(436 days)
K161165 Next Science™ Irrigation Solution
No
The 510(k) summary describes a wound wash solution and its intended use with a lavage system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No
The device is a wound wash solution designed for cleansing and removal of foreign material from wounds, which is a supportive rather than a direct therapeutic function.
No
This device is a wound wash solution used for cleansing and removing foreign material from wounds. Its function is therapeutic/cleaning, not diagnostic.
No
The device description clearly states it is an "aqueous solution" and lists chemical components, indicating it is a physical substance, not software.
Based on the provided information, the Armis VeriCyn® Wound Wash is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for cleansing and removing foreign material from wounds through mechanical action with a lavage system. This is a direct application to the body surface for therapeutic or cleansing purposes, not for examining specimens taken from the body to provide information about a disease or condition.
- Device Description: The description details an aqueous solution for irrigation and debridement of wounds. This aligns with a topical or irrigation solution, not a reagent or instrument used for in vitro testing.
- 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 specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Armis VeriCyn® Wound Wash is used in vivo (on the body) for wound care.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
FQH, FRO
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical testing was conducted, and results were substantially equivalent the prior non-clinical testing including 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 (pass) Bioburden USP and (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(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).
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.
K161165 Next Science™ Irrigation Solution
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.
K151186 Stay Fresh Hydrocolloid Dressing, K160192 Atteris Antimicrobial Skin & Wound Cleanser Rochal Industries
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
§ 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.
0
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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 Biopharma |
| 2950 E. Harmony Road Ste. 252 | |
| Fort Collins, CO, 80528 | |
| Contact Person | Franklin Okumu, Ph.D. |
| Vice President of Product Development | |
| 908-635-4172 | |
| Device Trade Name | VeriCyn® Wound Wash |
| Device Classification | Class 2 |
| 21 CFR 880.5475 | |
| FQH / FRO / General Hospital | |
| Lavage, Jet | |
| VeriCyn® Wound Wash | |
| Predicate Device | K161165 Next Science™ Irrigation Solution |
| Reference Device | K151186 Stay Fresh Hydrocolloid Dressing |
| K160192 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 at |
| the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign | |
| material including micro-organisms 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). | |
| 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, 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. |
| Comparison of
Technological
Characteristics | Minor differences exist between VeriCyn® and Next Science™ Irrigation Solution, these differences do
not 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. equivalent to a non-sterile reference device. |
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| Equivalence Comparison | ||||
|---|---|---|---|---|
| Subject Device | ||||
| VeriCyn® Wound Wash | ||||
| (K220759) | Predicate Device | |||
| Next Science™ | ||||
| Irrigation Solution | ||||
| (K161165) | Reference Device | |||
| Stay Fresh Hydrocolloid Dressing | ||||
| (K151186) | Reference Device | |||
| Atteris Antimicrobial Skin & | ||||
| Wound Cleanser Rochal | ||||
| Industries | ||||
| (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 for | ||||
| Use | Prescription (Rx) use: 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 micro-organisms and | ||||
| debris from wounds (such as stage I-IV | ||||
| pressure ulcers, diabetic foot ulcers, post | ||||
| surgical wounds, first degree and second | ||||
| degree partial thickness burns, grafted | ||||
| and donor sites). | To be used with a jet | |||
| lavage system and is | ||||
| indicated for use in | ||||
| cleansing and removal | ||||
| of debris, including | ||||
| microorganisms, from | ||||
| wounds. | For Over-the-Counter Use: The | |||
| Stay Fresh Hydrocolloid dressing | ||||
| acts as a barrier to bacterial | ||||
| penetration and is indicated for first | ||||
| aid to cover minor cuts, minor | ||||
| abrasions, and minor lacerations | ||||
| Rx Use: Under the supervision of a | ||||
| healthcare professional, the Stay | ||||
| Fresh Hydrocolloid dressing is | ||||
| intended for use as a primary | ||||
| dressing for exuding wounds that | ||||
| acts as a barrier to bacterial | ||||
| penetration, for use on first and | ||||
| second degree burns, surgical | ||||
| wounds, pressure ulcers, dermal | ||||
| ulcers, as well as minor cuts, | ||||
| abrasions, lacerations. | For Over-the-Counter Use: Atteris | |||
| Antimicrobial Skin & Wound | ||||
| Cleanser is intended for physical | ||||
| cleaning and removal of dirt and | ||||
| debris, from skin scrapes, cuts, | ||||
| lacerations, minor irritations, exit | ||||
| sites and unbroken skin. | ||||
| Rx Use: Atteris Antimicrobial Skin | ||||
| & Wound Cleanser is intended for | ||||
| mechanical cleansing and removal | ||||
| of debris, dirt and foreign materials, | ||||
| including microorganisms from | ||||
| wounds such as stage I-IV pressure | ||||
| ulcers, diabetic foot ulcers, post- | ||||
| surgical wounds, first and second | ||||
| degree burns, grafted and donor | ||||
| sites. | ||||
| Composition | Purified Water | |||
| Acetic Acid | ||||
| Hydrogen Peroxide | ||||
| Disodium EDTA | Purified water | |||
| Ethanol | ||||
| Acetic acid | ||||
| Sodium acetate | ||||
| Benzalkonium chloride | Hydrogen Peroxide | |||
| Inert polymer matrix | ||||
| Superabsorbent particles | ||||
| Polyurethane film | Purified Water | |||
| Poloxamer 407 | ||||
| Sodium Chloride | ||||
| EDTA | ||||
| Hypromellose | ||||
| Sensivas | ||||
| Polyaminopropyl | ||||
| Biguanide | ||||
| 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 of | ||||
| Action | 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 ISO | ||
| 10993 | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | ||
| How supplied | Non-sterile | Sterile | Sterile | Non-sterile |
| Single patient | ||||
| Use | Single patient Use | Single patient Use | Single patient Use | Single patient Use |
| Non-Clinical Tests
Performed | Non-Clinical testing was conducted, and results were substantially equivalent the prior non-clinical testing
including 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 (pass)
Bioburden USP and (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 performs
as well as the identified legally marketed predicate device (K161165 Next Science™ Irrigation Solution). |