(134 days)
Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
The subject device is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Vashe® Wound Therapy Solution, a wound cleansing solution, and a letter from the FDA confirming its substantial equivalence to predicate devices.
The information primarily focuses on:
- Device Identification: Trade Name, Common Name, Classification Name, Product Code.
- Submitter and Contact Information.
- Predicate Devices: A list of previously cleared devices to which Vashe® Wound Therapy Solution is compared for substantial equivalence.
- Device Description: What the device is and its mechanical action.
- Indications for Use: What the device is intended for (management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin).
- Substantial Equivalence Argument: How it is similar in function and intended use to the predicate devices.
- Non-clinical Performance: A brief mention that pre-clinical testing demonstrated biocompatibility.
- FDA Clearance Letter: Confirmation of substantial equivalence and regulatory information.
There is no mention of:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- A formal study designed to demonstrate the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type or establishment of ground truth.
The "Non-clinical Performance" section states: "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." This is the only mention of any testing, but it's limited to biocompatibility and does not involve performance metrics related to acceptance criteria for the indicated uses. The basis for clearance is substantial equivalence to already marketed predicate devices, not meeting specific performance criteria through a new clinical or benchmark study.
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510(k) Summary VASHE™ WOUND THERAPY SOLUTION
16093697
| 510 (k) Summary | This summary of 510(k) safety and effectiveness information is being submitted inaccordance with the requirements of 21 C.F.R. §807.92. |
|---|---|
| Submitter | PuriCore Inc.508 Lapp RoadMalvern, PA 19355 |
| Contact Person | Dennis MahoneyPuriCore Inc.508 Lapp RoadMalvern, PA 19355 APR 1 3 2010 |
| Contact Person | Dennis MahoneyPuriCore Inc.508 Lapp RoadMalvern, PA 19355484-321-2724 (ph); 610-341-0503 (fax) |
|---|---|
| Date Prepared | November 20th, 2009 |
| Trade Name | Vashe® Wound Therapy Solution |
| Common Name | Wound Cleanser |
| Classification Name | Solution, saline, (wound dressing) |
| Predicate Device | Anasept™ Antimicrobial Skin and Wound Cleanser; Anacapa™ Technologies, Inc. K073547, April 23rd, 2008, Oculus Puracyn™ Skin and Wound Cleanser with Preservatives, Oculus Innovative Sciences, K090206, June 2nd, 2009, Microcyn™ Skin Wound Gel, Oculus Innovative Sciences, K090725, May 20th 2009, Dermacyn™ Wound Cleanser and Wound Dressing, K041161, May 3rd, 2005. |
| Description | The subject device is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. |
| Indications for Use | Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin. |
| Substantial Equivalence | The product is similar in function and intended use to:• Anasept™ Antimicrobial Skin and Wound Cleanser manufactured by Anacapa™ Technologies, Inc. is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin.• Oculus Puracyn™ Skin and Wound Cleanser with Preservative manufactured by Oculus Innovative Sciences, is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin.• Microcyn™ Skin Wound Gel by Oculus Innovative Sciences is intended for the management of minor abrasions, lacerations, cuts, and intact skin.• Dermacyn™ Wound Cleanser and Wound Dressing manufactured by Oculus Innovative Sciences, is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution. |
| Conclusion | Vashe® Wound Therapy Solution is substantially equivalent to the currently cleared and marketed Anasept™ Antimicrobial Skin and Wound Cleanser, Oculus Puracyn™ Skin and Wound Cleanser with Preservative, Microcyn™ Skin Wound Gel and Dermacyn™ Wound Cleanser and Wound Dressing. |
Exhibit 3:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PuriCore, Inc. % Mr. Dennis Mahoney Director of Quality Assurance & Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355
APR 1 3 2010
Re: K093697
Trade/Device Name: Vashe® Wound Therapy Solution Regulatory Class: Unclassified Product Code: FRO Dated: April 1, 2010 Received: April 2, 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
urs,
Kelkerson
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:
Vashe® Wound Therapy Solution Device Name :
Indications for Use :
Vashe® Wound Therapy System is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use: XXX
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDHR, Office of Device Evaluation (ODE)
David Krone kimxm
Division of Surgical, Orthopedic. and Restorative Devic
510(k) Numbe
N/A