Rx: Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening absorbent wound dressings.

Device Description

Clyra Wound Irrigation Solution is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Clyra Wound Irrigation Solution will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps. Clyra Wound Irrigation contains Potassium Iodide and Copper Sulphate, which release iodine when combined, resulting in a concentration within the product of 250 parts per million (ppm). The iodine acts as a preservative to inhibit contamination within the solution.

AI/ML Overview

This document is a 510(k) summary for Clyra Wound Irrigation Solution, a wound cleansing solution. It demonstrates substantial equivalence to a predicate device, Puracyn Plus Skin and Wound Care (K133452).

There is no acceptance criteria or study proving device performance in the context of an AI/ML device provided in this document. The document describes a traditional medical device (wound irrigation solution) and its equivalence to a predicate device. Therefore, many of the requested fields regarding AI/ML performance metrics are not applicable.

Here's a breakdown of the information that is available or can be inferred, and where the requested information is not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: For this type of device (a wound irrigation solution seeking 510(k) clearance), the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This involves showing similar indications for use, technological characteristics, and safety profiles. Specific quantitative or qualitative performance targets related to clinical effectiveness are not typically "acceptance criteria" for a 510(k) that relies on substantial equivalence for this device type, but rather evidence of biocompatibility and stability.
Reported Device Performance:
- Pre-Clinical Testing:
  - pH: Tested (results not detailed, but implied to be acceptable for equivalence).
  - Shelf Life: 2 years (unopened, ambient temperature).
  - Chemical Stability: Tested (results not detailed).
  - Antimicrobial Preservative Effectiveness: Conforming to USP <51> against P. aeruginosa, E. coli, S. aureus, C. albicans, and A. brasiliensis.
  - Biocompatibility (ISO 10993): Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Material mediated pyrogenicity, Chemical characterization and toxicological risk assessment for systemic toxicity. (All results implied to be acceptable for safety).
  - Porcine Wound Healing Study: Performed (results not detailed, likely for safety/efficacy comparison against predicate, or to support mechanism of action).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as this is not an AI/ML device study. Biocompatibility and stability studies typically use material samples or animal models, not human "test sets" in the context of AI/ML performance evaluation. The provided document does not specify sample sizes for the pre-clinical tests performed, beyond noting the tests were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device study. Ground truth in this context would refer to established scientific and regulatory standards for biocompatibility and chemical stability, interpreted by qualified laboratory personnel, not clinical experts establishing ground truth for diagnostic accuracy in an AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device study.

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 a wound irrigation solution, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a wound irrigation solution, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness determination is based on established scientific methods for chemical analysis, microbiology (USP <51>), biocompatibility (ISO 10993 standards), and shelf-life testing, as well as the demonstration of substantial equivalence to a legally marketed predicate device with a known safety and efficacy profile. "Expert consensus," "pathology," or "outcomes data" in the AI/ML sense are not the primary ground truth types here.

8. The sample size for the training set

Not applicable. This is not an AI/ML device study, so there is no training set in that context.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device study.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.

September 20, 2019

Clyra Medical Technologies Inc. % Tanya Rhodes President Rhodes & Associates, Inc 211 Poinciana Lane Largo, Florida 33770

Re: K181428

Trade/Device Name: Clyra Wound Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 15, 2019 Received: September 17, 2019

Dear Tanya Rhodes:

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

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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 mediation-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.

Cynthia Chang Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181428

Device Name Clyra™ Wound Irrigation Solution

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for "CLYRA Medical Technologies Inc." The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and containing a white plus sign, and the bottom half being a light green color with a leaf-like design. The company name is written in a modern, sans-serif font, with "CLYRA" in a larger, dark blue font and "Medical Technologies Inc" in a smaller, light green font.

Section 6 510(k) Summary

Clyra™ Wound Irrigation Solution

K181428

1. Submission Sponsor

Clyra Medical Technologies Inc.

14921 Chestnut St.

Westminster

California 92683

United States

Contact: Steven V. Harrison

Title: President

2. Submission Correspondent

Rhodes & Associates, Inc.

211 Poinciana Lane

Largo

FL 33770

Office Phone: 727-458-4291

Contact: Tanya Rhodes

Title: President

3. Date Prepared

9.20.2019

4. Device Identification

Trade/Proprietary Name:	Clyra™ Wound Irrigation Solution
Common/Usual Name:	Wound Cleanser
Classification Name:	Dressing, Wound, Drug

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Image /page/4/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half with a white plus sign and a green lower half with a leaf-like shape. To the right of the emblem is the word "CLYRA" in a stylized, sans-serif font, with the letters in a dark blue color. Below "CLYRA" is the text "Medical Technologies Inc" in a smaller, lighter green font.

Regulation Number:	Unclassified
Product Code:	FRO
Device Class:	Unclassified (Pre-Amendment)
Classification Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

K133452 - Puracyn Plus Skin and Wound Care - Innovacyn, Inc. Rialto, CA 92377

6. Indication for Use Statement

Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, irrigating, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the Clyra Wound Irrigation to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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Image /page/5/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half with a white plus sign and a green lower half with a leaf design. To the right of the emblem is the word "CLYRA" in a stylized, sans-serif font, with the words "Medical Technologies Inc" underneath in a smaller font.

Manufacturer	Clyra MedicalTechnologies Inc.	Innovacyn Inc.	Device Comparison
Trade Name	Clyra WoundIrrigationSolution	Puracyn Plus Skin andWound Care
510(k) Number	K181428	K133542	Not applicable
Product Code	FRO	FRO	Same
Regulation Number	Unclassified	Unclassified	Same
Regulation Name	Dressing, Wound, Drug	Dressing, Wound, Drug	Same
Prescription OnlyIndications for Use	Rx: Clyra WoundIrrigation Solution isintended for use byhealthcare professionalsfor cleansing,irrigating,moisteningand debriding to removewound debris fromacute and chronicdermal lesions that arepartial or full thicknesswounds such as 1st and2nd degree burns, stageI - IV pressure ulcers,diabetic ulcers, stasisulcers, abrasions andminor skin irritations,post surgical wounds,grafted and donor sites,in addition tomoistening andlubricating absorbentwound dressings.	Rx: Puracyn Plus™ Skinand Wound Care isintended for use byhealthcare professionalsfor cleansing,irrigating, moistening,and debriding to removewound debris fromacute and chronicdermal lesions that arepartial or full thicknesswounds such as 1st and2nd degree burns, stageI - IV pressure ulcers,diabetic ulcers, stasisulcers, abrasions andminor skin irritations,post-surgical wounds,grafted and donor sites,in addition tomoistening andlubricating absorbentwound dressings.	SameEach device is indicatedfor topical wound care/irrigation.The Intended UseStatement utilizes thesame indications aspreviously clearedunder predicatedevices.
Manufacturer	Clyra MedicalTechnologies Inc.	Inovacyn Inc	Device Comparison
Trade Name	Clyra WoundIrrigationSolution	Puracyn PlusSkin and WoundCare
Device Description	Clyra Wound IrrigationSolution is a clearhypotonic solutiontopically applied to skinand wound areas. Thesubject device is awound management andcleansing solution that isintended for cleansing,irrigating, and debridingdermal wounds inaddition to moisteningand lubricatingabsorbent wounddressings (e.g. gauze).The mechanical action offluid moving across thewound provides for themechanism of action andaids in the removal offoreign objects such asdirt and debris.Clyra Wound IrrigationSolution will be suppliedin food grade 4 oz.plastic PET bottles withspray inserts and caps.Clyra Wound IrrigationSolution containsPotassium lodide andCopper Sulphate, whichrelease iodine whencombined, resulting in aconcentration within theproduct of 250 parts permillion (ppm). The iodineacts as a preservative toinhibit contaminationwithin the solution.	Puracyn Plus Skin andWound Care is a clearhypotonic solutiontopically applied to skinand wound areas. Thesubject device is awound managementand cleansing solutionthat is intended forcleansing, irrigating, anddebriding dermalwounds in addition tomoistening andlubricating absorbentwound dressings (e.g.gauze). The mechanicalaction of fluid movingacross the woundprovides for themechanism of actionand aids in the removalof foreign objects suchas dirt and debris.Puracyn Plus Skin andWound Care will besupplied in food grade 4oz. plastic PET bottleswith spray inserts andcaps.	Same.Additional informationregarding Clyra WoundIrrigation Solutionpreservative system
Manufacturer	Clyra MedicalTechnologies Inc.	Innovacyn Inc	Device Comparison
Trade Name	Clyra Wound IrrigationSolution	Puracyn Plus Skinand Wound Care
Form	The device is supplied infood grade 4 oz plasticPET bottles with sprayinserts and caps. Thisproduct is preserved andprovided non sterile	The device is supplied infood grade 4 oz plasticPET bottles with sprayinserts and caps. Thisproduct is preserved andprovided non sterile.	Same
Ingredients	Copper Sulphate;Potassium Iodide;Sodium Chloride;Water	Hypochlorous Acid;Sodium Hypochlorite;Phosphate;Sodium Chloride;Water	No significant difference.Materials used in eachproduct are similar intheir properties toprovide a preservedwound irrigationsolution
Pre-Clinical Testing	Pre-Clinical Testingincluded pH, Shelf Life,Chemical Stability,AntimicrobialPreservativeEffectiveness,	Pre-Clinical Testingincluded pH, Shelf Life,Chemical Stability,AntimicrobialPreservativeEffectiveness	No significantdifference.
Complies withISO 10993-1	Yes	Yes	No significant difference
Complies withAntimicrobial TestUSP<51>	Non-sterilePreserved/Conformingto USP <51>	Non-sterilePreserved/Conformingto USP <51>	Same
Sterile	Non-sterile	Non-sterile	Same
Shelf-Life	Two (2) Years	Two (2) years	Same

Table 6A – Comparison of Characteristics

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Image /page/6/Picture/0 description: The image contains the logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half and a green lower half, with a white medical cross symbol in the center. To the right of the emblem, the word "CLYRA" is written in a stylized, sans-serif font, with the words "Medical Technologies Inc" written in a smaller font below it.

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Image /page/7/Picture/0 description: The image shows the logo for "CLYRA Medical Technologies Inc". The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and the bottom half being a light green color. A white plus sign is in the center of the emblem. The company name is written in a sans-serif font, with "CLYRA" in a dark blue color and "Medical Technologies Inc" in a light green color.

9. Non-Clinical Performance Data

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Image /page/8/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and containing a white plus sign, and the bottom half being a light green color with a leaf-like design. The company name is written in a simple, sans-serif font, with "CLYRA" in a larger font size than "Medical Technologies Inc".

As part of demonstrating safety and effectiveness of Clyra Wound Irrigation Solution and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Clyra Medical Technologies Inc. completed ISO 10993 biocompatibility testing to establish the safety of Clyra Wound Irrigation Solution for its intended use.

Cytotoxicity Assay (ISO 10993-5:2009): ●
Porcine Wound Healing Study
. Sensitization Test (ISO 10993-10:2010):
Irritation Test (ISO 10993-10:2010):
Material medicated pyrogenicity
Chemical characterization and toxicological risk assessment for systemic toxicity
Antimicrobial Effectiveness Test (AET) (USP<51>): Clyra Wound Irrigation Solution was evaluated for preservative activity in compliance with USP Antimicrobial Effectiveness Test <51> , designed to test efficacy of preservatives. Exposure to Clyra Wound Irrigation Solution caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus brasiliensis .
Shelf Life Testing A maximum shelf life of 2 years has been assigned to the Clyra Wound ● Irrigation Solution, when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.

10. Clinical Performance Data

N/A

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Image /page/9/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc." The logo features a green and blue circle with a white medical cross in the center. To the right of the circle is the company name, "CLYRA" in large, sans-serif font, with the words "Medical Technologies Inc" in a smaller font below.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device(s).

The Clyra Wound Irrigation Solution, as designed and manufactured, is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

N/A