(13 days)
The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:
- . Dermatology
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery ●
- Orthopedic Surgery .
- Otorhinolaryngology .
- Pediatric Surgery ●
- Plastic & Reconstructive Surgery
- Podiatry .
- · Urology
The OmniGuide BeamPath® FELS 25A, CO2 Laser System intended to be used in conjunction with the OmniGuide BeamPath Adapter and the OmniGuide BeamPath fiber and is intended to be used for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues.
The OmniGuide BeamPath FELS 25A, CO2 Laser System, is a Carbon dioxide (CO2) Laser emitting light at a wavelength of 10.6 um. It has an RF excited laser tube which produces a maximum continuous wave (CW) output power of up to 30 watts. Laser energy (CO2), with a wavelength of 10.6 um, has a variety of attractive features for surgical use. Because it is strongly absorbed by water (the main constituent of biological tissue) it does not penetrate into tissue beyond the point of application of the laser energy. This small depth of penetration (0.1-0.2 mm) leads to high cutting precision and minimal thermal damage to adjacent tissue. In addition, the CO2 wavelength has excellent coagulation capabilities.
The laser console is a table top console which can be easily transported from one surgery room to the other. The controls for the physician are part of the console and the parameters are clearly displayed on a large screen display. The laser light is guided through different mirrors and focused via an attached adapter is the interface allowing an OmniGuide BeamPath Fiber or equivalent to attach to the laser.
Materials used are mainly machined aluminum or stainless Steel and standard optics for the transmission or the reflection of the CO2 laser wave length. Only the laser energy from the OmniGuide BeamPath FELS 25A, CO2 Laser System comes in contact with the patient. The energy is guided through a hollow waveguide such as the OmniGuide BeamPath hollow waveguide liber. It is worth noting that all components (mirrors, lenses and the fiber) that the CO2 light travels though are passive and do not alter the wayelength or any other of the fundamental properties or beneficial attributes of the CO2 Laser.
The OmniGuide BeamPath® FELS 25A, CO2 Laser System is a surgical CO2 laser designed for incision, excision, ablation, vaporization, and coagulation of soft tissues. The acceptance criteria and the study proving it meets these criteria are outlined below.
Acceptance Criteria and Reported Device Performance
The device's performance was evaluated through non-clinical testing and analysis, as formal clinical trials were not deemed necessary. The primary acceptance criterion was substantial equivalence to a predicate device (K063698 C-Las CO2 Laser System).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Laser Power Output | Evaluated through testing and analysis. "Performance of OmniGuide BeamPath® PELS 25A, CO2 Laser System and related parameters of the predicate device are the same." |
| Beam Quality | Evaluated through testing and analysis. "Performance of OmniGuide BeamPath® PELS 25A, CO2 Laser System and related parameters of the predicate device are the same." |
| Technology and Intended Use Equivalence | "using the same technology and intended use as predicate device" |
| Major Performance Parameters Equivalent | "The intended use and major performance parameters of the OmniGuide BeamPath® FELS 25A, CO2 Lascr System are equivalent to the characteristics of above mentioned legally marketed device." |
Study Details:
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Sample size used for the test set and the data provenance: Not applicable. The study primarily involved non-clinical performance testing and analysis of the laser's power output and beam quality. There was no test set of patient data, nor was there any human subject data, retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this type of non-clinical device testing focused on physical parameters.
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Adjudication method for the test set: Not applicable. There was no test set involving human judgment or interpretation.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical CO2 laser, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "study" was focused on the standalone performance of the laser system itself, specifically its power output and beam quality. It's an algorithm-only performance in the sense that it's the device operating independently of a human-in-the-loop for its basic function, but it's important to differentiate that it's not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" was established by engineering and physics principles, specifically measurements and analyses of laser power output and beam quality against established standards and comparison to the predicate device's measured parameters.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.