(79 days)
Emulsion SBTM is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
Emulsion SB 100 is a non-sterile, viscous, lipid rich emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in a 90 gm tube.
Here's an analysis of the provided text regarding the Emulsion SB™ device, focusing on acceptance criteria and study details:
Analysis of Acceptance Criteria and Device Performance for Emulsion SB™
Based on the provided 510(k) summary (K110732), it is crucial to note that this submission does not contain the detailed study information typically found for devices that rely on clinical performance data for substantial equivalence. This is a topical emulsion, primarily compared to a predicate device (Epiceram®) based on its characteristics and intended use. The 510(k) summary states:
"Functional and performance testing has been conducted to assess the safety and efficacy of Emulsion SB™ and the results are satisfactory."
This statement is very general and does not provide specific acceptance criteria or detailed performance metrics. For devices like topical emulsions, the "acceptance criteria" are often related to:
- Formulation equivalence: Similarity in ingredients and their concentrations compared to the predicate device.
- Biocompatibility: Absence of irritation or sensitization.
- Stability: Shelf-life and physical stability of the emulsion.
- Functionality: Ability to spread, absorb, and maintain a moist environment.
- Clinical Efficacy (if a clinical study was performed): Often assessed through subjective symptom reduction (burning, itching, dryness) and objective measures like skin hydration or barrier function. However, the provided document does not detail any clinical study for Emulsion SB™ beyond the general statement of "satisfactory" results.
Given the lack of specific data in the provided document, the table below will reflect that information is Not Provided (NP) where applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety | NP (Assumed: Biocompatibility, non-toxicity) | "Satisfactory" |
| Efficacy | NP (Assumed: Reduction of dry skin, burning, itching; maintenance of moist skin environment) | "Satisfactory" for assessing safety and efficacy |
| Material/Formulation | Equivalence to predicate (non-sterile, viscous, lipid-rich emulsion) | "Substantially Equivalent to Epiceram®" |
| Intended Use | To improve dry skin conditions and relieve burning/itching associated with various dermatoses (atopic, irritant contact, radiation dermatitis) | Stated intended use matches description, determined substantially equivalent |
| Functional/Performance | NP | "Satisfactory" |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not Provided (NP). The document does not describe a specific clinical test set or its sample size.
- Data Provenance: Not Provided (NP). No information on country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (NA). The document does not describe a clinical study involving expert assessment or ground truth establishment in this manner for a test set. This type of detail is more common for diagnostic devices or those requiring subjective clinical endpoints.
4. Adjudication method for the test set
- Not Applicable (NA). No information on a test set or adjudication method.
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
- Not Applicable (NA). This device is a topical emulsion, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (NA). This device is a topical emulsion, not an algorithm.
7. The type of ground truth used
- Not Applicable (NA). For this type of device, "ground truth" (in the sense of a diagnostic standard or confirmed pathology) isn't typically established for a 510(k) submission unless specific clinical endpoints require it. The determination of "satisfactory" safety and efficacy likely relied on standard pre-clinical tests and, if conducted, small-scale clinical observations or patient-reported outcomes, as opposed to a formal diagnostic ground truth. The primary "ground truth" for substantial equivalence is the predicate device's established safety and efficacy profile.
8. The sample size for the training set
- Not Applicable (NA). This device is a topical emulsion; there is no "training set" in the context of machine learning or complex diagnostic algorithms.
9. How the ground truth for the training set was established
- Not Applicable (NA). As above, no training set.
Summary of Study Information:
The 510(k) summary for K110732 indicates that "Functional and performance testing has been conducted to assess the safety and efficacy of Emulsion SB™ and the results are satisfactory." However, it does not provide any specific details about these tests, such as study design, sample sizes, endpoints, statistical analyses, or the methodology for establishing safety and efficacy beyond this general statement. The basis of substantial equivalence relies heavily on the comparison of the device's technical characteristics and intended use to the predicate device, Epiceram® (K052643). For topical products like this, the "study" often involves biocompatibility testing, stability testing, and potentially small-scale clinical evaluations that demonstrate equivalence in function and patient tolerance to the predicate. The provided document does not elaborate on these beyond the general affirmation.
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K110732
Page 1 of 1
UN
2011
510(k) Summary
Date Prepared: May 5, 2011
Owner's Name: 1.
Contact Person:
PruGen, IP Holdings Inc. 8714 E. Vista Bonita Drive Scottsdale, AZ 85255 Robert L. Knechtel, M.D., J.D. (T): 480-563-2406 (F): 815-261-5953 (E): rknechtel@prugen.com
- Emulsion SBTM 2. Proprietary Name: Topical Emulsion for skin Common Name: Classification Name: Dressing, Wound & Burn, Hydrogel.w/ Drug or Biologic (Product Code FRO)
Substantially Equivalent Device: 3.
PruGen IP Holdings, Inc. believes that Emulsion SBTM is substantially equivalent to the following currently marketed device: Epiceram® cleared under K052643.
4. Device Description:
Emulsion SB 100 is a non-sterile, viscous, lipid rich emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in a 90 gm tube.
ડ. Intended Use of the Device:
Emulsion SBTM is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
Summary of Technical Characteristics of Device compared to Predicate Devices 6.
The referenced predicate device is a non-sterile emulsion that is applied topically to relieve the symptoms of various dermatoses, including, but not limited to atopic dermatitis, irritant contact dermatitis, and radiation dermatitis.
7. Testing and Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of Emulsion SBTM and the results are satisfactory.
qree6/1/19
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring. MD 20993-0002
PruGen IP Holdings, Inc. % Robert L. Knechtel, M.D., J.D. SVP and General Counsel 8714 E. Vita Bonita Drive Scottsdale, Arizona 85255
Re: K110732
Trade/Device Name: Emulsion SB™ Regulatory Class: Unclassified Product Code: FRO Dated: February 23, 2011 Received: March 16, 2011
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
JUN - 3 2011
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Page 2 - Robert L. Knechtel, M.D., J.D.
forth in the quality systems (OS) 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 to!!-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.
Pothum Der On
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Date: May 5, 2011
Original: February 23, 2011
INDICATIONS FOR USE
Device Trade Name: Emulsion SBTM
510(k) number: K110732
Rx Only
FOR TOPICAL DERMATOLOGICAL USE ONLY
Emulsion SB104 is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Emulsion SBTM helps to relieve dry, waxy skin by maintaining a moist wound and 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)
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(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of Surgican
and Restorative Devices
510(k) Number .
N/A