3DMatrix is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include:

Suture line reinforcement including for hernia repair
Muscle flap reinforcement
General tissue reconstructions

Device Description

3DMatrix Surgical Mesh (3DMatrix) is a single-use, fully absorbable, colorless, non-woven, 3Dprinted, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). 3DMatrix is provided in two sizes, 60 mm x 55 mm and 60 mm x 145 mm that can be cut to the desired shape and size for each specific application at the time of use. 3DMatrix is terminally sterilized by Ethylene Oxide validated to an SAL of 10- and intended to be used by prescription only in a healthcare facility or hospital.

3DMatrix is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, 3DMatrix acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. 3DMatrix provides temporary mechanical support and stabilization during the healing process.

AI/ML Overview

The provided text describes a 510(k) summary for the 3DMatrix Surgical Mesh but does not specify acceptance criteria or a detailed study proving the device meets those criteria with specific performance metrics against defined thresholds. Instead, it presents a comparison to predicate devices and states that performance characteristics were "substantially equivalent."

Here's an analysis based on the information provided, highlighting what's available and what's missing:

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

The document doesn't explicitly state quantitative acceptance criteria for the 3DMatrix Surgical Mesh in terms of specific thresholds for strength, adhesion, degradation rate, etc. It focuses on demonstrating "substantial equivalence" to predicate devices, meaning the performance is comparable rather than meeting pre-defined numerical targets.

However, it does list several performance characteristics that were tested and compared, suggesting these were the implicit criteria for equivalence. The table below represents what can be inferred from the "SUMMARY OF PERFORMANCE DATA" section, but without explicit acceptance criteria, specific reported performance values for 3DMatrix, or performance values for the predicate device, a complete table cannot be generated from the provided text.

Acceptance Criteria (Inferred from tests)	Reported Device Performance (Specificity NOT available in document)
Biocompatibility (compliance with ISO 10993-1)	Met (conducted in compliance with GLP and ISO 10993-1)
Performance in terms of:
- Ball burst strength/force (ASTM D6797-15)	Substantially equivalent to predicate device
- Suture pull-out strength (Internal Test Method)	Substantially equivalent to predicate device
- Tear strength (ASTM D2261-13)	Substantially equivalent to predicate device
- Tensile strength (ASTM D5035-11)	Substantially equivalent to predicate device
Packaging performance	Met
Sterilization effectiveness	Met (SAL of 10-6 validated)
Shelf-life stability	Met (6 weeks stated in comparison table, but shelf-life "testing" is mentioned without details on the criteria or outcome)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the performance tests (benchtop or animal studies).
Data Provenance: The document only mentions "benchtop and animal studies." It does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not applicable as the device is a surgical mesh and the studies conducted are focused on physical and biological performance, not on image interpretation or diagnostic accuracy that would require expert consensus for ground truth.

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

This information is not applicable for the type of device and studies described. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images).

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:

This information is not applicable as the device is a surgical mesh, not an AI software or an assistive technology for human readers.

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

This information is not applicable as the device is a surgical mesh, not an algorithm.

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

For the performance data, the "ground truth" would be established by the standardized test methods for material properties (e.g., ASTM standards) and validated biological testing protocols (e.g., ISO 10993-1). For the animal studies, histological examination or other biological assessments would constitute the ground truth for biocompatibility and tissue ingrowth. The document generally states "biocompatibility studies" and "animal studies" without specific ground truth details.

8. The sample size for the training set:

This information is not applicable as the device is a physical surgical mesh, not a machine learning model.

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

This information is not applicable for the same reason as above.

In summary, the provided text is a regulatory submission for a physical medical device (surgical mesh). It demonstrates equivalence to predicate devices through various benchtop and animal studies evaluating physical properties and biocompatibility. However, it lacks specific quantitative acceptance criteria and detailed performance metrics for the 3DMatrix beyond stating "substantial equivalence" to its predicates. The types of questions related to expert consensus, adjudication, and AI performance are not relevant to this specific device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

May 23, 2024

PrintBio, Inc. Janet Vargo Official Correspondnet 51-36 35th Street Long Island City, New York 11101

Re: K232602

Trade/Device Name: 3DMatrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF, OWT, OWZ, OXC Dated: April 22, 2024 Received: April 22, 2024

Dear Janet Vargo:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.05.23 12:29:01
12:29:01
12:29:01 12:29:04:00' Tek Lamichhane Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232602

Device Name 3DMatrix Surgical Mesh ("3DMatrix")

Indications for Use (Describe)

Suture line reinforcement including for hernia repair
Muscle flap reinforcement
General tissue reconstructions

Type of Use (Select one or both, as applicable)
Research Use (Part 21 CFR 361.2 Subject to Review) Over-The-Counter Use (21 CFR 361.2 Subject to Review)	Research Use (Part 21 CFR 361.2 Subject to Review)	Over-The-Counter Use (21 CFR 361.2 Subject to Review)
Research Use (Part 21 CFR 361.2 Subject to Review)	Over-The-Counter Use (21 CFR 361.2 Subject to Review)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY-K232602

SUBMITTER 1

PrintBio, Inc. 51-36 35th Street Long Island City NY 11101 Regulatory Contact: Janet Vargo, PhD

Phone: 908-420-2707 email: jvargo@printbio.com

2 DATE PREPARED May 23, 2024

3 DEVICE NAMES/CLASSIFICATION Commercial Name: 3DMatrix Common Name: Surgical Mesh Regulation: 21CRF 878.3300 Regulatory Class: II Product Codes: OXF, OWT, OWZ, OXC

4 PREDICATE DEVICES

Predicate Device Name: GORE® BIO-A® Tissue Reinforcement 510(k) Number: K163217

Reference Device: Polydioxanone Surgical Scaffold™ 510(k) Number: K181094

Reference Device: Gore-Tex Soft Tissue Patch and Dualmesh (510(k) Number: K963619

Reference Device: PDS Flexible Plate 510(k) Number: K092590

DEVICE DESCRIPTION ട്

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6 INDICATIONS FOR USE

Suture line reinforcement including for hernia repair
Muscle flap reinforcement
General tissue reconstructions

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE

The information provided in this premarket notification supports that the differences in mesh thickness, density, material (PDO vs. 67% polyglycolic acid [PGA] + 33% trimethylene carbonate [TMC]), sterilization method (ethylene oxide vs gamma radiation) between the subject and predicate mesh device raise no new issues of safety or effectiveness when used as intended. 3DMatrix does have similar density to the legally marketed reference device K963619; similar material, sterilization method, mesh thickness, and density as the legally marketed reference device K092590; and has similar material and sterilization method to legally marketed reference device K181094.

	Subject Device -3DMatrix	Predicate-Gore® Bio-A®TissueReinforcement	ReferenceDevicePolydioxanone SurgicalScaffold™	ReferenceDevice - Gore®GORE-TEX®SOFT TISSUEPATCH	ReferenceDevice - PDSFlexible Plate	Comparison
510(k) number	K232602	K163217	K181094	K963619	K092590	NA
Classification	Class II, SurgicalMesh	Class II,Surgical Mesh	Class II,SurgicalMesh	Class II, Surgical Mesh	Class II; ear,nose and throatsyntheticpolymermaterial	Equivalent topredicate andreferencedevicesK181094 andK963619
Indications forUse/IntendedUse	Indicated for:thereinforcementof soft tissuewhere weaknessexists in patientsundergoingplastic andreconstructivesurgery.Examples ofapplicationswhere3DMatrix maybe used include:-Suture linereinforcementincluding forhernia repair-Muscle flapreinforcement	Intended for:use in thereinforcement ofsoft tissue. Thisincludes use inpatientsrequiring softtissuereinforcement inplastic andreconstructivesurgery.Examples ofapplicationswhere GORE®BIO-A® TissueReinforcementmay be usedinclude:-Hernia repair assuture linereinforcement	Intended for:use inreinforcementof soft tissuewhereweaknessexists.	Intended for:Used for thereconstructionof hernias andfor thetemporarybridging offascial defectsand soft tissuedeficiencies	Indicated for:-Nasal soft-tissue andcartilagereconstruction	Equivalent topredicate
Subject Device -3DMatrix	Predicate-Gore® Bio-A®TissueReinforcement	ReferenceDevicePolydioxanone SurgicalScaffold™	ReferenceDevice - Gore®GORE-TEX®SOFT TISSUEPATCH	ReferenceDevice - PDSFlexible Plate	Comparison
	-General tissuereconstructions	-Muscle flapreinforcement-General tissuereconstructions
Material	Polydioxanone(PDO) filament	67%polyglycolicacid (PGA):33%trimethylenecarbonate(TMC)	Polydioxanone(PDO) thread	ePTFE	Polydioxanone	Equivalent toreferencedevicesK181094 andK092590
Use	Single Use	Single Use	Single Use	Single Use	Single Use	Equivalent topredicate andreferencedevicesK181094,K963619 andK092590
SterilizationMode & SAL	Ethylene Oxide,SAL 10-6	Gamma, SAL10-6	EthyleneOxide, SAL10-6	Steam, SAL 10-6	EthyleneOxide, SAL10-6	Equivalent toreferencedevicesK181094 andK092590
Biodegradable	Yes	Yes	Yes	No	Yes	Equivalent topredicate andreferencedevicesK181094 andK092590
PrimaryMechanism ofDegradation	Degradation viahydrolysis	Degradation viahydrolysis	Degradationvia bulkhydrolysis	None	Degradationvia hydrolysis	Equivalent topredicate andreferencedevicesK181094 andK092590
Biocompatible	Yes	Yes	Yes	Yes	Yes	Equivalent topredicate andreferencedevicesK181094,K963619 andK092590
Packaging	Double-layerTyvek andpolyethylenepouch, which isthen sealed in amedical-gradefoil pouch	Double-layerTyvek andpolyethylenepouch, which isthen sealed in amedical-gradefoil pouch	Not available	Double sterilebarrier HDPEtrays withTYVEK®packaging lids	Not available	Equivalent topredicate
Shelf Life	6 weeks	3 years	Not available	>3 years	Not available	Differencedoes not raisedifferentquestions ofsafety oreffectiveness
Bioabsorption	6-7 months	6-7 months	9 months	None	6 months	Equivalent topredicate andreference
	Subject Device -3DMatrix	Predicate-Gore® Bio-A®TissueReinforcement	ReferenceDevicePolydioxanone SurgicalScaffold™	ReferenceDevice - Gore®GORE-TEX®SOFT TISSUEPATCH	ReferenceDevice - PDSFlexible Plate	Comparison
Storage	RoomTemperature	RoomTemperature	RoomTemperature	RoomTemperature	Below 25°C	deviceK092590Equivalent topredicate andreferencedevicesK181094 andK963619
Shape	Rectangular	Rectangular,Square	Not available	Rectangular,Square	Rectangular	Equivalent topredicate andreferencedevicesK963619 andK092590
Size (LxW)	60 x 55 mm60 x 145 mm	70 x 100 mm80 x 80 mm90 x 150 mm100 x 300 mm200 x 200 mm200 x 300 mm	Not available	50 x 100 mm50 x 150 mm100 x 150 mm150 x 200 mm200 x 300 mm	40 x 50 mm	Differencedoes not raisedifferentquestions ofsafety oreffectiveness;within rangeof sizesacrosspredicate andreferencedevicesK963619 andK092590
Thickness	0.6 mm	1.57 ± 0.02 mm	Not available	1 or 2 mm	0.5 mm	Equivalent toreferencedeviceK092590
Density	392 g/m²	Not available	Not available	400 g/m²	625 g/m²	Equivalent toreferencedeviceK963610

Table 1. Predicate and Reference Device Comparison Table - Technological Characteristics

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SUMMARY OF PERFORMANCE DATA 8

The data submitted in this application included benchtop and animal studies on biocompatibility, performance, packaging, sterilization, and shelf-life testing. Key performance characteristics of ball burst strength/force (ASTM D6797-15, Standard Test Method for Bursting Strength of Fabrics Constant-Rate-of-Extension (CRE) Ball Burst Test), suture pull-out strength (Internal Test Method), tear strength (ASTM D2261-13, Standard Test Method for Tearing Strength of Fabrics by the Tongue (Single Rip) Procedure (Constant-Rate-of-Extension Tensile Testing Machine), and tensile strength (ASTM D5035-11, Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) were substantially equivalent to the predicate device. The resulting data demonstrate that 3DMatrix functions as intended and performs comparably to the predicate device currently marketed for the same intended use.

All biocompatibility studies were conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and in accordance with FDA Guidance for Use of International

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Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020).

CONCLUSIONS 9

Nonclinical testing results demonstrate that the device is as safe, as effective, and performs at least as well as the legally marketed predicate and reference devices identified in Section 4 of this summary.

The data support that the 3DMatrix device is substantially equivalent to the predicate device in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization.

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.