(130 days)
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.
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.
The provided text is a 510(k) summary for the StarTrol™ LED Surgical Light System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states that no clinical data is required or was performed for this device classification submission.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training data provenance cannot be extracted from this document, as a performance study as typically understood in the context of AI/ML or diagnostic devices was not conducted.
Here's what can be gathered based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards | Conforms to: |
| UL 60601-1 | Yes |
| IEC 60601-2-41 | Yes |
| IEC 60601-1-2 (EMC) | Yes |
| IEC 60601-1-4 (PEMS) | Yes |
| IEC 60601-1-6 (Usability) | Yes |
| CSA C22.2 No. 60601.1 | Yes |
| CSA C.22.2 No. 60601-2-41 | Yes |
| Substantial Equivalence | Concluded to be substantially equivalent to predicate devices (Next Generation Surgery Light and AIM Burton Medical Products Corporation) based on non-clinical comparisons. |
| Intended Use | Provides visible illumination of the examination/surgical field of the patient during surgical and non-surgical procedures. (Assumed met by design and safety compliance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set was used for a clinical performance study. The evaluation focused on non-clinical and safety conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth was established by experts for a performance test set, as no clinical performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication was performed.
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
- No. A MRMC comparative effectiveness study was not performed. The device is a surgical light, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical light, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth for this submission was based on compliance with recognized electrical, safety, and usability standards (UL, IEC, CSA), and comparison to the design and intended use of predicate devices. There was no "clinical ground truth" in the traditional sense.
8. The sample size for the training set
- Not applicable. The device is a physical product, not a machine learning algorithm that requires a training set. The development likely involved engineering design, testing, and validation against specifications, not algorithmic training.
9. How the ground truth for the training set was established
- Not applicable. As above, there was no "training set" for an algorithm. Design and manufacturing "ground truth" would be established through engineering specifications, validated component performance, and adherence to quality system regulations like Good Manufacturing Practices.
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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
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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
§ 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.