(127 days)
The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.
The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.
Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation. These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera.
Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient. These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.
This K131893 submission is for surgical lights (Amico iCE LED Series and Amico Mira LED Series Minor Surgical Lights). The study provided is non-clinical performance testing. Therefore, many of the typical categories for AI/algorithm-based medical devices are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for these surgical lights are based on meeting established electrical safety and performance standards for medical electrical equipment and surgical luminaires. The reported device performance indicates that the devices passed these tests.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1: General requirements for basic safety and essential performance | Pass |
| IEC 60601-2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis | Pass |
| Constructional Data Report | Pass |
| IEC 60601-1-2 (Ed. 3): Electromagnetic compatibility - Requirements and tests (Report 1) | Pass |
| IEC 60601-1-2 (Ed. 3): Electromagnetic compatibility - Requirements and tests (Report 2) | Pass |
Study Details for Device Acceptance
It's important to note that this submission describes non-clinical performance testing for surgical lights, not a clinical study involving patients or an algorithm-based device. Therefore, many of the typical questions for AI/ML device studies are not applicable.
- Sample size used for the test set and the data provenance: Not applicable. This was testing of the physical device's electrical safety and performance, not a test on a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrical and performance standards is established by the specifications in the international standards, not by expert consensus in the context of an algorithm. The testing would be conducted by qualified engineers/technicians in an accredited lab.
- Adjudication method for the test set: Not applicable. The testing involves objective measurements against predefined thresholds within the standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. This device is a surgical lamp, not an AI or imaging device that would typically undergo such a study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used: The "ground truth" for this type of device and testing is defined by the requirements and thresholds set forth in the international electrical safety and performance standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2).
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion from Non-Clinical Testing:
The electrical safety testing concludes that the Amico Clinical Solutions Corp. iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights have been proven to be safe and effective and pose no foreseen hazards, having passed all specified IEC standards tests.
§ 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.