(192 days)
Not Found
No
The summary describes a resorbable mesh device for soft tissue repair and does not mention any computational or analytical functions that would involve AI or ML.
Yes.
The device is indicated for use in the "reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias," which aims to improve a diseased or injured condition, classifying it as a therapeutic device.
No.
The device is a resorbable mesh intended for reinforcing soft tissue, not for diagnostic purposes.
No
The device is a physical mesh prosthesis made of resorbable materials, clearly described as a hardware device for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a resorbable mesh made of specific materials designed to be implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
The Phasix™ ST Mesh is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.
Product codes (comma separated list FDA assigned to the subject device)
OWT, OOD, FTL
Device Description
The proposed Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix ™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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:
Studies completed: Cytotoxicity, Genotoxicity, Sensitization, Intracutaneous Reactivity, Local and Systemic Toxicity (4 and 13 week), Local Toxicity (4, 8, 13, and 20 week), Systemic Toxicity (Acute), Pyrogenicity.
Key results: Demonstrate biocompatibility in accordance with FDA guidance.
Electrical safety and electromagnetic compatibility (EMC):
Key results: Not required as there are no electrical or metal components.
Software Verification and Validation Testing:
Key results: Not required as the device does not contain software.
Bench Testing:
Study type: Bench testing comparing Phasix™ ST Mesh to predicate devices.
Evaluated characteristics: Mesh weave characteristics, Device stiffness, Mesh pore size, Burst strength, Mesh density, Tear resistance, Mesh thickness, Suture pullout strength.
Additional study: In vitro degradation study to demonstrate degradation of PGA fibers and hydrogel coating does not impact P4HB mesh resorption.
Animal Studies:
Study type: In vivo porcine studies.
Key results: Characterized mechanical strength, tissue response, and resorption profile at 4, 12, and 24 weeks in comparison to predicates.
Clinical Study:
Key results: No clinical study was required.
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.
K070894/K111946/K113723, K101851
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined strands and three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
C. R. Bard Incorporated Mr. Tony John Regulatory Affairs Specialist 100 Crossing Boulevard Warwick, Rhode Island 02886
Re: K143380
Trade/Device Name: Phasix™ ST Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWT, OOD, FTL Dated: November 24, 2014 Received: November 25, 2015
Dear Mr. John:
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/ResourcesforYou/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.
Jennifer R. Stevenson -S
For 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
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Indications for Use
510(k) Number (if known)
Device Name Phasix™ ST Mesh
Indications for Use (Describe)
The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.
| 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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510(K) SUMMARY
This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information:
| Company Name: | Davol Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Company Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8692 |
| Fax: | (401) 825-8765 |
| Submitter's Name: | Tony John, MS |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | June 4, 2015 |
Device Identification:
| Trade Name: | Phasix TM ST Mesh |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Device Class: | Class II |
| Regulation Number: | 21 CFR § 878.3300 |
| Product Code: | OWT, OOD, FTL |
Predicate Device Names:
- . TephaFLEX® Mesh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.
- Ventralight ST Mesh, K101851 (Davol Inc), FDA cleared on : July 15, 2010 ●
PREMARKET NOTIFICATION PHASIX™ ST MESH
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Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick. RI 02886 (401) 463-7000
Image /page/4/Picture/1 description: The image shows the logo for Bard Davol Inc. The logo features the word "BARD" in a bold, sans-serif font, with a green outline. Below the word "BARD" is the text "DAVOL INC." in a smaller font. To the right of the logo is the text "K143380 Pat", followed by the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically.
Device Description
The proposed Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix ™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
Indications for Use
Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.
Comparison of Technological Characteristics with the Predicate Device
The proposed Phasix™ ST Mesh has the same materials and design as the predicate TephaFlex® Mesh and Ventralight™ ST Mesh devices.
- The base mesh in the proposed Phasix™ ST Mesh is constructed of the same P4HB . monofilament and knit pattern as the predicate TephaFlex® Mesh. The base mesh component of the predicate Ventralight™ ST Mesh is made of polypropylene.
- Both the proposed Phasix™ ST Mesh and predicate Ventralight™ ST Mesh contain a HA/CMC . PEG based hydrogel. These devices also contain PGA fibers co-knit into the mesh to allow the
PREMARKET NOTIFICATION PHASIX™ ST MESH
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Image /page/5/Picture/1 description: The image shows the Bard Davol Inc. logo. The logo is green and features the word "BARD" in a stylized font. Below the word "BARD" is the text "DAVOL INC." On the right side of the image, there are four words stacked vertically: "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST". The image also includes the text "K143380 Page 3 of 4" at the top.
hydrogel to adhere to the mesh. The purpose of the hydrogel coating is to minimize tissue attachment to the mesh. The TephaFLex® Mesh predicate does not contain a hydrogel coating or PGA fibers.
The proposed and predicate devices have the same intended use and similar indications for use statements. In addition, all three devices are sterilized via ethylene oxide and packaged in a Tyveke envelope and foil pouch. Where minor technological differences exist between the proposed and predicate devices, testing demonstrates that the differences do not adversely affect the performance of the proposed device.
Performance Data:
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
The materials used in the construction of the proposed Phasix™ ST Mesh are known to be biocompatible as demonstrated by their safe clinical use in the predicate devices. However, in order to address any risks associated with interactions between the three device components (i.e. P4HB, PGA, and the hydrogel coating), complete biocompatibility testing in accordance with FDA's Blue Book Memorandum #G95-1 issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and FDA Guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process". The following studies were completed:
- . Cytotoxicity
- . Genotoxicity
- Sensitization
-
- Intracutaneous Reactivity .
- Local and Systemic Toxicity (4 and 13 week) ● Local Toxicity (4, 8, 13, and 20 week)
- . Systemic Toxicity (Acute)
- Pyrogenicity
.
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 PhasixTM Mesh does not contain software.
PREMARKET NOTIFICATION PHASIX™ ST MESH
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Image /page/6/Picture/1 description: The image shows the logo for BARD DAVOL INC. The logo is green and features the word "BARD" in a stylized font. To the right of the logo are the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically. At the top right of the image is the text "K143380 Page 4 of 4".
Bench Testing
Bench testing was performed to compare the proposed Phasix™ ST Mesh to the predicate TephaFlex® Mesh and Ventralight™ ST Mesh devices. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" published March 2, 1999, the following physical and performance characteristics were evaluated:
- . Mesh weave characteristics
- . Device stiffness
- . Mesh pore size
- Burst strength
- Mesh density
- Tear resistance ●
- . Mesh thickness
- . Suture pullout strength.
Additionally an in vitro degradation study was completed to demonstrate that the degradation of the PGA fibers and hydrogel coating present on the proposed Phasix™ ST Mesh construct do not impact the resorption profile of the P4HB mesh.
Animal Studies
In vivo porcine studies were performed to characterize the mechanical strength, tissue response, and resorption profile of the proposed Phasix™ ST Mesh device in comparison to the cited predicates at 4, 12, and 24 weeks.
Clinical Study
No clinical study was required in support of the Phasix™ ST Mesh.
Conclusion:
All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates.