(15 days)
The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
The OmniGuide OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
Acceptance Criteria and Study Details for OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip (K093451)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Laser Power Output | Comparable to predicate devices. |
| Beam Quality | Comparable to predicate devices. |
| Tip Heating (Continuous Wave Mode) | Reduced, allowing for continuous wave mode use without heating the tip. |
| Energy Transmission Levels | Similar or equivalent to legally marketed devices. |
| Intended Use Equivalence | Similar or equivalent to legally marketed devices. |
| Technology Equivalence | Uses the same technology as predicate devices. |
Explanation of the Acceptance Criteria (Implied):
The document does not explicitly list numerical acceptance criteria. Instead, the "Performance Data" section states that the device's performance characteristics (laser power output and beam quality) were evaluated through testing and analysis. The acceptance for these characteristics is implicitly defined by their comparability to legally marketed predicate devices. The new feature of "Low Profile/Low Loss Tip" specifically addresses tip heating, indicating that its performance in continuous wave mode without excessive heating was a key acceptance point. The overall conclusion reinforces the equivalence of energy transmission levels, beam quality, and intended use as the basis for acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "testing and analysis of laser power output and beam quality." This suggests a series of technical bench tests on the device itself, rather than a sample of patients or cases.
- Data Provenance: The "Non-clinical Performance Data" section implies that the testing was conducted internally by OmniGuide, Inc. (the submitter). The data would therefore be retrospective in terms of being collected prior to the 510(k) submission and for the purpose of demonstrating equivalence. There is no mention of country of origin for this testing, but given the submitter's location (Cambridge, MA), it is highly likely to be United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device's performance is based on engineering specifications and direct measurements of physical properties (laser power output, beam quality, tip temperature). There were no human experts establishing ground truth in the context of clinical interpretation or diagnosis.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The "experts" involved would have been engineers and technicians conducting the non-clinical performance testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a technical performance study, not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" would have been the comparison of the measured performance data to the established performance characteristics of the predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states: "Clinical Performance Data: Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices." This indicates that no human-in-the-loop clinical studies were conducted, thus no MRMC study.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this device is a surgical fiber for laser energy delivery, not an AI-assisted diagnostic or interpretative tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in essence. The "Non-clinical Performance Data" represents a standalone evaluation of the device's physical performance characteristics (laser power output, beam quality, tip heating) against engineering benchmarks and predicate device performance. This assesses the device's function directly without human interaction beyond operating the device for testing purposes.
- Description: The study involved "testing and analysis of laser power output and beam quality." The comparison to predicate devices served as the benchmark for "standalone" performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was primarily engineering specifications and measured physical performance data from established predicate devices. The predicate devices' "energy transmission levels" and "beam quality" served as the reference points for comparison. The performance in terms of "reduced tip heating" was also a key physical characteristic that was measured and compared to previous versions or requirements.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical instrument (laser fiber), not an AI/algorithm-based system that requires a "training set" of data in the machine learning sense. The development and design of the fiber would have relied on engineering principles, materials science, and possibly iterative design and testing, rather than an explicit "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" for this type of device. The "ground truth" during the device's engineering and development phase would have been established through physics, material science data, prior art, performance standards, and experimental results from prototypes.
§ 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.