(88 days)
Not Found
No
The 510(k) summary describes a surgical mesh implant for pelvic floor repair and does not mention any AI or ML components or functionalities.
Yes
The device is described as a surgical implant intended for tissue reinforcement and stabilization of fascial structures in vaginal wall prolapse, which directly addresses a medical condition to restore function.
No
The device description indicates it is an implant for tissue reinforcement and stabilization, not for diagnosing medical conditions.
No
The device description clearly states that the Avaulta™ Support System includes a sterile, single-use, permanent implant made of polypropylene mesh and potentially collagen. This is a physical medical device, not software.
Based on the provided information, the Avaulta™ Support System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "sterile, single use, permanent implant" made of mesh and potentially collagen, designed for surgical implantation. This aligns with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status, disease, or condition.
IVD devices are typically used to perform tests on samples taken from the body to aid in diagnosis, monitoring, or screening. The Avaulta™ Support System is a therapeutic device used during surgery to physically support and reinforce tissue.
N/A
Intended Use / Indications for Use
The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
Product codes
OTP, PAI
Device Description
The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse. The central soft knit section provides compliant organ support while the strong knit arms provide improved strength for tension free fixation of the implant.
The Avaulta™ Plus Biosynthetic Support System and Avaulta™ Solo support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta™ Plus Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, vaginal wall
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 to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
0
Image /page/0/Picture/2 description: The image shows the number 2063712 in the upper left corner. To the right of the number is the fraction 1/2. Below the fraction is the word "BARD" in all capital letters.
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 Urological Division 13183 Harland Drive Covington, GA 30014
Contact Person: John C. Knorpp Contact Person's Telephone Number: 678-342-4920 Contact Person's Fax: 770-788-5513
- B. DEVICE NAME:
| Trade Name(s): | Avaulta ™ Solo Support System
Avaulta ™ Plus Biosynthetic Support System |
|-----------------------|---------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Names: | 79 - Mesh, Surgical, Polymeric (OTP, PAI) |
| CFR Reference: | 21 CFR 878.3300 |
| Classification Panel: | General and Plastic Surgery |
C. PREDICATE DEVICE NAME:
Bard CollaMend™ Implant - K052322 Trade Names: UGYTEX® Dual Knit Mesh – K051503
- D. Device Description:
The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse. The central soft knit section provides compliant organ support while the strong knit arms provide improved strength for tension free fixation of the implant.
The Avaulta™ Plus Biosynthetic Support System and Avaulta™ Solo support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta™ Plus Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and
1
K0637/D
2/D
the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.
- E. Intended Use:
The Avaulta™ Support System is indicated for tissue reinforcement and longlasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject Avaulta™ Support System has the same intended use, general design and fundamental scientific technology as the predicate devices.
- G. Performance Data Summary:
The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
John C. Knorpp, RAC Manager, Regulatory Affairs Bard Urological Division 13183 Harland Drive COVINGTON GA 30014
Re: K063712 Trade/Device Name: Avaulta Solo™ Support System Avaulta Plus™ Biosynthetic Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: December 8, 2006 Received: December 14, 2006
Dear Mr. Knorpp:
This letter corrects our substantially equivalent letter of March 12, 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
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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 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/ReportalProblem/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. Krebs
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 Avaulta™ Support System Premarket Notification [510(k)]
KO 63712
1.3 Indications for Use Statement
510(k) Number (if known): __
Device Name: _ Avaulta™ Support System
ે
Indications for Use:
The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
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)
Pelo R
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
11063112 510(k) Number
(Recommended Format 11/13/2003)