(49 days)
Intended for the use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
The proposed Ventralex Patch is a self-expanding, three laver device. Two layers consist of polypropylene mesh. The top layer of polypropylene mesh forms a positioning strap and pocket. The purpose of the strap and pocket is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded. The monofilament PET polymer "ring" is captured between the two layers of polypropylene mesh and adds stability to the device enabling greater simplicity and assurance in the proper placement. The third layer of the device is a single layer of expanded polytetrafluoroethylene (ePTFE) that is attached to the polypropylene mesh with an interlocking PTFE stitch pattern. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.
This is a 510(k) premarket notification for a medical device called the Ventralex Patch, a surgical mesh for hernia repair. The request asks for details about acceptance criteria and a study proving the device meets those criteria.
However, the provided text does not describe a study with quantitative acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, which are typically associated with diagnostic or AI-driven devices. This document is for a physical surgical implant, and the performance data focuses on materials, manufacturing, and biological compatibility rather than statistical performance metrics from a clinical study comparing the device's efficacy in patients against specific thresholds.
Therefore, many of the requested details (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this 510(k) summary.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | "Biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use." |
| Bench Testing | "Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Ventralex Patch will meet the established specifications necessary for consistent performance during their intended use." |
| Material Equivalence | "The Ventralex Patch and the predicate Composix Kugel Mesh have a single layer of expanded polytetrafluoroethylene (ePTFE) and is attached to the polypropylene mesh with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer." "The proposed device has the same the same materials, and similar physical attributes and manufacturing methods." |
| Manufacturing Standards | "The Ventralex Patch and the predicate Composix Kugel Mesh are both intended for the use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material... The proposed device has the same the same materials, and similar physical attributes and manufacturing methods." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The summary refers to "biocompatibility and bench testing" but does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective clinical data) for these tests in the context of a "test set" as one would for an AI algorithm or diagnostic device. These tests would involve laboratory animals or materials testing according to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of this device, refers to the scientific and regulatory standards for biocompatibility and material performance. It's not established by a panel of medical experts reviewing individual cases in the way it would be for an AI diagnostic. Certification and standard compliance are the "ground truth" here.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in clinical studies, particularly for diagnostic devices. This 510(k) summary does not mention such a process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not applicable. This is not an AI device or a diagnostic imaging device that would involve human readers interpreting output. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical surgical implant, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Established biological testing standards and regulatory guidelines.
- For bench testing: Validated engineering specifications and material science principles.
- For substantial equivalence: The performance characteristics and material composition of the legally marketed predicate device (Bard Composix Kugel Mesh).
8. The sample size for the training set:
- Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms, not for the regulatory approval of a physical medical device like this surgical mesh. The "training" here would be the prior research, development, and manufacturing experience of Davol, Inc.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, the concept of a "training set" and its associated ground truth isn't applicable to this type of device and submission.
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K02 1736
JUL 1 6 2002
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE VENTRALEX PATCH
A. Submitter Information
Submitter's Name: Address:
Telephone: Fax: Contact Person: Date of Preparation: Davol, Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000 ext. 2263 401-463-3845 Brian A. Kanerviko May 1, 2002
B. Device Name
Ventralex Patch
C. Predicate Device Name
Trade name: Bard Composix Kugel Mesh (Davol Inc.)
D. Device Description
The proposed Ventralex Patch is a self-expanding, three laver device. Two layers consist of polypropylene mesh. The top layer of polypropylene mesh forms a positioning strap and pocket. The purpose of the strap and pocket is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded. The monofilament PET polymer "ring" is captured between the two layers of polypropylene mesh and adds stability to the device enabling greater simplicity and assurance in the proper placement. The third layer of the device is a single layer of expanded polytetrafluoroethylene (ePTFE) that is attached to the polypropylene mesh with an interlocking PTFE stitch pattern. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.
E. Intended Use
The Ventralex Patch is intended for use in all hernia repairs requiring reinforcement with a nonabsorbable support material.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
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The Ventralex Patch and the predicate Composix Kugel Mesh are both intended for the use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material.
Technologically, the proposed device has the same the same materials, and similar physical attributes and manufacturing methods.
The proposed device is designed to form a strap and pocket. The predicate device is designed to form just a pocket. The strap will be made of polypropylene. The purpose of the strap is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded.
G. Performance Data
Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Ventralex Patch for its intended use.
As previously mentioned, the Composix Kugel predicate and the proposed Ventralex Patch devices use the same materials and similar manufacturing methods for production. The Ventralex Patch and the Composix Kugel Mesh have a single layer of expanded polytetrafluoroethylene (ePTFE) and is attached to the polypropylene mesh with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.
The biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Ventralex Patch will meet the established specifications necessary for consistent performance during their intended use.
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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 consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2002
C. R. Bard, Inc. Brian A. Kanerviko 100 Sockanossett Crossroad Cranston, Rhode Island 02920
Re: K021736
Trade Name: Ventralex Patch Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 23, 2002 Received: May 28, 2002
Dear Mr. Kanerviko:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 Mr. Brian A. Kanerviko
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Styt Murdu
- Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1021736
510(k) Number (if known):
Device Name: Ventralex Patch
Indications for Use:
•••••
Intended for the use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
(Please do not write below this line -- Continue on another page if needed)
..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Davol Inc. | May 23, 2002 | CONFIDENTIAL |
|---|---|---|
| 510(k) for Ventralex | 510(k) Number | K021736 |
009
§ 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.