(90 days)
The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.
The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.
The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.
The Clinicon WaveGuide Platform with Interconnect for Luxar Accessories (K014236) is an accessory for CO2 laser systems designed to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory with minimal beam degradation. The specific indications for use are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached.
The provided document does not contain a detailed study report with specific acceptance criteria and performance data in a format suitable for the requested table. This submission primarily focuses on establishing substantial equivalence to predicate devices (K992472 and K960475) based on technological characteristics and intended use.
However, based on the information provided, we can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state quantitative acceptance criteria or provide detailed performance data from a dedicated study. The information below is inferred from the description of substantial equivalence and device characteristics.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Beam Degradation (Minimal) | Delivers CO2 laser energy with "minimal beam degradation" |
| Beam Characteristics (Luxar Interconnect) | Duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. |
| Has the same beam divergence and multimode character as the output of the Luxar Fiber cable. | |
| Compatibility | Can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon and Luxar accessories. |
| Wavelength Range | Functions over the wavelength range of 9 - 11 um. |
| Length Availability | Available in standard lengths between 0.5 m and 3.0 m. |
| Material/Construction | Hollow silica fiber with internal coating, flexible protective outer cover. |
| Connectors | FSMA 905 series fiber optic connectors on each end. |
2. Sample Size for the Test Set and Data Provenance
The document does not report on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The substantial equivalence claim is based on technological characteristics, intended use comparison to predicate devices, and likely internal engineering tests, rather than a clinical or performance study with a defined test set of patients or medical scenarios.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts or the establishment of ground truth in the context of a performance study for the K014236 device. This type of evaluation is not typically required for a device like a CO2 laser accessory where performance is primarily measured through engineering specifications and functional testing rather than interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Since no specific test set requiring expert interpretation is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or reported. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This device is a surgical instrument accessory, not a diagnostic tool requiring human interpretation of output.
6. Standalone Performance Study
The document describes the device's technological characteristics and its intended function (delivering laser energy with minimal degradation and maintaining specific beam characteristics). While implicit in the design and engineering, the document does not present a formal "standalone" performance study report in the manner of a clinical trial for a diagnostic or therapeutic device. The "proof" is largely based on demonstrating that its technical specifications and functional output are equivalent to the predicate devices and meet its stated purpose.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, expert consensus) is not applicable to this submission. The validation evidence for this device would rely on engineering measurements (e.g., laser power output, beam divergence, fiber transmission efficiency, material compatibility, sterile barrier integrity) and functional testing to confirm it performs as intended and is equivalent to the predicate devices.
8. Sample Size for the Training Set
No training set is mentioned or applicable as this device is a physical CO2 laser accessory, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for an AI/machine learning algorithm.
§ 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.