Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.

OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.

Device Description

PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.

The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.

The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).

AI/ML Overview

The provided text is a 510(k) Summary for the PuriCore Wound Hydrogel Spray Dressing. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against specific clinical efficacy metrics for a novel medical device. The document explicitly states "Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially equivalent to the predicate devices".

Therefore, based solely on the provided text, I cannot extract information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for a new device's clinical performance. The document describes pre-clinical testing for biocompatibility and shelf-life related attributes, which are important for safety and product stability, but not directly about clinical efficacy or specific functional performance criteria in a wound healing context beyond what the predicate devices are already cleared for.

Here's a breakdown of the requested information based on the provided text:

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

Since this 510(k) is about demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily that the PuriCore Wound Hydrogel Spray Dressing is as safe and effective as the predicates. The reported device performance is largely a confirmation of this equivalence through various non-clinical tests.

Acceptance Criteria (Implied for Substantial Equivalence to Predicates)	Reported Device Performance (Summary from Pre-Clinical Testing)
Biocompatibility (equivalent to predicate products)	Determined safe under worst-case scenario (highest specified concentration of available free chlorine and lowest specified pH).
Chemical Stability	Satisfactory (specific data not provided, but implied by conclusion of substantial equivalence).
pH within acceptable range	Satisfactory (specific data not provided, but implied by conclusion of substantial equivalence and mentioned in pre-clinical testing).
Free Available Chlorine within acceptable range	Satisfactory (specific data not provided, but implied by conclusion of substantial equivalence and mentioned in pre-clinical testing).
Shelf Life	Satisfactory (specific data not provided, but implied by conclusion of substantial equivalence and mentioned in pre-clinical testing).
Antimicrobial Preservative Effectiveness	Satisfactory (Implied by inclusion in pre-clinical testing and conclusion of substantial equivalence).
Agar Overlay Cytotoxicity (absence of cytotoxicity)	Satisfactory (Implied by inclusion in pre-clinical testing and conclusion of substantial equivalence).
Primary Skin Irritation (absence of irritation)	Satisfactory (Implied by inclusion in pre-clinical testing and conclusion of substantial equivalence).
Guinea Pig Maximization Sensitization (absence of sensitization)	Satisfactory (Implied by inclusion in pre-clinical testing and conclusion of substantial equivalence).

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

Sample Size for Test Set: Not specified. The document mentions "biocompatibility studies" and "Preservative Effectiveness testing" but does not detail the number of samples or subjects used for these specific tests.
Data Provenance: The tests are "Pre-Clinical Testing." No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

Not applicable as this is a pre-clinical, non-human study for substantial equivalence rather than a clinical trial requiring expert consensus on outcomes. The "ground truth" for these tests would be established by the standardized methods and criteria of the specific ISO standards (e.g., ISO-10993-1 for biocompatibility) and other test protocols.

4. Adjudication method for the test set:

Not applicable for the reported pre-clinical testing. Adjudication methods are typically relevant for human clinical trials or image interpretation studies where multiple expert opinions need to be reconciled.

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-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an algorithm or AI-based device.

7. The type of ground truth used:

For the pre-clinical tests (biocompatibility, chemical stability, etc.), the "ground truth" is defined by the objective results against established scientific and regulatory standards/protocols (e.g., ISO-10993-1, USP preservative effectiveness tests).

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set. The term "training set" refers to data used to train machine learning models.

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

Not applicable. (See #8)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

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

May 14, 2015

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

Re: K141863

Trade/Device Name: PuriCore Wound Hydrogel Spray Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 11, 2015 Received: April 14, 2015

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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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education 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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141863

Device Name PuriCore Wound Hydrogel Spray Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)	× Over-The-Counter Use (21 CFR 801 Subpart C)

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K141863, Page 1 of 2

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 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	May 8, 2015
Trade Names	Puricore Wound Hydrogel Spray Dressing
Common Name	Hydrogel Wound Dressing
Product Code	FRO (Dressing, Wound, Drug)
Predicate Devices	Predicates with substantially equivalent chemical composition, mechanical action, and labeling:Primary Predicate: K123071: Vashe Skin Wound Hydrogel, January 24, 2013; Secondary Predicates: K101882: Prontosan Wound Gel, November 3, 2010 K073547: Anasept Antimicrobial Skin and Wound Gel, April 23, 2008 K093585: Microcyn Skin and Wound Hydrogel, March 8, 2010
Product Description	PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The- Counter use.The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).
Intended Use Rx	Under the supervision of a healthcare professional, Puricore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.
Intended Use OTC	PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.
Summary ofTechnologicalCharacteristicsCompared to thePrimaryPredicateDevices	Puricore Wound Hydrogel Spray Dressing has the same or similar technical characteristics as thepredicates listed above:• An aqueous based topical hydrogel which controls moisture and wound exudates. Hydrogelcharacteristics are imparted by an inert viscosity controlling agent. Maintains a moist woundenvironment that supports the wound healing process by encouraging autolytic debridement. Thehydrogel barrier manages pain and itch by protecting the wound from contamination and irritation• 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 in aPET bottle and a Polypropylene spray cap.
SubstantialEquivalence -Effectiveness	Puricore Wound Hydrogel Spray Dressing utilizes the same fundamental scientific technology as thepredicate device (K123071).Biocompatibility studies proved that the product is equivalent to the predicate products as it wasdetermined safe under the worst case scenario of the highest specified concentration of available freechlorine and the lowest specified pH.
Pre-ClinicalTesting	Pre-Clinical Testing included pH, Free Available Chlorine, Shelf Life, Chemical Stability, AntimicrobialPreservative Effectiveness, Agar Overlay Cytotoxicity, Primary Skin Irritation, and Guinea PigMaximization Sensitization.
Conclusion:	Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantiallyequivalent to the predicate devices as the product has been subjected to in-vitro biocompatibilitytesting per ISO-10993-1 standards and Preservative Effectiveness testing. These results demonstratethat the product is as safe, as effective, and performs as well as or better than the legally marketeddevices identified as the predicate devices listed above and in the Substantial Equivalence.

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K141863, Page 2 of 2

Regulation Number and Section

N/A