(88 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a resorbable surgical mesh, with no mention of AI or ML technology.
Yes
The device is described as 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," which indicates it is used for treatment or mitigation of a condition.
No
The device is a resorbable construct used to reinforce soft tissue during surgical procedures; it does not diagnose medical conditions.
No
The device description clearly states it is a "resorbable construct prepared from poly-4-hydroxybutyrate (P4HB)" and is a "porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric." This describes a physical, material-based device, not software.
Based on the provided information, the TephaFLEX Meltblown Matrix is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is for reinforcing soft tissue in patients undergoing surgical procedures. This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a resorbable construct made of P4HB, a material used for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The TephaFLEX Meltblown Matrix does not fit this description.
N/A
Intended Use / 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.
Product codes
OOD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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 Premarket 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TephaFLEX Surgical Mesh - K113723, Cook Biodesign Surgisis Tissue Graft - K062696, Gore Bio-A Tissue Reinforcement - K033671, MAST Biosurgery Surgi-Wrap - K031995, K050332
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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