(344 days)
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
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.
This 510(k) summary (K060272) for Locobase® Wound and Skin Emulsion does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria. The submission is a "substantial equivalence" claim, meaning the device is compared to already legally marketed devices.
Here's an breakdown of the information that is and is not available in the provided text, based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states "Functional and performance testing has been conducted to assess the safety and efficacy of Locobase® Wound and Skin Emulsion," but it does not provide specific acceptance criteria or the results of this testing.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe a test set, sample size, or data provenance from a specific study for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available. There is no mention of a test set or expert involvement in establishing ground truth.
4. Adjudication Method for the Test Set
Not available. There is no mention of a test set or adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not available. The document does not describe an MRMC study or any comparative effectiveness data with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a topical emulsion, not an algorithm or AI.
7. The Type of Ground Truth Used
Not applicable. For a medical device like this emulsion, "ground truth" typically refers to the clinical outcomes and safety profiles observed in human subjects. The document states that "Functional and performance testing has been conducted to assess the safety and efficacy," implying that clinical evaluations or similar studies would have assessed the product's effect on symptoms (burning, itching, redness) associated with atopic dermatitis, though no details are provided.
8. The Sample Size for the Training Set
Not applicable/available. This device is a topical emulsion, not an AI model requiring a training set. If "training set" refers to participants in a clinical trial, this information is not provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available. As it's not an AI device, there's no "training set" in that sense. If the "training set" refers to subjects in a clinical study, the method for establishing "ground truth" (i.e., efficacy and safety endpoints) would typically involve clinical assessments by healthcare professionals, patient-reported outcomes, and possibly objective measures of skin condition. However, these details are not provided in the 510(k) summary.
Summary of Device and Approval:
The K060272 submission is for Locobase® Wound and Skin Emulsion. It states that the device is "similar in composition, function and intended use" to several predicate devices already on the market (Biafine™ Wound Dressing Emulsion, Sinclair (Atopiclair™) Wound and Skin Emulsion, and MimyX™ Cream). The FDA's letter confirms a "substantial equivalence" determination, allowing the device to be marketed. This type of submission relies on demonstrating similarity to existing devices rather than presenting extensive de novo clinical trial data with specific acceptance criteria in the 510(k) summary itself. The phrase "Functional and performance testing has been conducted to assess the safety and efficacy" indicates that some level of testing was performed, but the results and methodologies are not detailed in this public summary.
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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
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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.
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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.
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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
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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
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Concurrence of CDRH, Office of Device Devaluation (ODE)
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Division of General, Restorative and Neurological Devices
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510(k) Number [K060272
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