(83 days)
Not Found
No
The device description and performance studies focus solely on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is used to repair hernias and chest wall defects, which are therapeutic interventions.
No
Explanation: The device is a surgical mesh intended to reinforce soft tissue, such as in hernia repair, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical mesh constructed from polypropylene monofilament, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects." This describes a surgical implant used to physically support and repair tissue within the body.
- Device Description: The description details a surgical mesh made of polypropylene monofilament, designed for implantation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Bard Soft Mesh does not involve any such testing or analysis of biological samples.
Therefore, the Bard Soft Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.
Product codes
FTL
Device Description
The proposed Bard Soft Mesh is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.004 inches. The mesh is knitted to form a strong, porous, support material. The small diameter of the polypropylene monofilament allows for a thin profile and creates a mesh with increased flexibility and a reduced amount of material compared to traditional monofilament polypropylenc meshes. The proposed device is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction. The proposed device will be marketed as a stcrile, single use device and will be available in several sizes of rectangular sheets and pre-shaped forms. The option to restcrilize unused mesh has been provided in the instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias, 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 have been completed and support the safety and effectiveness of Bard Soft Mesh for its intended use.
The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with its intended use. Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Soft Mesh will meet the established specifications necessary for consistent performance during its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION VII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR BARD SOFT MESH
A. Submitter Information
| Submitter's Name: | Davol, Inc. |
|---|---|
| Address: | Subsidiary of C. R. Bard, Inc. |
| 100 Sockanossett Crossroad | |
| Cranston, RI 02920 | |
| Telephone: | 401-463-7000 ext. 2263 |
| Fax: | 401-463-3845 |
| Contact Person: | Suzanne LaScalza |
| Date of Preparation: | December 5, 2003 |
Device Name B.
| Trade name: | Bard Soft Mesh |
|---|---|
| Common/Usual name: | Surgical Mesh |
| Classification name: | Surgical Mesh, Polymeric |
Predicate Device Names C.
| Trade name: | Bard Mesh (Davol Inc.) |
|---|---|
| Trade name: | Atrium ProLite Ultra Mesh (Atrium Medical Corporation) |
| Trade name: | Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.) |
D. Device Description
The proposed Bard Soft Mesh is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.004 inches. The mesh is knitted to form a strong, porous, support material. The small diameter of the polypropylene monofilament allows for a thin profile and creates a mesh with increased flexibility and a reduced amount of material compared to traditional monofilament polypropylenc meshes. The proposed device is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction. The proposed device will be marketed as a stcrile, single use device and will be available in several sizes of rectangular sheets and pre-shaped forms. The option to restcrilize unused mesh has been provided in the instructions for use.
CONFIDENTIAL
1
K033814
page 2 of 2
Intended Use E.
The proposed device is indicated to reinforce soft tissue where weakness exists, i.e., repair of hemias and chest wall defects.
Summary of Similarities and Differences in Technological F. Characteristics, Performance and Intended Use
Bard Soft Mesh and the predicate Bard Mesh have an identical intended use. Both devices are indicated to reinforce soft tissue where weakness exists, i.c., repair of hernias and chest wall defects.
The proposed device has similar physical attributes and performance characteristics as the predicates Bard Mesh, ProLite Ultra and Mersilene Mesh. Furthermore, it has the same materials and similar manufacturing methods as the predicate Bard Mesh.
The key differences in the proposed device compared to the predicate devices is in the diameter of the polypropylene monofilaments and the knit pattern of the mesh. In order to create a thinner, lighter weight mesh while also reducing the amount of material used in the mesh compared to traditional monofilament polypropylene meshes, the proposed device was constructed from monofilaments with a diameter of approximately 0.004 inches similar to the prodicate ProLite Ultra. The knit pattern of the mesh was designed in order to create a mesh with a soft feel and to allow for a more even stretch in both directions of the prosthesis.
Performance Data ੁੱ
Biocompatibility and bench testing have been completed and support the safety and effectiveness of Bard Soft Mesh for its intended use.
The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with its intended use. Laboratory test results demonstrate that the material chosen and the design utilized in manufacturing Bard Soft Mesh will meet the established specifications necessary for consistent performance during its intended use.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and flow together, resembling a stylized human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR = 1 2004
Ms. Suzanne LaScalza Regulatory Affairs Associate Davol, Inc. 100 Sockanossett Crossroad Cranston, Rhode Island 02920
Re: K033814
Trade/Device Name: Bard Soft Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh polymeric Regulatory Class: II Product Code: FTL Dated: December 5, 2003 Received: December 9, 2003
Dear Ms. LaScalza:
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.
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Page 2 - Ms. Suzanne LaScalza
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 (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
4
Indications for Use
K033814 510(k) Number (if known):
Device Name:
Bard Soft Mesh
Indications for Use:
Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BLEOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, I storative and Neurological Deves
K033814 510(k) Number_
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