Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and physical structure of a hydrogel for wound management. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.

Therapeutic

Yes
The device is indicated for the "hydration and management of partial and full thickness wounds," which is a therapeutic purpose.

Diagnostic

No

The device, PuraDerm Gel, is indicated for the hydration and management of wounds, not for diagnosing them. It is a treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical hydrogel material provided in a prefilled syringe, along with an applicator nozzle. This indicates a hardware component and not a software-only 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 "hydration and management of partial and full thickness wounds." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a hydrogel material applied directly to wounds. This is consistent with a topical wound treatment, not a diagnostic device.
Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
Anatomical Site: The anatomical site is "Partial and full thickness wounds," which are external wounds, not internal bodily fluids or tissues typically used for IVD testing.

IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. PuraDerm Gel's function is to directly interact with and manage wounds, which falls outside the scope of IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

Product codes (comma separated list FDA assigned to the subject device)

FRO

Device Description

PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.

The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.

PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").

The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip. This same delivery system was previously cleared by FDA in K143058, and there have been no changes to the delivery system for PuraDerm Gel since K143058.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic.

New performance testing was not necessary to support the additional indications or the updates to the IFU.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K143058, K991202

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

May 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

3-D Matrix, Inc. % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Driveway Chevy Chase, Maryland 20815

Re: K193085

Trade/Device Name: PuraDERM Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2020 Received: April 9, 2020

Dear Stephen Rhodes:

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 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 803) for

1

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 medical devices and radiation-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,

Anjana Jain, Ph.D. For 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

2

Indications for Use

510(k) Number (if known) K193085

Device Name PuraDerm Gel

Indications for Use (Describe)

PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.

SUBMITTER 1.

3-D Matrix, Inc. 250 First Ave., Suite 205 Needham, MA 02494

Contact Person: Lisa Spirio, PhD Phone: 617-875-6204 Email: lisa@puramatrix.com

Prepared By: Stephen P. Rhodes, Streamline Regulatory, stephen.rhodes@streamlineregulatory.com Date Prepared: May 7, 2020

2. SUBJECT DEVICE

Name of Device: PuraDerm Gel Common Name: Wound Dressing Classification Regulation/Class: Unclassified Product Code: FRO Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Devices: PuraDerm Gel (K143058) and Woun'Dres (K991202)

DEVICE DESCRIPTION 4.

Description

PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.

The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.

PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore

4

sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").

The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip. This same delivery system was previously cleared by FDA in K143058, and there have been no changes to the delivery system for PuraDerm Gel since K143058.

5. INDICATION FOR USE

PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

SUBSTANTIAL EQUIVALENCE DISCUSSION 6.

As shown in the table below, the technical characteristics of the PuraDerm Gel are identical to the predicate (K143058). Additionally, the Woun'Dres predicate (K991202) is provided for comparison of the indications for use.

	Proposed Device	Predicate Device	Predicate Device
510(k) Number	K193085	K143058	K991202
Applicant	3-D Matrix	3-D Matrix	Coloplast Corp
Trade name	PuraDerm Gel	PuraDerm Gel	Woun'Dres Collagen Hydrogel
Classification
Regulation	Unclassified	Unclassified	Unclassified
Product Code	FRO	FRO	MGQ
Indications for
Use	PuraDerm Gel is indicated
for the hydration and
management of partial and
full thickness wounds, such
as pressure sores, leg
ulcers, diabetic ulcers,
surgical wounds, and
abrasions and burns
associated with
dermabrasion and laser
resurfacing.	PuraDerm Gel is used
for the management of
partial and full
thickness wounds,
such as pressure sores,
leg ulcers, diabetic
ulcers, and surgical
wounds.	May be used for superficial
wounds and abrasions and minor
burns. Use under the supervision of
health care professions for the
local management of partial- and
full-thickness wounds including
pressure, and diabetic ulcers; lower
extremity ulcers including those of
venous, arterial and mixed
etiology; surgical wounds; first-
and second-degree burns including
management of abrasions and
burns associated with
dermabrasion and laser
resurfacing.

Table 1: Device Comparison Table

5

	Proposed Device	Predicate Device	Predicate Device
Contraindications	Do not use on patients with
a known sensitivity to the
gel or any of its
components.

Do not use on third degree
burns. | Do not use on patients
with a known
sensitivity to the gel or
any of its components.

The indications for use for PuraDerm Gel has the following modifications from the predicate K143058):

"Used" has been replaced with "indicated" to more accurately reflect the indications.
. "Management" has been replaced with "hydration and management" to more completely describe the intended use of the hydrogel.
. "Abrasions and burns associated with dermabrasion and laser resurfacing" has been added to the indications for use. These additional indications were included in the predicate K991202 Coloplast Corporation's Woun'Dres Collagen Hydrogel, which was one of the predicate devices for the original PuraDerm Gel predicate (K143058).

The first two modifications to the predicate indications for use improve the accuracy of the indications and do not affect the intended use of the device. The additional indications of dermabrasion and laser resurfacing do not raise different questions of safety and effectiveness. In fact, the Woun'Dres predicate (K991202) for PuraDerm Gel (K143058) included these identical indications. Therefore, the modifications to the indications for use do not affect the intended use of the device, which is to hydrate and manage wounds.

Additionally, the technological characteristics of the new and predicate device are identical. There have been no design modifications to PuraDerm Gel since it was cleared in K143058.

6

7. PERFORMANCE DATA

Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic.

New performance testing was not necessary to support the additional indications or the updates to the IFU.

CONCLUSIONS 8.

In conclusion, PuraDerm Gel is substantially equivalent to the predicate devices (K143058 and K991202).