(146 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vashe® Wound Therapy System:
Based on the provided text, the Vashe® Wound Therapy System is a wound cleanser solution. The document is a 510(k) summary, which indicates a claim of substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to establish new acceptance criteria.
The device is not an AI-powered one, and therefore the details you requested regarding AI performance (test set, training set, experts, MRMC studies, standalone performance) are not applicable.
Here's a breakdown of the information that is available:
Acceptance Criteria and Device Performance for Vashe® Wound Therapy System
The acceptance criteria for the Vashe® Wound Therapy System are not explicitly stated in terms of specific performance metrics within this 510(k) summary. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices. This means the device is considered acceptable if its performance is comparable to or safe and effective as the predicate devices for its intended indications for use.
The study that "proves the device meets the acceptance criteria" is a pre-clinical testing study that demonstrated biocompatibility. The 510(k) process relies heavily on demonstrating similarity to already approved devices rather than establishing new efficacy or performance benchmarks via clinical trials, especially for devices like wound cleansers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: The device should be safe for use in contact with human tissue and not cause adverse biological reactions. (Implied for medical devices) | "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." |
| Functional Equivalence: Performs the intended actions of cleansing, irrigating, moistening, and debriding dermal wounds, and other stated indications. (Implied by comparison to predicate devices) | The description states: "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." The conclusion of the 510(k) is "substantially equivalent" to the predicate devices, implying functional equivalence. |
| Similar Mechanism of Action: Operates through a comparable mechanism to predicate devices. (Implied by comparison to predicate devices) | The device's description mentions "mechanical action of fluid moving across the wound" and "Free Available Chlorine (FAC) that inhibits contamination." This is implicitly compared to predicates like Anasept™ (which "delivering antimicrobial sodium hypochlorite") and Oculus Puracyn™ (which "includes a preservative which contains a broad spectrum of antimicrobial agents"), showing similar approaches to wound care and infection control. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate devices. (Fundamental requirement for 510(k) clearance) | The FDA's clearance letter ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms that no new questions of safety or effectiveness were raised, based on the submitted information. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a non-AI device. The "test set" here would refer to the subjects in the biocompatibility testing, but specific numbers are not provided.
- Data Provenance: The biocompatibility testing likely involved in-vitro and/or in-vivo animal studies, which are standard for such evaluations. The specific country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this is a non-AI device. Ground truth, in this context, would be the results of the biocompatibility tests themselves, assessed against established standards, not expert consensus on findings.
4. Adjudication Method for the Test Set
- Not applicable for a non-AI device. Adjudication methods are typically used in clinical studies or expert reviews of complex data (like medical images) where multiple interpretations are possible. Biocompatibility testing results are usually evaluated against pre-defined scientific standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is not an AI product and does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is not an AI algorithm. Its performance is inherent to the chemical composition and mechanical action of the solution itself.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility testing would be scientific standards and established biological responses to the test materials. This could involve cell viability assays, irritation tests, sensitization tests, and systemic toxicity tests, where the absence of adverse reactions against predefined thresholds constitutes "truth."
8. The Sample Size for the Training Set
- Not applicable as this is a non-AI device. There is no training set mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a non-AI device.
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Exhibit 3:
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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 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 19355484-321-2724 (ph); 610-341-0503 (fax) |
| Date Prepared | February 5th, 2010MAR - 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 withPreservatives, 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 absorbentwound dressings. The mechanical action of fluid moving across the wound provides for themechanism of action and aids in the removal of foreign objects such as dirt and debris. Inaddition, the subject device contains Free Available Chlorine (FAC) that inhibitscontamination within the solution. |
| Indications for Use | Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution) is intendedfor cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, suchas Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first andsecond degree burns, abrasions and minor irritations of the skin in addition to moisteningand 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 byAnacapa™ Technologies, Inc. that includes among it's labeled uses the managementof wounds by maintaining a moist wound environment that is conducive to healing byeither absorbing wound exude or donating moisture while delivering antimicrobialsodium hypochlorite which inhibits the growth of microorganisms.Oculus Puracyn™ Skin and Wound Cleanser with Preservative manufactured byOculus Innovative Sciences, that includes among its labeled uses the debridement ofwounds. The device also includes a preservative which contains a broad spectrum ofantimicrobial agents that inhibit growth of bacteria commonly found in the wound bed.Microcyn™ Wound Gel manufactured by Oculus Innovative Sciences, that includesamong its labeled uses the management of mechanically or surgically debridedwounds. The device includes FAC that inhibits contamination within the hydrogel. |
| Non-clinical Performance | Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound TherapySolution. |
| Conclusion | Vashe® Wound Therapy System containing the Vashe® Wound Therapy+ Solution issubstantially equivalent to the currently cleared and marketed Anasept™ AntimicrobialSkin and Wound Cleanser and Gel, the Oculus Puracyn™ Skin and Wound Cleanser withPreservative, and the Microcyn™ Wound Gel |
ះ ប៉ុ
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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
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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 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
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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
N/A