(130 days)
Not Found
No
The device description and performance studies focus on standard lighting technology and conformance to electrical and safety standards, with no mention of AI or ML capabilities.
No
The description states its purpose is to provide illumination for examination/surgical fields, not to treat any medical condition.
No
The device is a lighting system designed to illuminate the examination/surgical field. Its function is to provide visibility for procedures, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a "lighting system" utilizing LEDs and powered by AC voltage, indicating it is a hardware device.
Based on the provided information, the StarTrol LED Lighting system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide visible illumination of the examination/surgical field of the patient during procedures. This is a direct interaction with the patient's body for visualization, not for testing samples taken from the body.
- Device Description: The description focuses on the physical characteristics and function of a surgical light, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The StarTrol LED Lighting system does not fit this description.
N/A
Intended Use / Indications for Use
The StarTrol LED Lighting system is designed to provide a visible illumination of the examination /surgical field of the patient during surgical and non-surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FSY, FSS, FTD
Device Description
The StarTrol LED Lighting System is a Class II medical device that provides an illumination field for general examination and minor surgery. The lighting system utilizes LED's for illumination and is powered from standard AC voltage sources. The head design is comprised of multiple LED's (Light Emitting Diodes). The LED head is mounted such that it can be moved and oriented by the operator to place the illumination field on the subject by means of a removable handle (sterile, single use handle covers are available). The light head is balanced with a counterweight to provide flexibility and exact placement without the drifting of the light head. Maneyverability of the light head requires minimal force by the clinician to quickly and easily place it in the desired position. The intensity of illumination is variable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No clinical date is required for this device classification submission. The StarTrol LED Lighting System is a light that is substantially equivalent to our predicate devices, which have been available for decades and doing a clinical evaluation would be of no benefit.
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.
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.
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Appendix 4F
510(K) Summary
StarTrol™ LED Surgical Light System
- Huot Instruments, LLC Submitted by: N50 W13740 Overview Drive, Suite A Menomonee Falls, WI 53051
- Contact Person: Anne Ward Phone: 262-373-1700 Fax: 262-373-1800 Email: Anne@HuotInstruments.com
March 9, 2010 Date prepared:
Proprietary Name: StarTrol™ LED Lighting System
Common Name: Minor Surgical Light
Device Classification: Surgical Light (78 FSY) Class II, as listed per 21 CFR 878.4580
- Predicate Device: Next Generation Surgery Light Medical Illumination International K003489 Product Class: FSS, FTD, FSY
AIM Burton Medical Products Corporation Pre-Amendment Product Class: FSY
Description of Device:
The StarTrol LED Lighting System is a Class II medical device that provides an illumination field for general examination and minor surgery. The lighting system utilizes LED's for illumination and is powered from standard AC voltage sources. The head design is comprised of multiple LED's (Light Emitting Diodes). The LED head is mounted such that it can be moved and oriented by the operator to place the illumination field on the subject by means of a removable handle (sterile, single use handle covers are available). The light head is balanced with a counterweight to provide flexibility and exact placement without the drifting of the light head. Maneyverability of the light head requires minimal force by the clinician to quickly and easily place it in the desired position. The intensity of illumination is variable. Intended Use:
JUL 2 0 2010
1
The StarTrol LED Lighting system is designed to provide a visible illumination of the examination
/surgical field of the patient during surgical and non-surgical procedures.
Non-Clinical Comparisons to Predicate Devices:
The StarTrol LED Lighting System and the predicate devices are alike in they have variable intensity surgical lights which provide illumination, are available in various mounting configurations, similar power sources, and intended uses. The differences between the StarTrol LED Lighting System and the predicate devices are in the general appearance of the light, and in the case of the Next Generation the light source used is a halogen bulb, where as the StarTrol and the AlM feature LED's as the light source.
Test Data:
The test data supports conformance to:
UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
IEC 60601-2-41 Medical Electrical Equipment – Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility
IEC 60601-1-4 Medical Electrical Equipment - Part 1-4 General Requirements for Safety -Collateral Standard: Programmable Electrical Medical Systems
IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Safety collateral Standard: Usability
CSA C22.2 No. 60601.1 Medical Electrical Equipment, Part 1: General Requirements for safety
CSA C.22.2 No. 60601-2-41 Medical Electrical Equipment - Part 2-41: Particular Requirements for the safety of surgical
Clinical Data:
No clinical date is required for this device classification submission. The StarTrol LED Lighting System is a light that is substantially equivalent to our predicate devices, which have been available for decades and doing a clinical evaluation would be of no benefit.
Conclusion:
The modifications between the StarTrol LED Lighting System and the predicate devices (Next Generation and the AIM) are limited to the differences in the light, some materials, and the basic operations. These differences in the light do not create any new issues in the safety and efficacy. Based on the information provided in this 510(k) Premarket Notification, we conclude that the StarTrol LED Lighting System is substantially equivalent to the predicate devices and is safe and effective when used as intended.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 20 2010
Huot Instruments, LLC % Ms. Anne Ward N50 W13740 Overview Drive Suite A Menomonee Falls, Wisconsin 53051
Re: K100702
Trade/Device Name: StarTrol™ LED Lighting System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY, FSS, FTD Dated: July 14, 2010 Received: July 16, 2010
Dear Ms. Ward:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Anne Ward ·
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 forth in the quality systems (OS) 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/CDRH/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 1A
Indications for Use
510(k) Number: __ K100702
Device Name: StarTrol LED Lighting System
İndications for Use:
The StarTrol LED Lighting system is designed to provide a visible illumination of the examination /surgical field of the patient during surgical and non-surgical procedures.
Prescription Use × (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 (ODE)
510(k) Number
Mark A. Millerea
(Division Sign-Off) (Division Sign-on) / DIVISestorative Devices