Who is the manufacturer of TEPHAFLEX MELTBLOWN CONSTRUCT?

Tepha, Inc. filed the 510(k) submission for TEPHAFLEX MELTBLOWN CONSTRUCT (K130326).

What is the FDA product code for TEPHAFLEX MELTBLOWN CONSTRUCT?

OOD. 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 TEPHAFLEX MELTBLOWN CONSTRUCT?

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

What are the predicate devices for TEPHAFLEX MELTBLOWN CONSTRUCT?

TephaFLEX Surgical Mesh (K113723); Cook Biodesign Surgisis Tissue Graft (K062696); Gore Bio-A Tissue Reinforcement (K033671); MAST Biosurgery Surgi-Wrap (K031995, K050332).

Who can help prepare an FDA 510(k) submission like TEPHAFLEX MELTBLOWN CONSTRUCT?

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.

TEPHAFLEX MELTBLOWN CONSTRUCT

K130326 · Tepha, Inc. · OOD · May 7, 2013 · General, Plastic Surgery

Device Facts

Record ID	K130326
Device Name	TEPHAFLEX MELTBLOWN CONSTRUCT
Applicant	Tepha, Inc.
Product Code	OOD · General, Plastic Surgery
Decision Date	May 7, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TephaFLEX Meltblown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

TephaFLEX Meltblown Matrix is a resorbable, porous, non-woven surgical mesh construct. It is manufactured from poly-4-hydroxybutyrate (P4HB) fibers and provided in single sheets of various dimensions. The device is used by surgeons in clinical settings to reinforce soft tissue during surgical procedures requiring bridging or reinforcement material. It functions as a temporary scaffold that supports tissue during healing before undergoing resorption. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. Evidence includes mechanical characterization (burst strength, suture pull-out, tensile strength, tear resistance) and an in vivo subcutaneous implantation study to characterize strength retention. No human clinical trial data was provided.

Technological Characteristics

Material: Poly-4-hydroxybutyrate (P4HB). Form: Porous, fibrous, non-woven meltblown matrix. Thickness: ~1 mm. Sterilization: Ethylene Oxide (EO). Connectivity: None. Software: None.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue reinforcement or bridging where weakness exists.

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

TephaFLEX Surgical Mesh (K113723)
Cook Biodesign Surgisis Tissue Graft (K062696)
Gore Bio-A Tissue Reinforcement (K033671)
MAST Biosurgery Surgi-Wrap (K031995, K050332)

Related Devices

K113723 — TEPHAFLEX MESH · Tepha, Inc. · Feb 15, 2012
K111946 — TEPHAFLEX MESH · Tepha, Inc. · Sep 26, 2011
K113721 — TEPHAFLEX LIGHT MESH · Tepha, Inc. · Feb 15, 2012
K070894 — TEPHAFLEX SURGICAL MESH · Tepha, Inc. · Apr 13, 2007
K140533 — GALAFLEX MESH · Tepha, Inc. · May 21, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ K130326 page 1/3 # tepha 840 Memorial Drive Cambridge. MA 02139 tel: (617) 995-5400 fax: (617) 995-5401 ## MAY 0 7 2013 Section IX 510(k) Summary (April 18, 2013) Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Tepha, Inc. is submitting the following summary of information respecting safety and effectiveness: | Trade Name: | TephaFLEX® Melt blown Matrix | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 | | Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs Telephone: 781-357-1709 Fax: 781-357-1701 E-mail: legraw@tepha.com | | Device Classification Name: | CFR §878.3300 Surgical Mesh - Product Code: OOD | | Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards. | | Predicate Devices: | TephaFLEX Surgical Mesh - K113723 Cook Biodesign Surgisis Tissue Graft - K062696 Gore Bio-A Tissue Reinforcement - K033671 MAST Biosurgery Surgi-Wrap - K031995, K050332 Please see the attached Substantial Equivalence table comparing the | | Device Description: | TephaFLEX Meltblown Matrix to the predicate devices. The TephaFLEX Meltblown Matrix is a resorbable construct prepared from poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed or dyed with D&C Violet No. 2. It is a porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric. It is provided in single sheets of varying widths, lengths and shapes ranging from 1x1 to 10x14 inches. | | Indications for Use: | TephaFLEX Meltblown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | | Safety and Performance: | The P4HB material used to manufacture the TephaFLEX melt blown matrix is in compliance with the applicable parts of FDA's Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology. Mechanical testing, biocompatibility testing, and in vivo animal testing was performed based on recommendations identified in the FDA surgical mesh guidance document: The Guidance for the Preparation of a Pre- | {1}------------------------------------------------ K130326 page 2/3 Image /page/1/Picture/1 description: The image shows the word "tepha" in a bold, sans-serif font. A curved line underlines the word, starting from the left side of the 't' and extending to the right side of the 'a'. The text is black against a white background. 840 Memorial Drive Cambridge, MA 02139 tel: (617) 995-5400 fax: (617) 995-5401 market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the product to be substantially equivalent to the predicate devices. #### Conclusion: Based on the indications for use, technological characteristics, and safety and performance testing, the TephaFLEX Meltblown Matrix has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ Substantial Equivalence Comparison Tabl - . | Characteristic | Indications for Use | Material | Thickness | Dyed, Non-dyed | Size | Performance Results Suture Pullout Tensile Strength | Absorption Profile | Packaging | Sterilization | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------| | Tepha, Inc. Proposed TephaFLEX® Melt blown Matrix | The TephaFLEX melt blown matrix is intended to reinforce soft tissue in surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | Poly-4-hydroxybutyrate (P4HB) | ~ 1 mm | Non-dyed & Dyed (D&C Violet #2) | Single sheet sizes of: 1x2 through 10 X 12 inches | Substantially Equivalent | Absorption essentially complete within 12-18 months | Foil packaging with removable Tyvek header | Ethylene Oxide (EO) | | Tepha, Inc. Predicate TephaFLEX® Mesh K113723 | The TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result. | Poly-4-hydroxybutyrate (P4HB) | ~0.6 mm | Non-dyed & dyed (D&C Violet #2) | Single sheet sizes of: 1x2 through 12x14 inches | Substantially Equivalent | Absorption essentially complete within 12-18 months | Foil packaging with removable Tyvek header | Ethylene Oxide (EO) | | Cook Biotech Surgisis K062696 | Surgisis is Intended for implantation to reinforce soft tissue. The device is intended for one-time use. | Porcine small intestinal submucosa | Nominal thickness ranging from 0.04 mm to 0.7 mm | Non-dyed | Single sheet size of: 2x3 through 7x10 cm | Substantially Equivalent | Unknown | Inner pouch contained in outer bag composed of polymer film lined paper | Ethylene Oxide | | Gore Bio-A Tissue Reinforcement K033671 | Bio-A Tissue Reinforcement is intended for use in the reinforcement of soft tissue. Examples of applications where the Bio-A may be used include, but are not limited to, hernia repair (in non-load bearing applications), muscle flap reinforcement, and general tissue reconstruction | Poly(glycolide: trimethylene carbonate) copolymer | ~ 2 mm | Unknown | Available in single sheets and preformed, three- dimensional shapes. | Not tested | Biobsorption process should be complete by the end of six months (labeling) | Unknown, | Ethylene Oxide (EO) | | MAST Biosurgery, Inc. Surgi-Wrap K031955, K050332 | SurgiWrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension. The absorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera. | Polylactic acid (PLA) | 20 - 1000 microns | Undyed | Single sheet sizes of 25mm x 25mm to 500mm x 500mm | Substantially Equivalent | Absorption complete between 12-18 months depending on design. | Tyvek film pouch in individual cardboard box | Electron beam irradiation | K130326 page 3/3 {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Tepha, Inc. % Ms. Mary P. LeGraw Vice President, Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachusetts 02421 May 7, 2013 Re: K130326 Trade/Device Name: TephaFLEX® Meltblown Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD Dated: April 18, 2013 Received: April 23, 2013 Dear Ms. LeGraw: 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. Ilsting 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 {4}------------------------------------------------ Page 2 - Ms. Mary P. LeGraw 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 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, FOR Peter D. Rumm-S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Unknown Device Name: . TephaFLEX® Melt blown Matrix Indications for Use: : TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Prescription Use: X (21 CFR 801 Subpart D) AND/OR Over-The-Counter (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) Page 1 of 1 ## David Krajūsēs-S (Division Sign-Off) Division of Surgical Devices 510(k) Number: K130326