(115 days)
Not Found
No
The device description and performance studies focus on the chemical composition and barrier properties of the hydrogel, with no mention of AI or ML technologies.
Yes.
The device is intended for the management and relief of pain, burning, and itching associated with various dermatoses and burns, and aids in maintaining a moist wound and skin environment for healing, which are therapeutic functions.
No
The device is described as aiding in the management and relief of symptoms, and maintaining a moist environment for healing, not for diagnosing a condition. It requires a physician to diagnose the disease state prior to its prescription.
No
The device is a hydrogel, which is a physical substance applied to the skin and wounds, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management and relief of symptoms associated with various dermatoses and burns, and maintaining a moist wound environment. This is a therapeutic or supportive function applied directly to the patient's skin and wounds.
- Device Description: The description details a hydrogel applied topically to the skin to form a protective barrier and retain moisture.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (like blood, urine, or tissue) outside the body, or provide information for diagnostic purposes. IVDs are specifically designed for testing samples in vitro to provide diagnostic information.
The device is a topical hydrogel intended for wound and skin management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Vashe® Skin and Wound Hydrogel - For Professional Use Only
Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Product codes
FRO
Device Description
Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. The product contains hypochlorous acid as a preservative. The Hydrogel will be supplied in plastic tottles as described in Section 3.2. The device is presented as a prescription product that requires the physician 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
Skin, Wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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)
Vashe® Skin and Wound Hydrogel has been subjected to in-vivo and in-vitro biocompatibility testing to ISO-10993 standards and. These results demonstrate that Vashe® Skin and Wound Hydrogel is safe for use when in contact with abraded, breached or compromised skin. Furthermore, we have concluded that Vashe® Skin & Wound Hydrogel at its minimum recommended concentration demonstrates effective preservative activity and supports a preservative claim.
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
K123071 p.1/2
Vashe® Skin & Wound Hydrogel
:
510 (k) Premarket Notification
JAN 2 4 2013
| 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 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 24th, 2012 |
| Trade Name | Vashe® Skin & Wound Hydrogel |
| Common Name | Hydrogel Wound Dressing |
| Classification | |
| Name | Dressing, wound and burn drug/hydrogel |
| Predicate Devices | Epicyn™ HydroGel, Oculus Innovative Sciences, Inc., K102945, February 2nd, 2011. |
| Device Description | Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. |
| The gel forms a protective barrier which retains moisture and provides relief of | |
| the burning and itching experienced with various dermatoses, including atopic | |
| dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel | |
| when applied to diseased skin forms a protective barrier that helps to maintain a | |
| moist wound and skin environment. The product contains hypochlorous acid as a | |
| preservative. The Hydrogel will be supplied in plastic tottles as described in | |
| Section 3.2. | |
| The device is presented as a prescription product that requires the physician to | |
| diagnose the disease state and prescribe the product. | |
| Intended Use | Vashe® Skin and Wound Hydrogel - For Professional Use Only |
| Under the supervision of a health care professional, Vashe® Skin and Wound | |
| Hydrogel is indicated for the management and relief of pain, burning and itching | |
| experienced with various dermatoses, including atopic dermatitis, allergic contact | |
| dermatitis and radiation dermatitis, as well as for the relief of pain from first and | |
| second degree burns, and aids to relieve dry waxy skin by maintaining a moist | |
| wound and skin environment. A moist wound and skin environment is beneficial | |
| to the healing process. | |
| These indications are similar to the predicate device, Epicyn™ Hydrogel, K102945 | |
| cleared on February 2011. | |
| Summary of | |
| Technological | |
| Characteristics | |
| Compared to the | |
| Predicate Device | Vashe® Skin and Wound Hydrogel is an aqueous based topical hydrogel which |
| controls moisture and wound exudates. Hydrogel characteristics are imparted by | |
| an inert viscosity controlling agent and emollient. Vashe® Skin and Wound | |
| Hydrogel maintains a moist wound environment that supports the wound healing | |
| process by encouraging autolytic debridement. The hydrogel barrier manages | |
| pain and itch by protecting the wound from contamination and irritation | |
| Vashe® Skin and Wound Hydrogel is similar in function and has the same intended | |
| use as the predicate device Epicyn™ HydroGel legally marketed via 510(k) | |
| K102945 (Atrapro Antipruritic Hydrogel). | |
| Test & Conclusions | Vashe® Skin and Wound Hydrogel has been subjected to in-vivo and in-vitro |
| biocompatibility testing to ISO-10993 standards and. These results demonstrate | |
| that Vashe® Skin and Wound Hydrogel is safe for use when in contact with | |
| abraded, breached or compromised skin. Furthermore, we have concluded that | |
| Vashe® Skin & Wound Hydrogel at its minimum recommended concentration | |
| demonstrates effective preservative activity and supports a preservative claim. |
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Vashe® Skin & Wound Hydrogel
510 (k) Premarket Notification ______________________________________________________________________________________________________________________________________________________________________________
:
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 24, 2013
PuriCore Inc. % Mr. Art Morse 508 Lapp Road Malvern, Pennsylvania 19355
Re: K123071
Trade/Device Name: Vashe® Skin and Wound Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2012 Received: December 21, 2012
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 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
3
Page 2 - Mr. Art Morse
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. 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 is black and consists of the word "PuriCore" in a bold, sans-serif font. The "o" in "Core" is replaced with a circular image that appears to be a globe or a cell. Below the logo is the tagline "Pure Science. Pure Life."
Indications for Use Statement
510(k) Number:
Device Name: Vashe® Skin and Wound Hydrogel
Indications for Use:
Vashe® Skin and Wound Hydrogel – For Professional Use Only
Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Prescription Use XX (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use:
(21 CFR 801 Subpart C)
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 K123071
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