HALUX IRIS EXAMINATION AND SURGICAL LAMP

• K Number: K053364
• Device Name: HALUX IRIS EXAMINATION AND SURGICAL LAMP
• Manufacturer: WALDMANN LIGHTING
• Date Cleared: 2006-02-23 ( 83 days)
• Product Code: FTD
• Regulation Number: 878.4580
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K042395
• Predicate For: N/A

Intended Use

Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Device Description

Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp:

Smooth Operation and adjustability

Precise positioning

Compact and enclosed articulation system with counterbalance system.

A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions.

halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).

AI/ML Overview

This document describes a 510(k) premarket notification for the "Halux® Iris Examination and Surgical Lamp". The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets an extensive set of acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of regulatory submission for a simple medical lamp. The "study" here is primarily an engineering and bench testing comparison to a predicate device.

Here's the information that can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

   Items	Acceptance Criteria (Predicate Device K042395)	Reported Device Performance (Halux® Iris)
   Manufacturer	Burton Medical	Waldmann Lighting
   Model number(s)	Outpatient Plus or CoolSpot	Halux® Iris
   K number	K042395	SAME (Implied substantial equivalence)
   Electrical requirements	120 V. 50-60 Hz	SAME (120 V. 50-60 Hz)
   Light Output	4800 footcandles	45000 lux at 0.8 m (4180 footcandles)
   Color temperature	3600 K	4000 K
   Wattage	150 watts (three 50 watt halogen)	One 50 watt Halogen
   Power source	Transformer	SAME (Transformer)
   Operating environment	Minor surgeries	SAME (Minor surgeries, examinations)
   Bulb operating life	2000 hrs.	Up to 4000 hrs.
   Case material	Steel and plastics	SAME (Steel and plastics)
   Warranty	3 years	2 years
   Safety listing	UL	UL

   Note: The "acceptance criteria" for this submission are effectively the specifications and performance of the predicate device, which the new device aims to be "substantially equivalent" to or better in some aspects.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document mentions "bench and laboratory testing" and "user testing data" but does not provide specific sample sizes for these tests. For a medical lamp, this would likely involve a small number of units tested in a lab setting rather than human subjects or a large data set.
   • Data Provenance: The testing was conducted by Waldmann Lighting, the manufacturer. The document doesn't specify country of origin for the data beyond that. It is "retrospective" in the sense that it's a comparison to an existing device, but the testing itself would be prospective to evaluate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is a physical device (medical lamp), not an AI/diagnostic software. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The "truth" is established by direct measurement of physical properties (e.g., light output, color temperature, safety standards).

4. Adjudication method:

   • Not Applicable. See point 3.

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 is not an AI device or a diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is not an algorithm.

7. The type of ground truth used:

   • The "ground truth" for this device's performance is based on direct physical measurements and adherence to safety standards. For example, light output is measured in footcandles/lux, color temperature in Kelvin, and electrical safety is verified against UL standards and EN 60 601-2-41 (UL2601). The "ground truth" for substantial equivalence is the performance and specifications of the predicate device.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established:

   • Not Applicable. See point 8.

Summary

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EXHIBIT 2 510(k) Summary Waldmann Lighting 9 W. Century Drive Wheeling, IL 60090 Phone: [phone] Fax: [phone] Contact: Les Kaminski, Plant Manager Prepared November 5, 2005

• 1. Identification of the Device: Proprietary-Trade Name: Halux® Iris Examination and Surgical Lamp Classification Name: lamp, surgical Codes FTD and FSY .. Common/Usual Name: Surgical lamp
• 2. Equivalent legally marketed devices Burton Medical Products Corp Outpatient® Minor Surgical Light, K042395
• 3. Indications for Use (intended use) Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
• 4. Description of the Device: Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp:

Smooth Operation and adjustability

Precise positioning

Compact and enclosed articulation system with counterbalance system.

A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions.

halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).

• 5. Safety and Effectiveness, comparison to predicate device. The results of bench and laboratory testing indicates that the new device is as safe and effective as the predicate device.

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6. Substantial Equivalence Chart

Technical Specifications
Items	Value
Manufacturer	Burton Medical	Waldmann Lighting
Model number(s)	Outpatient Plus or CoolSpot	Halux® Iris
K number	K042395	SAME
Electrical requirements	120 V. 50-60 Hz	SAME
Light Output	4800 footcandles	45000 lux at 0.8 m (4180 footcandles)
Color temperature	3600 K	4000 K
Wattage	150 watts(three 50 watt halogen)	One 50 watt Halogen
Power source	Transformer	SAME
Operating environment	Minor surgeries	SAME
Bulb operating life	2000 hrs.	Up to 4000 hrs.
Case material	Steel and plastics	SAME
Warranty	3 years	2 years
Safety listing	UL	UL

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Waldmann Lighting that the Halux® Iris Examination and Surgical Lamp is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Waldmann Lighting c/o Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K053364

Trade/Device Name: Halux® Iris Examination and Surgical Lamp Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: February 13, 2006 Received: February 17, 2006

Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); 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.

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Page 2 - Mr. Kamm

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

peemel

-Mark N. Melkerson, M.S.
Acting Director
Division of General, Restorative and
Neurological Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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Indications for Use

KOS3864 510(k) Number (if known):

Device Name: Halux® Iris Examination and Surgical Lamp Indication for use: Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)

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Q.M.De
Division Sign-Off

Division of General, Restorative, and Neurological Devices

K053364 510(k) Numbe

Regulation Number and Section

§ 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.