(79 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, diabetic ulcers, and surgical wounds.
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).
This is a 510(k) summary for AC5 Topical Gel, which is a wound dressing. The document describes the device, its intended use, and claims substantial equivalence to predicate devices (PuraDermTM Gel and DuoDERM® Hydroactive Gel).
The 510(k) summary does not contain the specific acceptance criteria or a detailed study report that proves the device meets specific acceptance criteria in a quantitative manner as would typically be presented for a device reliant on algorithmic performance. Instead, the performance evaluation for this topical gel focuses on biocompatibility and non-clinical performance (in vivo and bench-top studies).
Here's an analysis of the provided text based on your request, keeping in mind that the nature of this submission (a topical gel, not an AI/algorithm-driven device) means some of your requested points are not directly applicable or are interpreted differently.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/algorithmic device, there are no specific numerical acceptance criteria like sensitivity, specificity, or AUC. The "acceptance criteria" for this type of device revolve around safety and demonstrating comparable performance to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | AC5 passed all recommended biocompatibility tests from ISO-10993, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation, and subchronic/subacute toxicity. |
| Non-Irritating & Non-Sensitizing in Humans | In the Human Repeat Insult Patch Testing (HRIPT), AC5 was found to be non-irritating and non-sensitizing. |
| Wound Hydration Performance (Effectiveness - Comparative) | The performance of AC5 Topical Gel for hydration of wounds was found equivalent to that of DuoDERM Hydroactive Gel in a bench-top study. This is a key comparative effectiveness claim for this type of device. |
| Similar Indications for Use | AC5 Topical Gel's indications for use (management of partial and full-thickness wounds: pressure sores, leg ulcers, diabetic ulcers, surgical wounds) are substantially equivalent to the predicate devices. |
| Similar Safety Profile | Risks addressed through materials, processing controls, quality assurance, and compliance with GMP. |
2. Sample size used for the test set and the data provenance
- Biocompatibility tests: These tests are typically conducted on standardized laboratory models (in vitro and animal models). The document doesn't specify the exact "sample size" in terms of number of animals or repeat tests but mentions it was done "in full accordance with the Food and Drug Administration's Good Laboratory Practice regulations."
- Human Repeat Insult Patch Testing (HRIPT): This is a human clinical study. The sample size is not specified in this document, nor is the country of origin. HRIPTs are typically prospective studies.
- Porcine Excisional Wound Model: This is an animal study. The sample size (number of pigs, number of wounds) is not specified. This is a prospective animal study.
- Bench-top study (Wound Hydration): This is an in vitro study. The sample size (e.g., number of test samples, replicates) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of device. There is no "ground truth" established by experts in the context of image interpretation or diagnostic accuracy for this topical gel. The evaluations are based on direct biological and physical measurements and observations in laboratory, animal, and human patch tests.
4. Adjudication method for the test set
Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases like radiological image reading or clinical event classification, which don't apply to the performance studies of a topical gel.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no human "readers" or AI assistance studies were conducted. The comparative effectiveness stated is about the wound hydration performance of the gel itself versus a predicate gel, not about clinician performance with or without the device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a topical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in the context of this device's performance studies relies on:
- Standardized endpoints for biocompatibility: Measured biological reactions (e.g., cell viability for cytotoxicity, skin reaction for sensitization, pyrogen levels).
- Observed outcomes in animal models: Healing progression in the porcine excisional wound model.
- Direct physical/chemical measurements in bench-top studies: Measurement of hydration properties.
- Clinical observations in human patch tests: Skin reactions (irritation, sensitization) assessed by trained professionals.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no training set in that sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm.
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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 (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
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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, 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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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 lyophilizedpeptide | 1 vial, 45 mg ± 5 mg |
| Diluent Vial | Glass 6 mL vial containing Sterile Waterfor Injection 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 |
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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 foruse | Under the supervision ofa health care professional,AC5 Topical Gel is atopical dressing used forthe management ofpartial and full-thicknesswounds, such as pressuresores, leg ulcers, diabeticulcers, and surgicalwounds. | DuoDERM Hydroactive Gelis designed for the hydrationand management of partialand full thickness woundssuch as pressure sores, legulcers, and diabetic ulcers.DuoDERM Hydroactive Gelprovides a moist woundenvironment that is supportiveof the healing process byaiding autolytic debridementand allowing non-traumaticremoval of the secondarydressing without damagingnewly formed tissue. | OTC: PuraDerm is usedfor the management ofminor cuts, abrasions,minor wounds andminor burns (1st degreeburns).Rx: Under thesupervision of a healthcare professionalPuraDerm is used forthe management ofpartial and full-thicknesswounds, such aspressure sores, legulcers, diabetic ulcers,and surgical wounds. |
| Composition | AC5 Topical Gel is asterile gel composed of asynthetic peptide andsterile water for injection.It is provided in a vialcontaining lyophilizedpeptide, which must bereconstituted using sterilewater prior to use. AC5is completely non-animaland non-plant derived,and contains nopreservatives | DuoDERM Gel is a sterile gelcomposed of naturalhydrocolloids (pectin, sodiumcarboxymethyl-cellulose) in aclear, viscous vehicle. | A sterile gel composedof a synthetic peptideand sterile water forinjection. It is providedas a prefilled syringeready for use as awound dressing.PuraDerm is completelynon-animal and non-plant derived, andcontains nopreservatives. |
| Mechanism ofOperation | AC5 forms a moistwound environment thatis supportive of thehealing process andallows non-traumaticremoval of the secondarydressing withoutdamaging newly formedtissue. | DuoDERM Gel forms a moistwound environment that issupportive of the healingprocess by aiding autolyticdebridement and allowingnon-traumatic removal of thesecondary dressing withoutdamaging newly formedtissue. | PuraDerm forms amoist woundenvironment that issupportive of thehealing process andallows non-traumaticremoval of thesecondary dressingwithout damagingnewly formed tissue. |
| Labeling | Sterile, Single Use OnlyPrescription Use Only | Sterile, Single Use OnlyPrescription Use Only | Sterile, Single UseOnlyPrescription & OTCUse |
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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
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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.
N/A