(408 days)
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.
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).
The provided document is a 510(k) Pre-Market Notification from the FDA regarding the AC5 Topical Gel. It confirms the substantial equivalence of the device to a predicate device and provides information on its intended use, composition, and some performance testing related to biocompatibility.
However, the document does not contain information about the acceptance criteria or a specific study that proves the device meets those acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness studies as typically found in an AI/ML device submission. The performance section (11.6) discusses biocompatibility testing, which is a different type of performance evaluation.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and performance study data as these details are not present in the provided text.
Based on the provided text, I can extract information related to biocompatibility testing, but not the specific type of performance study you are asking for (e.g., an MRMC study or standalone algorithm performance).
Here's what can be inferred from the document regarding "performance" though it pertains to biocompatibility, not clinical efficacy or AI performance:
- Acceptance Criteria (for Biocompatibility): The implicit acceptance criterion for biocompatibility was that AC5 Topical Gel passed all tests conducted in accordance with the specified guidelines.
- Study Proving Acceptance Criteria (for Biocompatibility): The document states:
- Types of tests conducted: 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.
- Standards followed: 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."
- Regulatory compliance: Conducted in full accordance with the FDA's Good Laboratory Practice regulations (21 CFR Part 58).
Missing Information:
The document does not provide any of the following details critical to your request:
- A table of acceptance criteria and reported device performance (for clinical or AI performance).
- Sample size used for a test set (clinical or AI).
- Data provenance (country of origin, retrospective/prospective for clinical or AI data).
- Number of experts used to establish ground truth or their qualifications (for clinical or AI data).
- Adjudication method (for clinical or AI data).
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical or AI performance.
- The sample size for the training set (for AI).
- How the ground truth for the training set was established (for AI).
This document is a 510(k) clearance letter and summary for a topical gel, which is a traditional medical device, not an AI/ML-driven device. Therefore, the performance evaluation focuses on material safety (biocompatibility) and equivalence to a predicate device based on material composition and mechanism of action, rather than clinical efficacy metrics or AI algorithm performance.
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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
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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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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, MD235 Walnut Street, Suite 6Framingham, MA 01702email: info@archtherapeutics.comPhone: (617) 431-2316 | ||
| Product |
Product
| Trade name: | AC5™ Topical Gel |
|---|---|
| Common name: | Wound Dressing |
| Classification: | Unclassified |
| Product Code: | FRO |
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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 forInjection USP | 1 vial, 5 mL |
| Reconstitution andApplication 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.
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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 healthcare professional, AC5 TopicalGel is a topical dressing used forthe management of partial andfull-thickness wounds, such aspressure sores, leg ulcers, diabeticulcers, and surgical wounds. | Under the supervision of a healthcare professional, AC5 TopicalGel is a topical dressing used forthe management of partial andfull-thickness wounds, such aspressure sores, leg ulcers, diabeticulcers, and surgical wounds. |
| Composition | AC5 Topical Gel is a sterile gelcomposed of a synthetic peptideand sterile water for injection. It isprovided in a vial containinglyophilized peptide, which mustbe reconstituted using sterile waterprior to use. AC5 is completelynon-animal and non-plant derived,and contains no preservatives. | AC5 Topical Gel is a sterile gelcomposed of a synthetic peptideand sterile water for injection. It isprovided in a vial containinglyophilized peptide, which mustbe reconstituted using sterile waterprior to use. AC5 is completelynon-animal and non-plant derived,and contains no preservatives. |
| Mechanism ofOperation | AC5 forms a moist woundenvironment that is supportive ofthe healing process and allowsnon-traumatic removal of thesecondary dressing withoutdamaging newly formed tissue. | AC5 forms a moist woundenvironment that is supportive ofthe healing process and allowsnon-traumatic removal of thesecondary dressing withoutdamaging newly formed tissue. |
| Labeling | Sterile, Single Use OnlyPrescription Use Only | Sterile, Single Use OnlyPrescription 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.
N/A