HPR PLUS EMOLLIENT FOAM

K113774 · Prugen IP Holdings, Inc. · FRO · Feb 9, 2012 · SU

Device Facts

• Record ID: K113774
• Device Name: HPR PLUS EMOLLIENT FOAM
• Applicant: Prugen IP Holdings, Inc.
• Product Code: FRO · SU
• Decision Date: Feb 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

HPR Plus Emollient Foam is a non-sterile, topical aerosol foam; dispensed as foam, propellant dissipates, product rubbed into affected skin. Forms protective barrier to maintain moist wound and skin environment. Prescription product; physician diagnoses disease state and prescribes. Used in clinical or home settings; applied by patient or caregiver. Benefits patient by managing symptoms of dermatoses and supporting healing process.

Clinical Evidence

Bench testing only. Functional and performance testing conducted to assess safety and effectiveness; results satisfactory.

Technological Characteristics

Non-sterile, off-white, low odor, fragrance-free topical aerosol foam. Propellant-based delivery system. Forms a protective barrier on skin. No software or electronic components.

Indications for Use

Indicated for patients suffering from dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis, to manage burning, itching, and pain, and to relieve dry, waxy skin.

Predicate Devices

• Hylatopic™ Plus Emollient Foam (K093051)

Submission Summary (Full Text)

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### 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): [e-mail] |

- 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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### 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.

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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

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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 [phone] or [phone] 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 .

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### 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