(88 days)
The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
The provided text describes a medical laser system, the ECHOLASER X4, and its substantial equivalence to a predicate device for the purpose of FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical or algorithmic efficacy.
The document focuses on regulatory compliance and comparison with a predicate device (DORNIER MEDILAS D 1064 laser system) based on technical specifications and intended use.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical or algorithmic performance, which is not detailed here.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be fully provided. The document lists technical specifications of the device and compares them to a predicate device. It doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific outcome measure for a therapeutic device) or detailed "reported device performance" against such criteria. The performance shown is primarily technical parameters.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (ECHOLASER X4) | Predicate Device Performance (DORNIER MEDILAS D 1064) |
|---|---|---|
| Indications for Use: Cutting, vaporization, ablation, coagulation of soft tissue (endoscopic, open surgery), treatment/removal of vascular lesions (tumors) | Same | Same |
| Laser Type: DIODE | DIODE | DIODE |
| Wavelength: 1064 nm ± 10% | 1064 nm ± 10% | 1064 nm ± 10% |
| Output Mode: Multimode | Multimode | Multimode |
| Maximum Delivered Power: Comparable | 28W | 30W |
| Stability of Output Power Level: ±20% | ±20% | ±20% |
| Beam Diameter: 0.3 mm | 0.3 mm | 0.3 mm |
| Mode of Operation: Continuous wave | Continuous wave | Continuous wave |
| Aiming Beam Laser Type: Diode | Diode | Diode |
| Aiming Beam Wavelength: Comparable | 630-670 nm | 632 nm |
| Aiming Beam Maximum Delivered Output Power: Comparable |
§ 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.