K120844 · Medlinx Acala Pte, Ltd. · FTL · Dec 13, 2012 · General, Plastic Surgery
Device Facts
Record ID
K120844
Device Name
MEDLINX SURGICAL MESH
Applicant
Medlinx Acala Pte, Ltd.
Product Code
FTL · General, Plastic Surgery
Decision Date
Dec 13, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.3300
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias and other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Device Story
Medlinx Surgical Mesh is a sterile, implantable, single-layer polymeric mesh; composed of non-absorbable polyvinylidene fluoride (PVDF) and absorbable poly(1,4-butylene adipate) (PBA). PBA acts as a plasticizer to increase mesh flexibility; partially absorbed post-implantation. Device used by surgeons in clinical settings for hernia repair and abdominal fascial defect reinforcement. Provides structural support to weakened soft tissue; facilitates surgical repair. Substantially equivalent to existing mesh products based on material composition and performance characteristics.
Clinical Evidence
Bench testing and animal testing conducted per FDA guidance. Bench testing included mesh density, tensile strength, device stiffness, suture pullout strength, burst strength, tear resistance, residual heavy metals, polymer purity, and biodegradation. Biocompatibility testing included cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, AMES test, chromosome aberration, mammalian cell gene mutation, intramuscular implantation, hemolysis, pyrogenicity, and sub-chronic systemic toxicity. Results demonstrated comparable safety and performance to predicates.
Indicated for patients requiring soft tissue reinforcement for hernia repair or abdominal fascial defects needing bridging or reinforcing material.
Regulatory Classification
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.
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510(k) Premarket Notification
Medlinx Acacia Pte Ltd
Medlinx Surgical Mesh
### 510(k) Summary
DEC 1 3 2012
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the Medlinx Surgical Mesh is provided below.
Device Common Name: Polymeric Surgical Mesh
Device Proprietary Name: Medlinx Surgical Mesh
Submitter:
Medlinx Acacia Pte Ltd 10 Anson Road #31-10 International Plaza Singapore 079903
Date Prepared:
November 6, 2012
21 CFR 878.
II
Classification Regulation:
Product Code:
Class:
Panel:
R. A. Fisher
General & Plastic Surgery Devices
FTL
Predicate Devices:
Ethicon, Inc's ULTRAPRO Mesh (K033337) C.R. Bard's Marlex Mesh (K922916)
3300
#### Indication for Use:
The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias and other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
#### Device Description:
The Medlinx Surgical Mesh is a sterile, implantable, single-layer polymeric mesh that is comprised of non-absorbable polyvinylidene fluoride (PVDF) and absorbable poly(1,4-butylene adipate) (PBA). The PBA plasticizer increases the flexibility of the mesh, and it is partially absorbed once implanted.
#### Comparison to the Predicate
The Medlinx Surgical Mesh has similar indications for use and technological characteristics as Ethicon Inc.'s UltraPro Mesh and C.R. Bard's Marlex Mesh. All
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510(k) Premarket Notification
K120844 Page 2/2
Medlinx Acacia Pte Ltd Medlinx Surgical Mesh
three meshes are manufactured with a non-absorbable polymer material. The Medlinx Surgical Mesh and the UltraPro Mesh both have a partially absorbable polymer material. All three are available in a similar range of sizes.
Mechanical testing; biocompatibility testing and animal testing were conducted per the recommendations in: Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance - Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," dated March 2, 1999." The following tests were conducted:
Biocompatibility Testing In Vitro Cytotoxicity Skin Sensitization (Maximization Method) Intracutaneous Reactivity Acute Systemic Toxicity In Vitro Bacterial Reverse Mutation (AMES) In Vitro Chromosome Aberration In Vitro Mammalian Cell Gene Mutation Intramuscular Implantation In Vitro Hemolysis Pyrogenicity Sub-Chronic Systemic Toxicity
Bench Testing Mesh Density Tensile Strength Device Stiffness Suture Pullout Strength Burst Strength Tear Resistance Residual levels of heavy metals Polymer purity Biodegradation PBA Extraction Expiration Dating
The biocompatibility testing showed the comparable safety profile of the Medlinx Surgical Mesh and the predicates. Bench testing demonstrated that the device is substantially equivalent for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
## Summary of Substantial Equivalence:
Based on the indications for use, technological characteristics and performance test results, the Medlinx Surgical Mesh is substantially equivalent to the predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
Medlinx Acacia Pte Ltd % Biologics Consulting Group Mr. Stephen P. Rhodes Senior Consultant, Medical Devices 3502 Dundee Drive Chevy Chase, Maryland 20815
Re: K120844
Trade/Device Name: Medlinx Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: December 13, 2012 Received: December 13, 2012
Dear Mr. Rhodes:
This letter corrects our substantially equivalent letter of December 13, 2012.
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 (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.
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
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Page 2 - Mr. Stephen P. Rhodes
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
# Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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#### 3.0 Indications for Use Statement
510(k) Number (if known):_K120844
Device Name: Medlinx Surgical Mesh
Indications for Use:
The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ゃ
Prescription Use __ × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120844
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