HANAULUX BLUE 75 AND HANAULUX BLUE 120

K973466 · Heraeus Med GmbH · FSY · Oct 24, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973466
• Device Name: HANAULUX BLUE 75 AND HANAULUX BLUE 120
• Applicant: Heraeus Med GmbH
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

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.

Device Story

Hanaulux blue 75 and 120 are surgical/examination luminaires; provide local illumination for surgical and diagnostic procedures. System consists of one, two, or three lightheads; installed in operating rooms. Operated by clinical staff. Device does not contact patient; UV irradiance limited to <6 W/m². Powered via remote 24V isolating transformer. Design, materials, and function are substantially equivalent to existing Hanaulux lighting series.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical/examination luminaires; lighthead combinations of 75 and 120. Materials: UL Recognized Component plastics. Electrical: 24V remote isolating transformer; internal wiring uses Listed fixture wire or Recognized Component appliance wiring. Compliance: UL 2601, IEC 601-1, IEC 601-2-41, UL 153. UV irradiance <6 W/m². Mechanical/electrical design.

Indications for Use

Indicated for local illumination of the patient's body to support treatment and diagnosis in operating rooms. Not intended for therapeutic use or direct patient contact.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HANAULUX "City" series
• HANAULUX 2000
• HANAULUX blue 30 / 80

Submission Summary (Full Text)

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| Date: | 04. August 1997 |
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| Address: | HERAEUS MED GmbH<br>Heraeusstraße 12 - 14<br>63450 Hanau |
| Contact person: | Mark Schulz |
| Establishment Registration Number: | 8010602 |
| Proprietary Name: | HANAULUX blue 75 and<br>HANAULUX blue 120 |
| Common Name: | Examination Luminaire and<br>Surgical Luminaire |
| Device Classification: | Regulatory Class II, 79FSY |
| Compliance with Standards: | UL 2601 Safety of Medical Electrical<br>Equipment<br>IEC 601-1 Safety of Medical Electrical<br>Equipment<br>IEC 601-2-41 Safety of Surgical<br>Luminaires and Luminaires for Diagnosis<br>UL 153 Portable Electric Lamps |
| Substantial equivalence: | This product is similar in funktion to the<br>existing surgical lighting program HANAU-<br>LUX "City" series, HANAULUX 2000 and<br>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".

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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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>annon and considerary computerial or | of<br>A MITS COLLEL L. L. L. LILLE CALL | |
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| 510(k) Number (if known): | K973466 |
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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)