SurgiLattice™ scaffold is indicated for use as a bioabsorbable 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. SurgiLattice scaffold is also indicated for the repair of hernia and other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

Device Description

SurgilLattice scaffold is a bioabsorbable surgical mesh manufactured from poly-butylene succinate (PBS). PBS is an absorbable polymer that is processed into monofilament fibers and knitted into a surgical scaffold. PBS degrades through the process of hydrolysis, is absorbed over time, and is ultimately eliminated as CO2 and H2O. It has been developed to optimize absorption 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 a 510(k) premarket notification for the SurgiLattice™ scaffold, a surgical mesh. The document focuses on demonstrating substantial equivalence to a predicate device (GalaFLEX® scaffold) rather than providing detailed acceptance criteria and a study report as one might find for a de novo device with novel performance metrics.

Therefore, the requested information in the form of a table of acceptance criteria and a description of a single study proving the device meets those criteria is not explicitly presented in this document. Instead, the document describes performance testing that establishes comparability to the predicate device to demonstrate substantial equivalence.

Here's an attempt to extract the relevant information based on the provided text, noting where specific details are not available or are framed in terms of comparability rather than predefined acceptance criteria for novel performance:

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

As mentioned, the document does not present explicit acceptance criteria in the typical sense for a new device's performance metrics. Instead, it aims to show comparability to a legally marketed predicate device. The "acceptance criteria" can be inferred as "comparable to the predicate device" for various characteristics.

Acceptance Criteria (Inferred as Comparability to Predicate)	Reported Device Performance (SurgiLattice™ scaffold)
Indications for Use: Same as predicate (with exception of not including bridging repair)	Indications statement is the same as the predicate, with the exception of bridging repair, which is not included for the subject device.
Technological Characteristics & Principles of Operation: Same as predicate	The technological characteristics and principles of operation are the same. Minor technological difference (biomaterial composition) does not raise new issues of safety or effectiveness.
Degradation Pathway: Comparable to predicate	Hydrolytic degradation products of PBS (1,4-butanediol and succinic acid) are metabolized via Krebs Cycle, similar to the predicate's P4HB degrading to 4HB which is also metabolized via Krebs Cycle.
Physical & Mechanical Properties: Comparable to predicate (mesh thickness, density, pore diameter, mesh knit characteristics, burst strength, bending stiffness, tensile strength, suture pull-out, tear strength)	Results from performance testing (based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", dated March 2, 1999) demonstrate comparable mesh thickness, density, pore diameter, mesh knit characteristics, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength. Both products have the same macroporous, monofilament warp knit construction.
Biocompatibility: Meets ISO 10993 requirements; comparable to predicate	Biocompatibility testing conducted per ISO 10993-1:2009 for an implant device (contact > 30 days). Passing results for cytotoxicity, irritation/intracutaneous reactivity, maximization, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity, hemolysis, subacute/subchronic/chronic local toxicity, subcutaneous implantation with histology (4, 12, 26 weeks), subcutaneous implantation with histology using partially-degraded mesh (simulating 116 weeks), coupled with a toxicological assessment (ISO 10993-18). The rabbit study (4, 8, 12, 26 weeks) showed comparable dimensional, morphologic, and histological properties, and a study simulating 116 weeks showed minimal or no reaction comparable to the predicate.
Strength Retention Profile: Comparable to predicate	Pre-clinical implantation studies indicate approximately 88% strength retention at 12 weeks. Minimal residual strength at 78 weeks based on in vitro degradation. A rabbit study showed comparable initial strength, strength retention profile, and degradation profile to the predicate.
Degradation Profile: Comparable to predicate	A rabbit study showed comparable degradation profile to the predicate.
Local Tissue Reaction (Long-term): Minimal or no reaction; comparable to predicate	A second rabbit study, using accelerated degraded material (simulating 116 weeks), microscopically showed minimal or no reaction and was comparable to the predicate device.
Functional Performance (Hernia Repair Model): Comparable to predicate (burst strength, stiffness, morphologic properties, molecular weight, histology)	Evaluated in a functional porcine model of hernia repair. The results support substantial equivalence of SurgiLattice scaffold to the predicate in terms of repair site mechanics (burst strength and stiffness), morphologic properties (fiber diameter/surface roughness), molecular weight, and histology.
Shelf Life: Passing results	Bench testing of physical and mechanical characteristics, and shelf life studies using real-time and accelerated aging were performed with passing results. (Specific criteria for "passing" are not detailed, but imply stability over time).

2. Sample sizes used for the test set and the data provenance

The document mentions several studies, primarily animal models:

Rabbit Biocompatibility Study (Subcutaneous implantation):
- Sample Size: Not explicitly stated as a number of animals, but refers to implantation with histology at "4, 12 and 26 weeks" and "using partially-degraded mesh (representing 116 weeks)". This implies multiple time points, likely requiring multiple animals or sites per animal.
- Provenance: Pre-clinical, GLP rabbit studies, in vivo. Country of origin is not specified.
Porcine Hernia Repair Model:
- Sample Size: Not explicitly stated.
- Provenance: Functional porcine model, in vivo. Country of origin is not specified.
In Vitro Degradation Studies:
- Sample Size: Not explicitly stated (e.g., number of samples tested).
- Provenance: In vitro studies.
Bench Testing:
- Sample Size: Not explicitly stated (e.g., number of mesh samples tested).
- Provenance: Bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily animal model and bench tests, not human reader studies requiring expert consensus on image interpretation or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the studies (animal models, bench tests), an adjudication method as typically used in human reader studies (e.g., 2+1, 3+1) would not apply. Results would likely be based on objective measurements, histological analysis by a pathologist, and possibly statistical comparisons.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this document. This is a medical device (surgical mesh), not an AI diagnostic imaging tool.

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

This question is not applicable. The device is a surgical mesh, not a software algorithm.

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

The "ground truth" for the performance evaluations described includes:

Histology/Pathology: For biocompatibility, local tissue reaction, and tissue ingrowth in rabbit and porcine models.
Objective Physical/Mechanical Measurements: For properties like mesh thickness, density, pore diameter, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength from bench testing.
Chemical Analysis: For molecular weight in the porcine study and for in vitro degradation.
Comparison to Predicate: The ultimate "ground truth" for demonstrating substantial equivalence is showing that the device performs similarly to the legally marketed predicate device across relevant metrics.

8. The sample size for the training set

This question is not applicable. This is a physical medical device (surgical mesh), not a machine learning model that requires a training set.

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

This question is not applicable.

Summary

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August 19, 2021

Tepha, Inc. Connie Garrison SVP, Regulatory, Clinical and Quality Systems 99 Hayden Avenue, Suite 360 Lexington, MA 02421

Re: K202425

Trade/Device Name: SurgiLattice scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: July 15, 2021 Received: July 20, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Deborah Fellhauer Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202425

Device Name SurgiLattice™ scaffold

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

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of SurgiLattice scaffold.

SUBMITTED BY:

Company Name:	Tepha, Inc.
Address:	99 Hayden Avenue Suite 360Lexington, MA 02421
Telephone:Fax:	781-357-1777781-357-1701
CONTACT PERSON:		Connie Garrison
DATE PREPARED:		13 August 2021
TRADE NAME:		SurgiLattice™ scaffold
COMMON NAME:		Surgical mesh
CLASSIFICATION NAME/PANEL:		Mesh, surgical, polymericCFR §878.3300 / General and Plastic Surgery
PROCODE:		FTL
PREDICATE DEVICE		K140533
TRADE NAME:		GalaFLEX® scaffold
COMMON NAME:		Surgical mesh
CLASSIFICATION NAME/PANEL:		Absorbable Poly(hydroxybutyrate) Surgical MeshProduced by Recombinant DNA TechnologyCFR §878.3300 / General and Plastic Surgery
PROCODE:		OOD

DEVICE DESCRIPTION:

Pre-clinical implantation studies indicate that SurgiLattice scaffold retains approximately 88% of its strength at 12 weeks, with minimal residual strength remaining at 78 weeks based on in vitro degradation studies.

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INDICATIONS FOR USE/INTENDED USE:

SurqiLattice™ scaffold is indicated for use as a bioabsorbable 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. SurgiLattice scaffold is also indicated for the repair of hernia and other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

COMPARISON of TECHNOLOGICAL CHARACTERISTICS:

SurgiLattice scaffold has an indications statement that is the same as the predicate, with the exception of bridging repair which is not included for the subject device. The technological characteristics and principles of operation are the same. The minor technological difference related to the biomaterial composition does not raise new issues of safety or effectiveness. The data demonstrate that SurgiLattice scaffold is substantially equivalent to the predicate device.

Both the subject and predicate devices are absorbable surgical mesh devices that slowly hydrolyze resulting in a gradual loss of strength and mass for the bulk material. In the body, the hydrolytic degradation products of PBS, 1,4-butanediol and succinic acid, are further metabolized through 4-hydroxybutyric acid (4HB) and succinic acid and eliminated from the body primarily by metabolism via the Krebs Cycle. In a similar degradation pathway, the predicate device, composed of poly-4-hydroxybutyrate (P4HB), hydrolyzes to 4-hydroxybutryate (4HB), which is also further metabolized into succinic acid and likewise is eliminated from the body via the Krebs Cycle.

The physical and mechanical properties of the subject and predicate device are also comparable. Results from performance testing based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", dated March 2, 1999, demonstrate comparable mesh thickness, density, pore diameter, mesh knit characteristics, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength. Both products have the same macroporous, monofilament warp knit construction.

PERFORMANCE DATA:

The performance characteristics of SurgiLattice scaffold were established via comprehensive studies of physical and mechanical properties, biocompatibility testing per ISO 10993 including a Toxicological Risk Assessment based on extractables and leachables data per ISO 10993-18, shelf life testing, lifecycle evaluation in GLP rabbit studies per ISO 10993-6 including implantation of pre-degraded biomaterial representative of longer term in-vivo data, in vitro degradation studies, and functional performance in a large animal model study.

Bench testing of physical and mechanical characteristics, and shelf life studies using real-time and accelerated aging were performed with passing results. Biocompatibility testing of SurgiLattice scaffold 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

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and having a duration of contact of greater than 30 days (permanent). Results from the panel of testing, specifically cytotoxicity, irritation or intracutaneous reactivity, maximization, acute systemic toxicity, material-mediated pyrogenicity, (bacterial reverse mutation), genotoxicity (mouse lymphoma assay), hemolysis, subacute/subchronic/chronic local toxicity, subcutaneous implantation with histology (4. 12 and 26 weeks), subcutaneous implantation with histology using partially-degraded mesh(representing 116 weeks), coupled with a toxicological assessment conducted per ISO 10993-18, support the biocompatibility and safety of the subject device.

A study was conducted to evaluate dimensional, morphologic, and histological properties of SurgiLattice at 4, 8, 12 and 26 weeks following subcutaneous dorsal implantation in a rabbit model, as compared to GalaFLEX Scaffold. The initial strength, the strength retention profile, and the degradation profile of the SurgiLattice™ scaffold were comparable to the predicate. The results from this study support the in vivo comparability of SurgiLattice™ scaffold with the predicate, GalaFLEX scaffold.

A second study was conducted to evaluate the local tissue reaction using SurgiLattice scaffold which had undergone accelerated hydrolytic degradation followed by 26 weeks implantation which simulated a final tissue assessment timepoint of approximately 116 weeks. This study was designed to assess the host response upon essentially complete mechanical and molecular weight polymer degradation. Microscopically, SurgiLattice scaffold caused minimal or no reaction and was comparable to the predicate device.

SurgiLattice scaffold was further evaluated in a functional porcine model of hernia repair through assessment of repair site mechanics (burst strength and stiffness), morphologic properties (fiber diameter/surface roughness), molecular weight, and histology. The results support substantial equivalence of SurqiLattice scaffold to the predicate.

CONCLUSION:

Based on the indications for use, technological characteristics, and the summary of data submitted, Tepha, Inc. has determined that the proposed subject device, SurgiLattice scaffold is substantially equivalent to the currently marketed predicate device, GalaFLEX scaffold. Performance testing, including in vivo data and a comprehensive assessment of biocompatibility, demonstrated that the device functions as intended without raising new questions of safety or effectiveness.

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.