(72 days)
Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).
Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic tubes.
The provided text is for a 510(k) premarket notification for Eletone® Cream, a wound dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance criteria against predefined acceptance criteria for a novel device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details is not available in this document.
The conclusion of the 510(k) summary (Section VII) explicitly states: "Functional and performance testing has been conducted to assess the safety and efficacy of Eletone® Cream. Based on the information provided herein, we conclude that the device is substantially equivalent to the above-mentioned predicate devices."
This indicates that the "study" conducted was a comparison to predicate devices to establish substantial equivalence, not a performance trial against specific numerical targets.
However, based on the provided document, here's what can be inferred or stated:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of numerical performance targets. The acceptance criterion for the 510(k) submission is "substantial equivalence" to the predicate devices. This means that the device must be as safe and effective as the predicate.
- Reported Device Performance: The document states that Eletone® Cream is "identical in composition and function to Locobase® Wound and Skin Emulsion (K060272)" and that its "intended use is identical to other legally marketed wound dressing products." This "identity" and "identical use" constitute the primary "performance" reported to meet the substantial equivalence criteria. Functional and performance testing was conducted but the specific results or metrics are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. Clinical trial data with specified sample sizes for a "test set" are not presented in this 510(k) summary. The comparison is primarily based on the composition and intended use relative to predicate devices.
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):
- Not applicable/Not provided. This type of information is relevant for studies involving diagnostic or AI-driven devices requiring expert-adjudicated ground truth, which is not the case for this wound dressing submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This is a medical device (topical cream) and not a diagnostic imaging or AI-assisted interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided in the context of a "test set" for performance evaluation against ground truth. The "truth" for this submission is that the device's composition and intended use are substantially equivalent to already approved devices.
8. The sample size for the training set:
- Not applicable/Not provided. This is relevant for machine learning models, not for a topical cream.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. Relevant for machine learning models, not for a topical cream.
In summary, the provided 510(k) notification for Eletone® Cream demonstrates substantial equivalence to predicate devices based on similarities in composition and intended use. It does not contain information about clinical trials, specific performance metrics, or "acceptance criteria" in the way a novel device or AI-driven system would. The "study" mentioned ("Functional and performance testing has been conducted") is not detailed in this summary, but its outcome was to support the claim of substantial equivalence to the listed predicate devices.
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510(k) premarket notification: Eletone® Cream Ferndale Laboratories, Inc.
K092297
page 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: July28, 2009
II. DEVICE NAME
Proprietary Name: Eletone® Cream
Common Name: Wound Dressing
Classification Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic
III. PREDICATE DEVICES
Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmaceuticals, Ltd.
MimyXTM Cream (K041342) Stiefel Laboratories, Inc.
Locobase® Wound and Skin Emulsion (Eletone® Cream) (K060272) Ferndale Laboratories, Inc.
IV. DEVICE DESCRIPTION
Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic 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 various types of dermatoses, including atopic dermatitis, radiation dermatitis and allergic contact dermatitis.
OCT - W LUUY
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510(k) premarket notification: Eletone® Cream Ferndale Laboratories, Inc.
K092297
page 2/2
The product, when applied topically to the affected areas, forms a protective barrier that helps keep the skin moist, which has a beneficial effect on the healing process.
VI. COMPARISON TO PREDICATE DEVICES
Eletone® Cream is identical in composition and function to Locobase® Wound and Skin Emulsion (K060272). Its intended use is identical to other legally marketed wound dressing products, such as Sinclair (Atopiclair™) Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (K024367), MimyXTM Cream, Stiefel Laboratories, Inc. (K041342). All referenced products are non-sterile emulsions that are applied topically to manage and relieve symptoms of various dermatoses.
VII. CONCLUSION
Functional and performance testing has been conducted to assess the safety and efficacy of Eletone® Cream. Based on the information provided herein, we conclude that the device is substantially equivalent to the above-mentioned predicate devices.
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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 three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ferndale Pharma Group, Inc. % Mr. Richard A. Hamer VP, Regulatory/Clinical Affairs Quality Assurance 780 West Eight Mile Road Ferndale, Michigan 48220
OCT - 9 2009
Re: K092297
Trade/Device Name: Eletone® Cream Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2009 Received: October 2, 2009
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. Ilsting 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 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 - Mr. Richard A. Hamer
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical Orthopaedics
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K092297
Device Name: Eletone® Cream
Indications For Use: Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kron
Page 1 of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092297
N/A