(73 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technologies.
No
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device, a surgical mesh, is used for reconstruction and repair of tissue deficiencies (hernias, chest wall defects), which is a treatment for a medical condition.
No
The device description clearly states its purpose as a reconstructive material for soft tissue deficiencies like hernias, not for diagnosing conditions.
No
The device description clearly states it is a physical mesh constructed from polypropylene monofilament, indicating it is a hardware device.
Based on the provided text, 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 hernias and chest wall defects. This is a surgical implant used in vivo (within the body) to repair physical defects.
- Device Description: The device is a surgical mesh made of polypropylene monofilament. This is a physical material implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.
Product codes
FTL
Device Description
The proposed Bard Large Pore Soft Mesh product is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.048 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 polypropylene meshes. It is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction and will be marketed as a sterile, single use device available in several sizes of rectangular sheets and pre-shaped forms. Predicates Bard Mesh, Mersilene Mesh, and Prolene Soft are sterile, single use products that can be tailored as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias, chest wall defects, inguinal hernia defects
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 Large Pore 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 Large Pore 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)
Bard Mesh (Davol Inc.), Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.), Ethicon Prolene Soft Polypropylene Mesh (Ethicon, Inc.)
Reference Device(s)
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
Kos 2155
1/2
7.0 510(k) Summary of Safety and Effectiveness:
A. Submitter Information:
(((1) 2 0 2005
| Submitter's Name: | Davol, Inc. |
|---|---|
| Address: | Subsidiary of C. R. Bard, Inc. |
| 100 Sockanossett Crossroad | |
| Cranston, RI 02920 | |
| Telephone: | 401-463-7000, Ext. 2386 |
| Fax: | 401-463-3845 |
| Contact Person: | Lucinda L. Fox |
B. Device Name:
| Trade Name: | Bard® Large Pore Soft Mesh and Soft Mesh Pre-shaped |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, Polymeric |
C. Predicate Device Names:
| Trade Name: | Bard Mesh (Davol Inc.) |
|---|---|
| Trade Name: | Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.) |
| Trade Name: | Ethicon Prolene Soft Polypropylene Mesh (Ethicon, Inc.) |
D. Device Description:
The proposed Bard Large Pore Soft Mesh product is a single layer of mesh constructed from polypropylene monofilament with a diameter of approximately 0.048 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 polypropylene meshes. It is manufactured utilizing a strong knit design that allows for bi-directional flexibility and tailoring in any direction and will be marketed as a sterile, single use device available in several sizes of rectangular sheets and pre-shaped forms. Predicates Bard Mesh, Mersilene Mesh, and Prolene Soft are sterile, single use products that can be tailored as well.
E. Intended Use:
1
KOS-2155
212
Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-Shaped is indicated for the repair of inquinal hernia defects.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
Bard Soft Mesh product and the Predicate Bard Mesh have the same indication: reinforce soft tissue, i.e., repair of hernias and chest wall defects.
The Proposed Product has similar physical attributes and performance characteristics as the Predicates Bard Mesh, Mersilene Mesh, and Prolene Soft Mesh. Furthermore, it has the same materials and similar manufacturing methods as the Predicate Bard Mesh.
The key differences in the Proposed Product compared to the Predicate Products are the diameter of the polypropylene monofilament and the knit pattern of the mesh. In order to create a thinner, lighter weight mesh and reduce the amount of material used in the mesh compared to traditional monofilament polypropylene meshes, the Proposed Product is constructed from monofilaments with a diameter of approximately 0.048 inches. However, the weights (grams/square inch) of both Predicates Prolene Soft (0.0287) and Mersilene Mesh (0.0274) are comparable to the Soft Mesh (0.0282).
G. Performance Data
Biocompatibility and bench testing have been completed and support the safety and effectiveness of Bard Large Pore 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 Large Pore 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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Public Health Service
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lucinda L. Fox Manager, International Regulatory & Clinical Affairs Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, Rhode Island 02920
Rc: K052155
Trade/Device Name: Bard" Large Pore Soft Mesh and Soft Mesh Prc-shaped Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 4, 2005 Received: August 8, 2005
Dear Ms. Fox:
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 Codc 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) rins ictir witi anow you to organization of substantial equivalence of your device to a legally premated predicated on "caresults 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 n you don't office of Compliance at (240) 276-0115. Also, please note the regulation entitled, Coniact the Office of Courter notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your corpumer 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 vours.
Sincerely yours,
Barbara Precht
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1052155 Indications for Use
510(k) Number (if known): Unknown
Bard® Large Pore Soft Mesh and Soft Mesh Pre-shaped Device Name:
indications for Use:
Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects,
Prescription Use 7 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Beulare Mueh)
Division of General, Restorative, and Neurological Devices
E10(k) Ni
FDA Page 1 of 1
| Davol Inc. | |
|---|---|
| ------------ | -- |
ONFIDENTIAL