(42 days)
The iLED lighting system is for illuminating an examination and surgical site on the patient in the clinic and doctor's office. The surgical light iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light.
The iLED surgical light is suitable for all types of surgical procedures. The iLED light heads consists of several hexagonal modules, which contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. The iLED5 has one center module and four edge modules; the iLED3 has three edge modules for the illumination. Each light head has its own control to adjust the illumination parameters. The light intensity is adjustable between 30% and 100%, the color temperature between 3500 K and 5000 K. A dimming of the light to the point of an application at endoscopical working is possible and a adaptability to different situations (shadow control) to improve the illumination of the surgical field. With the use of LEDs as light sources, TRUMPF realizes a high illumination intensity with a low heat radiation and a durability of at least 4 times compared with gas-discharging lamps. The light incorporates easy-to-operate swivel arms and can be combined to systems with one, two or three light heads of the type iLED3 or iLED5. An optional CCD-video-camera is available and the light could be combined with TRUMPF KREUZER ceiling mounted support systems.
The provided text is a 510(k) summary for the TRUMPF KREUZER Medizin Systeme GmbH + Co. KG iLED surgical lamp. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a medical AI context. The device described is a physical surgical lamp, not an AI software/device.
Therefore, I cannot provide the requested information as it is not present in the given input.
Reasoning for inability to answer the requested details:
- Acceptance Criteria & Device Performance Table: The document details the physical characteristics of the iLED surgical lamp and compares it to a predicate device (CHROMOPHARE X 65) based on its light source (LED vs. gas-discharge lamp), number of light sources, and expected lifespan. It states that "Any difference that exists between the CHROMOPHARE X65 and the iLED has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application." However, it does not provide specific quantitative acceptance criteria or a table of performance metrics for the iLED compared to these criteria.
- Sample Size, Data Provenance, Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Training Set: These concepts are typically associated with the evaluation of artificial intelligence (AI) or machine learning (ML) models, particularly in medical imaging or diagnostics. The iLED is a surgical lamp, a physical medical device. The 510(k) summary provided describes the device, its intended use, and its substantial equivalence to a predicate device for regulatory purposes. It does not involve any AI/ML components, and thus, terms like "test set," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," or "training set" are not applicable or mentioned in this context.
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K06/3/7
JUN 2 2 2 2006
5. 510 (k) Summary
| Submitter: | TRUMPF KREUZER Medizin Systeme GmbH + Co. KGBenzstraße 2682178 PuchheimGermany |
|---|---|
| Contact Person: | Willibald HiemerManager Regulatory AffairsPhone: ++49 89 80 90 7 - 0Fax: ++49 89 80 90 7 - 20 |
| Preparation Date: | April 28, 2006 |
| Trade Name: | iLED |
| Common Name: | Surgical lamp |
| Classification Name: | Light, Surgical, Ceiling Mounted |
| Device Description: | The iLED surgical light is suitable for all types of surgicalprocedures.The iLED light heads consists of several hexagonal modules,which contain the LEDs with their optical devices. Each LEDwith its optical device illuminates the complete light field. TheiLED5 has one center module and four edge modules; theiLED3 has three edge modules for the illumination. Each lighthead has its own control to adjust the illumination parameters.The light intensity is adjustable between 30% and 100%, thecolor temperature between 3500 K and 5000 K. A dimming ofthe light to the point of an application at endoscopical workingis possible and a adaptability to different situations (shadowcontrol) to improve the illumination of the surgical field.With the use of LEDs as light sources, TRUMPF realizes ahigh illumination intensity with a low heat radiation and adurability of at least 4 times compared with gas-discharginglamps. |
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The light incorporates easy-to-operate swivel arms and can be combined to systems with one, two or three light heads of the type iLED3 or iLED5. An optional CCD-video-camera is available and the light could be combined with TRUMPF KREUZER ceiling mounted support systems. Intended Use of The iLED lighting system is for illuminating an examination the Device: and surgical site on the patient in the clinic and doctor's office. Indication for use: The surgical light iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light. Predicate Device: CHROMOPHARE X 65 K# 024132 Substantial Equivalence: The iLED is substantially equivalent to the surgical light CHROMOPHARE X 65. Any difference that exists between the CHROMOPHARE X65 and the il.ED has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application. Main Difference: The light source LightEmittingDiode, used by iLED, has a life time, which is 4 times the life time of a gas-discharge lamp. The CHROMOPHARE has two light sources whereas the iLED use 36 or 37 light sources per module. A failure of one light
source of the iLED reduces the light intensity scarcely.
PAGE 12 of 137 PAGES
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 2006
Trumpf Kreuzer Medizin System GmbH % Underwriters Laboratories, Inc. Mr. Jeffrey D. Rongero Senior Project Engineer 12 Laboratory Drive Research Triangle Park, North Carolina 27709
Re: K061317
Trade/Device Name: iLED Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulation Class: II Product Code: FSY Dated: June 30, 2006 Received: June 30, 2006
Dear Mr. Rongero:
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
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Page 2 - Mr. Jeffrey D. Rongero
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. 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrf/dsma/dsmamain.html
Sincerely vours.
C. Herbert Lehman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indication for use Statement
510(k) Number: KO61317
Device Name:
ilED
Indications for use:
The surgical light iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WIRTE BELOW THIS LINE – CONTINUE ONANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office or Device Evaluation (ODE)
(Division ign-Off Division of General, Restorative。
and Neurological Devices
510(k) Number PAGE 10 of 137 PAGES
§ 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.