(24 days)
Not Found
No
The device description and performance studies focus on the mechanical components and placement of a surgical sling, with no mention of AI or ML technologies.
Yes.
The device is used for the treatment of a medical condition (female stress urinary incontinence).
No
The device is a surgical implant (sling) and instruments used for the treatment of stress urinary incontinence, not for diagnosing a condition.
No
The device description clearly outlines a physical medical device kit containing a mesh sling implant, instruments, stylet, and introducers, all made of various materials like polypropylene and stainless steel. This is not a software-only device.
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. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a surgical implant (mesh sling) and instruments used for its placement. It is designed to physically support the urethra, not to analyze biological samples for diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the Ajust® Helical Adjustable Single-Incision Sling is a surgical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PAH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, obturator membrane/muscle
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 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
- 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.
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.
Ajust® Adjustable Single-Incision Sling - K092607
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
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 Division
C. R. BARD, Inc.
8195 Industrial Blvd.
Covington, GA 30014 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michele Davis, RAC
Bard Medical Division
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30014
Ph: 770-784-6274
Fax: 770-385-4706
E-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 Urinary
Incontinence, Female, Single-Incision Mini-Sling |
| Predicate Device(s): | Ajust® Adjustable Single-Incision Sling - K092607 |
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
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
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 Devices | |
| 510(k) Number | K123179 |
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Special 510(k) Submission for the Ajust® Helical Adjustable Single-Incision Sling Page 17 of 38