(261 days)
PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
PR™ cream is a non-sterile cream formulation intended for topical use only. It is presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician. PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.
The provided text is a 510(k) summary for PR™ Cream, a topical dermatological cream. It is a marketing authorization document focusing on substantial equivalence to a predicate device, rather than detailed clinical study results demonstrating performance against specific acceptance criteria.
Therefore, the document does not contain the information requested to comprehensively describe acceptance criteria and the study proving the device meets them. Specifically, the following information is missing or not applicable:
- A table of acceptance criteria and the reported device performance: The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory," but it does not provide specific acceptance criteria or quantitative performance measures.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 device is a topical cream, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as it is not an algorithm-based device.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not relevant for a drug/cream.
- How the ground truth for the training set was established: Not relevant for a drug/cream.
Summary of what is present:
The document describes PR™ Cream as a non-sterile cream formulation for topical use, intended for prescription use, and indicated to manage various types of dermatoses (atopic dermatitis, allergic contact dermatitis, and irritant contact dermatitis). It aims to relieve dry, waxy skin by maintaining a moist wound and skin environment beneficial to healing. The submission asserts substantial equivalence to Tetrix® Cream (cleared under K07143). The conclusion states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory." However, no specific details about this testing (methodology, results, or acceptance criteria) are provided in this summary.
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093159
page 1 of 1
510(k) Summarv
Date Prepared: June 9, 2010
JUN 2 4 2010
| 1. | Owner's Name: | PruGen IP Holdings, Inc. |
|---|---|---|
| 8711 East Pinnacle Peak Road | ||
| Suite C-201 | ||
| PMB 225 | ||
| Scottsdale, AZ 85255 | ||
| Contact Person: | Robert L. Knechtel | |
| 8711 East Pinnacle Peak Road | ||
| Suite C-201 | ||
| PMB 225 | ||
| Scottsdale, AZ 85255 | ||
| (T): 480-563-2406 | ||
| (F): 815-261-5953 | ||
| (E): rknechtel@prugen.com | ||
| 2. | Proprietary Name: | PRT™ Cream |
| Common Name: | Dressing, Wound & Burn, Hydrogel w/ Drug or Biologi | |
| Classification Name: | Dressing, Wound & Burn, Hydrogel w/ Drug or Biologi |
Substantially Equivalent Devices: PruGen, Inc. believes that PR™ Cream is substantially 3. equivalent to the following currently marketed device: Tetrix® Cream cleared under 13 07143.
Device Description: PR™ cream is a non-sterile cream formulation intended for topical use only. It is 4. presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician.
PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.
- Intended Use of the Device: PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermativas. PRTM cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Summary of Technical Characteristics of Device compared to Predicate Devices: 6. The referenced predicate device is also a non-sterile cream that is applied to relieve the symptoms of various dermatoses.
- Conclusions: Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 4 2010
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
Re: K093159
Trade/Device Name: PR™ 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 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 - 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. Melke 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
Device Trade Name: PR™ Cream 510(k) number: K093159
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
PR ™ cream is a non-sterile cream formulation intended for prescription use only.
INDICATIONS AND USAGE:
PRTM cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the volly, waxy sking process.
Prescription Use X (Part 21 CFR 801 Subpart D) .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
David Kraeffermxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093159
N/A