(78 days)
Not Found
No
The document describes a resorbable surgical mesh and its mechanical and biological properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a surgical mesh used to reinforce and repair soft tissue. Its function is structural support, not to treat or cure a disease or condition in a therapeutic sense.
No
The device is a surgical mesh for soft tissue support and repair, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a sterile, knitted, resorbable mesh made of monofilament fibers, which is a physical hardware component. The performance studies also focus on mechanical and in vivo testing of this physical mesh.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that GalaFLEX mesh is used as a "transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description details a "sterile, knitted, resorbable mesh" made of a specific material, designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, GalaFLEX mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
OOD
Device Description
GalaFLEX mesh is a sterile, knitted, resorbable mesh, constructed of non-dyed monofilament fibers made from poly-4-hydroxybutyrate (P4HB). It is provided in single sheets of varying widths, lengths and shapes, and may also be cut to the shape or size desired for a specific application.
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)
Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document: The Guidance for the Preparation of a Pre-market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength were characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices.
Testing was also performed for conformance to ISO-10993 for biocompatibility. Tepha performed Cylotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, and 12, 26 and 52 week Subcutaneous Implantation studies in rabbits. All testing yielded a non-toxic response.
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.
K113723, K111946, K101287, K070894, K123128
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.
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MAY 2 1 2014
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99 Hayden Avenue Snite 360 Lexington, MA 02421 tel: (781) 357-1700 fax: (781) 357-1701
Image /page/0/Picture/4 description: The image shows the logo for TEPHA Medical Devices. The logo consists of the word "TEPHA" in large, bold, sans-serif font, with the words "MEDICAL DEVICES" in a smaller font below. To the left of the word "TEPHA" is a graphic element that appears to be a stylized representation of a medical device or a swoosh-like design.
Section IX 510(k) Summary
(Prepared on February 28, 2014)
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: | GalaFLEX® Mesh |
|---|---|
| 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 |
| Email: | legraw@tepha.com |
| Device Classification Name: | CFR §878.4494 - Product Code: OOD |
| Absorbable Poly(hydroxybutyrate) Surgical Mesh Produced by | |
| Recombinant DNA Technology | |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic |
| Act, the device classification is Class II, Performance Standards. | |
| Predicate Devices: | Tepha, Inc., TephaFLEX Mesh - K113723, K111946, K101287 |
| and K070894 | |
| Allergan, SERI Surgical Scaffold - K123128 | |
| Please see attached Substantial Equivalence table comparing | |
| the GalaFLEX mesh to the predicate devices. | |
| Device Description: | GalaFLEX mesh is a sterile, knitted, resorbable mesh, |
| constructed of non-dyed monofilament fibers made from poly-4- | |
| hydroxybutyrate (P4HB). It is provided in single sheets of varying | |
| widths, lengths and shapes, and may also be cut to the shape or | |
| size desired for a specific application. | |
| Indications for Use: | The GalaFLEX mesh is indicated for use as a transitory scaffold |
| for soft tissue support and to repair, elevate and reinforce | |
| deficiencies where weakness or voids exist that require the | |
| addition of material to obtain the desired surgical outcome. This | |
| includes reinforcement of soft tissue in plastic and reconstructive | |
| surgery, and general soft tissue reconstruction. | |
| Safety and Performance: | Mechanical testing, in vivo animal testing, and biocompatibility |
| testing, were performed based on recommendations identified in | |
| the FDA surgical mesh guidance document: The Guidance for |
the Preparation of a Pre-market Notification Application for a
98
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Image /page/1/Picture/1 description: The image shows the logo for TEPHA Medical Devices. The logo consists of a stylized graphic to the left of the word "TEPHA" in large, bold letters. Below "TEPHA" are the words "MEDICAL DEVICES" in a smaller font. The graphic to the left of the word "TEPHA" appears to be a stylized representation of a medical device.
99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700 fax: (781) 357-1701
ુવુ
Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength were characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices.
Testing was also performed for conformance to ISO-10993 for biocompatibility. Tepha performed Cylotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, and 12, 26 and 52 week Subcutaneous Implantation studies in rabbits. All testing yielded a non-toxic response.
Conclusion:
Based on the indications for use, technological characteristics, and the results of safety and performance testing described above, the GalaFLEX mesh has been shown to be substantially equivalent to predicate devices used for the same clinical indications under the Federal Food, Drug and Cosmetic Act.
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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
May 21, 2014
Tepha, Incorporated Mr. Andrew Joiner President and CEO 99 Hayden Avenue, Suite 360 Lexington, Massachusetts 02421
Re: K140533
Trade/Device Name: Galaflex Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OOD Dated: February 28, 2014 Received: March 4, 2014
Dear Mr. Joiner,
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 - Mr. Andrew Joiner
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,
David Krause -S
for Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Unknown 510(k) Number (if known):
GalaFLEX® Mesh Device Name:
Indications for Use:
GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the repair, oldiato and formore delicitived surgical outcome. This includes reinforcement addition of material to obtain the accercative surgery, and general soft tissue reconstruction.
AND/OR Prescription Use: X (21 CFR 801 Subpart D)
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)
Peter L. Hudson -S
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