(129 days)
Not Found
No
The description focuses on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML capabilities.
Yes
The device is indicated to reinforce soft tissue and repair defects, providing support and enabling tissue ingrowth, which aligns with the definition of a therapeutic device.
No
The device is a surgical mesh used to reinforce soft tissue, acting as a scaffold for tissue in-growth, rather than collecting or analyzing data for diagnostic purposes.
No
The device description clearly states it is a physical mesh made of a polymer material, which is a hardware component.
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 and provide physical support and a scaffold for tissue growth.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of Phasix™ Mesh does not involve any of these activities.
Therefore, Phasix™ Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, processed into monofilament fiber, and then knitted into a surgical mesh. Phasix™ Mesh is packaged individually as a sterile, single, flat mesh available in a wide range of shapes and sizes. Phasix™ Mesh provides immediate short-term support, and 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 is 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)
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of proposed devices.
The following non-clinical tests were completed for the proposed and predicate device. The proposed Phasix™ Mesh demonstrated equivalent performance in comparison to the predicate device.
- Mesh thickness
- Mesh knit construction
- Mesh pore size
- Mesh density
- Tensile strength
- Device stiffness
- Suture pullout strength
- Burst strength
- Tear resistance
Biocompatibility testing: The proposed Phasix™ Mesh uses the same P4HB monofilament and the same processing aids as the predicate Phasix™ Mesh. Therefore, biocompatibility testing previously conducted on the predicate device (as presented via K142818) is also applicable to the proposed device, and thus is adopted in support of the proposed Phasix™ Mesh device. All testing conducted to date per the requirements of ISO 10993-1 indicates the device is biocompatible for its intended use as a permanent, tissue-contacting, implant device. Additional confirmatory LAL and cytotoxicity testing was performed.
Simulated Distribution Testing: Testing is to be performed in accordance with ASTM-D4169, Standard Practice for Performance Testing of Shipping Containers and Systems, in which the distribution environment that Phasix™ Mesh is routinely shipped in is simulated to demonstrate that the packaging system is able to maintain sterile package integrity.
Animal Study: 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 device (K142818). Since the proposed Phasix™ Mesh is constructed of the same P4HB monofilament knitted into a mesh with the same knit characteristics as the predicate device, these resorption studies are adopted in support of the proposed Phasix™ Mesh device, and were therefore not repeated.
Clinical Studies: No clinical study was required in support of the proposed Phasix™ Mesh.
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.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
C.R. Bard, Inc. Ms. Janna Babson Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K161424
Trade/Device Name: Phasix Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD Dated: August 30, 2016 Received: August 31, 2016
Dear Ms. Babson:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K161424
Device Name Phasix™ Mesh
Indications for Use (Describe)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
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510(k) Summary Section 5
I. SUBMITTER
Davol Inc. 100 Crossings Boulevard Warwick, RI 02886
| Contact Person: | Janna Babson
Regulatory Affairs Specialist |
|-----------------|-----------------------------------------------|
| Phone: | (401) 825-8454 |
| Fax: | (401) 825-8765 |
| E-mail: | Janna.Babson@crbard.com |
Date Prepared: May 16, 2016
II. DEVICE
| Trade Name: | Phasix™ Mesh |
|---|---|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Film (21 CFR § 878.3300) |
| Regulatory Class: | Class II |
| Product Code: | OOD |
III. PREDICATE DEVICE
Phasix™ Mesh cleared in K142818 on March 31, 2015.
IV. 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, processed into monofilament fiber, and then knitted into a surgical mesh. Phasix™ Mesh is packaged individually as a sterile, single, flat mesh available in a wide range of shapes and sizes. Phasix™ Mesh provides immediate short-term support, and 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 is essentially complete within 12 to 18 months.
4
V. INDICATIONS FOR USE
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.
VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed Phasix™ Mesh has the same intended use as the predicate device. The following technological characteristics of Phasix™ Mesh are the same as the predicate device: device material, design, chemical composition, biocompatibility, packaging materials, and sterilization. The difference between the predicate and proposed devices arises in size availability. The proposed Phasix™ Mesh will be offered in 25 sizes in comparison to the 5 sizes currently marketed for the predicate Phasix™ Mesh (K142818).
The proposed Phasix™ Mesh has the same materials and design as the predicate Phasix™ 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, 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 envelope and foil pouch that undergo the same ethylene oxide sterilization method.
5
| Device
Features | Phasix™ Mesh
(Proposed Device) | Phasix™ Mesh
(Predicate device)
K142818 | Equivalency |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended
Use | Soft tissue reinforcement | Soft tissue reinforcement | Identical |
| Indication
for Use | 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. | 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. | Identical |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Identical |
| Poly-4-hydroxybutyrate
Material
(P4HB) | | Poly-4-hydroxybutyrate
(P4HB) | Identical |
| Structure | Knitted P4HB monofilament | Knitted P4HB monofilament | Identical |
6
| Device
Features | Phasix™ Mesh
(Proposed Device) | | Phasix™ Mesh
(Predicate device)
K142818 | | Equivalency |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------|-------------|
| Size and
Shape | Size | Shape | Size | Shape | Similar |
| | 3"
4" x 6"
6" x 8"
8" x 10"
10" x 12"
4.5"
2.4" x 6.3"
3" x 3"
3" x 6.3"
3" x 8"
4" x 4"
4" x 8"
4" x 10"
6" x 10"
6" x 12"
8" x 8"
8" x 12"
8" x 16"
10" x 16"
12" x 12"
12" x 18"
14" x 14"
16" x 16"
18" x 18"
19.5" x 19.5" | Circle
Rectangle
Rectangle
Rectangle
Rectangle
Circle
Rectangle
Square
Rectangle
Rectangle
Square
Rectangle
Rectangle
Rectangle
Rectangle
Square
Rectangle
Rectangle
Rectangle
Square
Rectangle
Square
Square
Square
Square | 3"
4" x 6"
6" x 8"
8" x 10"
10" x 12" | Circle
Rectangle
Rectangle
Rectangle
Rectangle | |
| Packaging
Type | Tyvek | | Tyvek | | Identical |
VII. PERFORMANCE DATA
Performance Testing
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of proposed devices.
The following non-clinical tests were completed for the proposed and predicate device. The proposed Phasix™ Mesh demonstrated equivalent performance in comparison to the predicate device.
7
- Mesh thickness ●
- Mesh knit construction
- Mesh pore size
- Mesh density
- Tensile strength
- Device stiffness
- Suture pullout strength
- Burst strength
- Tear resistance
Biocompatibility testing
The proposed Phasix™ Mesh uses the same P4HB monofilament and the same processing aids as the predicate Phasix™ Mesh. Therefore, biocompatibility testing previously conducted on the predicate device (as presented via K142818) is also applicable to the proposed device, and thus is adopted in support of the proposed Phasix™ Mesh device. All testing conducted to date per the requirements of ISO 10993-1 indicates the device is biocompatible for its intended use as a permanent, tissue-contacting, implant device. Additional confirmatory LAL and cytotoxicity testing was performed.
Electrical safety and electromagnetic compatibility (EMC)
The Phasix™ Mesh is not an electro-mechanical medical device nor is it a medical system, therefore this section does not apply.
Software Verification and Validation Testing
The Phasix™ Mesh does not contain software; therefore this section does not apply.
Simulated Distribution Testing
Testing is to be performed in accordance with ASTM-D4169, Standard Practice for Performance Testing of Shipping Containers and Systems, in which the distribution environment that Phasix™ Mesh is routinely shipped in is simulated to demonstrate that the packaging system is able to maintain sterile package integrity.
Animal Study
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 device (K142818). Since the proposed Phasix™ Mesh is constructed of the same P4HB monofilament knitted into a mesh with the same knit characteristics as the predicate device, these resorption studies are adopted in support of the proposed Phasix™ Mesh device, and were therefore not repeated.
8
Clinical Studies
No clinical study was required in support of the proposed Phasix™ Mesh.
VIII. CONCLUSIONS
The comparative analysis as well as the bench and preclinical testing results demonstrated that the Phasix™ Mesh has equivalent safety and performance as the predicate device that is currently marketed for the same intended use. Therefore, it is concluded that the proposed Phasix™ Mesh and the predicate device are substantially equivalent.