(146 days)
Not Found
No
The device description and intended use focus on a wound cleanser solution and its mechanical and chemical properties, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device functions as a wound cleanser and debrider, and while it aids in wound care, its primary action is not to directly treat or cure the underlying condition but rather to prepare the wound for healing.
No
The device is intended for cleansing, irrigating, moistening, and debriding dermal lesions, which are therapeutic actions, not diagnostic. It does not mention any function for identifying, analyzing, or predicting a medical condition or disease.
No
The device description explicitly states it includes a "wound cleanser solution," which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleansing, irrigating, moistening, and debriding dermal lesions. This is a direct application to the wound for therapeutic and cleaning purposes.
- Device Description: The description focuses on the mechanical action of the fluid and the presence of Free Available Chlorine (FAC) for inhibiting contamination within the solution. These are actions performed on the wound itself, not on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are used to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
The Vashe® Wound Therapy System is a wound care product used topically for cleaning and managing wounds.
N/A
Intended Use / 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.
Product codes
FRO
Device Description
The subject device includes a wound cleanser solution that is intended for cleansing, irrigating, and 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermal lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified health care personnel trained in its use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Exhibit 3:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
accordance with the requirements of 21 C.F.R. §807.92. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | PuriCore Inc.
508 Lapp Road
Malvern, PA 19355 |
| Contact Person | Dennis Mahoney
PuriCore Inc.
508 Lapp Road
Malvern, PA 19355
484-321-2724 (ph); 610-341-0503 (fax) |
| Date Prepared | February 5th, 2010
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,
Inc. K073547, April 23rd, 2008, Oculus Puracyn™ Skin and Wound Cleanser with
Preservatives, Oculus Innovative Sciences, K090206, June 2nd, 2009, and Microcyn™
Wound Gel, K090725, May 20th, 2009, Oculus Innovative Sciences |
| Description | The subject device includes a wound cleanser solution that is intended for cleansing,
irrigating, and 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. In
addition, the subject device contains Free Available Chlorine (FAC) that inhibits
contamination within the 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. |
| Substantial Equivalence | The product is similar in function and intended use to:
Anasept™ Antimicrobial Skin and Wound Cleanser and Gel manufactured by
Anacapa™ Technologies, Inc. that includes among it's labeled uses the management
of wounds by maintaining a moist wound environment that is conducive to healing by
either absorbing wound exude or donating moisture while delivering antimicrobial
sodium hypochlorite which inhibits the growth of microorganisms.Oculus Puracyn™ Skin and Wound Cleanser with Preservative manufactured by
Oculus Innovative Sciences, that includes among its labeled uses the debridement of
wounds. The device also includes a preservative which contains a broad spectrum of
antimicrobial agents that inhibit growth of bacteria commonly found in the wound bed.Microcyn™ Wound Gel manufactured by Oculus Innovative Sciences, that includes
among its labeled uses the management of mechanically or surgically debrided
wounds. The device includes FAC that inhibits contamination within the hydrogel. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy
Solution. |
| Conclusion | Vashe® Wound Therapy System containing the Vashe® Wound Therapy+ Solution is
substantially equivalent to the currently cleared and marketed Anasept™ Antimicrobial
Skin and Wound Cleanser and Gel, the Oculus Puracyn™ Skin and Wound Cleanser with
Preservative, and the Microcyn™ Wound Gel |
ះ ប៉ុ
1
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
2
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 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
3
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