(79 days)
Not Found
No
The 510(k) summary describes a topical skin care emulsion and does not mention any AI or ML components in its intended use, device description, or performance studies.
Yes
The device is intended to relieve and manage symptoms associated with various dermatoses by maintaining a moist wound and skin environment, which are therapeutic claims. Its mechanism of action (improving dry skin conditions, relieving burning and itching) points to a therapeutic function rather than just cosmetic or general wellness.
No
Explanation: The device is a topical skin care preparation intended to improve dry skin conditions and relieve associated symptoms, not to diagnose a disease or condition. The "Device Description" also mentions prescribed use where a "physician diagnosis disease state" is required, indicating the device itself is not performing the diagnosis.
No
The device description clearly states it is a "non-sterile, viscous, lipid rich emulsion intended for topical application," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Emulsion SBTM is a "topical skin care preparation applied at least twice daily to affected areas of the skin". This describes a product applied to the body, not used to test samples from the body (which is the core of IVD).
- Device Description: The description reinforces this by stating it's a "non-sterile, viscous, lipid rich emulsion intended for topical application".
- 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, Emulsion SBTM is a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FRO
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.
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
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 Emulsion SBTM and the results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized abstract symbol resembling a bird or a person with outstretched arms. 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 -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
2
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
3
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)
![. Sign-Off)
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of Surgican
and Restorative Devices
510(k) Number .