(267 days)
Not Found
No
The device description and performance studies focus on the material properties and surgical application of a physical mesh, with no mention of AI/ML or related concepts.
No
The device is described as a surgical mesh intended for soft tissue repair or reinforcement in plastic and reconstructive surgery. It is not described as providing therapy or treatment of a disease or condition.
No
The device is a surgical mesh used for soft tissue repair or reinforcement during plastic and reconstructive surgery, not for diagnosing conditions.
No
The device description explicitly states it is a physical surgical mesh composed of fabric, silicone, and ePTFE, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Facial Reconstructive Mesh is a surgical implant used in the body to repair or reinforce soft tissue. It is not used to test or analyze specimens outside the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FRM is intended for use in the reinforcement of soft tissue where weakness exists. It is placed by a surgeon into the tissue by conventional surgical techniques during plastic or reconstructive surgery.
The FRM is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The FRM is a non-absorbable, inert, sterile, porous, surgical mesh composed of reinforcing woven polyester fabric, silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric mesh is available in a range of lengths and widths to accommodate the surgical application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face and head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
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)
The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the FRM is substantially equivalent to the cited predicate devices.
The results of these evaluations of the FRM support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness.
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.
K851086, K013625, K952898, K971745
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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Replacement for Original Page 6
510(k) SUMMARY FOR THE FACIAL RECONSTRUCTIVE MESH Submission Date: October 16, 2006 JUL 1 0 2007 Submitter Information: Company Name: Becker and Associates Consulting, Inc. Company Address: 2001 Pennsylvania Ave. NW Suite 575 Washington, DC 20006 Contact Person: Campbell Tuskey 202-822-1844 Campbell.tuskey(@becker-consult.com Device Information: Trade Name: Facial Reconstructive Mesh (FRM) Common Name: Surgical Mesh Classification Name: 21 CFR § 878.3300
Classification Code: FTL
Device Class: Class II
Predicate Device(s):
2.0
| Trade Name: | Mersilene Polyester Fiber Mesh |
|---|---|
| Manufacturer: | Ethicon, Inc. |
| K Number: | K851086 |
| Product Code: | FTM |
| Trade Name: | Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh |
| Manufacturer: | Tissue Sciences Laboratories PLC |
| K Number: | K013625 |
| Product Code: | FTM |
| Trade Name: | Gore-Tex SAM Facial Implant with Introducer |
| Manufacturer: | W.L. Gore and Associates, Inc. |
| K Number: | K952898 |
| Product Code: | FTL |
1
| Replacement for Original Page 7 | |
|---|---|
| Trade Name: | Bard Composite Prosthesis |
| Manufacturer: | Davol, Inc. |
| K Number: | K971745 |
| Product Code: | FTL |
| Device Description: | The FRM is a non-absorbable, inert, sterile, porous, |
| surgical mesh composed of reinforcing woven polyester | |
| fabric, silicone elastomer and expanded | |
| polytetrafluoroethylene (ePTFE). This polymeric mesh is | |
| available in a range of lengths and widths to accommodate | |
| the surgical application. | |
| Intended Use: | The FRM is intended for use in the reinforcement of soft |
| tissue where weakness exists. It is placed by a surgeon into | |
| the tissue by conventional surgical techniques during | |
| plastic or reconstructive surgery. | |
| Indications for Use: | The FRM is intended for use in plastic and reconstructive |
| surgery of the face and head to provide soft tissue repair or | |
| reinforcement. | |
| Contraindications: | - Dermal placement |
- Cosmetic lip filler |
| Comparison to
Predicate Device: | The FRM has the same intended use and technological
characteristics as the predicate devices. Slight differences
in design and performance from the cited predicates do not
affect either the safety and/or effectiveness of the FRM for
its intended use. The safety and effectiveness evaluations
based on biocompatibility and biomechanical performance
data provided in this 510(k) demonstrate that the FRM is
substantially equivalent to the cited predicate devices. |
| Conclusion: | The results of these evaluations of the FRM support the
conclusion that it is safe and effective for its intended use
and that it is substantially equivalent to the cited predicate
device(s) with regards to its safety and effectiveness. |
CONFIDENTIAL
. .
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring four abstract human figures or profiles facing to the right, with flowing lines connecting them. The emblem is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2007
Evera Medical, Inc. % Mr. Randy Kesten Chief Technical Officer 353 Vintage Park Drive, Suite F Foster City, California 94404
Re: K063154
Trade/Device Name: Facial Reconstructive Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 12, 2007 Received: June 14, 2007
Dear Mr. Kesten:
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. Iisting 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.
3
Page 2 - Mr. Randy Kesten
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 402
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Replacement for Original Page 5
1. STATEMENT OF INDICATIONS FOR USE
K063154 510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________
Facial Reconstructive Mesh Device Name:
Indications for Use:
The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.
Contraindications:
- Dermal placement
- Cosmetic lip filler
Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
| 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 OF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative, | |
| and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K063154 |