(70 days)
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No
The document describes a surgical light and does not mention any AI or ML capabilities.
No
The device description explicitly states, "They are intended for illumination purpose and are not intended for therapeutic use." The intended use also mentions supporting treatment and diagnosis, but the primary function is illumination of the patient's body in operating rooms, not directly applying a therapy.
No
Explanation: The device is described as surgical luminaires intended to illuminate the body of the patient to support treatment and diagnosis. While it supports diagnosis, its primary function is illumination and it does not directly perform diagnostic measurements or analysis.
No
The device description clearly outlines physical components like lightheads, wiring, plastics, and a transformer, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Hanaulux blue 75 / 120 is a surgical luminaire (light). Its intended use is to illuminate the patient's body during surgical procedures.
- Lack of Specimen Examination: The device does not interact with or analyze any specimens from the human body. It provides light, not diagnostic information derived from biological samples.
- Direct Patient Interaction (Indirect): While used in the patient area, the description explicitly states it's "not for direct contact with patient." IVDs typically involve the analysis of samples taken from the patient.
Therefore, based on the provided information, the Hanaulux blue 75 / 120 is a surgical light and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
Hanaulux blue 75 / 120 is an Examination and Surgical Light with two lighthead combinations of blue 75 and blue 120. The Hanaulux® blue 75 / 120 is principally the same as the Hanaulux(") blue 30 / 80 in design, material and function. They are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient.
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 6 W / m² .
Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. The system is intended to be connected to a remote, listed, isolating type, 24V transformer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
locally the body of the patient.
Indicated Patient Age Range
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Intended User / Care Setting
used in operating rooms
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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| Date: | 04. August 1997 |
|---|---|
| Address: | HERAEUS MED GmbH |
| Heraeusstraße 12 - 14 | |
| 63450 Hanau | |
| Contact person: | Mark Schulz |
| Establishment Registration Number: | 8010602 |
| Proprietary Name: | HANAULUX blue 75 and |
| HANAULUX blue 120 | |
| Common Name: | Examination Luminaire and |
| Surgical Luminaire | |
| Device Classification: | Regulatory Class II, 79FSY |
| Compliance with Standards: | UL 2601 Safety of Medical Electrical |
| Equipment | |
| IEC 601-1 Safety of Medical Electrical | |
| Equipment | |
| IEC 601-2-41 Safety of Surgical | |
| Luminaires and Luminaires for Diagnosis | |
| UL 153 Portable Electric Lamps | |
| Substantial equivalence: | This product is similar in funktion to the |
| existing surgical lighting program HANAU- | |
| LUX "City" series, HANAULUX 2000 and | |
| HANAULUX blue 30 / 80. |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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Description of Device:
Hanaulux blue 75 / 120 is an Examination and Surgical Light with two lighthead combinations of blue 75 and blue 120. The Hanaulux® blue 75 / 120 is principally the same as the Hanaulux(") blue 30 / 80 in design, material and function. They are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient.
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 6 W / m² .
Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. The system is intended to be connected to a remote, listed, isolating type, 24V transformer.
August 04, 1997
Mark Schulz
Development Engeneer Electric Construct
Image /page/1/Picture/11 description: The image shows the logo for Heraeus MED GmbH. The text is in a bold, sans-serif font and is arranged in a slightly tilted manner. Below the company name is the address "Postfach 15 64 D-63405 Hanau".
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Mark Schulz . Heraeus Med GmbH, Hanau Heraeusstrasse 12-14 63450 Hanau Germany
OCT 2 4 1997
Re: K973466 Trade Name: Hanaulux® blue 75 and Hanaulux® blue 120 Regulatory Class: II Product Code: FSY Dated: August 8, 1997 Received: August 15, 1997
Dear Mr. Schulz:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Mark Schulz
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page
annon and considerary computerial or | of
A MITS COLLEL L. L. L. LILLE CALL | |
| ---------------------------------------------- | ----------------------------------------- | -- |
|---|
| 510(k) Number (if known): | K973466 |
|---|---|
| --------------------------- | --------- |
HANALII LIV LI blue 75 / 120Device Name:
HANAULUX blue 75 / 120
Indications For Use:
Intended Use:
Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.
Heraeus Med GmbH
M. Schulz
H. Schulz
Image /page/4/Picture/9 description: The image shows the logo for Heraeus MED GmbH. The logo is in black and white and consists of the word "Heraeus" in a bold, sans-serif font, with "MED GmbH" stacked below it in a smaller font. Below that is the text "Postfach 15 64" and "D-63405 Hanau".
Regulatory Affairs Manager
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation-(ODE)
toode
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973466
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1 -2-96)