(22 days)
No
The device description focuses on the physical materials and structure of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as being used for "reconstruction of soft tissue deficiencies" and "repair of hernias and chest wall defects," which are therapeutic actions.
No
The device is described as a hernia patch used for the reconstruction of soft tissue deficiencies, which is a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical mesh patch with rings, indicating it is a hardware 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 in vivo (within the body) to repair physical defects.
- Device Description: The description details a physical mesh made of polypropylene and PET polymer rings. This is a medical device designed for implantation, not for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The modified XL Composix Kugel Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. It has the same intended use as the predicate Composix Kugel Mesh.
Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
Product codes
FTL
Device Description
The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.
The overall design of the modified XL Composix Kugel is still equivalent to the predicate Composix Kugel describe in K003323. Both the modified XL Composix Kugel and the predicate Composix Kugel described in K003323 consist of two layers of polypropylene mesh and one layer of ePTFE and a PET recoil ring. The rings add stability to the device enabling greater simplicity and assurance in the proper placement of the device. K003323 covered product with both 0.030" and 0.042" diameter recoil rings. The current proposed design modifications involve using only the 0.030" ring in the XL Composix Kugel and increasing the strength specification of the ring weld in the XL size Composix Kugel codes. In order to achieve this a manufacturing change is being proposed which will increase the weld strength. Although the weld strength will be increased the ring will still have the same intended use (i.e. to add stability to the device enabling greater simplicity and assurance in the proper placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue deficiencies, hernias, chest wall defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Bench testing has been completed and supports the safety and effectiveness of the modified XL Composix Kugel Mesh for its intended use.
Key Metrics
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
JUN - 2 2006
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE MODIFIEDCOMPOSIX KUGEL 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. 2389 |
| Fax: | 401-463-3845 |
| Contact Person: | Robin M. Drago |
| Date of Preparation: | May 24, 2006 |
B. Device Name
XL Composix Kugel Mesh
C. Predicate Device Name
Trade name: Composix Kugel Mesh
D. Device Description
The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.
E. Intended Use
The modified XL Composix Kugel Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. It has the same intended use as the predicate Composix Kugel Mesh.
1
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The overall design of the modified XL Composix Kugel is still equivalent to the predicate Composix Kugel describe in K003323. Both the modified XL Composix Kugel and the predicate Composix Kugel described in K003323 consist of two layers of polypropylene mesh and one layer of ePTFE and a PET recoil ring. The rings add stability to the device enabling greater simplicity and assurance in the proper placement of the device. K003323 covered product with both 0.030" and 0.042" diameter recoil rings. The current proposed design modifications involve using only the 0.030" ring in the XL Composix Kugel and increasing the strength specification of the ring weld in the XL size Composix Kugel codes. In order to achieve this a manufacturing change is being proposed which will increase the weld strength. Although the weld strength will be increased the ring will still have the same intended use (i.e. to add stability to the device enabling greater simplicity and assurance in the proper placement of the device.
G. Performance Data
Bench testing has been completed and supports the safety and effectiveness of the modified XL Composix Kugel Mesh for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and healthcare, and it is depicted with a staff entwined by two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
Davol. Inc. % Ms. Robin M. Drago VP, Regulatory and Clinical Affairs 100 Scokanossett Crossroad Cranston, Rhode Island
Re: K061314
Trade/Device Name: Bard® Modified Extra Large Composix® Kugel® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 10, 2006 Received: May 11, 2006
Dear Ms. Drago:
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
3
Page 2 - Ms. Robin M. Drago
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Hernia Patch
Bard® Modified Extra Large Composix® Kugel®
Indications For Use:
Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
Prescription Use X (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)
elm
(Division Sign-Division of General, Restorative, and Neurological Devices
KOGI314 510(k) Number_
CONFIDENTIAL