VASHE WOUND CLEANSING SYSTEM

K093155 · Puricore, Inc. · FRO · Mar 1, 2010 · SU

Device Facts

• Record ID: K093155
• Device Name: VASHE WOUND CLEANSING SYSTEM
• Applicant: Puricore, Inc.
• Product Code: FRO · SU
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Vashe Wound Therapy System consists of a wound cleanser solution; used for cleansing, irrigating, and debriding dermal wounds; also moistens/lubricates absorbent dressings. Mechanism of action relies on mechanical fluid movement across wound surface to remove foreign objects, dirt, and debris. Solution contains Free Available Chlorine (FAC) to inhibit contamination within the solution. Intended for use by qualified healthcare personnel in clinical settings. Output is the physical cleansing and irrigation of the wound bed; aids in maintaining a moist wound environment conducive to healing. Benefits include removal of debris and inhibition of microbial contamination within the solution.

Clinical Evidence

Bench testing only. Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution.

Technological Characteristics

Wound cleanser solution containing Free Available Chlorine (FAC). Mechanical action via fluid irrigation. No electronic components, software, or energy sources.

Indications for Use

Indicated for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions (Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first/second degree burns, abrasions, minor skin irritations) and moistening/lubricating absorbent wound dressings. For use by trained healthcare personnel.

Predicate Devices

• Anasept™ Antimicrobial Skin and Wound Cleanser and Gel (K073547)
• Oculus Puracyn™ Skin and Wound Cleanser with Preservatives (K090206)
• Microcyn™ Wound Gel (K090725)

Submission Summary (Full Text)

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## 510(k) Summary VASHE® WOUND THERAPY SYSTEM (including the Vashe® Wound Therapy * Solution)

KO9355

| 510 (k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in<br>accordance with the requirements of 21 C.F.R. §807.92. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | PuriCore Inc.<br>508 Lapp Road<br>Malvern, PA 19355 |
| Contact Person | Dennis Mahoney<br>PuriCore Inc.<br>508 Lapp Road<br>Malvern, PA 19355<br>484-321-2724 (ph); 610-341-0503 (fax) |
| Date Prepared | February 5th, 2010<br>MAR - 1 2010 |
| Trade Name | Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution) |
| Common Name | Wound Cleanser |
| Classification Name | Solution, saline, (wound dressing) |
| Predicate Device | Anasept™ Antimicrobial Skin and Wound Cleanser and Gel; Anacapa™ Technologies,<br>Inc. K073547, April 23rd, 2008, Oculus Puracyn™ Skin and Wound Cleanser with<br>Preservatives, Oculus Innovative Sciences, K090206, June 2nd, 2009, and Microcyn™<br>Wound Gel, K090725, May 20th, 2009, Oculus Innovative Sciences |
| Description | The subject device includes a wound cleanser solution that is intended for cleansing,<br>irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent<br>wound dressings. The mechanical action of fluid moving across the wound provides for the<br>mechanism of action and aids in the removal of foreign objects such as dirt and debris. In<br>addition, the subject device contains Free Available Chlorine (FAC) that inhibits<br>contamination within the solution. |
| Indications for Use | Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution) is intended<br>for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such<br>as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and<br>second degree burns, abrasions and minor irritations of the skin in addition to moistening<br>and lubricating absorbent wound dressings. |
| Substantial Equivalence | The product is similar in function and intended use to:<br>Anasept™ Antimicrobial Skin and Wound Cleanser and Gel manufactured by<br>Anacapa™ Technologies, Inc. that includes among it's labeled uses the management<br>of wounds by maintaining a moist wound environment that is conducive to healing by<br>either absorbing wound exude or donating moisture while delivering antimicrobial<br>sodium hypochlorite which inhibits the growth of microorganisms.Oculus Puracyn™ Skin and Wound Cleanser with Preservative manufactured by<br>Oculus Innovative Sciences, that includes among its labeled uses the debridement of<br>wounds. The device also includes a preservative which contains a broad spectrum of<br>antimicrobial agents that inhibit growth of bacteria commonly found in the wound bed.Microcyn™ Wound Gel manufactured by Oculus Innovative Sciences, that includes<br>among its labeled uses the management of mechanically or surgically debrided<br>wounds. The device includes FAC that inhibits contamination within the hydrogel. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy<br>Solution. |
| Conclusion | Vashe® Wound Therapy System containing the Vashe® Wound Therapy+ Solution is<br>substantially equivalent to the currently cleared and marketed Anasept™ Antimicrobial<br>Skin and Wound Cleanser and Gel, the Oculus Puracyn™ Skin and Wound Cleanser with<br>Preservative, and the Microcyn™ Wound Gel |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

MAR - 1 2010

Puricore, Inc. % Mr. Dennis Mahoney Director, QA/RA 508 Lapp Road Malvern, Pennsylvania 19355

Re: K093155

Trade/Device Name: Vashe® Wound Therapy System (including Vashe® Wound Therapy

Solution) Regulatory Class: Unclassified Product Code: FRO Dated: February 5, 2010 Received: February 16, 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 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. Dennis Mahoney

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

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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Exhibit 2

## Indications for Use Statement

## 510(k) Number: K093155

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

Indications for Use :

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.

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)

OR

Over-The-Counter Use: __

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

David Krone for Ulkay
(Division S: Off)

Division of Nurgical, Orthopedic, and Nestorative Devices

Number KD93155