(408 days)
Not Found
No
The summary describes a topical gel and its components, focusing on biocompatibility and performance studies related to material safety and biological evaluation. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is described as a "Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, and surgical wounds," which indicates its use for treating medical conditions.
No.
The device is a topical dressing used for the management of wounds, not for diagnosing conditions.
No
The device description clearly states it is a topical gel and includes physical components like vials, a syringe, and needles, indicating it is a physical medical device, not software-only.
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 wounds (pressure sores, leg ulcers, surgical wounds) by applying a topical dressing. This is a therapeutic application directly on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a topical gel applied to wounds. It's a physical dressing, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to aid in wound healing, which is a therapeutic intervention.
N/A
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, leg ulcers, and surgical wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
AC5 Topical Gel is configured as a package 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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, irritation (animal irritation with abraded skin and animal intracutaneous reactivity), acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation and subchronic/subacute toxicity. AC5 passed all tests conducted.
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.
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
N/A
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.
March 11, 2020
Arch Therapeutics, Inc. Terrence Norchi President, Chief Executive Officer 235 Walnut Street, suite 6 Framingham, Massachusetts 01702
Re: K190129 Trade/Device Name: AC5 Topical Gel Regulatory Class: Unclassified Product Code: FRO Dated: March 11, 2020 Received: March 11, 2020
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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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
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Indications for Use
510(k) Number (if known) K190129
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, leg ulcers, and surgical wounds.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
× | 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
This summary of 510(k) is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR 807.92.
| Date prepared: | February 27, 2020 | ||
|---|---|---|---|
| The assigned 510(k) number is: | K190129 | ||
| 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
11.1 Predicate/ Legally Marketed Devices
Information about the device to which substantial equivalence is claimed:
| Manufacturer: | Arch Therapeutics, Inc |
|---|---|
| Device Trade Name: | AC5TM Topical Gel |
| 510 (k): | K182681 |
11.2 Device Description
AC5 Topical Gel is configured as a package 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).
11.3 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 11.3-1.
| 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 |
Table 11.3-1. AC5 Topical Gel Components, Description and Quantity
11.4 Indications for Use/ 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.
Please note: Arch Therapeutics is seeking prescription use indications.
5
11.5 Comparison of Technological Characteristics
A comparison of the technological characteristics of AC5 Topical gel and the above selected predicate device given a addition in manufacturer of the peptide is provided in Table 11.5-1
Table 11.5-1. Comparison of Technological Characteristics AC5 Topical Gel and Predicate Device
| Device Name | AC5TM Topical Gel | AC5TM Topical Gel |
|---|---|---|
| Manufacturer | Arch Therapeutics, Inc. | Arch Therapeutics, Inc. |
| 510(k) | K190129 | K182681 |
| Product code | 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. | 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. | ||
| 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. | 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. | ||
| 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. | 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. | ||
| Labeling | Sterile, Single Use Only | |
| Prescription Use Only | Sterile, Single Use Only | |
| Prescription Use Only |
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11.6 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 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, irritation (animal irritation with abraded skin and animal intracutaneous reactivity), acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation and subchronic/subacute toxicity. AC5 passed all tests conducted.
11.7 Substantial Equivalence
Following the examination of all the above-mentioned information, we believe that AC5 Topical Gel is substantially equivalent to the selected predicate device in terms of design, materials, intended use, and there are not different questions of safety and effectiveness.