Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

Device Description

Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. The product contains hypochlorous acid as a preservative. The Hydrogel will be supplied in plastic tottles as described in Section 3.2. The device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

AI/ML Overview

The document provided refers to a 510(k) premarket notification for a medical device called "Vashe® Skin & Wound Hydrogel". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating performance against specific numerical acceptance criteria through a clinical study.

Therefore, the information you've requested regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because the 510(k) summary focuses on biocompatibility and preservative activity, not a clinical efficacy study with numerical performance metrics against specific conditions.

However, I can extract what is mentioned about the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of numerical performance for efficacy. The implied acceptance criteria for the Vashe® Skin & Wound Hydrogel is that it is safe for use and has effective preservative activity, similar to its predicate device.
Reported Device Performance:
- "Vashe® Skin and Wound Hydrogel is safe for use when in contact with abraded, breached or compromised skin."
- "Vashe® Skin & Wound Hydrogel at its minimum recommended concentration demonstrates effective preservative activity and supports a preservative claim."

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are "in-vivo and in-vitro biocompatibility testing" and "preservative activity" testing, which are not typically presented with test set sample sizes or data provenance in the context of comparative clinical efficacy as one would expect for an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned (biocompatibility and preservative activity) do not involve expert-established ground truth for interpreting clinical outcomes.

4. Adjudication method for the test set: Not applicable based on the nature of the described studies.

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: No, an MRMC comparative effectiveness study was not done. This device is a hydrogel, not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hydrogel, not an algorithm.

7. The type of ground truth used:
* For biocompatibility: Adherence to ISO-10993 standards (likely comparing against established biological response limits).
* For preservative activity: Demonstrated effective preservative activity (likely against specific microbial challenges, though not detailed).

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.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document indicates that the Vashe® Skin & Wound Hydrogel underwent the following testing:

Study Type: In-vivo and in-vitro biocompatibility testing.
Standards: ISO-10993 standards.
Purpose: To demonstrate the device's safety when in contact with abraded, breached, or compromised skin.
Conclusion: The results demonstrated that Vashe® Skin & Wound Hydrogel is safe for such use.
Additional Study: Testing for preservative activity.
Purpose: To ascertain if the hydrogel, at its minimum recommended concentration, could effectively act as a preservative.
Conclusion: The device demonstrated effective preservative activity, supporting a preservative claim.

These studies were conducted to support the device's safety and preservative function, which are critical aspects of its substantial equivalence to the predicate device, Epicyn™ HydroGel (K102945). The 510(k) process primarily relies on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through non-clinical testing and comparison to an existing predicate.

Summary

{0}------------------------------------------------

K123071 p.1/2

Vashe® Skin & Wound Hydrogel

510 (k) Premarket Notification

JAN 2 4 2013

SECTION 2	510(k) SUMMARY
510(k) Summary	This summary of 510(k) safety and effectiveness information is being submitted inaccordance with the requirements of 21 CFR 807.92.
Submitter	PuriCore Inc.508 Lapp RoadMalvern, PA 19355
Contact Person	Art MorseDirector 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 24th, 2012
Trade Name	Vashe® Skin & Wound Hydrogel
Common Name	Hydrogel Wound Dressing
ClassificationName	Dressing, wound and burn drug/hydrogel
Predicate Devices	Epicyn™ HydroGel, Oculus Innovative Sciences, Inc., K102945, February 2nd, 2011.
Device Description	Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel.The gel forms a protective barrier which retains moisture and provides relief ofthe burning and itching experienced with various dermatoses, including atopicdermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogelwhen applied to diseased skin forms a protective barrier that helps to maintain amoist wound and skin environment. The product contains hypochlorous acid as apreservative. The Hydrogel will be supplied in plastic tottles as described inSection 3.2.The device is presented as a prescription product that requires the physician todiagnose the disease state and prescribe the product.
Intended Use	Vashe® Skin and Wound Hydrogel - For Professional Use OnlyUnder the supervision of a health care professional, Vashe® Skin and WoundHydrogel is indicated for the management and relief of pain, burning and itchingexperienced with various dermatoses, including atopic dermatitis, allergic contactdermatitis and radiation dermatitis, as well as for the relief of pain from first andsecond degree burns, and aids to relieve dry waxy skin by maintaining a moistwound and skin environment. A moist wound and skin environment is beneficialto the healing process.These indications are similar to the predicate device, Epicyn™ Hydrogel, K102945cleared on February 2011.
Summary ofTechnologicalCharacteristicsCompared to thePredicate Device	Vashe® Skin and Wound Hydrogel is an aqueous based topical hydrogel whichcontrols moisture and wound exudates. Hydrogel characteristics are imparted byan inert viscosity controlling agent and emollient. Vashe® Skin and WoundHydrogel maintains a moist wound environment that supports the wound healingprocess by encouraging autolytic debridement. The hydrogel barrier managespain and itch by protecting the wound from contamination and irritation

	Vashe® Skin and Wound Hydrogel is similar in function and has the same intended
	use as the predicate device Epicyn™ HydroGel legally marketed via 510(k)K102945 (Atrapro Antipruritic Hydrogel).
Test & Conclusions	Vashe® Skin and Wound Hydrogel has been subjected to in-vivo and in-vitro
	biocompatibility testing to ISO-10993 standards and. These results demonstrate
	that Vashe® Skin and Wound Hydrogel is safe for use when in contact with
	abraded, breached or compromised skin. Furthermore, we have concluded that
	Vashe® Skin & Wound Hydrogel at its minimum recommended concentration
	demonstrates effective preservative activity and supports a preservative claim.

2-1

{1}------------------------------------------------

Vashe® Skin & Wound Hydrogel

510 (k) Premarket Notification ______________________________________________________________________________________________________________________________________________________________________________

K123071

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 24, 2013

PuriCore Inc. % Mr. Art Morse 508 Lapp Road Malvern, Pennsylvania 19355

Re: K123071

Trade/Device Name: Vashe® Skin and Wound Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2012 Received: December 21, 2012

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

{3}------------------------------------------------

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 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 D. Rumm -S

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for PuriCore. The logo is black and consists of the word "PuriCore" in a bold, sans-serif font. The "o" in "Core" is replaced with a circular image that appears to be a globe or a cell. Below the logo is the tagline "Pure Science. Pure Life."

K123071

Indications for Use Statement

510(k) Number:

Device Name: Vashe® Skin and Wound Hydrogel

Indications for Use:

Vashe® Skin and Wound Hydrogel – For Professional Use Only

Prescription Use XX (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use:

(21 CFR 801 Subpart C)

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 K123071

1 | Page

Regulation Number and Section

N/A