(49 days)
Not Found
No
The device description and intended use clearly describe a topical emollient foam for skin conditions, with no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is indicated to manage and relieve symptoms (burning, itching, pain) associated with various dermatoses and aids in healing by maintaining a moist environment, which are therapeutic functions.
No
The device is an emollient foam used to manage and relieve symptoms associated with dermatoses and dry skin, and its description explicitly states that a physician is required for the diagnosis of the disease state before prescribing the product. The device itself does not perform any diagnostic function.
No
The device is described as a topical aerosol foam, which is a physical substance applied to the skin, 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 is to manage and relieve symptoms associated with various dermatoses by topical application to the skin. This is a therapeutic and symptomatic treatment, not a diagnostic test performed on samples from the body.
- Device Description: The device is a topical aerosol foam applied directly to the skin. It forms a protective barrier and maintains a moist environment. This is a physical interaction with the skin surface, not an analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, HPRTM Plus Emollient Foam is a topical medical device intended for the management of skin conditions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HPR™ Plus Emollient Foam is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HPR™ Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The HPR " Plus Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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
Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory.
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 effectiveness of HPR™ Emollient Foam and all results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Summary
113774
Date Prepared: December 19, 2011
| 1. | Owner's Name: | PruGen, IP Holdings Inc. |
|---|---|---|
| 8714 E. Vista Bonita Drive | ||
| Scottsdale, AZ 85255 | ||
| Contact Person: | Bhiku Patel, Ph.D. | |
| (T): 480-585-0122 ext. 3 | ||
| (F): 480-393-5873 | ||
| (E): bpatel@prugen.com |
- HPRTM Plus Emollient Foam 2. Proprietary Name: Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic Common Name: Classification Name: Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic (Product Code MGQ)
Substantially Equivalent Device: 3.
PruGen IP Holdings, Inc. believes that HPR™ Plus Emollient Foam is substantially equivalent to the following currently marketed device: Hylatopic™ Plus Emollient Foam cleared under K093051.
Device Description: 4.
HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The HPR " Plus Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
5. Intended Use of the Device:
HPR "M Plus Emollient Foam is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HPR™ Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Summary of Technical Characteristics of Device compared to Predicate Devices 6.
The predicate device referenced is a non-sterile foam that is applied topically to relieve the symptoms of various dermatoses. When HPRTM Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The rubbed in product is equivalent to gel or cream.
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.K 113774
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Testing and Conclusions: 7.
Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory.
2
Image /page/2/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-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 9 2012
PruGen, IP Holdings Inc. % Bhiku Patel, Ph.D. 8714 East Vista Bonita Drive Scottsdale, Arizona 85255
Re: K113774
Trade/Device Name: HPR™ Plus Emollient Foam Regulatory Class: Unclassified Product Code: FRO Dated: January 24, 2012 Received: January 25, 2012
Dear Dr. Patel:
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
3
Page 2 - Bhiku Patel, Ph.D.
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.
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. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use .
4
Date: December 19, 2011
INDICATIONS FOR USE
Device Trade Name: HPR™ Plus Emollient Foam
510(k) number: K113774
Rx Only
FOR TOPICAL DERMATOLOGICAL USE ONLY
HPRTM Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Prescription Use X (21 CFR 801 Subpart D)
Over-The-Counter (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone Mixm
Division Sign-( Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K113774