(34 days)
The OmniGuide Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology otorhinolaryngology, gastroenterology, neurosurgery pulmonary surgery for surgical and aesthetic applications.
The indications for use which the delivery system is used are dependant upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
The OmniGuide Beam Delivery System is an accessory for CO2 laser systems. It consists of an adapter and a fiber assembly that propagate CO2 laser beams. The OmniGuide Beam Delivery System Beampath 100 Handpeice Fiber is supplied sterile and is intended for single procedure use. The Beam Delivery System Adapter is provided non sterile for multiple uses. The Adapter will be configured to attach to specific CO- laser configurations. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber assembly is 1.0 m or 2.0 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The adapter links the fiber assembly and the CO2 laser.
The provided document is a 510(k) summary for the OmniGuide BeamPath Laser Beam Delivery System (K062423). It describes the device, its intended use, and the performance data submitted for regulatory review. However, it explicitly states that formal clinical trials were not deemed necessary and therefore, there is no detailed study proving the device meets specific acceptance criteria in the format requested.
The document indicates that substantial equivalence was claimed based on non-clinical performance data and comparability to predicate devices.
Here's a breakdown of the information that can be extracted or inferred based on the document's content, and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a formal table of "acceptance criteria" with quantitative targets. Instead, it states:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Laser Power Output: Comparable to predicate devices. | "The OmniGuide Beam Delivery System performance characteristics have been evaluated through testing and analysis of laser power output..." |
| Beam Quality: Comparable to predicate devices. | "...and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995)..." |
| Energy Transmission Levels: Similar or equivalent to predicate devices. | "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices." |
| Safety and Effectiveness: Consistent with predicate devices. | (Implied by the substantial equivalence claim based on comparable technology and intended use.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The "tests" mentioned are non-clinical, likely bench testing or simulations, not a formal clinical trial with a "test set" of patients.
- Data Provenance: Not applicable for clinical data. The performance data is from "testing and analysis" of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There was no clinical ground truth established through expert review for this submission.
4. Adjudication method for the test set:
Not applicable. No clinical test set or adjudication was performed.
5. 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 laser beam delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (hardware), not an algorithm. However, its "standalone" performance (efficacy of laser delivery) was assessed through non-clinical means.
7. The type of ground truth used:
Not applicable for clinical ground truth. For the non-clinical performance evaluation, the "ground truth" would be established engineering specifications, industry standards, and the performance characteristics of the predicate devices.
8. The sample size for the training set:
Not applicable. This is a hardware device, not an AI algorithm requiring a "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
Summary of what the document implies about meeting acceptance criteria:
The device did not undergo a clinical study with formal acceptance criteria for patient outcomes. Instead, it met regulatory requirements by demonstrating substantial equivalence to a predicate device (K050541, OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System) through:
- Non-clinical Performance Data: Evaluation of "laser power output and beam quality."
- Compliance with FDA Guidance: Adherence to the 1995 FDA Guidance for Medical Lasers.
- Comparability: The essential performance parameters (energy transmission levels and beam quality) and intended use were shown to be "similar or equivalent" to the predicate devices.
The FDA concluded that formal clinical trials were "not deemed necessary" because the device uses the "same technology and intended use as predicate devices." This means the "acceptance criteria" were met by demonstrating that the new device performs functionally equivalent to existing cleared devices based on non-clinical testing.
§ 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.