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Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.
This document describes a medical device, the HANAULUX blue 80 Hospital, which is an examination and surgical stand light. It does not describe an AI/ML powered device or a study involving such a device.
Therefore, I cannot provide the requested information regarding:
- Acceptance criteria and reported device performance related to a study. The document confirms compliance with safety standards (UL 2601, IEC 601-1, UL 153) and states a maximum UV irradiance (< 8 W/m²), but these are device specifications and regulatory compliance, not performance metrics from a study measuring accuracy, sensitivity, specificity, etc., as would be relevant for an AI/ML device.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a 510(k) summary for a conventional medical device, focusing on its design, function, safety standards, and substantial equivalence to existing devices. It does not mention any kind of study that would generate the type of performance data relevant to AI/ML or diagnostic devices.
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| Encl. A1 | K970886 | Heraeus | MED |
|---|---|---|---|
| blue 80 Hospital, K954169 | |||
| APR 16 1997Summary | |||
| Date: | 20. December 1995 | ||
| Address: | HERAEUS MED GmbHHeraeusstraße 12 - 1463450 Hanau | ||
| Contact person: | Mark Schulz | ||
| Establishment Registration Number: | 8010602 | ||
| Proprietary Name: | HANAULUX blue 30 & 80 | ||
| Version: | HANAULUX blue 80 Hospital | ||
| Common Name: | Examination Light and Surgical Light | ||
| Device Classification: | Regulatory Class II, 79FSY | ||
| Compliance with Standards: | UL 2601 Safety of Medical ElectricalEquipmentIEC 601-1 Safety of Medical ElectricalEquipmentUL 153 Portable Electric Lamps | ||
| Substantial equivalence: | This product is similar in funktion to theexisting surgical lighting program HANAU.LUX "City" series and HANAULUX 2000. |
HME/ FDA001.SAM Seite 1 von 2
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Encl. A2
blue 80 Hospital, K954169
Image /page/1/Picture/5 description: The image shows the logo for Heraeus MED. The word "Heraeus" is in a bold, sans-serif font and is stacked above the word "MED", which is in a smaller, sans-serif font. The logo is black and white.
Description of Device:
Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.
All used plastics are molded of UL Recognized Component material.
All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material.
The maximum of UV Irradiance is lower then 8 W / m2 .
Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code.
March 24, 1997
Mark Schulz
Development Engeneer Electric Construction
HME/ FDA001.SAM Seite 2 von 2
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.