(261 days)
K07143
Not Found
No
The device description and intended use clearly describe a topical cream formulation with no mention of software, algorithms, or data processing that would indicate AI/ML technology. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The cream is indicated to manage dermatoses and helps relieve dry, waxy skin, contributing to the healing process, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device description indicates PR™ cream is a "non-sterile cream formulation intended for topical use only" for managing dermatoses and relieving dry, waxy skin. Its purpose is to treat or manage existing conditions, not to diagnose them. It is applied after a "physician diagnosis disease state" has already occurred, meaning it relies on a prior diagnosis and does not perform diagnostic functions itself.
No
The device description clearly states it is a "non-sterile cream formulation intended for topical use only," indicating it is a physical product, 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 to manage various types of dermatoses by topical application to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a cream formulation for topical use. IVDs are typically reagents, instruments, or systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Anatomical Site: The anatomical site is the skin, and the application is topical. IVDs typically involve analyzing internal bodily fluids or tissues.
- No mention of diagnostic testing: There is no mention of analyzing samples, providing diagnostic information, or any of the typical characteristics of an IVD.
The device is clearly described as a topical cream for treating skin conditions, which falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FRO
Device Description
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. PR™ 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.
PR™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K07143
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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
2
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
3
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