Who is the manufacturer of AC5 Topical Gel?

Arch Therapeutics, Inc. filed the 510(k) submission for AC5 Topical Gel (K182681).

What is the FDA product code for AC5 Topical Gel?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for AC5 Topical Gel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AC5 Topical Gel?

PuraDermTM Gel (K143058); DuoDERM® Hydroactive Gel (K973806).

Who can help prepare an FDA 510(k) submission like AC5 Topical Gel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AC5 Topical Gel

K182681 · Arch Therapeutics, Inc. · FRO · Dec 14, 2018 · SU

Device Facts

Record ID	K182681
Device Name	AC5 Topical Gel
Applicant	Arch Therapeutics, Inc.
Product Code	FRO · SU
Decision Date	Dec 14, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

AC5 Topical Gel is a synthetic, self-assembling peptide-based wound dressing; supplied as a kit containing lyophilized peptide, sterile water for injection, syringe, and applicators. Reconstituted peptide solution (pH 2.3 ± 0.7) applied topically to wounds by healthcare professionals in clinical settings. Forms a moist wound environment; supports healing; facilitates non-traumatic removal of secondary dressings without damaging newly formed tissue. Benefits patient by providing a biocompatible, non-animal, non-plant derived dressing for complex wound management.

Clinical Evidence

Bench testing and non-clinical performance data provided. Biocompatibility testing (ISO 10993) included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, implantation, and subchronic/subacute toxicity; all passed. Human Repeat Insult Patch Testing (HRIPT) confirmed non-irritating and non-sensitizing properties. In vivo performance evaluated in a porcine excisional wound model. Bench-top study demonstrated hydration performance equivalent to DuoDERM Hydroactive Gel.

Technological Characteristics

Synthetic self-assembling peptide; sterile; non-animal/non-plant derived; no preservatives. Reconstituted with Sterile Water for Injection, USP. Kit includes 3mL Luer-Lok syringe, 18G needles, and 70% isopropyl alcohol pads. Sterilized via gamma irradiation. Biocompatible per ISO 10993.

Indications for Use

Indicated for management of partial and full-thickness wounds, including pressure sores, leg ulcers, diabetic ulcers, and surgical wounds, in patients under the supervision of a health care professional.

Predicate Devices

PuraDermTM Gel (K143058)
DuoDERM® Hydroactive Gel (K973806)

Related Devices

K190129 — AC5 Topical Gel · Arch Therapeutics, Inc. · Mar 11, 2020
K143058 — PuraDerm Gel · 3-D Matrix, Inc. · Feb 13, 2015
K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix · Gel4med, Inc. · Oct 11, 2023
K072068 — BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS · Bioartificial Gel Technologies (Bagtech), Inc. · Dec 21, 2007
K193085 — PuraDERM Gel · 3-D Matrix, Inc. · May 11, 2020

Submission Summary (Full Text)

{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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ # 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) ## 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}------------------------------------------------ # 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: info@archtherapeutics.com Phone: (617) 431-2316 | | 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 | {5}------------------------------------------------ #### 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 | {6}------------------------------------------------ #### 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.