(70 days)
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.
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.
This document describes the premarket notification (510(k)) for the Heraeus Hanaulux blue 75 and Hanaulux blue 120 surgical and examination luminaires. This submission focuses on the substantial equivalence of these devices to previously marketed devices and compliance with safety standards rather than clinical performance studies. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are primarily related to safety standards and functional equivalence to predicate devices, rather than specific performance metrics in a clinical context.
| Acceptance Criteria (from "Compliance with Standards") | Reported Device Performance |
|---|---|
| UL 2601 Safety of Medical Electrical Equipment | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| IEC 601-1 Safety of Medical Electrical Equipment | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| IEC 601-2-41 Safety of Surgical Luminaires and Luminaires for Diagnosis | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| UL 153 Portable Electric Lamps | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| Maximum UV Irradiance < 6 W/m² | The maximum of UV Irradiance is lower then 6 W / m². |
| Use of UL Recognized Component material for plastics | All used plastics are molded of UL Recognized Component material. |
| Use of Listed fixture wire or Recognized Component appliance wiring material for internal wiring | All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material. |
| Intended for illumination, not therapeutic use or direct patient contact | The devices are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient. |
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. The document describes a premarket notification for a medical device (surgical/examination lights), not a clinical study involving a test set of data. The "study" mentioned here refers to compliance with standards and demonstrating substantial equivalence 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. As this is not a clinical study with a test set requiring ground truth, no experts were used in this capacity. The evaluation involved regulatory bodies (FDA) reviewing technical specifications and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
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. This device is a surgical/examination luminaire; it is not an AI-assisted diagnostic or interpretative device, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical light, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this regulatory submission is compliance with established electrical and medical device safety standards, and functional equivalence to legally marketed predicate devices, as assessed through engineering specifications and regulatory review.
8. The sample size for the training set
Not applicable. This is not a machine learning device or a clinical study that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, this question is not relevant.
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| Date: | 04. August 1997 |
|---|---|
| Address: | HERAEUS MED GmbHHeraeusstraße 12 - 1463450 Hanau |
| Contact person: | Mark Schulz |
| Establishment Registration Number: | 8010602 |
| Proprietary Name: | HANAULUX blue 75 andHANAULUX blue 120 |
| Common Name: | Examination Luminaire andSurgical Luminaire |
| Device Classification: | Regulatory Class II, 79FSY |
| Compliance with Standards: | UL 2601 Safety of Medical ElectricalEquipmentIEC 601-1 Safety of Medical ElectricalEquipmentIEC 601-2-41 Safety of SurgicalLuminaires and Luminaires for DiagnosisUL 153 Portable Electric Lamps |
| Substantial equivalence: | This product is similar in funktion to theexisting surgical lighting program HANAU-LUX "City" series, HANAULUX 2000 andHANAULUX 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".
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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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| Pageannon and considerary computerial or | ofA 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)
§ 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.