AC5 Topical Gel

• K Number: K182681
• Device Name: AC5 Topical Gel
• Manufacturer: Arch Therapeutics, Inc.
• Date Cleared: 2018-12-14 ( 79 days)
• Product Code: FRO
• Regulation Number: N/A

Intended Use

Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.

Device Description

AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).

Predicate Devices

K143058, K973806

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biological effects of a topical gel, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is described as a "Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds," which are conditions that require therapeutic intervention.

Diagnostic

No

The device description and intended use indicate it is a wound dressing for managing partial and full-thickness wounds, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a kit containing physical components such as vials, a syringe, a needle, applicators, and alcohol pads, which are hardware. The device is a topical gel, not software.

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 "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 topical gel applied to wounds. This is consistent with a wound dressing or treatment, not a diagnostic device.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
• Performance Studies: The performance studies focus on wound healing models, irritation/sensitization, and hydration, which are relevant to a wound care product, not a diagnostic test.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to aid in the healing of wounds, which is a therapeutic intervention.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.

Product codes

FRO

Device Description

AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).

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

Under the supervision of a health care professional

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

Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. The recommended biocompatibility tests for this category of devices were identified from the Guidance for Industry and Food and Drug Administration Staff, issued on June 16, 2016 entitled Use of International Standard ISO-10993, Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process. The testing was conducted in full accordance with the Food and Drug Administration's Good Laboratory Practice regulations (21 CFR Part 58). Specifically, AC5 was evaluated for cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation and subchronic/subacute toxicity. AC5 passed all tests conducted.

Substantial equivalence evaluation was supported by non-clinical performance including in vivo performance testing in a porcine excisional wound model. In the Human Repeat Insult Patch Testing (HRIPT), AC5 was found to be non-irritating and nonsensitizing. The performance of AC5 Topical Gel for hydration of wounds was found equivalent to that of DuoDERM Hydroactive Gel in a bench-top study.

Key Metrics

Not Found

Predicate Device(s)

K143058, K973806

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

December 14, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Arch Therapeutics, Inc. Terrence Norchi President, Chief Executive Officer 235 Walnut Street. Suite 6 Framingham, Massachusetts 01702

Re: K182681

Trade/Device Name: AC5 Topical Gel Regulatory Class: Unclassified Product Code: FRO Dated: September 25, 2018 Received: September 26, 2018

Dear Terrence Norchi:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

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manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Lixin Liu

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K182681

Device Name AC5 Topical Gel

Indications for Use (Describe)

Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(k) is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.

	Date prepared: December 12, 2018
	The assigned 510(k) number is: K182681
Applicant	Arch Therapeutics, Inc.
Company Contact	Terrence Norchi, MD
235 Walnut Street, Suite 6
Framingham, MA 01702
email: [e-mail]
Phone: [phone]
Product

Product

Trade name:	AC5™ Topical Gel
Common name:	Wound Dressing
Classification:	Unclassified
Product Code:	FRO

4

Predicate/ Legally Marketed Devices 5.1

Information about the devices to which substantial equivalence is claimed:

Manufacturer:	3-D Matrix, Inc.
Device Trade Name:	PuraDermTM Gel
510 (k):	K143058
Manufacturer:	ConvaTec, Inc.
Device Trade Name:	DuoDERM® Hydroactive Gel
510 (k):	K973806

5.2 Device Description

AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).

5.3 Device Components

The vial containing AC5 peptide is sterilized by gamma irradiation. All components of AC5 Topical Gel are sterile and packaged into a kit in a controlled environment with IFU and Labels.

A list of the components, description and quantity is listed in Table 5.3-1.

Table 5.3-1. AC5 Topical Gel Components, Description and Quantity
-------------------------------------------------------------------	--	--	--

Component	Description	Quantity
Peptide Vial	Glass 3 mL vial containing lyophilized
peptide	1 vial, 45 mg ± 5 mg
Diluent Vial	Glass 6 mL vial containing Sterile Water
for Injection USP	1 vial, 5 mL
Reconstitution and
Application Syringe	Sterile 3 mL syringe with Luer-Lok™ tip	1 syringe
Needle	Sterile 18G X 1.5 inch	1 needle
Blunt applicator	Sterile 18G X 1.5 inch	2 blunt applicators
Alcohol Prep pad wipes	1" X 1 ¼" folded, saturated with 70%
isopropyl alcohol	2 pads

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Indications for Use/ Intended Use 5.4

Under the supervision of a health care professional, AC5 Topical Gel is a topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

Please note: Arch Therapeutics is seeking prescription use indications.

Comparison of Technological Characteristics ર્ રંડ

A comparison of technological characteristics of AC5 Topical gel and the above selected predicate devices is provided in Table 5.5-1.

	Table 5.5-1. Comparison of Technological Characteristics AC5 Topical Gel and Predicate Devices

Device Name	AC5TM Topical Gel	DuoDERM® Hydroactive Gel	PuraDerm™ Gel
Manufacturer	Arch Therapeutics, Inc.	ConvaTec, Inc.	3-D Matrix, Inc.
510(k)	K182681	K973806	K143058
Product code	FRO	FRO	FRO
Indication for
use	Under the supervision of
a health care professional,
AC5 Topical Gel is a
topical dressing used for
the management of
partial and full-thickness
wounds, such as pressure
sores, leg ulcers, diabetic
ulcers, and surgical
wounds.	DuoDERM Hydroactive Gel
is designed for the hydration
and management of partial
and full thickness wounds
such as pressure sores, leg
ulcers, and diabetic ulcers.
DuoDERM Hydroactive Gel
provides a moist wound
environment that is supportive
of the healing process by
aiding autolytic debridement
and allowing non-traumatic
removal of the secondary
dressing without damaging
newly formed tissue.	OTC: PuraDerm is used
for the management of
minor cuts, abrasions,
minor wounds and
minor burns (1st degree
burns).
Rx: Under the
supervision of a health
care professional
PuraDerm is used for
the management of
partial and full-
thickness
wounds, such as
pressure sores, leg
ulcers, diabetic ulcers,
and surgical wounds.
Composition	AC5 Topical Gel is a
sterile gel composed of a
synthetic peptide and
sterile water for injection.
It is provided in a vial
containing lyophilized
peptide, which must be
reconstituted using sterile
water prior to use. AC5
is completely non-animal
and non-plant derived,
and contains no
preservatives	DuoDERM Gel is a sterile gel
composed of natural
hydrocolloids (pectin, sodium
carboxymethyl-cellulose) in a
clear, viscous vehicle.	A sterile gel composed
of a synthetic peptide
and sterile water for
injection. It is provided
as a prefilled syringe
ready for use as a
wound dressing.
PuraDerm is completely
non-animal and non-
plant derived, and
contains no
preservatives.
Mechanism of
Operation	AC5 forms a moist
wound environment that
is supportive of the
healing process and
allows non-traumatic
removal of the secondary
dressing without
damaging newly formed
tissue.	DuoDERM Gel forms a moist
wound environment that is
supportive of the healing
process by aiding autolytic
debridement and allowing
non-traumatic removal of the
secondary dressing without
damaging newly formed
tissue.	PuraDerm forms a
moist wound
environment that is
supportive of the
healing process and
allows non-traumatic
removal of the
secondary dressing
without damaging
newly formed tissue.
Labeling	Sterile, Single Use Only
Prescription Use Only	Sterile, Single Use Only
Prescription Use Only	Sterile, Single Use
Only
Prescription & OTC
Use

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5.6 Performance

Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

The recommended biocompatibility tests for this category of devices were identified from the Guidance for Industry and Food and Drug Administration Staff, issued on June 16, 2016 entitled

7

Use of International Standard ISO-10993, Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process. The testing was conducted in full accordance with the Food and Drug Administration's Good Laboratory Practice regulations (21 CFR Part 58). Specifically, AC5 was evaluated for cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation and subchronic/subacute toxicity. AC5 passed all tests conducted.

Substantial equivalence evaluation was supported by non-clinical performance including in vivo performance testing in a porcine excisional wound model.

In the Human Repeat Insult Patch Testing (HRIPT), AC5 was found to be non-irritating and nonsensitizing.

The performance of AC5 Topical Gel for hydration of wounds was found equivalent to that of DuoDERM Hydroactive Gel in a bench-top study.

5.7 Substantial Equivalence

Following the examination of all the above-mentioned information, we believe that AC5 Topical Gel is substantially equivalent to the selected predicate devices in terms of design, materials, intended use, and there are not different questions of safety and effectiveness.