(267 days)
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.
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.
The provided document is a 510(k) summary for a medical device called "Facial Reconstructive Mesh" (FRM). It details the device's description, intended use, indications for use, and a comparison to predicate devices, ultimately concluding that the FRM is substantially equivalent to existing devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. The 510(k) summary focuses on demonstrating substantial equivalence based on the device's characteristics and its similarity to predicate devices, rather than on new performance data from a dedicated clinical study with acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document implicitly claims that the device meets safety and effectiveness criteria because it is substantially equivalent to predicate devices that are already deemed safe and effective.
Here's why the specific information requested is missing from this type of document:
- 510(k) Premarket Notification: This is a submission pathway for medical devices that are "substantially equivalent" to an already legally marketed device (predicate device). The primary goal is to show similarity, not necessarily to conduct a new clinical study from scratch with fresh acceptance criteria and extensive performance data.
- Safety and Effectiveness: For 510(k)s, safety and effectiveness are often demonstrated by showing that the new device has the same technological characteristics and intended use as predicate devices, and that any minor differences do not raise new questions of safety or effectiveness. This can involve bench testing (biocompatibility, biomechanical performance), but typically not large-scale clinical trials measuring performance against defined acceptance criteria in the way a PMA (Premarket Approval) submission would.
Information I can extract from the provided text, related to the request:
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Acceptance Criteria and Reported Device Performance: Not explicitly stated in terms of numerical thresholds or metrics. The "performance" is implicitly tied to biocompatibility and biomechanical performance data which, according to the document, was provided in the 510(k) submission and demonstrated substantial equivalence to predicate devices. The conclusion states: "The results of these evaluations... 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." This means the "acceptance criterion" was effectively "substantially equivalent to predicate devices based on safety and effectiveness evaluations."
Acceptance Criteria Reported Device Performance Device is safe and effective for its intended use, and substantially equivalent to predicate devices (K851086, K013625, K952898, K971745). "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." -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. This type of detail would be expected from a clinical study, which is not described. The evaluations were based on biocompatibility and biomechanical performance data, which usually involves laboratory testing rather than human subject test sets.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no human-expert-validated test set is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human-expert-validated test set is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical surgical mesh, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical surgical mesh.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence was established by comparing the FRM's characteristics and performance (biocompatibility, biomechanical properties) to those of the predicate devices already on the market and considered safe and effective. This isn't a "ground truth" in the clinical data sense, but rather a regulatory benchmark.
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The sample size for the training set: Not applicable, as no AI model or training set is mentioned.
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How the ground truth for the training set was established: Not applicable, as no AI model or training set is mentioned.
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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 |
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| 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 polyesterfabric, silicone elastomer and expandedpolytetrafluoroethylene (ePTFE). This polymeric mesh isavailable in a range of lengths and widths to accommodatethe surgical application. |
| Intended Use: | The FRM is intended for use in the reinforcement of softtissue where weakness exists. It is placed by a surgeon intothe tissue by conventional surgical techniques duringplastic or reconstructive surgery. |
| Indications for Use: | The FRM is intended for use in plastic and reconstructivesurgery of the face and head to provide soft tissue repair orreinforcement. |
| Contraindications: | - Dermal placement- Cosmetic lip filler |
| Comparison toPredicate Device: | The FRM has the same intended use and technologicalcharacteristics as the predicate devices. Slight differencesin design and performance from the cited predicates do notaffect either the safety and/or effectiveness of the FRM forits intended use. The safety and effectiveness evaluationsbased on biocompatibility and biomechanical performancedata provided in this 510(k) demonstrate that the FRM issubstantially equivalent to the cited predicate devices. |
| Conclusion: | The results of these evaluations of the FRM support theconclusion that it is safe and effective for its intended useand that it is substantially equivalent to the cited predicatedevice(s) with regards to its safety and effectiveness. |
CONFIDENTIAL
. .
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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.
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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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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 |
§ 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.