducted under U.S. or internationally recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Experts: The text does not explicitly mention the use of experts to establish ground truth for the cadaver study in the way one might for a diagnostic imaging device. Instead, the "ground truth" for the non-clinical tests (dimensional, tensile, insertion force, cadaver study) would be based on engineering specifications and direct observation/measurement. For the cadaver study, the assessment of "ease of glide" and "ease of removal" would likely be subjective evaluations by the operators performing the study (e.g., surgeons or medical device engineers experienced with such procedures). No specific number or qualifications are provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable in the context of these non-clinical performance studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical studies or for diagnostic evaluations where multiple human readers interpret data. For mechanical and cadaveric testing, the results are typically objectively measured or observed, and consensus among experts for subjective assessments (like "ease of use") would be part of the testing protocol rather than a formal adjudication process described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data is not necessary to determine substantial equivalence." The comparison for effectiveness is primarily based on non-clinical performance against predicate devices' characteristics and performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Standalone Performance: Not applicable. This device is a surgical implant system, not an AI algorithm or a diagnostic tool that would have a "standalone" or "human-in-the-loop" performance metric. The performance is related to its physical and functional characteristics.

7. The Type of Ground Truth Used:

Ground Truth: For the non-clinical tests (dimensional, tensile, insertion force), the ground truth is based on engineering specifications and direct measurements. For the cadaver study, the ground truth for "ease of glide" and "ease of removal" is based on direct observation and subjective assessment during the simulation of the surgical procedure.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is a medical device (a surgical mesh system), not an AI algorithm that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices, not machine learning.

9. How the Ground Truth for the Training Set Was Established:

Training Set Ground Truth: Not applicable, as there is no training set for this type of medical device.

Summary

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Bard Medical Division C & Bad Inc 9195 Industral Blu. Councin GA 10514

MAY - 7 2010

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:

Address:

Contact Person: Contact Person's Telephone Number: Contact Person's Fax:

Covington, GA 30014 John Knorpp

Bard Medical Division 8195 Industrial Blvd.

770-784-6316 770-385-4706

C. R. Bard, Inc.

Summary Prepared On:

February 17, 2010

B. DEVICE NAME:

Align® Urethral Support System Trade Name(s): Align® TO Urethral Support System Common/Usual Name: Surgical Mesh Mesh, Surgical, Polymeric Classification Name: (21 CFR 878.3300, Product Code OTN

C. PREDICATE DEVICE NAME:

Trade Names:	Align ® Urethral Support System
	Align ® TO Urethral Support System
	K070073

D. DEVICE DESCRIPTION:

The mesh sling is encased in a removable, protective sheath assembly. The sheath assembly consists of a PTFE tube with a Peel-Away tab that is used to separate the two sections of the sheath for removal of the sheath assembly after the implant has

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K093747

been placed. At the ends of the sheath are flexible green polyurethane tubes to aid in placing the device and for easy visualization during cystoscopy. The sheath incorporates a stainless steel dilator that smoothes the transition from the green tubing to the protective sheath to aid in sheath removal. Push on polypropylene connectors at each end of the green tubes are used to connect the device to the introducers.

Because of the different surgical approaches that may be used to place the device, the same implant is offered in several kit configurations depending on the surgical approach (retropybic, suprapubic, or transobturator) to be used for placement of the mesh implant.

E. INTENDED USE:
The Align® System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. There have been no changes to the intended use or indications for use.

F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device Align® System has the same design, materials and fundamental scientific technology as the predicate device (described above) with the exception of the dilator. The predicate device does not include a dilator. The subject device incorporates a stainless steel dilalor that smoothes the transition from the green lubing to the protective sheath to aid in sheath removal.

Non-clinical Performance Data Summary: G.
The tests performed include dimensional, tensile strength and insertion force testing. A cadaver study was also performed to evaluate the ability of the sheath to easily glide through lissue during implantation and the ease of sheath removal. The results of these non-clinical tests demonstrate that the subject device met the predetermined acceptance criteria and performed as well or better than the predicate device and/or other legally marketed devices that incorporate a dilating feature (American Medical System's Monarc Sling (K051530, K081613) and Boston Scientific's Obtryx® / Lynx® Sling (K081275)).
H. Clinical Data Summary:
Clinical data is not necessary to determine substantial equivalence.
l, CONCLUSION:
The results from the non-clinical performance data summarized above demonstrate that the Align System is as safe, as effective, and performs as well as or better than the predicate device and/or other legally marketed devices that incorporate a dilating feature.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, oriented to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is in a simple, sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

C.R. Bard, Inc. % Ms. Michelle Gudith Bard Medical Division 8195 Industrial Boulevard COVINGTON GA 30014

SEP 2 8 2012

Re: K093747 Trade/Device Name: Align® Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 8, 2010 Received: April 8, 2010

Dear Ms. Gudith:

This letter corrects our substantially equivalent letter of May 7, 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 (2) 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 100.97). 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 Four may 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,

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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C.R. Bard, Inc., Bard Medical Division Align® Urethral Support System Premarket Notification [510(k)]

1.4 Indications for Use Statement

510(k) Number (if known): _

Device Name: __ Aligny Urethral Support System

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 (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)

Daniel Krouise for MXM

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093747

Regulation Number and Section

§ 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.