Vashe® Wound Therapy System (including 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

The subject device includes a wound cleanser solution that is intended for cleansing, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.

Vashe® Wound Therapy System consists of a Vashe® Wound Therapy Generator and Vashe® Wound Therapy+ Solution. The Vashe® Wound Therapy+ Solution is produced from a Vashe® Wound Therapy Generator. The generator is an electromechanical device containing an electromechanical cell, power supply, storage tank, pump, valve, tubing, various mechanical hardware, etc. The Vashe® Wound Therapy Solution is a clear solution with a controlled pH and containing free available chlorine at a designated concentration (ppm). Cleaning and debriding is caused by the physical action of the of the Vashe® Wound Therapy Solution moving across the wound while the hypochlorous acid acts as a preservative to ensure no growth of micro-organisms in the solution. In addition. The Vashe® Wound Therapy Solution also moistens and lubricates absorbent wound dressings.

AI/ML Overview

The provided document describes the Vashe® Wound Therapy System and its 510(k) submission (K100918) for market clearance. The information focuses on demonstrating substantial equivalence to predicate devices and provides details on performance testing related to safety and biocompatibility, as well as the solution's ability to inhibit contamination.

However, the document does not contain the following information typically found in studies related to AI/algorithm-based medical devices:

Acceptance Criteria for Device Performance (beyond safety and biological compatibility): The document establishes basic safety and inhibitory properties of the solution but does not specify performance metrics for "cleansing, irrigating, moistening, and debriding" with quantitative acceptance criteria.
Study proving device meets acceptance criteria (in terms of clinical efficacy compared to a standard or a specific performance benchmark).
Sample size for test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for training set.
How ground truth for the training set was established.

Summary of available information from the document related to performance/testing:

The document describes performance testing primarily focused on safety, biocompatibility, and the preservative effectiveness of the Vashe® Wound Therapy Solution. It does not present a clinical study with specific performance metrics for the "cleansing, irrigating, moistening, and debriding" functions against pre-defined acceptance criteria.

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

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance
Generator Safety	Compliance with UL 61010 and EN 61010-1:2001 (electrical safety, etc.).	"None of the testing demonstrated any design characteristics that violated the requirements or resulted in any safety hazards. It was concluded that the Vashe® Wound Therapy Generator tested met all relevant requirements of the aforementioned test."
Solution Biocompatibility	No irritation, skin sensitization, or mutagenic effects. Acute oral toxicity showing no toxic effects. Meeting ISO 10993-5 requirements (grade less than 2 for reactivity).	"The solution showed no irritation or skin sensitization and was not mutagenic in the bacterial mutation genotoxicity assay. In addition, the acute oral toxicity studies showed no toxic effects. In all cases, the Vashe® Wound Therapy Solution test articles met the requirements of the ISO 10993-5 since the grade was less than a grade 2 (mild reactivity)."
Solution Antimicrobial / Preservative Effectiveness	Inhibiting contamination within the solution. Meeting USP 51 requirements when aged beyond shelf-life. Achieving significant reduction against various microorganisms.	"The Vashe® Wound Therapy Solution, at its minimum recommended concentration and aged beyond its shelf-life, meets USP 51 requirements. No growth was observed from any of the 21 tests micro-organisms when challenged with aged Vashe solution. Results showed a >99.999% reduction against 20 organisms and 99.995% reduction was observed against the Staphyloccoccus aureus strain (ATCC 6538). Endospore Time Kill Assay results showed that the aged Vashe® Wound Therapy Solution after 15 seconds contact time produced >99.999% reduction against Clostridium difficile endospores."
GMP Compliance	Manufacturing according to product specifications and Good Manufacturing Practices (GMP). Risk analysis performed to identify potential failure modes. Manufacturing controls developed and implemented.	"The Vashe® Wound Therapy Generator containing the automatic dispense feature will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure modes during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured at PuriCore meets all the established specifications prior to release and is safe and effective for its intended use."
Substantial Equivalence	Similar function and intended use to predicate devices, including managing wounds by maintaining a moist environment, debridement, and inhibiting microorganism growth via free available chlorine.	The device is deemed substantially equivalent to Anasept™ Antimicrobial Skin and Wound Cleanser and Gel (K073547), Oculus Puracyn™ Skin and Wound Cleanser with Preservatives (K090206), and Microcyn™ Wound Gel (K090725) due to similar intended uses, mechanism of action (mechanical cleansing, moistening, and preservative action of FAC), and device characteristics. The predicate devices' labeled uses include maintaining a moist wound environment, debridement, and antimicrobial properties.

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

Sample Size for Test Set: Not explicitly stated for any clinical performance or efficacy studies. For the antimicrobial efficacy, 21 test microorganisms were used.
Data Provenance: Not explicitly stated as being from a specific country or whether it was retrospective or prospective for a clinical efficacy study. The testing for generator safety (UL, Demko A/S) and toxicology/biocompatibility does not represent patient data.

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

This information is not provided because no clinical efficacy study with expert interpretation of the results is described. The evaluations were laboratory-based (UL, Demko A/S, toxicology labs, microbiology labs).

4. Adjudication method for the test set:

Not applicable/Not provided, as no clinical study amenable to such a method is described.

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 not an AI or imaging device, and no MRMC study was performed.

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

Not applicable, as this is not an algorithm-based device.

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

The "ground truth" for the tests performed was based on established laboratory testing standards:
- Generator Safety: Compliance with UL and EN standards.
- Biocompatibility: ISO 10993-5 (reactivity grade), bacterial mutation genotoxicity assay, acute oral toxicity studies, irritation/sensitization tests.
- Antimicrobial Efficacy: USP 51 requirements, quantitative reduction against specific microorganisms (e.g., Staphyloccoccus aureus, Clostridium difficile endospores).

8. The sample size for the training set:

Not applicable, as this is not a machine learning/AI device, and no training set was used.

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

Not applicable, as this is not a machine learning/AI device.

Summary

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K100918 page 1/3

Puricore
Pure Science. Pure Life.

Attachment 1: 510(k) Summary VASHE® WOUND THERAPY SYSTEM (including the Vashe® Wound Therapy + Solution)

Submitter:	PuriCore Inc.508 Lapp RoadMalvern, PA 19355	AUG 09 2010
Contact Person:	Dennis MahoneyPuriCore Inc.508 Lapp RoadMalvern, PA 19355484-321-2724 (ph)610-341-0503 (fax)
Date Prepared:	July 7th, 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.

The assigned 510(k) number is : K100918

Device Name (proprietary):	Vashe® Wound Therapy System (including Vashe® WoundTherapy+ Solution)
Common Name:	Wound Cleanser
Classification Name:	Solution, saline, (wound dressing)
Classification:	Unclassified
Product Code:	FRO

Legally Marketed Devices for substantial equivalence comparison:

Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) is substantially equivalent to the following devices:

Anasept™ Antimicrobial Skin and Wound Cleanser and Gel; Anacapa™ Technologies, Inc. . K073547, April 23d, 2008
Oculus Puracyn™ Skin and Wound Cleanser with Preservatives, Oculus Innovative Sciences, . K090206, June 2nd, 2009
Microcyn™ Wound Gel, K090725, May 20th, 2009, Oculus Innovative Sciences .

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K100918 Page 2/3

Description of Device:

Intended Use of the Device:

These indications are similar to PuriCore predicate device 510(k) #K093155.

Device Technological Characteristics:

Manufacturing: The Vashe® Wound Therapy Generator containing the automatic dispense feature will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure modes during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured at PuriCore meets all the established specifications prior to release and is safe and effective for its intended use.

Performance Testing:

The Vashe® Wound Therapy Generator has been tested for safety and effectiveness in its intended environment. Testing was conducted by Underwriters Laboratories Inc. on the device per UL 61010 and by UL International Demko A/S per EN 61010-1:2001. None of the testing demonstrated any design characteristics that violated the requirements or resulted in any safety hazards. It was concluded that the Vashe® Wound Therapy Generator tested met all relevant requirements of the aforementioned test.

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Pre-clinical toxicology evaluations were conducted on the Vashe® Wound Therapy demonstrated the solution is biocompatible and safe for clinical use. Testing was performed to determine the potential toxicological effects of exposure to Vashe® Wound Therapy Solution. The solution showed no irritation or skin sensitization and was not mutagenic in the bacterial mutation genotoxicity assay. In addition, the acute oral toxicity studies showed no toxic effects. In all cases, the Vashe® Wound Therapy Solution test articles met the requirements of the ISO 10993-5 since the grade was less than a grade 2 (mild reactivity).

Testing was conducted to confirm that the free available chlorine (FAC) contained in the Vashe® Wound Therapy Solution inhibits contamination within the solution. The Vashe® Wound Therapy Solution, at its minimum recommended concentration and aged beyond its shelf-life, meets USP 51 requirements. No growth was observed from any of the 21 tests micro-organisms when challenged with aged Vashe solution. Results showed a >99.999% reduction against 20 organisms and 99.995% reduction was observed against the Staphyloccoccus aureus strain (ATCC 6538). Endospore Time Kill Assay results showed that the aged Vashe® Wound Therapy Solution after 15 seconds contact time produced >99.999% reduction against Clostridium difficile endospores.

Substantial Equivalence Conclusion:

The product is similar in function and intended use to:

Anasept™ Antimicrobial Skin and Wound Cleanser and Gel manufactured by Anacapa™ . Technologies. Inc. that includes among it's labeled uses the management of wounds by maintaining a moist wound environment that is conducive to healing by either absorbing wound exude or donating moisture while delivering antimicrobial sodium hypochlorite which inhibits the growth of microorganisms.
Oculus Puracyn™ Skin and Wound Cleanser with Preservative manufactured by Oculus . Innovative Sciences, that includes among its labeled uses the debridement of wounds. The device also includes a preservative which contains a broad spectrum of antimicrobial agents that inhibit growth of bacteria commonly found in the wound bed.
Microcyn™ Wound Gel manufactured by Oculus Innovative Sciences, that includes among its . labeled uses the management of mechanically or surgically debrided wounds. The device includes FAC that inhibits contamination within the hydrogel.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

Public Health Service

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

PuriCore Inc. % Mr. Dennis Mahoney Director, Quality Assurance and Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355

AUG 09 2010

Re: K100918

Trade/Device Name: Vashe® Wound Therapy System (including Vashe® Wound Therapy* Solution) Regulatory Class: Unclassified Product Code: FRO Dated: August 04, 2010 Received: August 05, 2010

Dear Mr. Mahoney:

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

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Page 2 - Mr. Dennis Mahoney

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 100-1050.

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/CDRH0fffices/ucm/1750111717/1 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For
Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

AUG 09 2010

510(k) Number: K 100 GI B

Device Name: Vashe® Wound Therapy System (including Vashe® Wound Therapy* Solution)

Indications for Use:

The Vashe® Wound Therapy System is intended for used by qualified health care personnel trained in its use

Prescription Use XX (Per 21 CFR 801.109)

Over-The-Counter Use:

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

510(k) Number

Concurrence of CDHR, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

MXM

and Restorative Devices

Regulation Number and Section

N/A