(87 days)
Align® Urethral Support System, Tissue Fixation System Sling, MiniArc™ Sling System, IVS Tunneller™ System, Elevate™ Prolapse Repair System
Not Found
No
The description focuses on a physical surgical implant and its mechanical components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the treatment of female stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device is described as a "sling" and "implant" used for surgical treatment, not for diagnosing a condition.
No
The device description clearly describes a physical implant (sling, anchors, introducer, locking mechanism) used in a surgical procedure, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Ajust™ Adjustable Single Incision Sling is a surgical implant used to treat stress urinary incontinence. It is physically placed within the patient's body.
- Intended Use: The intended use is the treatment of a medical condition through a surgical procedure, not the analysis of samples outside the body.
The description clearly indicates a device used in vivo (within the living body) for a therapeutic purpose, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ajust™ 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
PAH
Device Description
The Ajust™ Adjustable Single Incision Sling is for use in urological and gynecological procedures for the treatment of stress urinary incontinence in women. The sling is secured in the patient's tissue using two soft tissue anchors. An introducer is used to insert the anchors using a similar approach to a transobturator sling. The implant design allows independent adjustment of the mesh relative to the anchors, after which, the mesh is secured in place using a small locking mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench performance testing, pre-clinical studies and clinical data were used to determine equivalence of the Ajust™ Adjustable Single Incision Sling to the predicate devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Align® Urethral Support System, Tissue Fixation System Sling, MiniArc™ Sling System, IVS Tunneller™ System, Elevate™ Prolapse Repair System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K09 2607
pg 1082
NOV 2 0 2009
Bard Medical Division C. R. Bard, Inc 8195 Industrial Blvd. Covington, GA 30014
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:
C. R. Bard, Inc. Bard Medical Division 8195 Industrial Blvd. Covington, GA 30014
Contact Person: John Knorpp Contact Person's Telephone Number: 770-784-6316
-
B. DEVICE NAME:
Trade Name(s): Aiust TM Adiustable Single Incision Sling Common/Usual Name: Jrethral Sling; Surgical Mesh PAH - Mesh, Surgical, Polymeric; Classification Names: CFR Reference: 21 CFR 878.3300, Surgical mesh -
C. PREDICATE DEVICES:
Trade Name(s): Align® Urethral Support System Tissue Fixation System Sling MiniArc™ Sling System IVS Tunneller™ System Elevate™ Prolapse Repair System
D. DEVICE DESCRIPTION:
The Ajust™ Adjustable Single Incision Sling is for use in urological and gynecological procedures for the treatment of stress urinary incontinence in women. The sling is secured in the patient's tissue using two soft tissue anchors. An introducer is used to insert the anchors using a similar approach to a transobturator sling. The implant design allows independent adjustment of the mesh relative to the anchors, after which, the mesh is secured in place using a small locking mechanism.
. E. Intended Use:
The Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The principles of operation and fundamental scientific technology are equivalent to the predicate devices
G. PERFORMANCE DATA SUMMARY:
Bench performance testing, pre-clinical studies and clinical data were used to determine equivalence of the Ajust™ Adjustable Single Incision Sling to the predicate devices
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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 eagle or bird-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C. R. Bard, Inc. % Bard Medical Division John C. Knorpp, RAC Director, Regulatory Affairs 8195 Industrial Boulevard COVINGTON GA 30014
SEP 2 8 2012
K092607 Trade/Device Name: Ajust™ Adjustable Single Incision Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: August 21, 2009 Received: August 25, 2009
Dear Mr. Knorpp:
Re:
This letter corrects our substantially equivalent letter of November 20, 2009.
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 (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.
Benjamin R. Rooks
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 Ajust™ Adjustable Single Incision Sling Premarket Notification {510(k)}
1.3 Indications for Use Statement
510(k) Number (if known): K09260
Ajust™ Adjustable Single Incision Sling Device Name: ___
Indications for Use:
The Ajust™ Adjustable Single Incision Sling 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 Kraemer
(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092607
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