(27 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, postsurgical 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 is a wound cleansing and disinfecting solution that is intended for cleansing, irrigating, debriding and disinfecting 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 an FDA clearance letter for a later submission (K092232) for Vashe® Wound Cleanser. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device's performance.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and sample sizes for testing and training sets cannot be extracted from this document in the typical sense applied to a performance study for, for example, an AI medical device.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Performance for wound cleansers is typically demonstrated through biocompatibility, chemical and physical properties, and a comparison of intended use to similar predicate devices. The document does not specify quantitative "acceptance criteria" in the format one might expect for a performance study (e.g., specific sensitivity/specificity thresholds). Instead, "performance" is implicitly demonstrated through substantial equivalence to existing, legally marketed devices.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic, non-irritating, non-sensitizing outcomes. | Pre-clinical testing demonstrated biocompatibility of the Vashe Wound Cleanser. (K060922 summary) |
| Mechanism of Action: Aids in removal of foreign objects, cleansing, irrigating, debriding. | "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." (K060922 summary) |
| Intended Use Equivalence: Cleansing, irrigating, moistening, debriding, disinfecting acute and chronic dermal lesions, and moistening/lubricating absorbent wound dressings. | Vashe™ is "similar in function and intended use" to predicate devices for these indications. (K060922 summary) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a "test set" in the context of an algorithm or performance study involving specific data samples (e.g., patient images or cases). The "pre-clinical testing" for biocompatibility would have involved a sample size of test subjects (e.g., animals or in vitro cultures), but this specific information is not provided.
- Sample Size for Test Set: Not specified in the provided text for a "test set" for performance evaluation. The "pre-clinical testing" likely involved a sample size for biocompatibility testing, but details are not given.
- Data Provenance: Not applicable in the context of a "test set" for algorithm performance. The pre-clinical testing would have been conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The device is a wound cleanser, not an AI diagnostic device that requires expert-established ground truth on a test set of medical cases. Biocompatibility testing is typically assessed by laboratory experts following standardized protocols, not by medical experts establishing "ground truth" on patient data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. There is no "test set" or diagnostic assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device is a wound cleanser, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a wound cleanser, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used for AI medical devices (e.g., pathology, outcomes data) is not directly applicable here. For a wound cleanser, the "ground truth" for demonstrating safety and effectiveness relies on:
- Biocompatibility testing standards: Meeting established standards for non-toxicity, non-irritation, etc.
- Chemical and physical properties: Verifying the composition and stability of the solution.
- Clinical experience with predicate devices: Relying on the known safety and effectiveness of similar products already on the market.
8. The Sample Size for the Training Set
This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set with established ground truth.
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Attachment 4
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922-
510 (k) Summary
| 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 | Sterilox Technologies, 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 and disinfecting solution that isintended for cleansing, irrigating, debriding and disinfecting dermalwounds in addition to moistening and lubricating absorbent wounddressings. The mechanical action of fluid moving across the woundprovides for the mechanism of action and aids in the removal of foreignobjects such as dirt and debris. Vashe is offered in various volumes. |
| Indications for Use | Vashe™ Wound Cleanser and Disinfectant is intended for cleansing,irrigating, moistening, debriding and disinfecting acute and chronicdermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabeticulcers, post-surgical wounds, first and second degree burns, abrasionsand minor irritations of the skin in addition to moistening andlubricating absorbent wound dressings. |
| 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 labeled usesthe 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 the Vashe WoundCleanser. |
| Conclusion | Vashe™ Wound Cleanser is substantially equivalent to the currentlycleared and marketed Allklenz™ Cleanser, CarraKlenz WoundCleansers, Dermacyn™ Wound Cleanser, Dermacyn™ Wound Dressingand 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 Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing to the right and has three stripes on each wing. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
PuriCore Inc. % Mr. Dennis J. Mahoney Director of Quality Assurance/ Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355
AUG 1 9 2009
Re: K092232
Trade/Device Name: Vashe® Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2009 Received: August 22, 2009
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.
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 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.
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Page 2 - Mr. Dennis J. Mahoney
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/ucm1158001, prefact 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/cdrh/mdr/ 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 tollom are (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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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92232 11,
Attachment 2
Indications for Use Statement
12092232 510(k) Number :
Vashe® Wound Cleanser Device Name :
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, postsurgical 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 used by qualified health care personnel trained in its use
Prescription Use
(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 MKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092232
N/A