(129 days)
No
The device description focuses on the materials and mechanical properties of a hernia patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The Bard Ventralex Hernia Patch is intended for use in hernia repair and soft tissue deficiencies, which involves treating or correcting a medical condition.
No
Explanation: The Bard® Ventralex™ Hernia Patch is a surgical implant designed for hernia repair and soft tissue reinforcement, which is a therapeutic function, not diagnostic.
No
The device description clearly details a physical, implantable hernia patch made of various materials (polypropylene mesh, ePTFE, PDO monofilament). It is a hardware device, not software.
Based on the provided information, the Bard® Ventralex™ Hernia Patch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "hernia repair requiring reinforcement with a nonabsorbable support material" and "to repair soft tissue deficiencies." This describes a surgical implant used in vivo (within the body) to physically repair tissue.
- Device Description: The description details a physical prosthesis made of mesh and other materials designed to be implanted. It discusses its structure, materials, and how it functions within the body (tissue in-growth, minimizing tissue attachment, providing stability).
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ventralex Hernia Patch does not perform any such function. It is a therapeutic device used directly on the patient's body.
Therefore, the Bard® Ventralex™ Hernia Patch is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material. The small Bard Ventralex Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The proposed Ventralex Hernia Patch is a self-expanding, sterile prosthesis, containing two primary layers of polypropylene mesh stitched with polytetrafluoroethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh component is non-absorbable; however, the device contains a fully absorbable recoil ring using SorbaFlex™ Memory Technology, an absorbable polydioxanone (PDO) monofilament.
The mesh is constructed from knitted polypropylene monofilament and forms a strong, porous, support material. The top layer of mesh has a mesh strap and forms a positioning pocket with the second mesh layer. The propylene mesh side promotes tissue in-growth and repairs the defect. The strap and pocket facilitate placement, positioning and fixation of the device. For a reference point, the small Ventralex Hernia Patch is constructed with a depth marker on the positioning strap. The depth marker is polypropylene monofilament dyed with a blue colorant to indicate the position of the device relative to the end of the laparoscopic trocar sleeve. After fixation to the abdominal wall, excess positioning strap material above the fixation line and at the level of the fascia is cut off and discarded.
A layer of ePTFE is stitched with PTFE monofilament thread and edge heat sealed to the polypropylene mesh. The ePTFE layer minimizes tissue attachment to the device. The SorbaFlex Memory Technology is comprised of an absorbable PDO monofilament welded to form a ring. The PDO monofilament recoil ring provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the PDO monofilament recoil ring during the degradation process.
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)
Biocompatibility testing previously conducted for the Ventrio Hernia Patch (as presented via K081777) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses In support of this submission, the proposed Ventralex Hernia Patch was deployed in a laparoscopic deployment model to evaluate the integrity of the PDO monofilament recoil ring and mesh tube when in a folded position. Additionally, the proposed Ventralex Hernia Patch underwent bench testing to ensure that the device recoiled to a flat position after folding. Whole system simulated use testing was conducted in an animal model to ensure that the proposed Ventralex Hernia Patch met key user needs. In vivo and in vitro resorption studies were performed and provided in support of the Ventrio Hernia Patch via K081777. These resorption studies were adopted for the proposed Ventralex Hernia Patch.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicates.
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.
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.
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
AUGUST 27, 2013
This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information:
| Submitter's Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Contact Person: | Mariya Buharin |
| Regulatory Affairs Specialist | |
| Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8729 |
| Fax: | (401) 825-8765 |
| Email: | marie.buharin@crbard.com |
| Device Name: |
Trade Name:
Common/Usual Name: Classification Name: Classification Code:
- Surgical Mesh - Mesh, Surgical, Polymeric - Class II, § 878.3300, Product Code FTL
Bard® Ventralex™ Hernia Patch
Predicate Device Names:
- . Bard® Ventralex™ Hernia Patch,
- Bard® Ventrio™ Hernia Patch, .
- K081777 (Davol, Inc.), FDA cleared on 09/29/2008 o
- K 100229 (Davol, Inc.), FDA cleared on 04/21/2010 o
Device Description:
The proposed Ventralex Hernia Patch is a self-expanding, sterile prosthesis, containing two primary layers of polypropylene mesh stitched with polytetrafluoroethylene (PTFE) monofilament to an expanded polytetrafluoroethylene (ePTFE) sheet. The mesh component is non-absorbable; however, the device contains a fully absorbable recoil ring using SorbaFlex™ Memory Technology, an absorbable polydioxanone (PDO) monofilament.
The mesh is constructed from knitted polypropylene monofilament and forms a strong, porous, support material. The top layer of mesh has a mesh strap and forms a positioning pocket with the second mesh layer. The propylene mesh side promotes tissue in-growth and repairs the defect. The strap and pocket facilitate placement, positioning and fixation of the device. For a reference point, the small Ventralex Hernia Patch is constructed with a depth marker on the positioning strap. The depth marker is polypropylene monofilament dyed with a blue colorant to indicate the position of the device relative to the end of the laparoscopic trocar sleeve. After fixation to the abdominal wall, excess positioning strap material above the fixation line and at the level of the fascia is cut off and discarded.
PREMARKET NOTIFICATION FOR THE BARD® VENTRALEX™ HERNIA PATCH
1
A layer of ePTFE is stitched with PTFE monofilament thread and edge heat sealed to the polypropylene mesh. The ePTFE layer minimizes tissue attachment to the device. The SorbaFlex Memory Technology is comprised of an absorbable PDO monofilament welded to form a ring. The PDO monofilament recoil ring provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the PDO monofilament recoil ring during the degradation process. Intended Use:
The Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material. The small Bard Ventralex Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The proposed Ventralex™ Hernia Patch has the same indications for use, technological characteristics, and performance characteristics as the original Ventralex Hernia Patch, cleared via K021736 and K024008, with the exception of the material type of the recoil ring and the containment mesh tube in which it is encased.
In this submission. Davol proposes modifying the material type of the recoil ring used in the Ventralex Hernia Patch. In the proposed device, the non-absorbable PET recoil ring will be replaced with an absorbable PDO monofilament recoil ring encased in a containment mesh tube The proposed PDO monofilament ring and containment mesh tube are identical to the PDO monofilament ring and containment mesh tube used in the previously cleared Ventria Hernia Patch (K081777/K 100229).
Performance Data:
Biocompatibility testing previously conducted for the Ventrio Hernia Patch (as presented via K081777) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses In support of this submission, the proposed Ventralex Hernia Patch was deployed in a laparoscopic deployment model to evaluate the integrity of the PDO monofilament recoil ring and mesh tube when in a folded position. Additionally, the proposed Ventralex Hernia Patch underwent bench testing to ensure that the device recoiled to a flat position after folding. Whole system simulated use testing was conducted in an animal model to ensure that the proposed Ventralex Hernia Patch met key user needs. In vivo and in vitro resorption studies were performed and provided in support of the Ventrio Hernia Patch via K081777. These resorption studies were adopted for the proposed Ventralex Hernia Patch.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicates. .
PREMARKET NOTIFICATION FOR THE BARD® VENTRALEX™ HERNIA PATCH
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
C.R. Bard Incorporated Ms. Mariya Buharin Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
December 13, 2013
Re: K132441
Trade/Device Name: Bard® Ventralex™ Hernia Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: November 15, 2013 Received: November 18, 2013
Dear Ms. Buharin:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, 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.
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 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
3
Page 2 - Ms. Mariya Buharin
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours. Joshua ©. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known):
Not known
Device Name:
Bard® Ventralex™ Hernia Patch
The Bard® Ventralex™ Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard® Ventralex™ Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.
Prescription Use ਮ (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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132441