Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, 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, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Device Description

Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a moist environment and loosens contaminated exudate, slough and other foreign materials within the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe Wound Solution, better allows for the natural healing process to take place. This device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:

Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.

Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.

AI/ML Overview

The provided 510(k) summary for Vashe® Wound Solution (K131848) does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or quantifiable outcomes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, safety, and effectiveness, primarily through non-clinical testing.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the format requested, as the submission relies on demonstrating substantial equivalence, not on meeting specific, quantifiable performance targets for the device's intended use in treatment. The "performance" is primarily shown through a comparison to existing, legally marketed predicate devices and through non-clinical safety/stability testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Effectiveness: Same fundamental scientific technology as predicate devices.	Vashe® Wound Solution utilizes the same fundamental scientific technology as the predicate device (K123072).
Effectiveness: Mechanism of cleaning is the same as predicates.	The mechanism of cleaning is the same as the predicates; the mechanism of fluid moving across the wound aids in the physical removal of foreign objects, foreign debris and exudate from a wound.
Effectiveness: Same intended use statement as predicates.	The Intended Use Statement utilizes the same indications as previously cleared under these predicate devices.
Effectiveness: Closure system is substantially equivalent to predicates.	The closure system for this product is substantially equivalent to the predicates as it is packaged in a bottle and a Polypropylene cap (with a laminated induction seal or septum seal).
Safety: Biocompatibility equivalent to predicate products (worst-case scenario).	Biocompatibility studies proved that the product is equivalent to the predicate products as it was determined safe under the worst case scenario of the highest specified concentration of available free chlorine and the lowest specified pH.
Safety: Additional in-vitro biocompatibility on specific cell types.	Additional in-vitro biocompatibility studies were conducted on keratinocytes and fibroblasts at the upper specification for available free chlorine concentration and at the lowest pH specification.
Stability/Shelf Life: Chemical stability over time.	Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for Chemical Stability (See Section 6).
Microbial Contamination (Preservative Effectiveness): Meets USP standards.	Preservative Effectiveness testing to USP <51> was conducted.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implicit acceptance criteria is a compilation of non-clinical equivalency testing aimed at demonstrating substantial equivalence to predicate devices. This includes:

Comparison of Technical Characteristics: A qualitative comparison highlighting similarities in chemical composition, mechanical action, intended use, and packaging/closure systems to K123072, K113820, K083355, and K111313.
Biocompatibility Studies: In-vivo and in-vitro biocompatibility testing per ISO-10993-1 standards. These were conducted to prove the product is safe, particularly under worst-case scenarios for active ingredient concentration and pH.
Shelf Life and Chemical Stability Testing: Non-clinical tests to evaluate the product's stability over its intended shelf life.
Preservative Effectiveness Testing: To USP <51> standards, demonstrating the solution's ability to inhibit microbial contamination within the product.

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

Test Set Sample Size: Not explicitly stated as a "test set" for a clinical performance evaluation. The non-clinical studies (biocompatibility, stability, preservative effectiveness) would have their own sample sizes for the materials tested, but these are not detailed in the summary. For example, for biocompatibility, it would involve a certain number of test replicates or animal subjects, but these specifics are missing.
Data Provenance: Not specified for the non-clinical tests. It's implied these were conducted internally or by contract labs in support of the submission. The origin (e.g., country) is not mentioned. They would be considered prospective for the purpose of demonstrating equivalence for this submission.

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

Not applicable. This device is a solution, and the testing outlined is primarily chemical, physical, and biological in nature (biocompatibility, stability). There is no "ground truth" derived from expert consensus on images or clinical outcomes in the summary provided.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as there isn't a "test set" requiring such a method for this type of device.

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 device is a wound care solution, not an AI-powered diagnostic or imaging tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical solution, not an algorithm or AI.

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

Not applicable in the clinical sense. For the non-clinical tests:

Biocompatibility: Ground truth is established by recognized international standards (ISO-10993-1) for evaluating biological response to medical devices.
Chemical Stability: Ground truth is against established chemical specifications and analytical methods.
Preservative Effectiveness: Ground truth is against microbial reduction targets defined by compendial standards (USP <51>).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set mentioned for this device.

Summary

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510 (k)

Vasne® Wound Solution

MAR 3 | 2014

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 therequirements of 21 CFR 807.92.
Submitter	PuriCore Inc., 508 Lapp RoadMalvern, PA 19355
Contact Person	Art Morse; Director of Quality Assurance and Regulatory Affairs; PuriCore Inc.508 Lapp Road, Malvern, PA 19355484 321 2728 (O), 484 321 2704 (F), 610 306 2870 (C)
Date Prepared	June 18th, 2013
Trade Names	Vashe® Wound Solution
Common Name	Wound Cleanser, Hypochlorous Acid Solution
ClassificationName	Solution, Saline, Wound Dressing
Product Code	FRO (Dressing, Wound, Drug)
PredicateDevices	Predicates with substantially equivalent chemical composition, mechanical action, and labeling:NeutroPhase Skin and Wound Cleanser®; NovaBay Pharmaceuticals, Inc. K113820, August 8th, 2012;Vashe® Wound Therapy Solution; PuriCore Inc. K123072, February 14, 2013Wound Wash Saline; Blairex Laboratories, Inc. K083355, December 29, 2008ExSept Skin and Wound Cleanser; Alcavis HDC LLC, K111313, December 14, 2011
ProductDescription	Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as apreservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates amoist environment and loosens contaminated exudate, slough and other foreign materials within thewound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, andmicroorganisms are more readily removed. Moistening and cleansing a wound, such as by using VasheWound Solution, better allows for the natural healing process to take place. This device is presented as aprescription product that requires the physician to diagnose the disease state and prescribe the product.The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.
Intended Use	Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing,irrigating, moistening, debridement and removal of foreign material including microorganisms and debrisfrom exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressureulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions,minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites.It is also intended for moistening and lubricating absorbent wound dressings.
Summary ofTechnologicalCharacteristicsCompared to thePrimaryPredicateDevices(K123072)(K113820)(K083355)(K111313)	Vashe® Wound Solution has the same or similar technical characteristics as Vashe® Wound TherapySolution, K123072, and NeutroPhase® Skin and Wound Cleanser K113820, Wound Wash Saline®, BlairexLaboratories, Inc. K083355, December 29th, 2008; ExSept Skin and Wound Cleanser, K111313, December14th, 2011;
	The mechanism of cleaning is the same as the predicates; the mechanism of fluid moving across thewound aids in the physical removal of foreign objects, foreign debris and exudate from awound; The Intended Use Statement utilizes the same indications as previously cleared under thesepredicate devices; The closure system for this product is substantially equivalent to the predicates as it is packaged ina bottle and a Polypropylene cap (with a laminated induction seal or septum seal).
SubstantialEquivalence -Effectiveness	Vashe® Wound Solution utilizes the same fundamental scientific technology as the predicate device(K123072);
	Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for Chemical Stability (SeeSection 6);
SubstantialEquivalence -Safety	Biocompatibility studies proved that the product is equivalent to the predicate products as it wasdetermine safe under the worst case scenario of the highest specified concentration of available freechlorine and the lowest specified pH.
	Additional in-vitro biocompatibility studies were conducted on keratinocytes and fibroblasts at theupper specification for available free chlorine concentration and at the lowest pH specification.
Conclusion:	Non clinical product testing has proven that Vashe Wound Solution is substantially equivalent to thepredicate devices as the product has been subjected to in-vivo and in-vitro biocompatibility testing perISO-10993-1 standards and Preservative Effectiveness testing to USP <51>. These results demonstratethat the product is as safe, as effective, and performs as well as or better than the legally marketeddevices identified as the reference predicate devices listed above and in the Substantial Equivalencesection (5).

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Vashe® Wound Solution

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

March 31, 2014

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

Re: K131848

Trade/Device Name: Vashe Wound Solution Regulatory Class: Unclassified Product Code: FRO Dated: February 28, 2014 Received: March 4, 2014

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 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Art Morse

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131848

Device Name Vashe Wound Solution

Indications for Use (Describe)

Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, II is also intended for moistening and lubricating absorbent wound dressings.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

N/A