GalaSHAPE 3D

K161092 · Tepha, Inc. · OOD · Aug 23, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161092
• Device Name: GalaSHAPE 3D
• Applicant: Tepha, Inc.
• Product Code: OOD · General, Plastic Surgery
• Decision Date: Aug 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

GalaSHAPE 3D is a bioresorbable surgical mesh scaffold; manufactured from poly-4-hydroxybutyrate (P4HB) monofilament fibers; knitted into a 3D curved structure to improve anatomical conformance compared to flat meshes. Device provides temporary soft tissue support; promotes native tissue ingrowth; gradually transfers load to tissue as scaffold resorbs via hydrolysis and enzymatic digestion. Resorption essentially complete within 18-24 months; retains ~70% strength at 12 weeks. Used by surgeons in clinical settings for soft tissue reconstruction and fascial defect repair. Benefits include reinforcement of weakened tissue and support during healing process.

Clinical Evidence

No human clinical data. Evidence consists of bench performance testing and a comparative animal study. Rabbit subcutaneous implantation study (n=not specified) compared GalaSHAPE 3D to predicate at 4, 8, and 12 weeks. Primary endpoints included tissue response, resorption profile, and burst strength. Results showed no statistically significant difference (p>0.05) in burst strength between groups at any time point; molecular weight profiles were similar. Biocompatibility supported by predicate data and repeated cytotoxicity testing.

Technological Characteristics

Material: Poly-4-hydroxybutyrate (P4HB). Construction: Knitted monofilament fibers. Form factor: 3D curved mesh. Sterilization: Ethylene oxide. Single-use. Biocompatibility: ISO 10993-1:2009 (permanent implant).

Indications for Use

Indicated for patients requiring soft tissue support, reinforcement, or repair of fascial defects in plastic, reconstructive, or general surgery where weakness or voids exist.

Regulatory Classification

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.

Predicate Devices

• GalaFLEX® scaffold (K140533)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) K161092

Device Name GalaSHAP 3D

#### Indications for Use (Describe)

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.

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

| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

SUBMITTED BY:

| Company Name: | Tepha, Inc. |
|---------------------------------|-------------------------------------------------------------------|
| Address: | 99 Hayden Avenue Suite 360<br>Lexington, 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 and<br>reconstructive surgery |
| CLASSIFICATION REG/PANEL: | CFR §878.3300 / General and Plastic Surgery |
| PROCODE: | OOD |

# PREDICATE DEVICE:

K140533 GalaFLEX® scaffold

# 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.

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:

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

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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.