(87 days)
Not Found
No
The description focuses on the chemical and mechanical action of a wound cleansing solution, with no mention of AI or ML.
No.
The device is a wound cleansing solution, which, while used in the treatment of wounds, does not itself provide a therapeutic effect. Its function is to cleanse, irrigate, moisten, and debride, supporting the healing process rather than directly treating the underlying condition.
No
The device is a wound cleanser, intended for cleansing, irrigating, moistening, and debriding wounds, which are therapeutic actions rather than diagnostic ones.
No
The device description clearly states it is a "wound cleansing solution," which is a liquid substance, 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 (wounds). This is a direct application to the body surface for therapeutic or cleansing purposes.
- Device Description: The description reinforces the intended use as a wound cleansing solution with a mechanical action for removing debris.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state. IVDs are specifically designed for testing samples in vitro (outside the body).
The device is a wound care product applied directly to the wound, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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, 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 Cleanser is intended for use by qualified health care personnel trained in its use.
Product codes
FRO
Device Description
The subject device is a wound cleansing 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. Vashe is offered in various volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal wounds/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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical testing demonstrated biocompatibility of Vashe Wound Cleanser.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K965120, K022670, K042729, K041161, K053167
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
KO60901 EXHIBIT C a marka mana mana mana mana mana mana mara mara mara mara marka marka mara mara mara mara mara mara mara mara mara mara marka marka marka marka marka marka marka marka marka
510(k) SUMMARY OF VASHE™ WOUND CLEANSER
| 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.
320 King of Prussia Road
Radnor, PA 19087 |
| Contact Person | Howard Mann
320 King of Prussia Road
Radnor, PA 19087
484-321-2703
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.
CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670,
Oct. 17th, 2002. Dermacyn™ Wound Cleanser, Oculus Innovative
Sciences, K042729, September 30th, 2004 and Dermacyn™ Wound
Dressing, Oculus Innovative Sciences, K041161, February 1st, 2005.
Biopure™ MTAD™ Root Canal Cleanser, Dentsply International,
K053167, December 8, 2005 |
| Description | The subject device is a wound cleansing 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. Vashe is offered in various volumes. |
| Indications for Use | Vashe™ Wound Cleanser is intended for cleansing, irrigating,
moistening, and debriding acute and chronic dermal lesions, such as
Stage 1-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 Cleanser is intended for use by
qualified health care personnel trained in its use. |
| Substantial Equivalence | The product is similar in function and intended use to:
Allklenz™ and CarraKlenz Wound Cleansers, manufactured by
Healthpoint Medical and Carrington Laboratories, Inc. that include
among their labeled uses the cleansing and irrigation of dermal
wounds and removal of foreign material. Dermacyn™ Wound Cleanser and Wound Dressing manufactured
by Oculus Innovative Sciences, that include among it's labeled
uses the cleansing, moistening and debriding of dermal wounds in
addition to moistening and lubricating absorbent wound dressings. Biopure™ MTAD™ Root Canal Cleanser manufactured by
Dentsply International, that include among its labeled uses the
cleaning and disinfecting of the root canal system. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of Vashe Wound
Cleanser. |
| Conclusion | Vashe™ Wound Cleanser is substantially equivalent to the currently
cleared and marketed Allklenz™ Cleanser, CarraKlenz Wound
Cleansers, Dermacyn™ Wound Cleanser, Dermacyn™ Wound
Dressing and Biopure™ MTAD™ Root Canal Cleanser |
.. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle and profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
PuriCore Inc. c/o Mr. Howard K. Mann Vice President Quality Assurance and Regulatory Affairs 320 King of Prussia Road, Suite 200 Radnor, Pennsylvania 19087
Re: K060901
Trade/Device Name: Vashe™ Wound Solution Regulatory Class: Unclassified Product Code: FRO Dated: May 25, 2006 Received: May 26, 2006
Dear Mr. Mann:
This letter corrects our substantially equivalent letter of June 29, 2006.
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your becally be device is substantially equivalent (for the indications felerenced above and have determined in marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regally manatinent date of the Medical Device American Drug commerce pror to thing 20, 1978, in email and one with the provisions of the Federal Food, Drug, devices that have been roomssined in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appto the general controls provisions of the Act. The r ou may, merciole, market the det result of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller is the 21, Parts 800 to 898. In addition, FDA may be found in the Gode of I cases and
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised had IDA s issuation of a backers of a became of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations administer or registration and listing (21)
comply with all the Act's requirements, including, but not limited to set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800); good manager (20); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. Howard K. Mann
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Exhibit B
Indications for Use
Page __ 1___ of __ 1 __
... . . . . . . . . . . . . . . . . . . .
510(k) Number: K060901
Device Name: Vashe™ Wound Cleansing System
Indications For Use:
Vashe™ Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressuring und 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 Cleanser is intended for use by qualified health care personnel trained in its use.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative. | |
| and Neurological Devices |
16510(k) Number