(49 days)
HPR™ 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 Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
HPR 114 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ 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™ 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.
The provided document is a 510(k) summary for a medical device called "HPR™ Emollient Foam". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving those criteria are met.
Specifically, the document states: "Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory." This indicates that testing was performed, but it does not provide any specific acceptance criteria or the results or details of the study itself.
Therefore, I cannot provide most of the requested information.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
- Cannot provide. The document states that testing was conducted and results were satisfactory but does not specify the acceptance criteria or report any performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot provide. The document mentions functional and performance testing but provides no details about sample size, study design, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot provide. This information is typically relevant for studies evaluating human interpretation aided by or compared to AI. This device is an emollient foam, not an AI or diagnostic imaging device, so "ground truth" in this context would likely refer to clinical outcomes, not expert interpretation of data. Even so, no details of such a study are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot provide. As above, this is not relevant or provided for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot provide. This type of study is for diagnostic or AI-assisted devices involving human readers. HPR™ Emollient Foam is a topical product, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot provide. This refers to AI algorithm performance. HPR™ Emollient Foam is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot provide. While a clinical trial for an emollient foam would typically use patient-reported outcomes or clinical assessments as "ground truth" (e.g., reduction in itching, pain, skin condition improvement), the document does not mention the specifics of the study, nor how "ground truth" was established.
8. The sample size for the training set
- Cannot provide. This is relevant for AI models, not for a topical emollient foam.
9. How the ground truth for the training set was established
- Cannot provide. This is relevant for AI models, not for a topical emollient foam.
In summary, the provided 510(k) document only states that "Functional and performance testing has been conducted... and all results are satisfactory" for the HPR™ Emollient Foam. It does not offer any specifics on the acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods that would be necessary to answer your detailed questions.
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K 113772
FEB - 9 2012
510(k) Summary
Date Prepared: December 19, 2011
| 1. | Owner's Name: | PruGen, IP Holdings Inc.8714 E. Vista Bonita DriveScottsdale, AZ 85255 |
|---|---|---|
| Contact Person: | Bhiku Patel, Ph.D.(T): 480-585-0122 ext. 3(F): 480-393-5873(E): bpatel@prugen.com |
HPRTM Emollient Foam Proprietarv Name: 2. 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™ Emollient Foam is substantially equivalent to the following currently marketed device: Hylatopic ™ Emollient Foam cleared under K083024.
Device Description: 4.
HPR 114 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ 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™ 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.
Intended Use of the Device: ડ.
HPRTM 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™ 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 HPR™ 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 & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PruGen. IP Holdings Inc. % Bhiku Patel, Ph.D. 8714 East Vista Bonita Drive Scottsdale, Arizona 85255
FEB - 9 2012
Re: K113772
Trade/Device Name: HPR™ Emollient Foam Regulatory Class: Unclassified Product Code: FRO Dated: January 24, 2012 Received: January 31, 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Pon Dof-b
Nof L.
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Date: December 19, 2011
INDICATIONS FOR USE
Device Trade Name: HPR™ Emollient Foam
510(k) number: K113772
Rx Only
FOR TOPICAL DERMATOLOGICAL USE ONLY
HPR™ 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 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 Ksonetu MKM
Page 1 of
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Ivision of Sinces
510(k) Number K113772
N/A