MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014

K092232 · Puricore, Inc. · FRO · Aug 19, 2009 · SU

Device Facts

• Record ID: K092232
• Device Name: MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
• Applicant: Puricore, Inc.
• Product Code: FRO · SU
• Decision Date: Aug 19, 2009
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical 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 Cleanser is intended for used by qualified health care personnel trained in its use

Device Story

Vashe® Wound Cleanser is a liquid solution for cleansing, irrigating, debriding, and disinfecting dermal wounds; also used to moisten/lubricate absorbent dressings. Mechanism of action relies on mechanical fluid action across wound surface to remove foreign objects, dirt, and debris. Used in clinical settings by trained healthcare personnel. Output is a clean, irrigated wound site; facilitates wound management and healing. No complex electronics or software involved.

Clinical Evidence

Non-clinical performance testing demonstrated biocompatibility of the Vashe Wound Cleanser. No clinical data provided.

Technological Characteristics

Wound cleansing and disinfecting solution. Mechanical action via fluid irrigation. No electronic components, software, or specific material standards cited.

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, 1st/2nd degree burns, abrasions, minor skin irritations) and moistening/lubricating absorbent wound dressings. For use by trained healthcare personnel.

Predicate Devices

• Allklenz™ Cleanser (K965120)
• CarraKlenz Wound Cleanser (K022670)
• Dermacyn™ Wound Cleanser (K042729)
• Dermacyn™ Wound Dressing (K041161)
• Biopure™ MTAD™ Root Canal Cleanser (K053167)

Submission Summary (Full Text)

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Attachment 4

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## 510 (k) Summary

| 510(k) SUMMARY OF VASHE™ WOUND CLEANSER | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. §807.92. |
| Submitter | Sterilox Technologies, Inc.<br>320 King of Prussia Road<br>Radnor, PA 19087 |
| Contact Person | Howard Mann<br>320 King of Prussia Road<br>Radnor, PA 19087<br>484-321-2703<br>610-341-0503 fax |
| Date Prepared | March 24th, 2006 |
| Trade Name | Vashe™ |
| Common Name | Wound Cleanser |
| Classification Name | Solution, saline, (wound dressing) |
| Predicate Device | Allklenz™ Cleanser; Healthpoint Medical K965120, March 21st 1997.<br>CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670,<br>Oct. 17th, 2002. Dermacyn™ Wound Cleanser, Oculus Innovative<br>Sciences, K042729, September 30th, 2004 and Dermacyn™ Wound<br>Dressing, Oculus Innovative Sciences, K041161, February 1st, 2005.<br>Biopure™ MTAD™ Root Canal Cleanser, Dentsply International,<br>K053167, December 8, 2005 |
| Description | The subject device is a wound cleansing and disinfecting solution that is<br>intended for cleansing, irrigating, debriding and disinfecting dermal<br>wounds in addition to moistening and lubricating absorbent wound<br>dressings. The mechanical action of fluid moving across the wound<br>provides for the mechanism of action and aids in the removal of foreign<br>objects such as dirt and debris. Vashe is offered in various volumes. |
| Indications for Use | Vashe™ Wound Cleanser and Disinfectant is intended for cleansing,<br>irrigating, moistening, debriding and disinfecting acute and chronic<br>dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic<br>ulcers, post-surgical wounds, first and second degree burns, abrasions<br>and minor irritations of the skin in addition to moistening and<br>lubricating absorbent wound dressings. |
| Substantial Equivalence | The product is similar in function and intended use to:<br>Allklenz™ and CarraKlenz Wound Cleansers, manufactured by<br>Healthpoint Medical and Carrington Laboratories, Inc. that include<br>among their labeled uses the cleansing and irrigation of dermal<br>wounds and removal of foreign material. Dermacyn™ Wound Cleanser and Wound Dressing manufactured<br>by Oculus Innovative Sciences, that include among it's labeled uses<br>the cleansing, moistening and debriding of dermal wounds in<br>addition to moistening and lubricating absorbent wound dressings. Biopure™ MTAD™ Root Canal Cleanser manufactured by<br>Dentsply International, that include among its labeled uses the<br>cleaning and disinfecting of the root canal system. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of the Vashe Wound<br>Cleanser. |
| Conclusion | Vashe™ Wound Cleanser is substantially equivalent to the currently<br>cleared and marketed Allklenz™ Cleanser, CarraKlenz Wound<br>Cleansers, Dermacyn™ Wound Cleanser, Dermacyn™ Wound Dressing<br>and Biopure™ MTAD™ Root Canal Cleanser |

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

PuriCore Inc. % Mr. Dennis J. Mahoney Director of Quality Assurance/ Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355

AUG 1 9 2009

Re: K092232

Trade/Device Name: Vashe® Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2009 Received: August 22, 2009

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.

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 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.

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Page 2 - Mr. Dennis J. Mahoney

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/ucm1158001, prefact 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/cdrh/mdr/ 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 tollom are [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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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92232 11,

## Attachment 2

## Indications for Use Statement

12092232 510(k) Number :

Vashe® Wound Cleanser Device Name :

Indications for Use :

Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical 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 Cleanser is intended for used by qualified health care personnel trained in its use

Prescription Use
(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 MKM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092232