(183 days)
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.
The device acts as a reinforcing or bridging material for soft tissue repair, which is a supportive rather than a therapeutic function in the sense of treating a disease or disorder. It facilitates the body's natural healing process by providing a scaffold for tissue growth, rather than directly curing or mitigating a condition itself.
No
The device description indicates that the Phasix™ Mesh is a surgical mesh designed to reinforce soft tissue, acting as a scaffold for tissue in-growth. Its function is to provide physical support and promote healing, not to diagnose medical conditions by identifying diseases or conditions through data analysis.
No
The device description clearly indicates it is a physical mesh made of a polymer material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair of hernia or other fascial defects." This describes a surgical implant used directly on a patient's body for structural support.
- Device Description: The description details a surgical mesh made of a resorbable polymer, designed to be implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. This device does not perform any such diagnostic testing on specimens.
The information clearly indicates a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product codes
OOD
Device Description
The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical mesh. The Phasix™ Mesh is packaged individually as a sterile, single flat mesh available in several rectangular sizes and one small circle. Phasix™ Mesh provides immediate short term support and provides a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material will be essentially complete within 12 to 18 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, hernia, fascial 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 Testing: The proposed Phasix™ Mesh uses the same P4HB monofilament as the predicate TephaFLEX® Mesh. Biocompatibility testing previously conducted for the predicate TephaFLEX® Mesh was leveraged. Additional cytotoxicity testing was performed on the proposed device to confirm that manufacturing facility changes and minor process modifications had no impact. The cytotoxicity results met acceptance criteria. Tests leveraged from the predicate device include Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity, Chronic Toxicity, Implantation, and Haemocompatibility. All biocompatibility data leveraged and additional cytotoxicity testing met acceptance criteria.
Electrical safety and electromagnetic compatibility (EMC): There are no electrical or metal components in the Phasix™ Mesh; therefore the proposed device does not require EMC and Electrical Safety evaluation.
Software Verification and Validation Testing: The proposed Phasix™ Mesh does not contain software.
Bench Testing: Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh. Evaluated characteristics include Mesh weave characteristics, Mesh pore size, Mesh density, Mesh thickness, Device stiffness, Burst strength, Tear resistance, and Suture pullout strength.
Animal Studies: In vivo studies were performed to characterize the mechanical strength and resorption profile of the P4HB monofilament mesh and were originally provided in support of the predicate TephaFLEX® Mesh via K113723. These resorption studies were adopted and provided in support of the Phasix™ Mesh because it is constructed of the same P4HB monofilament knitted into a mesh with the same weave characteristics.
Clinical Study: No clinical study was required in support of the Phasix™ Mesh.
Key Results: All test results provided in this submission support and demonstrate that the proposed Phasix™ Mesh is substantially equivalent to the cited TephaFLEX® Mesh predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of three human profiles facing right, arranged in a way that they appear interconnected. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2015
Davol Incorporated, Subsidiary of C. R. Bard Incorporated Mr. Steve Keenan Regulatory Affairs Engineer 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K142818
Trade/Device Name: Phasix" Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OOD Dated: February 18, 2015 Received: February 19, 2015
Dear Mr. Keenan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142818
Device Name Phasix™ Mesh
Indications for Use (Describe)
The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92
I. Submitter
| Company Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc |
|---|---|
| Company Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8499 |
| Fax: | (401) 825-8765 |
| Submitter's Name: | Steve Keenan |
| Regulatory Affairs Engineer | |
| Email: | steve.keenan@crbard.com |
| Date Prepared: | September 26, 2014 |
| II. | |
| Device | |
| Trade Name: | Phasix™ Mesh |
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Film (21 CFR § 878.3300) |
Regulatory Class: Product Code:
III. Predicate Device
- TephaFLEX® Mesh ●
- K113723 (Tepha, Inc.), FDA cleared on February 15, 2012 o
Class II
OOD
- K111946 (Tepha Inc.), FDA cleared on September 26, 2011 O
- K070894 (Tepha Inc.), FDA cleared on April 13, 2007 O
PREMARKET NOTIFICATION FOR PHASIX™ MESH
4
Device Description IV.
The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical mesh. The Phasix™ Mesh is packaged individually as a sterile, single flat mesh available in several rectangular sizes and one small circle. Phasix™ Mesh provides immediate short term support and provides a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material will be essentially complete within 12 to 18 months.
Indications for Use v.
Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Comparison of Technological Characteristics with the Predicate Device VI.
The proposed Phasix™ Mesh has the same materials and design as the predicate TephaFLEX® Mesh. The proposed and predicate devices are constructed of the same P4HB monofilament knitted to create a mesh with the same weave characteristics. Both devices have the same indications for use statement and are intended for use in the reconstruction and repair of soft tissue deficiencies where weakness exists such as hernia repair. In addition, the proposed device and the predicate device are packaged in the same materials including a DuPont™ Tyvek® envelop and foil pouch that undergo the same ethylene oxide sterilization method. Where minor process technology differences
PREMARKET NOTIFICATION FOR PHASIX™ MESH
5
exist, or manufacturing facilities have been changed between the proposed device and the predicate device, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.
Performance Data: VII.
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
The proposed Phasix™ Mesh uses the same P4HB monofilament as the predicate TephaFLEX® Mesh. Therefore, biocompatibility testing previously conducted for the predicate TephaFLEX® Mesh was leveraged in support of the proposed device. Additional cytotoxicity testing was performed on the proposed device to confirm that the manufacturing facility changes and minor process modifications had no impact on the device. The cytotoxicity results met acceptance criteria with passing results. The biocompatibility evaluation for the TephaFLEX® Mesh was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The proposed Phasix™ Mesh and predicate TephaFLEX® Mesh are considered tissue/bone contacting permanent implants. Therefore, the following tests were leveraged from the predicate device in support of this premarket notification:
- Cytotoxicity .
- Sensitization ●
- Intracutaneous Reactivity ●
- Systemic Toxicity .
- Genotoxicity .
PREMARKET NOTIFICATION FOR PHASIX™ MESH
6
- Chronic Toxicity .
- Implantation ●
- Haemocompatibility o
All biocompatibility data leveraged from the predicate TephaFLEX® Mesh and the additional cytotoxicity testing on proposed Phasix™ Mesh met acceptance criteria.
Electrical safety and electromagnetic compatibility (EMC)
There are no electrical or metal components in the Phasix™ Mesh; therefore the proposed device does not require EMC and Electrical Safety evaluation.
Software Verification and Validation Testing
The proposed Phasix™ Mesh does not contain software.
Bench Testing
Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" published March 2, 1999, the following physical and performance characteristics were evaluated:
- Mesh weave characteristics ●
- Mesh pore size o
- Mesh density
- Mesh thickness ●
- Device stiffness ●
- Burst strength ●
PREMARKET NOTIFICATION FOR PHASIX™ MESH
7
- Tear resistance .
- Suture pullout strength. ●
Animal Studies
In vivo studies were performed to characterize the mechanical strength and resorption profile of the P4HB monofilament mesh and were originally provided in support of the predicate TephaFLEX® Mesh via K113723. Since the proposed Phasix™ Mesh is constructed of the same P4HB monofilament knitted into a mesh with the same weave characteristics as the predicate TephaFLEX® Mesh, these resorption studies were adopted and provided in support of the Phasix™ Mesh.
Clinical Study
No clinical study was required in support of the Phasix™ Mesh.
Conclusion: VIII.
All test results provided in this submission support and demonstrate that the proposed Phasix™ Mesh is substantially equivalent to the cited TephaFLEX® Mesh predicate.