Who is the manufacturer of VASHE SKIN AND WOUND HYDROGEL?

Puricore, Inc. filed the 510(k) submission for VASHE SKIN AND WOUND HYDROGEL (K123071).

What is the FDA product code for VASHE SKIN AND WOUND HYDROGEL?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for VASHE SKIN AND WOUND HYDROGEL?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VASHE SKIN AND WOUND HYDROGEL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VASHE SKIN AND WOUND HYDROGEL

K123071 · Puricore, Inc. · FRO · Jan 24, 2013 · SU

Device Facts

Record ID	K123071
Device Name	VASHE SKIN AND WOUND HYDROGEL
Applicant	Puricore, Inc.
Product Code	FRO · SU
Decision Date	Jan 24, 2013
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Vashe® Skin and Wound Hydrogel - For Professional Use Only 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 Story

Vashe® Skin & Wound Hydrogel is an aqueous-based, non-oily topical hydrogel; contains hypochlorous acid as a preservative; utilizes inert viscosity-controlling agents and emollients. Applied by healthcare professionals to abraded, breached, or compromised skin; forms a protective barrier to maintain a moist wound/skin environment. Functions to manage pain, burning, and itching; supports autolytic debridement; protects against contamination and irritation. Supplied in plastic tottles for clinical use. Benefits patient by facilitating healing process and providing symptomatic relief for dermatoses and burns.

Clinical Evidence

No clinical data. Safety and effectiveness supported by in-vivo and in-vitro biocompatibility testing conducted in accordance with ISO-10993 standards and preservative efficacy testing.

Technological Characteristics

Aqueous-based topical hydrogel; contains hypochlorous acid (preservative), inert viscosity-controlling agents, and emollients. Form factor: plastic tottles. Biocompatibility: ISO-10993 compliant. Mechanism: moisture control, autolytic debridement, and physical barrier protection.

Indications for Use

Indicated for management and relief of pain, burning, and itching associated with dermatoses (atopic dermatitis, allergic contact dermatitis, radiation dermatitis) and pain from first and second degree burns; aids in relieving dry waxy skin by maintaining a moist environment. For professional use under healthcare supervision.

Predicate Devices

Epicyn™ HydroGel (K102945)

Related Devices

K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL · Oculus Innovative Sciences, Inc. · Feb 2, 2011
K150799 — Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula · Innovacyn, Inc. · Nov 19, 2015
K141863 — PURICORE WOUND HYDROGEL SPRAY DRESSING · Puricore, Inc. · May 14, 2015
K171935 — Alevicyn SG Antimicrobial Gel · Sonoma Pharmaceuticals, Inc. · Dec 1, 2017
K093585 — MICROCYN SKIN AND WOUND HYDROGEL · Oculus Innovative Sciences, Inc. · Mar 8, 2010

Submission Summary (Full Text)

{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 in accordance with the requirements of 21 CFR 807.92. | | Submitter | PuriCore Inc. 508 Lapp Road Malvern, PA 19355 | | Contact Person | Art Morse Director Quality Assurance and Regulatory Affairs PuriCore Inc. 508 Lapp Road Malvern, PA 19355 484 321 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 | | Classification Name | 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 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. | | Intended Use | Vashe® Skin and Wound Hydrogel - For Professional Use Only 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. These indications are similar to the predicate device, Epicyn™ Hydrogel, K102945 cleared on February 2011. | | Summary of Technological Characteristics Compared to the Predicate Device | Vashe® Skin and Wound Hydrogel is an aqueous based topical hydrogel which controls moisture and wound exudates. Hydrogel characteristics are imparted by an inert viscosity controlling agent and emollient. Vashe® Skin and Wound Hydrogel maintains a moist wound environment that supports the wound healing process by encouraging autolytic debridement. The hydrogel barrier manages pain 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 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. 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