(44 days)
Composix Mesh (Davol Inc.), SpermaTex Mesh (Davol Inc.)
Not Found
No
The device description and performance studies focus on the material properties and physical construction of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is described as a mesh intended for the reconstruction of soft tissue deficiencies, such as hernias and chest wall defects, within the human body, indicating a therapeutic purpose.
No
The device, Composix E/X Mesh, is described as a surgical mesh for the repair of soft tissue deficiencies like hernias, indicating it is an implantable medical device for reconstructive purposes, not for diagnosing conditions.
No
The device description clearly states it is a physical mesh made of polypropylene and ePTFE, which are hardware components.
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 to repair physical defects.
- Device Description: The device is a "Composix E/X Mesh" made of polypropylene and ePTFE. This is a physical material designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health or condition. The provided description does not mention any interaction with biological specimens for diagnostic purposes.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Composix E/X Mesh is intended 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 proposed Composix E/X Mesh will be elliptical in shape and manufactured from a single layer of knitted polypropylene monofilament. A single layer of expanded polytetrafluoroethylene (ePTFE) will be attached to this mesh with polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.
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
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 the Composix E/X Mesh 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 Composix E/X Mesh will meet the established specifications necessary for consistent performance during their intended use.
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.
Composix Mesh (Davol Inc.), SpermaTex Mesh (Davol Inc.)
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.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE COMPOSIX E/X MESH
A. Submitter Information
Submitter's Name: Address:
Telephone: Fax: Contact Person: Date of Preparation: Davol, Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000 ext. 2529 401-463-3845 Ruth C. Forstadt August 25, 2000
B. Device Name
Composix E/X Mesh
Predicate Device Name C.
Trade name: Composix Mesh (Davol Inc.) SpermaTex Mesh (Davol Inc.)
D. Device Description
The proposed Composix E/X Mesh will be elliptical in shape and manufactured from a single layer of knitted polypropylene monofilament. A single layer of expanded polytetrafluoroethylene (ePTFE) will be attached to this mesh with polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.
E. Intended Use
The Composix E/X Mesh is intended 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
The Composix E/X Mesh and the predicate Composix Mesh have the same intended use, which is for the reconstruction of soft tissue deficiencies, such as the repair of hernias and chest wall defects. The technological characteristics are the same or similar to the predicate
1
devices in that the materials used to manufacture these products are similar to the predicate polypropylene and ePTFE meshes. Differences include the material used to attach the layers, the shape, the number of layers of mesh, the thickness of the ePTFE layer and the edge design.
G. Performance Data
Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Composix E/X Mesh 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 Composix E/X Mesh will meet the established specifications necessary for consistent performance during their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2000
Ms. Ruth C. Forstadt Regulatory Affairs Administration Davol. Inc. 100 Sockanossett Crossroad Canston, Rhode Island 02920
Re: K002684 Trade Name: Composix E/X Mesh Regulatory Class: II Product Code: FTL Dated: August 25, 2000 Received: August 28, 2000
Dear Ms. Forstadt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Ruth C. Forstadt
This letter will allow you to begin marketing your device as described in your 510(k) This letter will allow you to begin marketing your also and ence of your device to a
premarket notification. The FDA finding of substantial equivalence of your device and th premarket notification. The FDA miding of substance of subscribed 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 If you desire specific advice for your actives and as a suces), please contact the Office of and additionally 809.10 for in Vitto diagnolice as researchs on the promotion and Compliance at (501) 594-4395. Aduntonatify office of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance to promories Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation cities, " maller general information on your responsibilities under the notification" (21 CFK 807.97). Other general Manufacturers Assistance at its toll-free Act may be obtained from and 1443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Mark N Millhuser
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
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510(k) Number (if known):
Device Name: _Composix E/X Mesh
Reconstruction of soft tissue deficiencies, such as for Indications for Use: the repair of hernias and chest wall defects.
14002684
(Please do not write below this line – Continue on another page if needed)
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801,109)
(Division Sign-Off)
OR
Division of General Restorative, Devices 510(k) Number _ 00 2684 Over-the Counter Use
(Optional Format 1-2-96)
Davol Inc. 510(k) for Composix E/X Mesh August 25, 2000
CONFIDENTIAL
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