VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)

K131848 · Puricore, Inc. · FRO · Mar 31, 2014 · SU

Device Facts

• Record ID: K131848
• Device Name: VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
• Applicant: Puricore, Inc.
• Product Code: FRO · SU
• Decision Date: Mar 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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 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 Story

Vashe Wound Solution is a saline-based wound cleanser containing hypochlorous acid as a preservative. It functions via mechanical action; the flow of solution across the wound bed loosens and removes exudate, slough, debris, and microorganisms. The device is intended for use in clinical settings under the supervision of healthcare professionals. It is supplied in PET bottles with either a flip-top cap for manual pouring or a septum cap for use with a vented spike connector. By maintaining a moist wound environment and facilitating physical cleansing, the solution supports the natural healing process. It is a prescription-only product.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including chemical stability, shelf-life evaluation, and in-vitro biocompatibility studies on keratinocytes and fibroblasts. Preservative effectiveness was validated per USP <51> standards.

Technological Characteristics

Saline-based solution containing hypochlorous acid. Materials: PET bottles, polypropylene caps, laminated induction seals, or septum seals. Mechanical cleansing principle. No energy source. Standalone product. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for cleansing, irrigation, moistening, and debridement of exudating or dirty wounds, acute and chronic dermal lesions (Stage I-IV pressure ulcers, stasis/diabetic ulcers, post-surgical wounds, 1st/2nd degree burns, abrasions, minor skin irritations, ingrown toenails, grafted/donor sites, exit sites) and lubrication of absorbent dressings. For use under healthcare professional supervision.

Predicate Devices

• NeutroPhase Skin and Wound Cleanser (K113820)
• Vashe Wound Therapy Solution (K123072)
• Wound Wash Saline (K083355)
• ExSept Skin and Wound Cleanser (K111313)

Submission Summary (Full Text)

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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 the<br>requirements of 21 CFR 807.92. |
| Submitter | PuriCore Inc., 508 Lapp Road<br>Malvern, PA 19355 |
| Contact Person | Art Morse; Director of Quality Assurance and Regulatory Affairs; PuriCore Inc.<br>508 Lapp Road, Malvern, PA 19355<br>484 321 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 |
| Classification<br>Name | Solution, Saline, Wound Dressing |
| Product Code | FRO (Dressing, Wound, Drug) |
| Predicate<br>Devices | Predicates with substantially equivalent chemical composition, mechanical action, and labeling:<br>NeutroPhase Skin and Wound Cleanser®; NovaBay Pharmaceuticals, Inc. K113820, August 8th, 2012;<br>Vashe® Wound Therapy Solution; PuriCore Inc. K123072, February 14, 2013<br>Wound Wash Saline; Blairex Laboratories, Inc. K083355, December 29, 2008<br>ExSept Skin and Wound Cleanser; Alcavis HDC LLC, K111313, December 14, 2011 |
| Product<br>Description | Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a<br>preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a<br>moist environment and loosens contaminated exudate, slough and other foreign materials within the<br>wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and<br>microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe<br>Wound Solution, better allows for the natural healing process to take place. This device is presented as a<br>prescription product that requires the physician to diagnose the disease state and prescribe the product.<br><br>The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:<br><br>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.<br><br>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,<br>irrigating, moistening, debridement and removal of foreign material including microorganisms and debris<br>from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure<br>ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions,<br>minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites.<br>It is also intended for moistening and lubricating absorbent wound dressings. |
| Summary of<br>Technological<br>Characteristics<br>Compared to the<br>Primary<br>Predicate<br>Devices<br>(K123072)<br>(K113820)<br>(K083355)<br>(K111313) | Vashe® Wound Solution has the same or similar technical characteristics as Vashe® Wound Therapy<br>Solution, K123072, and NeutroPhase® Skin and Wound Cleanser K113820, Wound Wash Saline®, Blairex<br>Laboratories, Inc. K083355, December 29th, 2008; ExSept Skin and Wound Cleanser, K111313, December<br>14th, 2011; |
| | The mechanism of cleaning is the same as the predicates; the mechanism of fluid moving across the<br>wound aids in the physical removal of foreign objects, foreign debris and exudate from a<br>wound; The Intended Use Statement utilizes the same indications as previously cleared under these<br>predicate devices; The closure system for this product is substantially equivalent to the predicates as it is packaged in<br>a bottle and a Polypropylene cap (with a laminated induction seal or septum seal). |
| Substantial<br>Equivalence -<br>Effectiveness | Vashe® Wound Solution utilizes the same fundamental scientific technology as the predicate device<br>(K123072); |
| | Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for Chemical Stability (See<br>Section 6); |
| Substantial<br>Equivalence -<br>Safety | Biocompatibility studies proved that the product is equivalent to the predicate products as it was<br>determine safe under the worst case scenario of the highest specified concentration of available free<br>chlorine and the lowest specified pH. |
| | Additional in-vitro biocompatibility studies were conducted on keratinocytes and fibroblasts at the<br>upper 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 the<br>predicate devices as the product has been subjected to in-vivo and in-vitro biocompatibility testing per<br>ISO-10993-1 standards and Preservative Effectiveness testing to USP <51>. These results demonstrate<br>that the product is as safe, as effective, and performs as well as or better than the legally marketed<br>devices identified as the reference predicate devices listed above and in the Substantial Equivalence<br>section (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 [phone] or [phone] 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 [phone] or [phone] 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)