(344 days)
Not Found
No
The summary describes a topical emulsion/cream and does not mention any AI or ML components or functionalities.
Yes
The intended use explicitly states, "the product is intended for the management and relief of burning, itching and redness associated with atopic dermatitis," which describes a therapeutic purpose.
No
The device is described as an emulsion for topical application intended for the "management and relief of burning, itching and redness associated with atopic dermatitis" and for forming a "protective barrier," not for diagnosing conditions.
No
The device description clearly states it is a "semi-viscous emulsion/cream formulation intended for topical application," indicating it is a physical product, 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 the product is for the "management and relief of burning, itching and redness associated with atopic dermatitis" and is applied "topically to the affected area." This describes a treatment applied to the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "semi-viscous emulsion/cream formulation intended for topical application." This is a topical medication, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
In summary, the device is a topical treatment for a skin condition, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
"Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with atopic dermatiis. The product, when applied topically to the affected area, forms a protective barrier.that tells. Ins keep the skin moist, which has a beneficial effect on the healing rooces of"
"Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with atopic dermatitis."
Product codes
FRO
Device Description
"Locobase® Wound and Skin Emulsion is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 30 g and 100g tubes."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"Under the supervision of a healthcare professional"
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 Locobase® Wound and Skin Emulsion."
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
1/2
510 (k) SUMMARY
I. ADMINISTRATIVE
Submitter: Ferndale Laboratories, Inc. 780 W. 8 Mile Rd Ferndale, Michigan 48220 (248) 548-0900
Contact Person: Richard A. Hamer
Date of Preparation: February 3, 2006
II. DEVICE NAME
Proprietary Name: Locobase® Wound and Skin Emulsion
Common Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
Classification Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
III. PREDICATE DEVICES
Biafine™ Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc. Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmacreut;cals, Ltd.
MimyXTM Cream (K041342) Stiefel Laboratories, Inc.
IV. DEVICE DESCRIPTION
Locobase® Wound and Skin Emulsion is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 30 g and 100g tubes.
V. INTENDED USE
Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with atopic dermatiis. The product, when applied topically to the affected area, forms a protective barrier.that tells. Ins keep the skin moist, which has a beneficial effect on the healing rooces of
JAN 1 2 2007
1
VI. COMPARISON TO PREDICATE DEVICES
2/2 Locobase® Wound and Skin Emulsion is similar in composition, function and intended use to other legally marketed hydrogel wound dressing products, such as Biafine™ Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc., Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmaceutcals, I.t., and MimyX™ Cream (K041342) Stiefel Laboratories, Inc. All referenced products, are nonsterile viscous emulsions/creams that are applied topically to manage and relieve symtoms of various dermatoses.
VII. CONCLUSION
Functional and performance testing has been conducted to assess the safety and efficacy of Locobase® Wound and Skin Emulsion.
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ferndale Laboratories, Inc. % Mr. Richard A. Hamer Vice President, Regulatory/Clinical Affairs and Quality Assurance 780 West Eight Mile Road Ferndale, Michigan 48220
JAN 1 2 2007
Re: K060272
Trade/Device Name: Locobase® Wound and Skin Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: October 13, 2006 Received: October 16, 2006
Dear Mr. Hamer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 -- Mr. Richard A. Hamer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
y yours, Mark N
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K060J7S
INDICATIONS FOR USE
510(k) Number (if known): __
Device Name: Locobase® Wound and Skin Emulsion
Indications for Use:
Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with atopic dermatitis.
Prescription Use X (Per 21 CFR §801.109 OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Devaluation (ODE)
elf
(Division Sign-Off)
Pa
Division of General, Restorative and Neurological Devices
Page ot
510(k) Number [K060272
00 ને .