GalaFORM 3D scaffold 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. GalaFORM 3D scaffold 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

GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold has a 3D curvature supported with a P4HB rim 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 with 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 the GalaFORM 3D device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific performance study in the way one might evaluate a diagnostic algorithm or a similar device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

No Acceptance Criteria or Reported Device Performance Table: The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or other performance metrics) nor does it report specific performance values against such criteria.
No Test Set Information (Sample Size, Data Provenance, Experts, Adjudication): The document mentions an "animal study" but does not detail the size of a "test set" in the context of clinical or diagnostic performance, its data provenance, the number and qualifications of experts, or adjudication methods. The animal study focused on tissue response, resorption, and strength characteristics, not diagnostic or clinical accuracy.
No MRMC Comparative Effectiveness Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any human readers or AI assistance.
No Standalone Performance Study: While an animal study was done, it was not described as a standalone performance study in the context of an algorithm or diagnostic device.
Type of Ground Truth: The "ground truth" in the animal study would presumably be derived from histopathology and physical measurements (e.g., burst strength) in animal tissues, not expert consensus or patient outcomes in a diagnostic context.
No Training Set Information: The document makes no mention of a training set, as it is not describing an AI/algorithm-based device that would require such.
No Ground Truth for Training Set: Consequently, there is no information on how ground truth for a training set was established.

Summary of what the document does provide regarding studies:

Animal Studies:
- Purpose: To characterize tissue response, resorption profile, and strength characteristics of the device after implantation and to verify no changes due to the modified manufacturing process (addition of a rim for 3D shape).
- Design: Subject device (GalaFORM 3D) and predicate (GalaFLEX scaffold) subcutaneously implanted in rabbits.
- Time Points: Necropsies performed at 4, 8, 12, and 40 weeks.
- Findings: Local tissue reaction was similar between the predicate and the shaped mesh. No statistically significant difference (p>0.05) in burst strength between the curved mesh and GalaFLEX groups at each time point, indicating comparable bioresorption. Similar molecular weights of the polymer also supported comparable resorption.
Biocompatibility Testing: Conducted per ISO 10993-1:2009 for an implant device in contact with tissue and bone for greater than 30 days. Results supported biocompatibility and safety.

The information primarily describes pre-clinical testing to demonstrate the safety and comparable performance characteristics of the physical mesh material itself, rather than the performance of a diagnostic or AI-driven device against specific clinical acceptance criteria.

Summary

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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

February 23, 2017

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

Re: K162922

Trade/Device Name: GalaFORM, 3D Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OOD Dated: January 17, 2017 Received: January 22, 2017

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

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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

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Indications for Use

510(k) Number (if known) K162922

Device Name GalaFORM 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)

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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:	October 14, 2016
TRADE NAME:	GalaFORM™ 3D
COMMON and CLASSIFICATION NAME:	Mesh, surgical, absorbable, plastic and
	reconstructive surgery
CLASSIFICATION REG/PANEL:	CFR §878.3300 / General and Plastic Surgery
PROCODE:	OOD

PREDICATE DEVICES:

K161092 GalaSHAPE™ scaffold K140533 GalaFLEX® scaffold

DEVICE DESCRIPTION:

Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. The outer rim may be palpable throughout the expected period of healing.

INDICATIONS FOR USE/INTENDED USE:

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or bridging material to obtain the desired surgical result.

The indications for use statement for GalaFORM 3D is identical to that of the predicates.

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 GalaFORM 3D to the predicate devices. GalaFORM 3D is unchanged in materials, knit construction, and bioresorption profile from the predicates. The only difference between the predicate, GalaSHAPE 3D, and the subject device is the addition of a P4HB rim along the perimeter of the mesh to provide a stiffer edge and curvature. Both the predicate devices and GalaFORM 3D are ethylene oxide sterilized and intended for single use only. The 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 device family 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 testing 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 to verify no changes to these characteristics due to the modified manufacturing process to add a rim to the edge of the mesh and create a three-dimensional shape. In this study, the subject device and the predicate GalaFLEX scaffold, were subcutaneously implanted in rabbits. Necropsies were performed at 4, 8, 12 and 40 week time points. The results from the study support the comparability of GalaFORM 3D with the predicates. 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 the resorption profile of GalaFORM 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, GalaFORM™ 3D is substantially equivalent to the predicate devices.

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.