(76 days)
The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.
The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.
The provided text describes the Integra™ LED Headlight System, a surgical headlight. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the document focuses on:
- 510(k) Summary details: Contact information, device trade name, common name, classification, product code, and predicate device.
- Device Description: Discusses the power options (battery/direct), LED light source, and active cooling system.
- Indications For Use: States that the device provides illumination for visualization during minor surgical, diagnostic, or therapeutic procedures.
- Performance Standards: Lists various international electrical and medical safety standards (CAN/CSA, EN, IEC, UL) that the device conforms to, but these are general safety standards, not specific performance acceptance criteria for its intended function (illumination quality, brightness, etc.).
- Technological Characteristics: Compares features of the Integra LED Surgical Headlight with its predicate device (Welch Allyn Solid State Headlight), highlighting improvements in user control of attenuated light level, fan monitoring/control, and over-temperature monitoring/control.
- Substantial Equivalence: Concludes that the Integra LED Surgical Headlight is substantially equivalent to the predicate device based on performance testing (though the specific performance testing data and acceptance criteria are not detailed in this summary).
- FDA Communication: A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to the predicate device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them, because this information is not present in the provided text.
The document states: "The Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness." This implies that performance testing was conducted, but the specifics of what was tested, what the acceptance criteria were, and what the reported performance was are not provided.
§ 886.4335 Operating headlamp.
(a)
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.