Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biological interaction of a surgical mesh, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.

Therapeutic

Yes
The device is a surgical mesh indicated for the reinforcement of soft tissue, acting as mechanical support and a scaffold for tissue ingrowth, which falls under the definition of a therapeutic device.

Diagnostic

No

The device description clearly states that 3DMatrix is a "medical device used for surgical repair or reinforcement of soft tissue" and acts as "mechanical support and provides a scaffold for tissue ingrowth." It is designed for therapeutic or reconstructive purposes, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical surgical mesh made of polydioxanone (PDO) and describes its physical properties and intended use as a mechanical support. It is a tangible, implantable hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery." This is a surgical application, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a "surgical mesh" that is "implanted" to provide "mechanical support to soft tissues and provides a scaffold for tissue ingrowth." This describes an implantable medical device used for structural support and tissue repair, not a diagnostic tool.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.

The device is clearly described as a surgical mesh used for tissue reinforcement during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

OXF, OWT, OWZ, OXC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D) in a healthcare facility or hospital.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K163217

Reference Device(s)

K181094, K963619, K092590

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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).

1

2

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

2

Indications for Use

510(k) Number (if known) K232602

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

Indications for Use (Describe)

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

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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3

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

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.

4

6 INDICATIONS FOR USE

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

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®
Tissue
Reinforcement | Reference
Device
Polydioxano
ne Surgical
Scaffold™ | Reference
Device - Gore®
GORE-TEX®
SOFT TISSUE
PATCH | Reference
Device - PDS
Flexible Plate | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K232602 | K163217 | K181094 | K963619 | K092590 | NA |
| Classification | Class II, Surgical
Mesh | Class II,
Surgical Mesh | Class II,
Surgical
Mesh | Class II, Surgical Mesh | Class II; ear,
nose and throat
synthetic
polymer
material | Equivalent to
predicate and
reference
devices
K181094 and
K963619 |
| Indications for
Use/Intended
Use | 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 | Intended for:
use in the
reinforcement of
soft tissue. This
includes use in
patients
requiring soft
tissue
reinforcement in
plastic and
reconstructive
surgery.
Examples of
applications
where GORE®
BIO-A® Tissue
Reinforcement
may be used
include:
-Hernia repair as
suture line
reinforcement | Intended for:
use in
reinforcement
of soft tissue
where
weakness
exists. | Intended for:
Used for the
reconstruction
of hernias and
for the
temporary
bridging of
fascial defects
and soft tissue
deficiencies | Indicated for:
-Nasal soft-
tissue and
cartilage
reconstruction | Equivalent to
predicate |
| Subject Device -
3DMatrix | Predicate-
Gore® Bio-A®
Tissue
Reinforcement | Reference
Device
Polydioxanone Surgical
Scaffold™ | Reference
Device - Gore®
GORE-TEX®
SOFT TISSUE
PATCH | Reference
Device - PDS
Flexible Plate | Comparison | |
| | -General tissue
reconstructions | -Muscle flap
reinforcement
-General tissue
reconstructions | | | | |
| Material | Polydioxanone
(PDO) filament | 67%
polyglycolic
acid (PGA):
33%
trimethylene
carbonate
(TMC) | Polydioxanone
(PDO) thread | ePTFE | Polydioxanone | Equivalent to
reference
devices
K181094 and
K092590 |
| Use | Single Use | Single Use | Single Use | Single Use | Single Use | Equivalent to
predicate and
reference
devices
K181094,
K963619 and
K092590 |
| Sterilization
Mode & SAL | Ethylene Oxide,
SAL 10-6 | Gamma, SAL
10-6 | Ethylene
Oxide, SAL
10-6 | Steam, SAL 10-6 | Ethylene
Oxide, SAL
10-6 | Equivalent to
reference
devices
K181094 and
K092590 |
| Biodegradable | Yes | Yes | Yes | No | Yes | Equivalent to
predicate and
reference
devices
K181094 and
K092590 |
| Primary
Mechanism of
Degradation | Degradation via
hydrolysis | Degradation via
hydrolysis | Degradation
via bulk
hydrolysis | None | Degradation
via hydrolysis | Equivalent to
predicate and
reference
devices
K181094 and
K092590 |
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Equivalent to
predicate and
reference
devices
K181094,
K963619 and
K092590 |
| Packaging | Double-layer
Tyvek and
polyethylene
pouch, which is
then sealed in a
medical-grade
foil pouch | Double-layer
Tyvek and
polyethylene
pouch, which is
then sealed in a
medical-grade
foil pouch | Not available | Double sterile
barrier HDPE
trays with
TYVEK®
packaging lids | Not available | Equivalent to
predicate |
| Shelf Life | 6 weeks | 3 years | Not available | >3 years | Not available | Difference
does not raise
different
questions of
safety or
effectiveness |
| Bioabsorption | 6-7 months | 6-7 months | 9 months | None | 6 months | Equivalent to
predicate and
reference |
| | Subject Device -
3DMatrix | Predicate-
Gore® Bio-A®
Tissue
Reinforcement | Reference
Device
Polydioxano
ne Surgical
Scaffold™ | Reference
Device - Gore®
GORE-TEX®
SOFT TISSUE
PATCH | Reference
Device - PDS
Flexible Plate | Comparison |
| Storage | Room
Temperature | Room
Temperature | Room
Temperature | Room
Temperature | Below 25°C | device
K092590
Equivalent to
predicate and
reference
devices
K181094 and
K963619 |
| Shape | Rectangular | Rectangular,
Square | Not available | Rectangular,
Square | Rectangular | Equivalent to
predicate and
reference
devices
K963619 and
K092590 |
| Size (LxW) | 60 x 55 mm
60 x 145 mm | 70 x 100 mm
80 x 80 mm
90 x 150 mm
100 x 300 mm
200 x 200 mm
200 x 300 mm | Not available | 50 x 100 mm
50 x 150 mm
100 x 150 mm
150 x 200 mm
200 x 300 mm | 40 x 50 mm | Difference
does not raise
different
questions of
safety or
effectiveness;
within range
of sizes
across
predicate and
reference
devices
K963619 and
K092590 |
| Thickness | 0.6 mm | 1.57 ± 0.02 mm | Not available | 1 or 2 mm | 0.5 mm | Equivalent to
reference
device
K092590 |
| Density | 392 g/m² | Not available | Not available | 400 g/m² | 625 g/m² | Equivalent to
reference
device
K963610 |

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

5

6

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

7

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.