GalaSHAPE™ 3D is indicated for use as a bioresorbable 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. GalaSHAPE™ 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

GalaSHAPE 3D is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength over time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called GalaSHAPE 3D, a bioresorbable surgical mesh. The document focuses on demonstrating substantial equivalence to a predicate device (K140533 GalaFLEX scaffold), rather than presenting a study to prove the device meets pre-defined acceptance criteria in the typical sense of a diagnostic or algorithmic device.

Therefore, the requested information elements (acceptance criteria table, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.

This document is a regulatory filing, and its core purpose is to show that the new device (GalaSHAPE 3D) is as safe and effective as a device already legally marketed (GalaFLEX scaffold). It does this by comparing technological characteristics, biocompatibility, and animal study results.

Here's an explanation based on the provided text's context:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The document does not present specific quantitative acceptance criteria for device performance that GalaSHAPE 3D needed to meet as a new device. Instead, it aims to demonstrate substantial equivalence to a predicate device (GalaFLEX scaffold). The performance is reported in terms of comparability to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Animal Study: The document mentions an animal study involving rabbits ("subcutaneously implanted in rabbits").
Sample Size: The exact number of rabbits used is not specified in the provided text.
Data Provenance: The country of origin and whether it was retrospective or prospective is not specified. However, animal studies are inherently prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. This is not a study involving human interpretation or diagnoses that would require expert-established ground truth. The animal study involved measuring tissue response, resorption profiles, and strength characteristics, which are objective measures, not subjective expert interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No adjudication method is mentioned as the study did not involve subjective assessments requiring human consensus.

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 device is a physical surgical mesh, not a diagnostic imaging or AI-assisted device. Therefore, a MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the animal study: The ground truth was based on objective biological and mechanical measurements, specifically:
- Tissue response (presumably histological examination, although not explicitly stated)
- Resorption profile (implied by molecular weight changes and strength retention over time)
- Strength characteristics (burst strength).
These are not "expert consensus" in the way a diagnostic algorithm's ground truth would be established.

8. The sample size for the training set:

Not Applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. No training set exists.

In summary, the provided text describes a regulatory filing for a surgical mesh, focusing on demonstrating substantial equivalence to a predicate device. It includes findings from an animal study comparing the new device to the predicate in terms of tissue response, resorption, and strength. The detailed elements requested in the prompt, which are typically relevant for AI/ML or diagnostic device evaluations, are not applicable to this context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2016

Tepha, Inc. Ms. Connie H. Garrison Vice President, Regulatory Affairs 99 Havden Avenue Lexington, MA 02421

Re: K161092

Trade/Device Name: GalaSHAPE 3D Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD Dated: July 21, 2016 Received: July 22, 2016

Dear Ms. Garrison:

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

{1}------------------------------------------------

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/Resourcesfor You/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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161092

Device Name GalaSHAP 3D

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

SUBMITTED BY:

Company Name:	Tepha, Inc.
Address:	99 Hayden Avenue Suite 360Lexington, MA 02421
Telephone:	781-357-1709
Fax:	781-357-1701
CONTACT PERSON:	Connie H. Garrison, MBA, RAC
DATE PREPARED:	April 15, 2016
TRADE NAME:	GalaSHAPE™ 3D
COMMON and CLASSIFICATION NAME:	Mesh, surgical, absorbable, plastic andreconstructive surgery
CLASSIFICATION REG/PANEL:	CFR §878.3300 / General and Plastic Surgery
PROCODE:	OOD

PREDICATE DEVICE:

K140533 GalaFLEX® scaffold

DEVICE DESCRIPTION:

Pre-clinical implantation studies indicate that the GalaSHAPE 3D retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.

INDICATIONS FOR USE/INTENDED USE:

{4}------------------------------------------------

reinforcing or bridging material to obtain the desired surgical result.

The indications for use statement for GalaSHAPE 3D is identical to that of the predicate.

SUMMARY of TECHNOLOGICAL CHARACTERISTICS:

Results from performance testing based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", dated March 2, 1999, demonstrate substantial equivalence of GalaSHAPE 3D to the predicate GalaFLEX® scaffold cleared under K140533. The device is unchanged in materials, knit construction, and bioresorption profile from the Both GalaFLEX scaffold and GalaSHAPE 3D are ethylene oxide sterilized and predicate. intended for single use only. Both devices are suitable 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.

BIOCOMPATIBILTY:

Biocompatibility testing of the predicate device was conducted per the categorization principles in ISO 10993-1:2009. Based on the standard, the device was categorized as an implant device in contact with tissue and bone, and having a duration of contact of greater than 30 days (permanent). Results from the predicate testing coupled with cytotoxicity testing repeated for verification of biocompatibility, support the biocompatibility and safety of the subject device.

ANIMAL STUDIES:

An animal study was conducted to characterize the tissue response, resorption profile, and strength characteristics of the device after implantation. In this study, the subject device and predicate were subcutaneously implanted in rabbits. Necropsies were performed at 4, 8, and 12 week time points. The results from the study support the comparability of GalaSHAPE 3D with the predicate. The local tissue reaction was judged to be similar between the predicate and the shaped mesh, and there was no statistically significant difference (p>0.05) in burst strength between the curved mesh and the GalaFLEX sample groups at each of the time points indicating a comparable bioresorption profile. Comparability of GalaSHAPE 3D and the predicate was also supported by similar molecular weights of the polymer at each of the time points.

CONCLUSION:

Based on the intended use, technological characteristics, biocompatibility studies, and animal testing, GalaSHAPE™ 3D is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.