(261 days)
Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.
PruClair™ non-steroidal cream is a non-sterile, viscous emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.
The provided K093156 510(k) summary for "PruClair™ non-steroidal cream" does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or MRMC studies) typically associated with an AI/ML device.
This document describes a drug/biologic product (a cream), not an AI/ML powered medical device. The "functional testing" mentioned is likely related to the chemical and physical properties of the cream, its stability, safety (e.g., irritation studies), and possibly its efficacy in a clinical setting as a topical treatment for dermatoses, minor burns, cuts, lacerations, and irritations.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving device performance as they would apply to an AI/ML device. The information you are asking for is not present in this type of submission for a non-AI/ML product.
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K09 3156
page 1 of 2
510(k) Summary
Date Prepared: June 22, 2010
JUN 2 4 2010
| 1. | Owner's Name: | PruGen IP Holdings, Inc.8711 East Pinnacle Peak RoadSuite C-201PMB 225Scottsdale, AZ 85255 |
|---|---|---|
| Contact Person: | Robert L. Knechtel(T): 480-563-2406(F): 815-261-5953(E): rknechtel@prugen.com | |
| 2. | Proprietary Name: | PruClair™ non-steroidal cream |
| Common Name: | Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic | |
| Classification Name: | Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic(Product Code MGQ) |
Substantially Equivalent Devices: PruGen, Inc. believes that PruClair™ non-steroidal cream is 3. substantially equivalent to the following currently marketed device: Atopiclair® Cream cleared under K024367.
Device Description: PruClair™ non-steroidal cream is a non-sterile, viscous 4. emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.
INDICATIONS FOR USE- PRESCRIPTION
Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
INDICATIONS FOR USE- OTC
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.
DIRECTIONS FOR USE- PRESCRITION AND OTC
PruClair™ non-steroidal cream is applied to the affected skin areas 2 to 3 times a day (or as needed), and massage gently into the skin. If the skin is broken, cover PruClair™ nonsteroidal cream with a dressing of choice.
PHYSICAL DESCRIPTION OF DEVICE
PruClair™ cream is an off-white, nonsteroidal cream comprised of Deionized water, Ethylhexyl palmitate, Pentylene glycol, Butyrospermum parkii, Capryloyl glycine, Glyceryl stearate, PEG-100 stearate, Arachidyl glucoside, Behenyl alcohol, Bisabolol, Tocopheryl acetate (antioxidant), Glycyrrhetinic acid, Carbomer, Ethylhexylglycerin, Piroctone olamine, Sodium hydroxide, Allantoin, DMDM hydantoin, Vitis vinifera, Disodium EDTA, Ascorbyl tetraisopalmitate, Sodium hvaluronate, Propyl gallate, Telmesteine and Butylene glycol.
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K093156
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Intended Use of the Device: The prescription form of PruClair™ non-steroidal cream requires a 5. physician diagnosis of a disease state and is indicated to manage various types of dermatoses. The OTC version of the device is indicated for minor burns, minor lacerations, and minor irritations.
Summary of Technical Characteristics of Device compared to Predicate Devices: 6. The referenced predicate device is also a non-sterile emulsion that is applied to relieve the symptoms of various dermatoses.
Conclusions: Functional testing has been conducted to assess the safety and efficacy PruClair™ 7. non-steroidal cream and results are satisfactory.
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Image /page/2/Picture/1 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 a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Prugen IP Holdings, Inc. % Robert L. Knechtel, M.D. EVP and General Counsel 8711 East Pinnacle Peak Road Suite C201, PMB 225 Scottsdale, Arizona 85255
JUN 2 4 2010
Re: K093156
Trade/Device Name: PRuClair™ non-steroidal cream Product Code: FRO Dated: April 15, 2010 Received: April 16, 2010
Dear Dr. Knechtel:
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 deternaination 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 - Robert L. Knechtel, M.D.
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,
Mark N. Molkerson
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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INDICATIONS FOR USE
(OTC VERSION)
Device Trade Name: PruClair™ non-steroidal cream 510(k) number: K093156
PruClair™ non-steroidal cream is indicated for minor cuts, minor cuts, minor lacerations, and minor irritations.
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane McKay
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093156
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INDICATIONS FOR USE
(PRESCRIPTION VERSION)
Device Trade Name: PruClair™ non-steroidal cream 510(k) number: K093156
Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
Prescription Use メ (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
N/A