(124 days)
Not Found
No
The device description and performance studies focus on the physical properties of the mesh and a delivery tool, with no mention of AI or ML.
Yes
The device is indicated for "reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects," which aligns with the definition of a therapeutic device as it treats or ameliorates a medical condition.
No
The device description and intended use clearly state that the Bard Composix L/P Mesh is used for reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. This is a surgical implant designed to repair tissue, not to diagnose a condition.
No
The device description clearly details physical components like polypropylene mesh, ePTFE, PTFE thread, and a stainless steel Introducer Tool, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects." This describes a surgical implant used directly in the body for structural repair.
- Device Description: The description details a physical mesh made of polypropylene and ePTFE, along with an introducer tool for surgical placement. This is a physical medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
Bard Composix L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Composix® L/P Mesh, will consist of a layer of polypropylene mesh and a layer of expanded polytetrafloroethylene (ePTFE) stitched together using Polytetrafluroethylene (PTFE) monofilament thread sewn in a lock stitch formation. The polypropylene layer is knitted from 0.0048 inch polypropylene monofilament, which is identical to the currently marketed Large Pore Soft™ Mesh. The thickness of the ePTFE layer is identical to the currently marketed Composix® E/X Mesh. As with the currently marketed Composix E/X, the peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.
The layers of the Composix L/P Mesh will be sewn together using rows of interspaced stitching, which will allow the surgeon to tailor the product. Using the stitch pattern as a guide, the surgeon can tailor the product. For user convenience to facilitate the deployment of the larger sized Composix L/P products, the larger sizes of the Composix L/P products will be packaged with an Introducer Tool. This Introducer Tool is similar to the rolling tines/plunger assembly and T-handle of the PrecisionPass™ Delivery Device. The Introducer Tool consists of a handle with a thin stainless steel rod. The stainless steel rod is split into two pieces along its length and has ridges around the perimeter to facilitate use. Similar to the T-handle provided with the PrecisionPass Device, the Introducer Tool's T-cap will be used to secure the open end of the metal rolling tines during the rolling process, then removed prior to delivering the device through the trocar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias and chest 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)
Biocompatibility and bench testing provided in this submission support the safety and effectiveness of Bard Composix® L/P Mesh for its intended use. The biocompatibility testing completed on the product manufactured with the same materials and similar processes as the Bard Composix L/P Mesh demonstrate the device is non-toxic and non-sensitizing to biological tissues consistent with its intended use. Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing Bard Composix® L/P Mesh is substantially equivalent to the referenced Predicate Products.
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.
Not Found
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
KDG1754
Page 1 of 3
510(k) Summary of Safety and Effectiveness: 7.
0C1 2 3 2006
Submitter Information: A.
| Submitter's Name: | Davol, Inc. |
|---|---|
| Address: | Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 |
| Telephone: | (401) 215-2642 |
| Fax: | (401) 215-2031 |
| Contact Person: | Gail Dow |
B. Device Name:
Trade Name: Bard Composix® L/P Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, Polymeric
C. Predicate Device Names:
- Bard Large Pore Soft™ Mesh Pre-Shaped, K052155 (Davol Inc.), FDA cleared . on 10/20/2005;
- Bard Composix® E/X Mesh, K002684 (Davol Inc.), FDA cleared on 10/11/2000; .
- Davol Delivery System (currently marketed as PrecisionPass Laparoscopic . Delivery Device), K041641 (Davol Inc.), FDA cleared on 07/01/2004.
D. Device Description:
The Composix® L/P Mesh, will consist of a layer of polypropylene mesh and a layer of expanded polytetrafloroethylene (ePTFE) stitched together using Polytetrafluroethylene (PTFE) monofilament thread sewn in a lock stitch formation. The polypropylene layer is knitted from 0.0048 inch polypropylene monofilament, which is identical to the currently marketed Large Pore Soft™ Mesh. The thickness of the ePTFE layer is identical to the currently marketed Composix® E/X Mesh. As with the currently marketed Composix E/X, the peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.
The layers of the Composix L/P Mesh will be sewn together using rows of interspaced stitching, which will allow the surgeon to tailor the product. Using the stitch pattern as a guide, the surgeon can tailor the product. For user convenience to facilitate the
1
deployment of the larger sized Composix L/P products, the larger sizes of the Composix L/P products will be packaged with an Introducer Tool. This Introducer Tool is similar to the rolling tines/plunger assembly and T-handle of the PrecisionPass™ Delivery Device. The Introducer Tool consists of a handle with a thin stainless steel rod. The stainless steel rod is split into two pieces along its length and has ridges around the perimeter to facilitate use. Similar to the T-handle provided with the PrecisionPass Device, the Introducer Tool's T-cap will be used to secure the open end of the metal rolling tines during the rolling process, then removed prior to delivering the device through the trocar.
E. Intended Use:
Bard Composix® L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
Bard Composix® L/P Mesh and the Predicate mesh have the same indication: reinforce soft tissue, i.e., repair of hemias and chest wall defects.
The Proposed Product has similar physical attributes, performance characteristics, and materials as the Predicates Bard Composix® E/X and Bard Large Pore Soft™ Mesh. Furthermore, it has similar manufacturing methods as the Predicate Bard Large Pore Soft™ Mesh and Predicate Bard Composix E/X Mesh.
The key differences in the Proposed Product as compared to the Predicate Products, is that the Predicate Bard Large Pore Soft™ Mesh Product is a large pore singlelayer polypropylene monofilament mesh and the Proposed Product is a bilayer construction. While both the Predicate Bard Composix E/X Mesh and the Proposed Product Bard Composix® L/P Mesh are similar in their bilayer construction, the two products combine different types of knitted polypropylene mesh with the same ePTFE layer. The Predicate Bard Composix E/X Mesh utilizes 0.006" Bard Flat Mesh with ePTFE, and the Proposed Product Bard Composix® L/P Mesh uses the 0.0048" Predicate Bard Large Pore Soft™ Mesh with a layer of ePTFE. In addition, the larger sizes of the Proposed Product Bard Composix® L/P Mesh will be packaged with an Introducer Tool. The Bard Composix® L/P Mesh Introducer Tool will facilitate rolling the device with a consistent technique; this will allow a low-profile device to be placed through the appropriate trocar sizes. The mesh side is visually distinguishable from the ePTFE side to determine correct prosthetic orientation. This is standard practice, similar to the other Composix® line products. Furthermore, the Introducer Tool is similar to the tines packaged with the Precision Pass
2
tool. The Precision Pass tool is packaged separately but often used jointly with the Bard Composix® E/X. The mode of operation, physical attributes, performance characteristics and materials of the Bard Composix® L/P Mesh Introducer Tool packaged with the larger sizes of the are all similar to the Davo! Delivery System (Precision Pass tool).
ું. Performance Data
Biocompatibility and bench testing provided in this submission support the safety and effectiveness of Bard Composix® L/P Mesh for its intended use. The biocompatibility testing completed on the product manufactured with the same materials and similar processes as the Bard Composix L/P Mesh demonstrate the device is non-toxic and non-sensitizing to biological tissues consistent with its intended use. Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing Bard Composix® L/P Mesh is substantially equivalent to the referenced Predicate Products.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings. The text is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Davol Inc. % Ms. Gail Dow Regulatory Associate 100 Sockanossett Crossroad Cranston, Rhode Island 02920
OCT 2 3 2006
Re: K061754
Trade/Device Name: Bard® Composix® L/P Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 3, 2006 Received: October 5, 2006
Dear Ms. Dow:
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.
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.
4
Page 2 - Ms. Gail Dow
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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification for the Bard® Composix® L/P Mesh
Indications for Use
510(k) Number (if known): Unknown
Bard® Composix® L/P Mesh Device Name:
Indications for Use:
・
Bard Composix L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices FDA Page 1 of 1
| Davol Inc. | 510(k) Number | TL061754 | 000010 |
|---|---|---|---|
| ------------ | --------------- | ---------- | -------- |