K Number
K091246
Device Name
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
Date Cleared
2009-09-28

(154 days)

Product Code
Regulation Number
878.4580
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".
Device Description
The iLED surgical light mobile family is suitable for all types of surgical procedures. TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters. The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.
More Information

K# 061317, K # 011693

Not Found

No
The description focuses on LED technology, optical devices, and basic electronic controls for illumination parameters. There is no mention of AI, ML, image processing, or data-driven learning.

No
The device is a surgical light designed to illuminate the operating site, which is not a therapeutic function.

No
Explanation: This device is a surgical light, which is used for illumination during surgical procedures. It does not perform any diagnostic functions like detecting, identifying, or characterizing a disease or condition.

No

The device description explicitly details hardware components such as "light heads," "light modules," "LEDs," and "optical devices," indicating it is a physical medical device with integrated software, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "illuminate locally the operating site on the patient's body". This is a direct interaction with the patient's body for a surgical procedure, not for examining specimens in vitro (outside the body).
  • Device Description: The description details a surgical light system designed to provide illumination during surgery. This aligns with a surgical device, not an IVD.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening based on sample analysis

IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical light does not perform such tests.

N/A

Intended Use / Indications for Use

The iLED surgical light mobile family is for illuminating an examination and surgical site on the patient in the clinic and doctor's office.
The iLED surgical lamps illuminate the surgical site with a high intensity, homogenous light.
The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

Product codes (comma separated list FDA assigned to the subject device)

FSS

Device Description

The iLED surgical light mobile family is suitable for all types of surgical procedures.
TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters.
The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinic and doctor's office

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K# 061317, K # 011693

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.

Not Found

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.

0

KC091246

5. 510 (k) Summary

SEP 2 8 2009

Submitter: TRUMPF Medizin Systeme GmbH + Co. KG Benzstraße 26 82178 Puchheim Germany

Contact Person:

Michae! Bartesch product manager

April 16, 2009

Phone: ++49 89 80 90 7 - 0 Fax: ++49 89 80 90 7 - 20

Preparation Date:

Trade Name: iLED Surgical Family, Mobile

Surgical lamp, Mobile Common Name:

Classification Name: Surgical Lamp

Device Description:

The iLED surgical light mobile family is suitable for all types of surgical procedures.

TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters.

The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

PAGE 10 of 13 PAGES

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Intended Use of the Device

Indication for use:

Predicate Device:

The iLED surgical light mobile family is for illuminating an examination and surgical site on the patient in the clinic and doctor's office.

The iLED surgical lamps illuminate the surgical site with a high intensity, homogenous light.

iLED (lamp heads are identical) K# 061317

Trumpf surgical light models 301, 501, 701, and 1001 (mobile stand option was included) K # 011693

Substantial Equivalence:

Main Difference:

Substantial Equivalence: The iLED surgical light mobile family had identical lamp heads as the iLED surgical light ceiling mounted versions. The iLED surgical light mobile family uses the same spring arm as the ceiling mounted version and same electronics as the ceiling mounted version. The mobile family is substantially equivalent to the mobile stand approved in K #011693 and other mobile surgical light systems. There is no difference between the devices that raise any significant issues of safety and effectiveness.

The method of mounting the spring arm is the main difference from the iLED surqical light ceiling mounted, the unit is made mobile. The spring arm for the unit is mounted to a mobile stand with a base and 4 casters and plugs into an outlet. The main difference from the mobiles included in K # 011693 is the light heads, which are LED light heads (identical to those sold as ceiling mounted per K#061317).

PAGE 11 of 13 PAGES

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird-like figure with three stylized wing or feather shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

TRUMPF Medizin Systeme GmbH + Co. KG % TRUMPF Medical Systems, Inc. Ms. Lindsey Hengel 415 Jessen Lane Charleston, South Carolina 29492

Re: K091246

Trade/Device Name: Surgical Lamp Mobile Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSS Dated: September 15, 2009 Received: September 16, 2009

SEP 2 8 2009

Dear Ms. Hengel:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

3

Page 2 - Ms. Lindsey Hengel

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

FOR

Sincerely vours.

Klaus L. Beyer

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known): K091246

Device Name: Surgical Lamp Mobile

Indications for Use: The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
M. FOR M. MELKERSON

(Division Sign-Off), Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091246

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