(78 days)
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.
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.
The provided text describes the regulatory filing for the GalaFLEX® Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria for an AI device. Therefore, a direct table of acceptance criteria and reported device performance in the context of an AI study (as requested in the prompt) cannot be extracted from this text.
However, I can extract the information related to the study performed to establish substantial equivalence for the GalaFLEX® Mesh device itself based on its safety and performance.
Here's the breakdown of the information relevant to the device's evaluation, framed to address the prompt's categories where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As this K140533 filing is a medical device submission (GalaFLEX® Mesh) and not an AI device, the "acceptance criteria" are related to demonstrating substantial equivalence for the surgical mesh. These criteria are comparative metrics against predicate devices and biocompatibility standards. "Reported device performance" refers to the results of these tests for the GalaFLEX® Mesh.
| Acceptance Criteria (for Substantial Equivalence of Surgical Mesh) | Reported GalaFLEX® Mesh Performance |
|---|---|
| Mechanical Testing: | |
| - Comparative burst strength to predicate devices | Characterized (presumably met substantial equivalence as concluded) |
| - Suture pull-out strength to predicate devices | Characterized (presumably met substantial equivalence as concluded) |
| - Tensile strength to predicate devices | Characterized (presumably met substantial equivalence as concluded) |
| - Tear resistance strength to predicate devices | Characterized (presumably met substantial equivalence as concluded) |
| In vivo Strength Retention Testing: | |
| - Strength retention via subcutaneous implantation study (comparative to predicate devices) | Characterized (presumably met substantial equivalence as concluded) |
| Biocompatibility Testing (conformance to ISO-10993): | |
| - Cylotoxicity | Yielded a non-toxic response |
| - Intracutaneous Irritation | Yielded a non-toxic response |
| - Sensitization | Yielded a non-toxic response |
| - Acute Systemic Toxicity | Yielded a non-toxic response |
| - Pyrogenicity | Yielded a non-toxic response |
| - Genotoxicity | Yielded a non-toxic response |
| - 12, 26, and 52-week Subcutaneous Implantation studies (in rabbits) | Yielded a non-toxic response |
| Overall Performance Conclusion: Substantial equivalence to predicate devices for safety and effectiveness. | Based on indications for use, technological characteristics, and results of safety and performance testing, the GalaFLEX mesh has been shown to be substantially equivalent to predicate devices for the same clinical indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Mechanical Testing: Not explicitly stated, but the tests performed were comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength. The number of samples for each test is not specified.
- In vivo Testing: Not explicitly stated for the subcutaneous implantation study, but it was performed in rabbits.
- Biocompatibility Testing: Not explicitly stated for each test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity), except for the remark that the subcutaneous implantation studies were conducted in "rabbits" (plural, but not an exact number).
- Data Provenance: The studies were internal testing by Tepha, Inc. The in vivo and biocompatibility studies involved animal subjects (rabbits). It is not specified if any human data was used, but the context is pre-market notification (510(k)) based on substantial equivalence, often relying on non-clinical data. These studies are prospective from the perspective of their execution for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a 510(k) submission for a non-AI medical device. "Ground truth" in this context refers to the measured physical properties of the mesh and biological responses in animal models, not expert interpretations of images or patient data. The "experts" would be the scientists and engineers conducting the tests and interpreting the results according to established scientific and regulatory standards (e.g., ISO-10993). No specific number or qualifications are mentioned for these individuals beyond the performing entity being Tepha, Inc.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here comprises physical and biological measurements. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on subjective interpretations (e.g., image reading) in clinical trials or AI performance evaluations, not for objective mechanical or biocompatibility testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
Not applicable. This is a 510(k) submission for a surgical mesh, not an AI device. Therefore, no MRMC study, human reader performance, or AI assistance elements are present or relevant in this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a surgical mesh, not an algorithm or AI device.
7. The Type of Ground Truth Used
- Mechanical Testing: Objective physical measurements (e.g., burst strength, tensile strength) determined by standardized test methods.
- In vivo Testing: Biological observation and measurement of strength retention in animal models.
- Biocompatibility Testing: Bioreactivity responses (e.g., cytotoxicity, irritation, sensitization, toxicity, pyrogenicity, genotoxicity, implantation reactions) according to ISO-10993 standards and protocols.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set." The development of the GalaFLEX® Mesh would involve research, material science, and engineering, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set for an AI algorithm, there is no corresponding ground truth to establish.
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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 360Lexington, 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: OODAbsorbable Poly(hydroxybutyrate) Surgical Mesh Produced byRecombinant DNA Technology |
| Classification: | According to Section 13 of the Federal Food, Drug and CosmeticAct, the device classification is Class II, Performance Standards. |
| Predicate Devices: | Tepha, Inc., TephaFLEX Mesh - K113723, K111946, K101287and K070894Allergan, SERI Surgical Scaffold - K123128Please see attached Substantial Equivalence table comparingthe 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 varyingwidths, lengths and shapes, and may also be cut to the shape orsize desired for a specific application. |
| Indications for Use: | The GalaFLEX mesh is indicated for use as a transitory scaffoldfor soft tissue support and to repair, elevate and reinforcedeficiencies where weakness or voids exist that require theaddition of material to obtain the desired surgical outcome. Thisincludes reinforcement of soft tissue in plastic and reconstructivesurgery, and general soft tissue reconstruction. |
| Safety and Performance: | Mechanical testing, in vivo animal testing, and biocompatibilitytesting, were performed based on recommendations identified inthe 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
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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
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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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§ 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.