Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution.

Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.

AI/ML Overview

This document describes the FDA's decision regarding Innovacyn, Inc.'s Puracyn® Plus Antimicrobial Irrigation Solution (K232080).

Here's an analysis of the provided text with respect to your questions about acceptance criteria and study details:

The provided text is a 510(k) summary for a medical device that aims to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a particular device meeting acceptance criteria in the sense of a clinical performance study with human subjects, AI systems, or diagnostic accuracy metrics. Instead, it focuses on the device's characteristics and various types of performance testing related to its manufacturing, safety, and physical properties to show that it is as safe and effective as a previously cleared device.

Therefore, many of your questions, particularly those related to AI assistance, human readers, diagnostic performance, and ground truth in a clinical context, are not applicable to the information presented.

Here's what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a tabular format with corresponding reported device performance for clinical efficacy or diagnostic accuracy. Instead, it lists various performance tests conducted to support safety and effectiveness, implicitly asserting that the device met the requirements of these tests.

No direct "acceptance criteria" and "reported device performance" table is present for clinical/diagnostic efficacy.

However, the "Comparison of Technological Characteristics" table can be interpreted as a comparison against the predicate device, implying that the subject device's characteristics meet or are equivalent to the predicate's.

Characteristic	Subject Device (Puracyn® Plus Antimicrobial Irrigation Solution - K232080)	Primary Predicate (Puracyn Plus™ Skin and Wound Care - K133542)	Implied "Acceptance" / Equivalence
Composition	Purified water, Hypochlorous acid, phosphates	Purified water, Hypochlorous acid, phosphates	Equivalent chemical composition.
Description	Clear, colorless solution packaged in flexible plastic bags	Clear, colorless, non-sterile solution packaged in plastic PET bottles	Essentially equivalent in physical appearance and solution type, with differences in packaging material and sterility status noted and addressed by compliance with relevant standards.
Volume	1000 mL, 3000 mL	1000 ml to 55 ml	Volume differences are noted as not raising new questions of safety and effectiveness.
Indications For Use	Applied with irrigation to cleanse and remove debris from wounds.	Professional Use: 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.	The subject device's indications are narrower ("cleanse and remove debris from wounds") but fall within the scope of the predicate's broader indications, and are deemed substantially equivalent in effect for the specified use. The wording difference is noted as not raising new questions of safety and effectiveness.
Mechanism(s) of Action	Mechanical action of fluid moving across the wound aids in removal of foreign objects.	Mechanical action of fluid moving across the wound aids in removal of foreign objects such as dirt and debris.	Equivalent mechanism of action.
Antimicrobial Preservative	Preservative: Hypochlorous acid	Preservative: Hypochlorous acid	Equivalent preservative.
Microbial Control and Sterility	Meets USP <71> and USP <51>	Meets USP <51>	The subject device meets additional sterility requirements (USP <71>) compared to the predicate, which strengthens its safety profile, not posing new questions.
Biocompatibility	Meets ISO 10993-1 requirements	Meets ISO 10993-1 requirements	Equivalent biocompatibility standards.
Use	Multiple use within a single patient	Multiple use for multiple patients	"Multiple use within a single patient" for the subject device is a more restrictive use case than "multiple use for multiple patients" for the predicate. This difference is noted as not raising new questions of safety and effectiveness, implying it is equally safe or safer.

The performance testing section lists general tests to ensure safety and quality, not clinical efficacy:

Stability Studies per ICH Q1A(R2)
Biocompatibility studies in accordance with ISO10993-1
Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
Sterilization in accordance with ISO 11737-1 and 11737-2
Endotoxin Testing per USP<85>
Preservative Antimicrobial Effectiveness Testing per USP <51>
Sterility Testing per USP <71>
Bioburden Testing per USP <61> and USP<62>

For these tests, the implied acceptance criterion is "meets the standard" (e.g., "Meets USP <71>"). The document asserts that these studies were "performed to support the safety and effectiveness" and contribute to the conclusion of substantial equivalence.

2. Sample size used for the test set and the data provenance

Not applicable in the context of clinical performance or diagnostic accuracy. The performance tests listed are laboratory and materials tests. Sample sizes for these tests (e.g., number of units for stability, packaging, or sterility testing) are not detailed in this summary. Data provenance is not described as it relates to patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert-established ground truth for a test set (e.g., in imagery or diagnostic interpretation). The "ground truth" for the performance tests would be defined by the specifications of the standards themselves (e.g., a certain level of sterility, a certain shelf-life).

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

Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation of results.

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. The device is an antimicrobial irrigation solution, not an AI-assisted diagnostic tool.

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

Not applicable. The device is not an algorithm.

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

For the listed performance tests, the "ground truth" is defined by the industry and regulatory standards themselves (e.g., USP, ISO standards for sterility, biocompatibility, stability). For example, the "ground truth" for sterility is the absence of viable microorganisms as determined by USP <71>. For biocompatibility, it's compliance with ISO 10993-1.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device, so there is no "training set" or establishment of ground truth for it.

Summary

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May 31, 2024

Innovacyn, Inc. Hungnan Lo Vice President, Technical Operations 3546 N. Riverside Ave. Rialto, California 92377

Re: K232080

Trade/Device Name: Puracyn® Plus Antimicrobial Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: April 26, 2024 Received: April 29, 2024

Dear Hungnan Lo:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K232080

Device Name

Puracyn® Plus Antimicrobial Irrigation Solution

Indications for Use (Describe)

Puracyn® Plus Antimicrobial Irrigation is applied with irrigation to cleanse and remove debris from 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

Date Prepared:	4/26/2024
Applicant:	Innovacyn, Inc.3546 N. Riverside AvenueRialto, CA 92377
Contact Person:	Hungnan LoVice President, Technical Operations866-787-2296
Device Trade Name:	Puracyn® Plus Antimicrobial Irrigation Solution
Device Code:	FRO
Regulatory Class:	Unclassified

Predicate Device: K133542, Puracyn Plus Skin and Wound Care, Innovacyn, Inc.

Device Description:

Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.

Indications For Use:

Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.

Comparison of Technological Characteristics:

A comparison of technological characteristics between Puracyn® Plus Antimicrobial Irrigation Solution and the predicate device Puracyn Plus™ Skin and Wound Care (K133542) is provided in the following Table 1:

	SUBJECT DEVICE:Puracyn® Plus AntimicrobialIrrigation Solution(K232080)	PRIMARY PREDICATE:Puracyn Plus™ Skin and Wound Care(K133542)
Composition	Purified water, Hypochlorous acid,phosphates	Purified water, Hypochlorous acid,phosphates
Description	Clear, colorless solution packaged inflexible plastic bags	Clear, colorless, non-sterile solutionpackaged in plastic PET bottles
Volume	1000 mL, 3000 mL	1000 ml to 55 ml
Indications	Puracyn® Plus AntimicrobialIrrigation Solution is applied with

Table 1. Comparison of Puracyn Antimicrobial Irrigation Solution to Predicate Device

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	SUBJECT DEVICE:Puracyn® Plus AntimicrobialIrrigation Solution(K232080)	PRIMARY PREDICATE:Puracyn Plus™ Skin and Wound Care(K133542)
	irrigation to cleanse and removedebris from wounds.	Professional Use: Puracyn Plus™ Skin andWound Care is intended for use byhealthcare professionals for cleansing,irrigating, moistening, and debriding toremove wound debris from acute andchronic dermal lesions that are partial orfull thickness wounds such as Is' and 2nddegree burns, stage I - IV pressure ulcers,diabetic ulcers, stasis ulcers, abrasions andminor skin irritations, post-surgicalwounds, grafted and donor sites, inaddition to moistening and lubricatingabsorbent wound dressings.
Mechanism(s) ofAction	The mechanical action of fluidmoving across the wound providesfor the mechanism of action and aidsin the removal of foreign objects.	The mechanical action of fluid movingacross the wound provides for themechanism of action and aids in theremoval of foreign objects such asdirt and debris.
AntimicrobialPreservative	Preservative: Hypochlorous acid	Preservative: Hypochlorous acid
Microbial Controland Sterility	Meets USP <71> and USP <51>	Meets USP <51>
Biocompatibility	Meets ISO 10993-1 requirements	Meets ISO 10993-1 requirements
Use	Multiple use withina single patient	Multiple use formultiple patients

Discussion:

The Puracyn Plus Antimicrobial Irrigation Solution is substantially equivalent to the primary predicate, Puracyn Plus Skin and Wound Care (K133542), with respect to intended use and technological characteristics such as chemical composition, mechanism of action, preservative, and biocompatibility. While there are slight differences in packaging/volume, use, and wording for the indications for use, these do not raise new questions of safety and effectiveness when compared to the primary predicate device.

Performance Testing:

The following studies have been performed to support the safety and effectiveness of the subject device:

. Stability Studies per ICH Q1A(R2)
Biocompatibility studies in accordance with ISO10993-1
Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
Sterilization in accordance with ISO 11737-1 and 11737-2
Endotoxin Testing per USP<85>
Preservative Antimicrobial Effectiveness Testing per USP <51> ●

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Sterility Testing per USP <71> ●
Bioburden Testing per USP <61> and USP<62> .

Conclusion:

In summary, the Puracyn Plus Antimicrobial Irrigation Solution is substantially equivalent to the primary predicate in essential aspects critical to its clinical use. The noted differences in packaging/volume, use, and wording for the indications for use align with the subject device's specific application and operational requirements. These differences do not raise new questions of safety and effectiveness, thereby supporting its substantial equivalence to the primary predicate device.

Regulation Number and Section

N/A