Who is the manufacturer of BIOMERIX COMPOSITE SURGICAL MESH?

Biomerix Corporation filed the 510(k) submission for BIOMERIX COMPOSITE SURGICAL MESH (K112499).

What is the FDA product code for BIOMERIX COMPOSITE SURGICAL MESH?

FTL. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BIOMERIX COMPOSITE SURGICAL MESH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BIOMERIX COMPOSITE SURGICAL MESH?

Biomerix Composite Surgical Mesh (K082941); Atrium Advanta PTFE Facial Implant (K992991); Tissue Sciences Laboratories Permacol (K013625); Lifecell LTM-BPS Surgical Mesh (K082176).

Who can help prepare an FDA 510(k) submission like BIOMERIX COMPOSITE SURGICAL MESH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOMERIX COMPOSITE SURGICAL MESH

K112499 · Biomerix Corporation · FTL · Dec 23, 2011 · General, Plastic Surgery

Device Facts

Record ID	K112499
Device Name	BIOMERIX COMPOSITE SURGICAL MESH
Applicant	Biomerix Corporation
Product Code	FTL · General, Plastic Surgery
Decision Date	Dec 23, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.

Device Story

Biomerix Composite Surgical Mesh is a non-absorbable, porous polymer scaffold composed of polycarbonate polyurethane urea incorporating knitted polypropylene monofilament fibers. Device serves as a structural implant for soft tissue repair and reinforcement in plastic and reconstructive surgery. Implanted by surgeons in clinical settings. Provides mechanical support to weakened tissue; promotes tissue integration; minimizes foreign body response. Benefits include stable long-term tissue repair without device degradation.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal studies. Bench testing confirmed performance specifications. Biocompatibility testing performed per ISO 10993-1. Animal testing demonstrated well-tolerated long-term histomorphologic response, good tissue integration, minimal foreign body response, and no device degradation or necrosis.

Technological Characteristics

Non-absorbable porous polymer scaffold; materials: polycarbonate polyurethane urea and knitted polypropylene monofilament fibers. Biocompatibility per ISO 10993-1. Mechanical performance verified via bench testing.

Indications for Use

Indicated for patients requiring repair or reinforcement of soft tissues with existing weakness in the context of plastic and reconstructive surgery.

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.

Predicate Devices

Biomerix Composite Surgical Mesh (K082941)
Atrium Advanta PTFE Facial Implant (K992991)
Tissue Sciences Laboratories Permacol (K013625)
Lifecell LTM-BPS Surgical Mesh (K082176)

Related Devices

K082941 — BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 · Biomerix Corporation · Jan 7, 2009
K070961 — BIOMERIX SURGICAL MESH, MODEL: RCR-01 · Biomerix Corporation · Feb 25, 2008
K052864 — TYRX SURGICAL MESH, MODEL SMPC-0501 · Tyrx Pharma, Inc. · Dec 22, 2005
K112567 — BIOMERIX ASSURE · Biomerix Corporation · Dec 23, 2011
K163217 — GORE BIO-A Tissue Reinforcement · W. L. Gore & Associates, Inc. · Feb 10, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(K) SUMMARY 3.0 | Applicant Name: | Biomerix Corporation 47757 Fremont Boulevard Fremont, CA 94538 Phone: (510) 933-3450 Fax: (510) 933-3451 | DEC 23 2011 | |--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Contact Person: | Maybelle Jordan VP of Regulatory Affairs & Business Development | | | Date Prepared: | December 22, 2011 | | | Device Trade Name: Device Common Name: Classification Name: | Biomerix Composite Surgical Mesh Polymeric surgical mesh Mesh, surgical, polymeric | | | Predicate Devices: | Biomerix Composite Surgical Mesh (K082941) Atrium Advanta PTFE Facial Implant (K992991) Tissue Sciences Laboratories Permacol (K013625) Lifecell LTM-BPS Surgical Mesh (K082176) | | | Device Description | Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers. | | | Intended Use | The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. | | | Device Technological Characteristics and Comparison to Predicate Device(s): | The Biomerix Composite Surgical Mesh is similar in materials, design, performance and intended use to other surgical mesh devices. Any differences in the above characteristics have been adequately tested to support substantial equivalence. | | | Performance Data: | Material testing was performed to demonstrate that the material properties are suitable for the intended use. Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications. Test results demonstrate that the device meets the specifications and is acceptable for clinical use. Biocompatibility testing in accordance to ISO 10993-1 recommended standards was conducted, and results demonstrated that the device is biocompatible according to these standards. Animal testing demonstrates that the mesh exhibits a | | p 1/2 {1}------------------------------------------------ 02 well-tolerated long-term histomorphologic response with good integration with surrounding tissue, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis. Based on the material, biocompatibility, bench, and Conclusion: animal testing, and the proposed device labeling, the Biomerix Composite Surgical Mesh is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Biomerix % Ms. Maybelle Jordan Vice President of Regulatory Affairs & Business Development 47757 Fremont Boulevard Fremont, California 94538 DEC 2 3 2011 Re: K112499 Trade/Device Name: Biomerix Composite Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 19, 2011 Received: December 22, 2011 Dear Ms. Jordan: 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 {3}------------------------------------------------ ## Page 2 - Ms. Maybelle Jordan 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/Resourcesfor You/Industry/default.htm. Sincerely yours, For Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE 4.0 112499 ps 1071 ## Indications for Use 510(k) Number (if known): K112499 Device Name: Biomerix Composite Surgical Mesh Indications for Use: The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Kine for NKM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112499