(136 days)
No
The description focuses on the chemical composition and intended use of a wound therapy solution, with no mention of AI or ML technologies.
No
The device is described as a "wound cleanser solution" intended for cleansing, irrigating, moistening, and debriding wounds, which are supportive care functions rather than direct therapeutic treatment of the underlying condition.
No
The device description and intended use clearly state that Vashe® Wound Therapy Solution is for cleansing, irrigating, moistening, and debriding wounds, and that it acts as a wound cleanser and preservative. There is no mention of it being used to diagnose a disease or condition. The text also states that a practitioner needs to "diagnose the disease state and prescribe the product," indicating the product itself is not diagnostic.
No
The device description clearly states it is a "wound cleanser solution" and contains "hypochlorous acid," indicating it is a physical 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. This is a direct application to the wound for therapeutic purposes, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description focuses on the chemical composition and function as a wound cleanser. It doesn't mention any analysis of biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays to detect specific substances
The device is clearly intended for wound care and treatment, which falls under the category of therapeutic devices, not diagnostic devices.
N/A
Intended Use / Indications for Use
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.
These indications are identical to the predicate device Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918.
Product codes
FRO
Device Description
Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution.
The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.
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 healthcare 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)
Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for Chemical Stability (See Section 6).
Biocompatibility studies were conducted under verse case scenario, doubled initial concentration of available free chlorine relative to the beginning of shelf life, and reduced below minimal pH and doubled final concentration of available free chlorine relative to the end of shelf life (See Section 7)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
:
K123072
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510(k) SUMMARY |
| SECTION 2 | 510(k) SUMMARY | |
|---|---|---|
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. | |
| Submitter | PuriCore Inc. | |
| 508 Lapp Road | ||
| Malvern, PA 19355 | ||
| Contact Person | Art Morse | |
| Director of Quality Assurance and Regulatory Affairs | ||
| PuriCore Inc. | ||
| 508 Lapp Road | ||
| Malvern, PA 19355 | ||
| 484 321 2728 (O), 484 321 2704 (F), 610 306 2870 (C) | ||
| Date Prepared | September 28th, 2012 | |
| Trade Name | Vashe® Wound Therapy Solution | |
| Common Name | Wound Cleanser | |
| Classification Name | Solution, Saline, (Wound Dressing) | |
| Predicate Devices | Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution); PuriCore Inc. K100918, August 9th, 2010 | |
| Modified Device Description | Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution. | |
| The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product. | ||
| Intended Use | 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. | |
| These indications are identical to the predicate device Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918. | ||
| Summary of Technological Characteristics Compared to the Predicate Device | Vashe® Wound Therapy Solution similar to Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918, includes among its labeled uses the 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 predicate device Vashe® Wound Therapy System (including Vashe® Wound Therapy+ Solution), K100918, produces Vashe® Wound Therapy Solution for intended use at the customer's location. The modified device, Vashe® Wound Therapy Solution, is produced by the Vashe® Production System in a validated manufacturing process at PuriCore Inc. Malvern, PA, bottled and distributed in bottles to customers. All other indications are identical. These differences are not critical because the intended use and the fundamental scientific technology are the same. | ||
| PREDICATE DEVICES | MODIFIED DEVICE | |
| K100918 | ||
| Vashe® Wound® Therapy System and | ||
| Solution | Vashe® Wound® Therapy Solution | |
| Aqueous solution and electrochemical | ||
| generator: | Aqueous solution: | |
| Design | ||
| Material | Vashe® Wound® Therapy Solution | |
| (Produced from on-site Vashe® Wound® | ||
| Therapy System) to the following product | ||
| specifications: | Vashe® Wound® Therapy Solution | |
| (Produced from central manufacturing, | ||
| packaging, and distribution from PuriCore in | ||
| Malvern, PA) to the following product | ||
| specifications: | ||
| ● Available Free Chlorine (AFC) at 150 to | ||
| 250 ppm | ||
| ● pH at 5.3 to 6.75ppm | ● Upper specification expanded Available | |
| Free Chlorine (AFC) at 150 to 330 ppm | ||
| ● Lower specification expanded pH at 3.5 | ||
| to 6.75ppm | ||
| Chemical | ||
| Composition | Approximate percentages: | |
| Water 99.574% | ||
| Sodium Chloride (0.4%) | ||
| Hypochlorous Acid (0.025%) | ||
| Sodium Chlorate (0.001%) | Approximate percentages: | |
| Water 99.574% | ||
| Sodium Chloride (0.4%) | ||
| Hypochlorous Acid (0.025%) | ||
| Sodium Chlorate (0.001%) | ||
| Wound Therapy Solution with Hypochlorous | ||
| Acid as solution preservative | Wound Therapy Solution with Hypochlorous | |
| Acid as solution preservative | ||
| Energy Source | No Energy Requirements | |
| Aqueous Solution | No Energy Requirements | |
| Aqueous Solution | ||
| Substantial | ||
| Equivalence - | ||
| Effectiveness | The Modified Device utilizes the same fundamental scientific technology as the predicate | |
| devices. The only difference is the specification changes and place of production: at the | ||
| Customer's Location (K100918) verses PuriCore in Malvern, PA (modified device). | ||
| Non-Clinical equivalency testing was conducted for Shelf Life and Evaluated for Chemical | ||
| Stability (See Section 6). | ||
| Substantial | ||
| Equivalence - | ||
| Safety | Preservative effectiveness of hypochlorous acid at below minimal recommended | |
| concentration of hypochlorous acid | ||
| Biocompatibility studies were conducted under verse case scenario, doubled initial | ||
| concentration of available free chlorine relative to the beginning of shelf life, and reduced | ||
| below minimal pH and doubled final concentration of available free chlorine relative to the | ||
| end of shelf life (See Section 7) | ||
| Test & | ||
| Conclusion | Modifications to Vashe® Wound® Therapy Solution has not changed the Intended Use or has | |
| not altered the Fundamental Scientific Technology of the predicate device; Vashe® Wound® | ||
| Therapy System (with Vashe® Wound® Therapy® Solution) K100918. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Puricore, Incorporated % Mr. Art Morse Director of Quality Assurance and Regulatory Affairs 508 Lapp Road Malvern, Pennsylvania 19355
February 14, 2013
Re: K123072
Trade/Device Name: Vashe® Wound Therapy Solution Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2013 Received: January 31, 2013
Dear Mr. Morse:
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 truthfull 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 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. Art Morse
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for PuriCore. The logo consists of the word "PuriCore" in a bold, sans-serif font. Below the logo is the tagline "Pure Science. Pure Life." The logo is simple and clean, and the tagline emphasizes the company's focus on science and life.
Indications for Use Statement
510(k) Number:
Device Name: Vashe Wound Therapy Solution
Indications for Use:
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.
Vashe Wound Therapy Solution is intended for use by a qualified healthcare personnel trained in its use.
Prescription Use XX
OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDHR, Office of Device Evaluation (ODE)
Jiyoung Dang
(Division Sign-Off) Division of Surgical Devices 510(k) Number K123072
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