Vashe® Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Device Description

Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution. The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vashe® Wound Therapy Solution, based on the provided 510(k) summary:

The document does not detail a clinical study with human subjects, but rather focuses on non-clinical equivalency testing related to product specifications and stability. This is a common approach for 510(k) submissions where a device is substantially equivalent to a predicate device and the changes made do not significantly alter its fundamental scientific technology or intended use.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified device (Vashe® Wound Therapy Solution manufactured centrally) are primarily based on the chemical specifications of the solution, which were slightly expanded compared to the predicate device.

Acceptance Criteria (Modified Device)	Reported Device Performance
Available Free Chlorine (AFC)	150 to 330 ppm
pH	3.5 to 6.75 pH

Note: The document states "Lower specification expanded pH at 3.5 to 6.75ppm", which appears to be a typo and should likely read "pH at 3.5 to 6.75". The predicate device had a pH specification of "5.3 to 6.75ppm".

Study Details

The provided 510(k) summary indicates non-clinical equivalency testing was conducted.

Sample size used for the test set and the data provenance: Not specified in terms of number of samples, but the testing was for Shelf Life and Chemical Stability of the modified product. The data provenance is internal to PuriCore Inc. as the manufacturing process was moved from on-site generation to central manufacturing at PuriCore in Malvern, PA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For chemical stability testing, the "ground truth" is established by standard analytical chemistry methods and adherence to the defined chemical specifications.
Adjudication method for the test set: Not applicable. This was chemical and stability testing against predefined specifications.
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 therapy solution, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical solution, not an algorithm.
The type of ground truth used: For the non-clinical testing, the ground truth was chemical specifications and stability over time, assessed through analytical methods.
The sample size for the training set: Not applicable. This is a non-clinical submission for a chemical product, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Justification

The core of the submission for Vashe® Wound Therapy Solution relies on demonstrating substantial equivalence to its predicate device (Vashe® Wound Therapy System, K100918) through non-clinical testing. The key changes are:

Place of Production: Moving from on-site generation at the customer's location to central manufacturing at PuriCore Inc.
Expanded Specifications: The acceptable range for Available Free Chlorine (AFC) and pH was slightly expanded.
Shelf Life and Stability: Non-clinical testing was performed to ensure that the modified device, with its expanded specifications and centralized production, maintains chemical stability and preservative effectiveness (due to hypochlorous acid) throughout its shelf life, including under worst-case scenarios for initial and final concentrations and pH.

The conclusion drawn by PuriCore Inc. (and accepted by the FDA for 510(k) clearance) is that these modifications have not changed the Intended Use or altered the Fundamental Scientific Technology of the device, thereby demonstrating substantial equivalence.

Summary

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510(k) SUMMARY |

SECTION 2	510(k) SUMMARY
510(k) Summary	This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter	PuriCore Inc.508 Lapp RoadMalvern, PA 19355
Contact Person	Art MorseDirector of Quality Assurance and Regulatory AffairsPuriCore Inc.508 Lapp RoadMalvern, PA 19355484 321 2728 (O), 484 321 2704 (F), 610 306 2870 (C)
Date Prepared	September 28th, 2012
Trade Name	Vashe® Wound Therapy Solution
Common Name	Wound Cleanser
Classification Name	Solution, Saline, (Wound Dressing)
Predicate Devices	Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution); PuriCore Inc. K100918, August 9th, 2010
Modified Device Description	Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution.The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.
Intended Use	Vashe® Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.These indications are identical to the predicate device Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918.
Summary of Technological Characteristics Compared to the Predicate Device	Vashe® Wound Therapy Solution similar to Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918, includes among its labeled uses the cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.The predicate device Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918, produces Vashe® Wound Therapy Solution for intended use at the customer's location. The modified device, Vashe® Wound Therapy Solution, is produced by the Vashe® Production System in a validated manufacturing process at PuriCore Inc. Malvern, PA, bottled and distributed in bottles to customers. All other indications are identical. These differences are not critical because the intended use and the fundamental scientific technology are the same.
	PREDICATE DEVICES	MODIFIED DEVICE
	K100918
	Vashe® Wound® Therapy System andSolution	Vashe® Wound® Therapy Solution
	Aqueous solution and electrochemicalgenerator:	Aqueous solution:
DesignMaterial	Vashe® Wound® Therapy Solution(Produced from on-site Vashe® Wound®Therapy System) to the following productspecifications:	Vashe® Wound® Therapy Solution(Produced from central manufacturing,packaging, and distribution from PuriCore inMalvern, PA) to the following productspecifications:
	● Available Free Chlorine (AFC) at 150 to250 ppm● pH at 5.3 to 6.75ppm	● Upper specification expanded AvailableFree Chlorine (AFC) at 150 to 330 ppm● Lower specification expanded pH at 3.5to 6.75ppm
ChemicalComposition	Approximate percentages:Water 99.574%Sodium Chloride (0.4%)Hypochlorous Acid (0.025%)Sodium Chlorate (0.001%)	Approximate percentages:Water 99.574%Sodium Chloride (0.4%)Hypochlorous Acid (0.025%)Sodium Chlorate (0.001%)
	Wound Therapy Solution with HypochlorousAcid as solution preservative	Wound Therapy Solution with HypochlorousAcid as solution preservative
Energy Source	No Energy RequirementsAqueous Solution	No Energy RequirementsAqueous Solution
SubstantialEquivalence -Effectiveness	The Modified Device utilizes the same fundamental scientific technology as the predicatedevices. The only difference is the specification changes and place of production: at theCustomer's Location (K100918) verses PuriCore in Malvern, PA (modified device).Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for ChemicalStability (See Section 6).
SubstantialEquivalence -Safety	Preservative effectiveness of hypochlorous acid at below minimal recommendedconcentration of hypochlorous acid
	Biocompatibility studies were conducted under verse case scenario, doubled initialconcentration of available free chlorine relative to the beginning of shelf life, and reducedbelow minimal pH and doubled final concentration of available free chlorine relative to theend of shelf life (See Section 7)
Test &Conclusion	Modifications to Vashe® Wound® Therapy Solution has not changed the Intended Use or hasnot altered the Fundamental Scientific Technology of the predicate device; Vashe® Wound®Therapy System (with Vashe® Wound® Therapy® Solution) K100918.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Puricore, Incorporated % Mr. Art Morse Director of Quality Assurance and Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355

February 14, 2013

Re: K123072

Trade/Device Name: Vashe® Wound Therapy Solution Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2013 Received: January 31, 2013

Dear Mr. Morse:

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. 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 truthfull 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. .

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Page 2 - Mr. Art Morse

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter Di Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K123072

Indications for Use Statement

510(k) Number:

Device Name: Vashe Wound Therapy Solution

Indications for Use:

Vashe Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Vashe Wound Therapy Solution is intended for use by a qualified healthcare personnel trained in its use.

Prescription Use XX

Over-The-Counter Use: (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDHR, Office of Device Evaluation (ODE)

Jiyoung Dang

(Division Sign-Off) Division of Surgical Devices 510(k) Number K123072

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Regulation Number and Section

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