(87 days)
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.
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.
The provided text is a 510(k) summary for the Vashe™ Wound Cleanser and associated FDA correspondence. This device is a wound cleansing solution, and the documentation focuses on demonstrating its substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel diagnostic or therapeutic device.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in this type of submission.
Here's an attempt to extract and interpret the information based on the provided text, noting where specific details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device must not cause adverse biological reactions. | "Pre-clinical testing demonstrated biocompatibility of Vashe Wound Cleanser." |
| Functionality/Intended Use Equivalence: Device performs similar wound cleansing, irrigating, debriding, and moistening functions as predicates. | The submission asserts and FDA concurs that the device is "substantially equivalent in function and intended use" to the listed predicate devices based on its description and indicated uses. |
| Safety: Device is safe for its intended use. | Demonstrated through substantial equivalence to legally marketed predicate devices that are presumed safe. |
| Effectiveness: Device is effective for its intended use. | Demonstrated through substantial equivalence to legally marketed predicate devices that are presumed effective. |
2. Sample Size Used for the Test Set and Data Provenance
- The document describes pre-clinical testing for biocompatibility, but does not specify a "test set" in the context of clinical performance data or algorithm validation.
- Sample Size: Not specified. Pre-clinical testing often involves in-vitro or animal studies, but no numbers are provided here.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While "pre-clinical" implies lab or animal studies, the specific details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to this type of submission. There is no mention of a "test set" requiring expert-established ground truth in the context of diagnostic performance. The evaluation is based on substantial equivalence to existing products.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" and corresponding adjudication methods are mentioned for evaluating device performance in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not applicable. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical wound cleanser, not an algorithm.
7. The Type of Ground Truth Used
- For the biocompatibility testing, the "ground truth" would be established by standard biological assays and observation for adverse reactions, comparing results against established safety thresholds for medical devices.
- For the overall device, the "ground truth" for substantial equivalence is derived from a comparison of its characteristics (indications, technology, performance, safety) to those of the legally marketed predicate devices. The predicates themselves are considered "proven" safe and effective through prior FDA clearance.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI model.
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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 beingsubmitted in accordance with the requirements of 21 C.F.R §807.92. |
|---|---|
| Submitter | PuriCore, Inc.320 King of Prussia RoadRadnor, PA 19087 |
| Contact Person | Howard Mann320 King of Prussia RoadRadnor, PA 19087484-321-2703610-341-0503 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 InnovativeSciences, K042729, September 30th, 2004 and Dermacyn™ WoundDressing, 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 forcleansing, irrigating, and debriding dermal wounds in addition tomoistening and lubricating absorbent wound dressings. The mechanicalaction of fluid moving across the wound provides for the mechanism ofaction and aids in the removal of foreign objects such as dirt anddebris. 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 asStage 1-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgicalwounds, first and second degree burns, abrasions and minor irritationsof the skin in addition to moistening and lubricating absorbent wounddressings. The Vashe™ Wound Cleanser is intended for use byqualified 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 byHealthpoint Medical and Carrington Laboratories, Inc. that includeamong their labeled uses the cleansing and irrigation of dermalwounds and removal of foreign material. Dermacyn™ Wound Cleanser and Wound Dressing manufacturedby Oculus Innovative Sciences, that include among it's labeleduses the cleansing, moistening and debriding of dermal wounds inaddition to moistening and lubricating absorbent wound dressings. Biopure™ MTAD™ Root Canal Cleanser manufactured byDentsply International, that include among its labeled uses thecleaning and disinfecting of the root canal system. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of Vashe WoundCleanser. |
| Conclusion | Vashe™ Wound Cleanser is substantially equivalent to the currentlycleared and marketed Allklenz™ Cleanser, CarraKlenz WoundCleansers, Dermacyn™ Wound Cleanser, Dermacyn™ WoundDressing and Biopure™ MTAD™ Root Canal Cleanser |
.. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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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.
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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
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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
N/A