(44 days)
The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.
The proposed device is a self-expanding, two-layered polypropylene mesh containing an extruded monofilament PET polymer "ring". The top layer of polypropylene mesh has two slits in it to form pockets. The purpose of the pockets is to facilitate placement, positioning and fixation of the device. The mesh is constructed from knitted polypropylene monofilament. The monofilament PET "ring" adds stability to the device facilitating placement and assurance in the proper placement of the patch. A single layer of expanded polytetrafluoroethylene (ePTFE) is attached to the polypropylene mesh. The attachment is accomplished with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge (excluding the off-center opening) of the polypropylene mesh is heat sealed to the ePTFE layer. An off-center opening in the proposed device accommodates the stoma and this opening is surrounded by an ePTFE collar. The ePTFE collar is attached to the mesh side of the proposed device with an interlocking stitch using PTFE monofilament. A slit in the proposed device extends from the opening in the proposed device to the perimeter to facilitate positioning of the proposed device around the stoma. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.
The provided document describes the Bard CK Parastomal Hernia Patch (K042026) and its comparison to predicate devices for 510(k) clearance. The focus of the performance data section is on biocompatibility and bench testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device evaluations.
Here's an analysis based on the provided text, addressing the requested information where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are non-toxic and non-sensitizing to biological tissues | Test results show materials are non-toxic and non-sensitizing consistent with intended use. |
| Bench Testing: Device design and materials meet established specifications for consistent performance during intended use. | Laboratory test results demonstrate materials chosen and design utilized meet established specifications for consistent performance. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set with human subjects or a dataset for AI/ML evaluation. The "tests" mentioned are biocompatibility and bench tests performed on the device itself. Therefore, sample sizes and data provenance in the context of human data are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth as typically defined for AI/ML device evaluation (e.g., expert consensus on medical images or patient outcomes) is not mentioned or required for this type of device and submission.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as no clinical or image-based test set needing expert review is used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh; the evaluation focuses on its physical and biological properties rather than its effectiveness in aiding human readers with diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on established industry standards and regulatory requirements for biocompatibility and mechanical/material properties of surgical meshes. For biocompatibility, this would involve standardized in vitro and in vivo tests to assess cytotoxicity, sensitization, irritation, etc. For bench testing, it refers to pre-defined specifications for material strength, flexibility, porosity, and other physical attributes relevant to its function as a hernia patch.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
{0}------------------------------------------------
K042026 P.1/3
SEP 1 0 2004
SECTION VII.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE BARD® CKTM PARASTOMAL PATCH
Submitter Information A.
| Submitter's Name: | Davol Inc. |
|---|---|
| Address: | Subsidiary of C. R. Bard, Inc. |
| 100 Sockanossett Crossroad | |
| Cranston, RI 02920 | |
| Telephone: | 401-463-7000 ext. 2529 |
| Fax: | 401-463-3845 |
| Contact Person: | Karen S. Gwozdowski Gauvin |
| Date of Preparation: | July 27, 2004 |
Device Name B.
| Trade Name: | Bard CK Parastomal Hernia Patch |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, Polymeric |
C. Predicate Device Name
| Trade name: | Bard® Composix® Kugel® Mesh (Davol Inc.) |
|---|---|
| Trade name: | Gore® SEAMGUARD Staple Line Reinforcement Material (W.L. Gore & Associates, Inc.) |
D. Device Description
The proposed device is a self-expanding, two-layered polypropylene mesh containing an extruded monofilament PET polymer "ring". The top layer of polypropylene mesh has two slits in it to form pockets. The purpose of the pockets is to facilitate placement, positioning and fixation of the device. The mesh is constructed from knitted polypropylene monofilament. The monofilament PET "ring" adds stability to the device facilitating placement and assurance in the proper placement of the patch. A single layer of expanded polytetrafluoroethylene (ePTFE) is attached to the polypropylene mesh. The attachment is accomplished with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge (excluding the off-center opening) of the polypropylene mesh is heat sealed to the ePTFE layer. An off-center opening in the proposed device accommodates the stoma and this opening
CONFIDENTIAL
{1}------------------------------------------------
K04202612/3
is surrounded by an ePTFE collar. The ePTFE collar is attached to the mesh side of the proposed device with an interlocking stitch using PTFE monofilament. A slit in the proposed device extends from the opening in the proposed device to the perimeter to facilitate positioning of the proposed device around the stoma. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.
Intended Use E.
The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.
Summary of Similarities and Differences in Technological F. Characteristics, Performance and Intended Use
The proposed device has the same exact materials as the predicate Composix Kugel, along with similar physical attributes, performance characteristics and manufacturing methods as the predicate Composix Kugel.
The difference between the proposed and predicate device includes the opening in the proposed device surrounded by the ePTFE collar and the slit in the proposed device to access the opening in the proposed device. The predicate device does not have an opening surrounded by an ePTFE collar and does not have a slit in the device. The shape of the memory recoil "ring" in the proposed device is different from the shape of the memory recoil "ring" in the predicate device.
The Gore SEAMGUARD Staple Line Reinforcement Material (K001789) indication includes the repair of hernias, including paracolostomy hernias. This indication is the same as the proposed device indication statement.
The proposed device is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias. The predicate Composix Kugel and the proposed device are both intended for use in hernia repair. The proposed device provides an additional example of a parastomal hernia. The parastomal hernia is part of the broader indication of a hernia. A hernia is part of a broader indication of soft tissue deficiency. Therefore, the predicate Composix Kugel and the proposed device have the same indication statement.
CONFIDENTIAL
{2}------------------------------------------------
K042026
P3/3
Performance Data G.
Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Bard CK Parastomal Hernia Patch for its intended use.
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 Bard CK Parastomal Hernia Patch will meet the established specifications necessary for consistent performance during their intended use.
CONFIDENTIAL
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Ms. Karen S. Gwozdowski Gauvin Regulatory Affairs Associate Davol, Inc. 100 Sockanossett Crossroad Cranston, Rhode Island 02920
Re: K042026
Ro42020
Trade/Device Name: Bard® CK™ Parastomal Hernia Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 27, 2004 Received: July 28, 2004
Dear Ms. Gauvin:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the that to ria) 20, 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter recept inter, that be device, subject to the general controls provisions of the Act. The Fourmaly, dicrere, many 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 or car) i 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.
{4}------------------------------------------------
Page 2 - Ms. Karen S. Gwozdowski Gauvin
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 p arketed 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Bard® CK™ Parastomal Hernia Patch
The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K042026
Page 1 of 1
§ 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.