Ajust® Helica! Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Ajust® Helical Adjustable Single-Incision Sling System is a sterile, single use procedure kit that consists of a mesh sling implant and instruments, flexible stylet and two helical shaped introducers, which aid in the placement of the mesh in the pelvic floor. The product is offered in a single kit and dispenser pack of 5 individual kits. The sling implant is composed of four primary components - polypropylene flat mesh, polypropylene tube mesh, polypropylene anchors and a polypropylene sling lock. The adjusting tab is only used during adjustment and is not part of the permanent implant. The flexible stylet is a thin, flexible, Nitinol wire that allows the stylet to conform and flex to follow the path of the tube mesh to push the sling lock into position. The stainless steel helical shaped introducers allow for placement of the anchors in the obturator membrane/muscle by rotation of the handle of the introducer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ajust® Helical Adjustable Single-Incision Sling:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Test Performed)	Reported Device Performance
Introducer compression and side load strength	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Weld strength of the introducer cannula to cannula plate	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Introducer handle pull apart strength	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Introducer collet retention of anchor	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Introducer collet release of anchor	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Anchor placement	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Biocompatibility testing	Not explicitly stated as pass/fail, but implied to meet requirements for substantial equivalence.
Overall Performance for Substantial Equivalence	The product performance is "substantially equivalent" to the predicate device, Ajust® Adjustable Single-Incision Sling.

Important Note: The document does not provide specific numerical acceptance criteria or detailed results for each test. Instead, it broadly states that the tests were performed for "design verification and validation" and that the product performance is "substantially equivalent" to the predicate device. This is common for 510(k) submissions, especially for modifications to existing devices, where the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate.

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

This information is not provided in the document. The text describes a series of "design verification and/or validation testing" on the modified introducers, but it does not specify the number of units tested, the origin of any data (e.g., in-house lab testing, animal studies, human clinical studies), or whether it was retrospective or prospective. Given the nature of the submission (Special 510(k) for a device modification), it's highly likely these were bench tests performed internally by the manufacturer.

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

This information is not applicable/not provided in the context of this 510(k) submission. The "ground truth" here is the successful performance of the device's mechanical and biocompatibility characteristics, determined through engineering tests rather than expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective assessments, such as interpreting diagnostic images. The tests described are engineering and materials assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. An MRMC comparative effectiveness study is used for evaluating diagnostic imaging AI. The Ajust® Helical Adjustable Single-Incision Sling is a surgical mesh product, not a diagnostic AI tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a physical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device's "performance data summary" appears to be based on engineering specifications and established test methodologies to evaluate the mechanical properties and biocompatibility of the introducers. For example, "Introducer compression and side load strength" would have a pre-defined acceptance range based on engineering requirements for the device's function. The ultimate "ground truth" for the overall device is its demonstrated "substantial equivalence" to the predicate device, meaning it performs as expected for its intended use based on these tests.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a "training set."

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

This information is not applicable/not provided for the same reason as point 8.

Summary

{0}------------------------------------------------

14123179

Image /page/0/Picture/1 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and blocky, with a unique design. The "A" is represented by a triangle, adding a geometric element to the word.

Bard Medical Division

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

NOV 2 2012

Section 6: 510(k) Summary

The following information is provided as required by 21 CFR §807.92 for the Ajust® Helical Adjustable Single-Incision Sling Special 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor:	BARD Medical DivisionC. R. BARD, Inc.8195 Industrial Blvd.Covington, GA 30014
Contact:	Michele Davis, RACBard Medical DivisionC. R. Bard, Inc.8195 Industrial Blvd.Covington, GA 30014Ph: 770-784-6274Fax: 770-385-4706E-mail: michele.davis@crbard.com
Submission Date:	October 5, 2012
Proprietary Name:	Ajust® Helical Adjustable Single-Incision Sling
Common Name:	Surgical Mesh
Regulation:	21 CFR §878.3300
Regulatory Class:	II
Product Code:	PAH - Mesh, Surgical, Urogynecologic, For Stress UrinaryIncontinence, Female, Single-Incision Mini-Sling
Predicate Device(s):	Ajust® Adjustable Single-Incision Sling - K092607

Device Description:

{1}------------------------------------------------

pelvic floor. The product is offered in a single kit and dispenser pack of 5 individual kits.

दी हिंदी

'The sling implant is composed of four primary components - polypropylene flat mesh, polypropylene tube mesh, polypropylene anchors and a polypropylene sling lock. The adjusting tab is only used during adjustment and is not part of the permanent implant. The flexible stylet is a thin, flexible, Nitinol wire that allows the stylet to conform and flex to follow the path of the tube mesh to push the sling lock into position. The stainless steel helical shaped introducers allow for placement of the anchors in the obturator membrane/muscle by rotation of the handle of the introducer.

Intended Use:

، ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

The Ajust® Helical Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Summary of the Technological Characteristics Comparison to Predicate Device:

The Ajust® Helical Adjustable Single-Incision Sling System has the same intended use and fundamental scientific technology as the predicate device. The only difference between the predicate device and the proposed device is the shape of the introducer offered in the kit. The predicate device has a hook shaped introducer and the proposed device has an introducer with a helical shape. The modification to the Ajust Helical Adjustable Single-Incision Sling System is deemed equivalent to the current device, Ajust Adjustable Single-Incision Sling.

Performance Data Summary:

The modified introducers of the Ajust® Helical Adjustable Single-Incision Sling have been tested for design verification and validation. Design verification and/or validation testing of the helical introducers included the following tests:

Introducer compression and side load strength .
. Weld strength of the introducer cannula to cannula plate

{2}------------------------------------------------

Introducer handle pull apart strength .
Introducer collet retention of anchor .
Introducer collet release of anchor .
Anchor placement .
Biocompatibility testing .

The product performance of the Ajust® Helica! Adjustable Single-Incision Sling is substantially equivalent to the Ajust® Adjustable Single-Incision Sling.

Substantial Equivalence:

The Ajust® Helical Adjustable Single-Incision Sling has the same indications for use and fundamental scientific technological characteristics as the predicate device. Based on this, the design and the summary of design control activities provided in this submission, the proposed Ajust® Helical Adjustable Single-Incision Sling has been shown to be substantially equivalent to the cleared Ajuste Adjustable Single-Incision Sling.

Conclusions:

The modified device, Ajust® Helical Adjustable Single-Incision Sling, is substantially equivalent to the predicate device, Ajust® Adjustable Single-Incision Sling.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three distinct, curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-002

Letter Date: November 2, 2012

C. R. Bard, Inc. % Ms. Michele Davis, RAC Regulatory Affairs Project Manager 8195 Industrial Blvd. COVINGTON GA 30014

Re: K123179

Trade/Device Name: Ajust® Helical Adjustable Single-Incision Sling Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: October 5, 2012 Received: October 9, 2012

Dear Ms. Davis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorolery to regions and 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. T ou may, increfere, manisons of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease noter US2020, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr has Intacted and regulations administered by other Federal agencies. You must or any I vature 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 do related daviers of ends) 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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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

{5}------------------------------------------------

Section 5: Indications for Use Statement

K123179

510(k) Number (if known): '_ Ajust® Helical Adjustable Single-Incision Sling Device Name: Indications for Use:

Ajust® Helica! Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

AND/OR Prescription Use __ x

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.11.02 1,7:51:59 -04'00'

(Division Sign-Off)Division of Reproductive, Gastro-Renal, and
Urological Devices510(k) Number	K123179

Page 1 of 1

Special 510(k) Submission for the Ajust® Helical Adjustable Single-Incision Sling Page 17 of 38

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.