(85 days)
The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
The Ventrio Hernia Patch is a sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device contains two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet to form a positioning pocket. The device also contains an absorbable recoil ring using AbsorbaFlex Memory Technology, which provides memory and stability to the device and facilitates ease of initial insertion, proper placement, and fixation of the device. The AbsorbaFlex Memory Technology is comprised of an absorbable polydioxanone (PDO) monofilament, which fully absorbs in vivo between 6-8 months. The polydioxanone monofilament is dyed violet using D & C Violet No. 2.
Here's an analysis of the provided text regarding the Ventrio Hernia Patch, focusing on acceptance criteria and supporting studies:
This submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Ventrio Hernia Patch K081777), rather than proving the de novo effectiveness of a novel device. Therefore, the "acceptance criteria" discussed are primarily about ensuring the proposed device's performance is comparable to the predicate, and not necessarily about meeting specific clinical performance thresholds for a disease outcome in the same way an AI/software device would.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | |
| Linear verification | Met product specifications |
| Visual inspections | Met product specifications |
| Recoil testing | Met product specifications |
| Ball burst strength testing | Met product specifications |
| Suture pullout testing | Met product specifications |
| Laparoscopic deployment testing | Met product specifications |
| PDO containment testing | Met product specifications |
| Mesh/fixation holding strength | Met product specifications |
| PDO weld testing (Predicate device, as no PDO change) | Met product specifications |
| Monofilament testing (Predicate device, as no PDO change) | Met product specifications |
| Seal strength testing (Predicate device, as no packaging change) | Met product specifications |
| Package qualification testing (Predicate device, as no packaging change) | Met product specifications |
| Biocompatibility testing (Predicate device, as no material change) | Met product specifications |
| Animal Studies | |
| Tissue attachment (4-week porcine model) | Comparable to predicate device |
| Mesh contracture (4-week porcine model) | Comparable to predicate device |
| Tissue in-growth (4-week porcine model) | Comparable to predicate device |
| Host inflammatory and fibrotic response (4-week porcine model) | Comparable to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify the exact sample sizes for each type of bench test. It generally states that "Bench testing... was performed."
- Animal Study: The document refers to "A 4 week post-implantation study in a porcine model." It does not specify the number of animals used in this model.
- Data Provenance: Not explicitly stated, but based on the nature of bench and animal studies conducted by a medical device manufacturer, this would be prospective data generated specifically for this submission. The country of origin for the studies is not specified, but the manufacturer is based in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For mechanical device testing and animal studies, "ground truth" is typically established through standardized measurements and observations by qualified laboratory personnel and veterinary pathologists, not clinical experts in the same way as an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for clinical endpoints or image interpretation where expert consensus is needed. For bench and animal studies, results are based on objective measurements and pathological assessments, not subjective interpretations requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices that assist human readers in making clinical decisions. The Ventrio Hernia Patch is a surgical mesh; its evaluation focuses on its physical and biological performance, not its interpretive aid to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This concept is applicable to AI algorithms. The Ventrio Hernia Patch is a physical medical device.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth was based on product specifications (measurement standards, strength requirements, deployment functionality) and established engineering principles.
- Animal Study: Ground truth was established through histopathological analysis and macroscopic observation by qualified personnel (likely veterinary pathologists) to assess tissue attachment, contracture, in-growth, inflammation, and fibrotic response. This is essentially pathology/biological outcome data in an animal model.
8. The Sample Size for the Training Set
This concept is not applicable to this device and submission. "Training set" refers to data used to train machine learning models. The Ventrio Hernia Patch is a physical medical device, not an AI/software device. There is no algorithm to train.
9. How the Ground Truth for the Training Set was Established
As established in point 8, the concept of a "training set" is not applicable.
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8. 510(k) Summary
510(k) SUMMARY
This 510(k) Summary is provided per the requirements of section 807.92(c).
| 510(k) Number: | TBD |
|---|---|
| Owner Name: | Davol Inc., Subsidiary of C. R. Bard, Inc. |
| Address: | 100 Crossings BoulevardWarwick, RI 02886 |
| Contact Person: | Michelle GodinRegulatory Affairs AssociateTel: 401-825-8589Fax: 401-825-8765Email address: michelle.godin@crbard.com |
| Alternate Contact: | Thomas HutchinsonVice President, Quality Assurance, Regulatory and ClinicalAffairsTel: 401-825-8409Fax: 401-825-8765Email address: tom.hutchinson@crbard.com |
| Date Prepared: | January 25, 2010 |
| Device Trade Name: | Ventrio Hernia Patch |
| Device Common Name: | Surgical Mesh |
| Class: | Class II, 21 CFR 878.3300, Product Code FTL |
Predicate Device(s):
- Ventrio Hernia Patch (K081777) .
Device Description:
The Ventrio Hernia Patch is a sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device contains two primary layers of monofilament polypropylene mesh stitched with PTFE
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monofilament to an ePTFE sheet to form a positioning pocket. The device also contains an absorbable recoil ring using AbsorbaFlex Memory Technology, which provides memory and stability to the device and facilitates ease of initial insertion, proper placement, and fixation of the device. The AbsorbaFlex Memory Technology is comprised of an absorbable polydioxanone (PDO) monofilament, which fully absorbs in vivo between 6-8 months. The polydioxanone monofilament is dyed violet using D & C Violet No. 2.
Indication for Use:
The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Comparison to Predicate Devices:
The Ventrio Hernia Patch has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the Ventrio Hernia Patch are the same as the predicate device including packaging, biocompatibility, sterilization, and labeling. The technological characteristics include polypropylene mesh layers to allow for tissue in-growth, an ePTFE layer to minimize tissue attachment, and a PDO monofilament ring to provide stability to the device. Two minor differences exist between the predicate device and the proposed device. The first difference is that the anterior polypropylene slit mesh layer for all product sizes is now constructed of a lighter weight, larger pore knitted polypropylene monofilament which is identical in the polypropylene material composition. The knitted polypropylene monofilament differs in diameter (.006 in to .004 in) and knit design (pore size and knit pattern) only. The second difference is that the PDO monofilament ring is contained within a knitted polypropylene mesh tube for the 4 larger sizes while the PDO monofilament ring is contained between two stitched layers of knitted polypropylene mesh for the small sizes. The purpose of the containment mesh is to contain the PDO ring during the degradation process; there is no difference in functionality of the polypropylene mesh tube versus the two stitched layers of knitted mesh. The knitted polypropylene mesh tube and the two stitched layers of knitted polypropylene mesh are the same material composition and only differ in
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monofilament diameter (.006 in to .005 in) and knit design (pore size and knit pattern). Where minor technological differences exist between the proposed device and the predicate device, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.
Summary of Non-Clinical Testing:
Bench testing and animal studies were performed on the Ventrio Hernia Patch to support substantial equivalence. Bench testing on the proposed device included linear verification, visual inspections, recoil testing, ball burst strength testing, suture pullout testing, laparoscopic deployment testing, PDO containment testing, and mesh/fixation holding strength. Predicate device testing included PDO weld and monofilament testing, seal strength testing, package qualification testing, and biocompatibility testing as there were no PDO, packaging, or material changes to the device. A 4 week post-implantation study in a porcine model was completed on the predicate device and proposed device to evaluate tissue attachment, mesh contracture, tissue in-growth, and host inflammatory and fibrotic response for both devices. Results of testing demonstrate that the Ventrio Hernia Patch design meets product specifications and intended uses.
Statement of Equivalence:
The Ventrio Hernia Patch has the same indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the Premarket Notification, the proposed Ventrio Hernia Patch has been shown to be substantially equivalent to the cleared Ventrio Hernia Patch.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and service, and is a common emblem used by the U.S. government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 1 2010
C.R. Bard, Inc. % Davol, Inc. Ms. Michelle Godin, MS, RAC 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K100229
Trade/Device Name: Ventrio Hernia Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 19, 2010 Received: March 22, 2010
Dear Ms. Godin:
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
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Page 2 - Ms. Michelle Godin, MS, RAC
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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Bryson
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Statement of Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: Ventrio Hernia Patch
Indications for Use:
The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
for DXK
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100229
Special 510(k) Submission for the Bard Ventrio Hernia Patch
§ 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.