(436 days)
The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.
The provided text describes information for a 510(k) submission for the Armis VeriCyn® Wound Wash. Based on the content, this is a medical device (a wound wash solution) and not an AI/ML device, therefore, many of the requested criteria (like ground truth, experts, MRMC studies, training set, etc.) are not applicable.
However, I can extract the relevant acceptance criteria and details of the non-clinical testing performed to establish substantial equivalence.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely based on demonstrating substantial equivalence to a predicate device (Next Science™ Irrigation Solution) through non-clinical testing, ensuring safety and effectiveness for its intended use. The "reported device performance" refers to the results of these non-clinical tests.
| Acceptance Criteria Category | Specific Test/Attribute | Predicate Device (K161165) | Subject Device (Armis VeriCyn® Wound Wash) Performance | Demonstrated Equivalence to Predicate? |
|---|---|---|---|---|
| Device Characteristics | Clarity | No visible particles | No visible particles | Yes |
| Color | Clear | Clear | Yes | |
| pH | Unknown | 3.0-3.8 | Yes. The document states: "The difference in pH do not raise any new questions of safety and effectiveness. During intended use of the product the pH of VeriCyn® increase to a higher, physiological, pH upon contact with the skin or wound; this is based on the low concentration of acetic acid." This indicates that despite a numerical difference (predicate pH unknown, but implied to be lower due to buffering system), the physiological effect is considered equivalent or safer. | |
| Viscosity | N/A (not explicitly stated for predicate in comparison) | Tested (met internal specifications) | Yes. Implied through "Device met internal specifications" and "substantially equivalent the prior non-clinical testing". | |
| Safety & Biocompatibility | Sterility | Sterile | Non-sterile | Yes. The document states: "The difference in sterility does not raise any new questions of safety and effectiveness VeriCyn® has been tested against USP <51>. equivalent to a non-sterile reference device." This indicates that while different, the safety standards have been met for a non-sterile product as intended. |
| Biocompatibility (ISO 10993) | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | Yes | |
| Cytotoxicity (ISO 10993-5) | N/A (not explicitly stated for predicate) | Pass | Yes (implies compliance with overall biocompatibility). | |
| Sensitization (ISO 10993-10) | N/A (not explicitly stated for predicate) | Pass | Yes (implies compliance with overall biocompatibility). | |
| Irritation (ISO 10993-10) | N/A (not explicitly stated for predicate) | Pass | Yes (implies compliance with overall biocompatibility). | |
| Acute Systemic Toxicity (ISO 10993-11) | N/A (not explicitly stated for predicate) | Pass | Yes (implies compliance with overall biocompatibility). | |
| Material Mediated Pyrogenicity (ISO 10993-11) | N/A (not explicitly stated for predicate) | Pass | Yes (implies compliance with overall biocompatibility). | |
| Microbiological | Preservative Effectiveness (USP <51>) | N/A (not explicitly stated for predicate; predicate is sterile) | Pass | Yes. This criterion supports the safety of the non-sterile product. The document states: "VeriCyn® uses a two-preservative system designed to provide preservative effectiveness for the shelf life of the product." |
| Bioburden (USP <61> and <62>) | N/A (not explicitly stated for predicate; predicate is sterile) | Pass | Yes. This criterion supports the safety of the non-sterile product. | |
| Functional | Mechanical removal of debris (Wound Wash Study) | Mechanical removal of debris (Implied as predicate function) | A wound-wash study was conducted, and results were "substantially equivalent the prior non-clinical testing". | Yes. This study directly supports the primary intended function of the device against the predicate. The document states: "Conclusion(s) drawn from the nonclinical tests demonstrate the device is as safe, as effective, and performs as well as the identified legally marketed predicate device (K161165 Next Science™ Irrigation Solution)." |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device (wound wash solution). The "test set" here refers to the samples of the wound wash solution and materials that underwent physical, chemical, and biological testing, not a dataset of patient images or clinical cases. The provenance of the data is from specific laboratory tests conducted on the device components and the final product, as detailed under "Non-Clinical Tests Performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No expert consensus "ground truth" as typically understood for AI/ML devices is relevant here. The standards for testing (e.g., ISO 10993, USP <51>, <61>, <62>) provide the "ground truth" of performance criteria, and the tests themselves are conducted by qualified laboratory personnel following these established protocols.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials involving human interpretation, often for AI/ML device validation. For this wound wash solution, performance is assessed against established physical, chemical, and biological standards through laboratory testing.
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/ML device; it is a physical wound wash solution. MRMC studies are used to evaluate diagnostic or screening AI/ML devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established international and national standards and test methodologies for medical device safety, biocompatibility, and functional performance. These include:
- ISO 10993 series: For biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity).
- USP <51>: For Preservative Effectiveness.
- USP <61> and <62>: For Bioburden.
- Internal specifications: For physical properties like Clarity, Color, pH, and Viscosity, which are then compared to the predicate or deemed safe.
- Functional wound-wash study: To demonstrate mechanical removal of debris.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not have a training set.
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May 25, 2023
Armis Biopharma, Inc. Angela Mallery Principle Product Development Specialist 2950 E. Harmony Road Ste. 252 Fort Collins, Colorado 80528
Re: K220759
Trade/Device Name: Armis VeriCyn Wound Wash Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH, FRO Dated: April 18, 2023 Received: April 18, 2023
Dear Angela Mallery:
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.
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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-reportingcombination-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.
Digitally signed by Tek N. I Tek N. Lamichhane -S Lamichhane -S Date: 2023.05.25 13:09:44 -04'00' For Julie A. Morabito, Ph.D. Assistant Director 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) K220759
Device Name VeriCyn® Wound Wash
Indications for Use (Describe)
The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
| 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 K220759
| Date Prepared | May 25, 2023 |
|---|---|
| Applicant | Armis Biopharma2950 E. Harmony Road Ste. 252Fort Collins, CO, 80528 |
| Contact Person | Franklin Okumu, Ph.D.Vice President of Product Development908-635-4172 |
| Device Trade Name | VeriCyn® Wound Wash |
| Device Classification | Class 221 CFR 880.5475FQH / FRO / General HospitalLavage, JetVeriCyn® Wound Wash |
| Predicate Device | K161165 Next Science™ Irrigation Solution |
| Reference Device | K151186 Stay Fresh Hydrocolloid DressingK160192 Atteris Antimicrobial Skin & Wound Cleanser Rochal Industries |
| Indications for Use | The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement atthe wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreignmaterial including micro-organisms and debris from wounds (such as stage I-IV pressure ulcers, diabeticfoot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites). |
| Device Description | The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds.The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, includingmicroorganisms from wounds though the use of a lavage system.ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA andPurified water.VeriCyn® Wound Wash has been tested for compliance with ISO 10993. |
| Comparison ofTechnologicalCharacteristics | Minor differences exist between VeriCyn® and Next Science™ Irrigation Solution, these differences donot raise different questions of safety and effectiveness when compared to the predicate device.Therefore, VeriCyn® is considered substantially equivalent to Next Science™ Irrigation Solution. |
|---|---|
| The difference in materials and composition do not raise any new questions of safety and effectiveness. The materials of construction of VeriCyn® are non-novel to wound wash products cleared by FDA. Each ingredient has a stated purpose, literature data to support its function, and testing demonstrated there are no new questions raised related to safety or effectiveness compared to the predicate. The difference in composition do not raise any new questions of safety and effectiveness. The composition of the materials of the lavage solution are similar between the subject device and the predicate device. VeriCyn® uses a two-preservative system designed to provide preservative effectiveness for the shelf life of the product. | |
| The difference in pH do not raise any new questions of safety and effectiveness. During intended use of the product the pH of VeriCyn® increase to a higher, physiological, pH upon contact with the skin or wound; this is based on the low concentration of acetic acid. The predicate contains a higher concentration of acetic acid and sodium acetate as a pH buffer system that is used to control changes in pH and would maintain lower pH upon contact with skin or wounds than the non-buffered VeriCyn® product. Therefore, no additional risks have been identified related to pH. | |
| The difference in sterility does not raise any new questions of safety and effectiveness VeriCyn® has been tested against USP<51>. equivalent to a non-sterile reference device. |
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| Equivalence Comparison | ||||
|---|---|---|---|---|
| Subject DeviceVeriCyn® Wound Wash(K220759) | Predicate DeviceNext Science™Irrigation Solution(K161165) | Reference DeviceStay Fresh Hydrocolloid Dressing(K151186) | Reference DeviceAtteris Antimicrobial Skin &Wound Cleanser RochalIndustries(K160192) | |
| Rx / OTC | Rx | Rx | Rx and OTC | Rx and OTC |
| Product Code | FQH / FRO | FQH / FRO | FRO | FRO |
| Intended Use | Wound lavage | Wound lavage | Wound dressing | Wound Dressing |
| Indications forUse | Prescription (Rx) use: The ArmisVeriCyn® Wound Wash is to be usedwith a lavage system to create mechanicalmovement at the wound surface bydelivery of a solution and is indicated foruse in cleansing and removal of foreignmaterial including micro-organisms anddebris from wounds (such as stage I-IVpressure ulcers, diabetic foot ulcers, postsurgical wounds, first degree and seconddegree partial thickness burns, graftedand donor sites). | To be used with a jetlavage system and isindicated for use incleansing and removalof debris, includingmicroorganisms, fromwounds. | For Over-the-Counter Use: TheStay Fresh Hydrocolloid dressingacts as a barrier to bacterialpenetration and is indicated for firstaid to cover minor cuts, minorabrasions, and minor lacerationsRx Use: Under the supervision of ahealthcare professional, the StayFresh Hydrocolloid dressing isintended for use as a primarydressing for exuding wounds thatacts as a barrier to bacterialpenetration, for use on first andsecond degree burns, surgicalwounds, pressure ulcers, dermalulcers, as well as minor cuts,abrasions, lacerations. | For Over-the-Counter Use: AtterisAntimicrobial Skin & WoundCleanser is intended for physicalcleaning and removal of dirt anddebris, from skin scrapes, cuts,lacerations, minor irritations, exitsites and unbroken skin.Rx Use: Atteris Antimicrobial Skin& Wound Cleanser is intended formechanical cleansing and removalof debris, dirt and foreign materials,including microorganisms fromwounds such as stage I-IV pressureulcers, diabetic foot ulcers, post-surgical wounds, first and seconddegree burns, grafted and donorsites. |
| Composition | Purified WaterAcetic AcidHydrogen PeroxideDisodium EDTA | Purified waterEthanolAcetic acidSodium acetateBenzalkonium chloride | Hydrogen PeroxideInert polymer matrixSuperabsorbent particlesPolyurethane film | Purified WaterPoloxamer 407Sodium ChlorideEDTAHypromelloseSensivasPolyaminopropylBiguanide |
| Color | Clear | Clear | N/A | Clear |
| Clarity | No visible particles | No visible particles | N/A | No visible particles |
| pH | 3.0-3.8 | unknown | N/A | unknown |
| Mechanism ofAction | Mechanical removal of debris | Mechanical removal of debris | Wound dressing | Mechanical removal of debris |
| Packaging | Single use package | Single use package | Pouch | Single use package |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO10993 | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 |
| How supplied | Non-sterile | Sterile | Sterile | Non-sterile |
| Single patientUse | Single patient Use | Single patient Use | Single patient Use | Single patient Use |
| Non-Clinical TestsPerformed | Non-Clinical testing was conducted, and results were substantially equivalent the prior non-clinical testingincluding visual and chemical tests, biocompatibility, and a wound-wash study. |
|---|---|
| Testing Clarity, Color, pH, and Viscosity were tested. Device met internal specifications Preservative Effectiveness USP <51> (pass)Bioburden USP <61> and <62> (pass)Cytotoxicity per ISO 10993-5 (pass)Sensitization per ISO 10993-10 (pass)Irritation ISO 10993-10 (pass)Acute Systemic Toxicity per ISO 10993-11 (pass)Material Mediated Pyrogenicity ISO 10993-11 (pass) | |
| Conclusion | Conclusion(s) drawn from the nonclinical tests demonstrate the device is as safe, as effective, and performsas well as the identified legally marketed predicate device (K161165 Next Science™ Irrigation Solution). |
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.