(62 days)
The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.).
The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses.
I am sorry, but based on the provided document, there is no information about the acceptance criteria, study details, or performance of the "Derma Hood" device. The document is an FDA 510(k) clearance letter, which primarily focuses on classifying the device and confirming its substantial equivalence to a predicate device. It does not include the detailed technical performance data or specific study results you've requested.
The document mentions:
- Trade/Device Name: Derma Hood
- Regulation Number: 21 CFR 880.6320 (AC-Powered Medical Examination Light)
- Regulatory Class: I
- Product Code: PEQ
- Indications for Use: "The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.)."
However, it does not provide any of the following information requested in your prompt:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2013
GlobalMedia Group, LLC Mr. Nicholas Campbell Quality and Regulatory Manager 15020 North 74th Street Scottdale AZ 85260
Re: K131338
Trade/Device Name: Derma Hood Regulation Number: 21 CFR 880.6320 Regulation Name: AC-Powered Medical Examination Light Regulatory Class: I Product Code: PEQ Dated: April 23, 2013 Received: May 9, 2013
Dear Mr. Campbell:
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.
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Page 2 - Mr. Campbell
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 toll-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,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131338
Device Name: Derma Hood
Indications For Use:
The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Richard C. Chapman 2013.07.10 11:20:17 -04'00'
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510(k) Number: K131338
§ 880.6320 AC-powered medical examination light.
(a)
Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.