(90 days)
The SurgiLight 1470 Diode Laser System (Model: Halo) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux.
The SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, footswitch, a power cord and remote interlock components. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via optical fibers with SMA905 connectors.
This document is a 510(k) clearance letter for the SurgiLight 1470 Diode Laser System (Model:Halo). It states that the device is substantially equivalent to legally marketed predicate devices.
Important Note: The provided document is a 510(k) clearance letter for a laser surgical instrument. These types of devices typically demonstrate substantial equivalence through performance testing against recognized consensus standards and comparison of technological characteristics to predicate devices. They do not involve AI-based image analysis or diagnostic capabilities that would require the kind of complex study design (e.g., MRMC studies, human reader improvement metrics, expert consensus ground truth for image data) described in your request.
Therefore, many of the specific criteria related to AI performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device clearance.
Here's an analysis based on the information provided in the 510(k) document, addressing your questions where applicable and noting when information is not pertinent to this device type:
Acceptance Criteria and Device Performance for SurgiLight 1470 Diode Laser System (Model:Halo)
Based on the 510(k) summary, the "acceptance criteria" are primarily demonstrated through compliance with recognized international standards for medical electrical equipment and a comparison of technical specifications to legally marketed predicate devices. The "study" proving the device meets these criteria is the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the compliance with the listed standards and the demonstrated substantial equivalence to predicate devices in key technical specifications.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety and Essential Performance (General) | Compliance with IEC 60601-1:2005/A2:2021 (General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances - Requirements and tests). |
| Laser Specific Safety and Performance | Compliance with IEC 60601-2-22:2019 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment). |
| Laser Product Safety Classification | Compliance with IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification and requirements). Device is Level 4 Laser. |
| Intended Use/Indications for Use Equivalence | Same as predicate devices (K240644, K152722): surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties (Urology, Thoracic, Plastic/Dermatology, General, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal, Gynecology, Pulmonary, Neurosurgery, Gastroenterology, Head/neck/ENT, Radiology, Oral/Dental, Endovascular coagulation, and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux). Target population: Adult. |
| Technological Characteristics Equivalence | Product Code: GEX (Same) |
| Regulation No.: 21 CFR 878.4810 (Same) | |
| Class: II (Same) | |
| Laser Type: Diode laser (Same) | |
| Wavelength: 1470nm (Same) | |
| Working Mode: CW, Single Pulse, Repeat Pulse (Same) | |
| Laser Beam Transmission Mode: fiber (Same) | |
| Laser Level: Level 4 (Same) | |
| Operation Interface: Color LCD touch screen (Same) | |
| Microprocessor Control: Yes (Same) | |
| Therapeutic Maximum Laser Output Power: 12 W (Same as K240644, Similar to K152722 – 10 W). This is acceptable as new device is within safe and effective range. | |
| Pulse Width: 5 ms - 9,000 ms (Similar to K240644 (10ms-25s), within scope of K152722 (100μs-30s)). | |
| Repetition Rate: 0.06HZ-100HZ (Similar to K240644 (0-50HZ), within scope of K152722 (0.02 Hz to 5,000 Hz)). | |
| Aiming Beam Technical Features: Visible red laser Power: |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.