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510(k) Data Aggregation
(10 days)
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
The OmniGuide Sterile WaveGuide Adapter System 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 Sterile WaveGuide Adapter System connects a hospitals CO2 laser to the OmniGuide WaveGuide Fibers. The additional filter and autoclave sterilization of the adapter and hose allows for use in sterile surgical procedures.
The output tube and gas hose will be sold non-sterile and the hospital will autoclave sterilize. The filter element may be provided as a gamma sterilized device (high Pressure option) or as a non sterile device for autoclave sterilization. The low pressure filter may be autoclave sterilized or provided sterile at the end users request.
The provided document describes a 510(k) premarket notification for the "OmniGuide Sterile WaveGuide Adapter System." The core of this submission is to claim "substantial equivalence" to a predicate device, not to prove clinical safety and effectiveness through extensive studies or acceptance criteria as would be typical for novel devices or AI/software.
Therefore, many of the requested categories are either not applicable or not explicitly detailed in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense for this 510(k) submission. The submission does not define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy against a gold standard) because it relies on demonstrating substantial equivalence to a legally marketed predicate device.
Instead, the performance evaluation focused on demonstrating comparable technical characteristics to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent laser power output and beam quality | "The OmniGuide Sterile WaveGuide Adapter System performance characteristics have been evaluated through testing and analysis of laser power output and beam quality." |
| Comparable intended use | "The intended use... of the OmniGuide Sterile WaveGuide Adapter System are similar or equivalent to the characteristics of above mentioned legally marketed devices." |
| Comparable major performance parameters (energy transmission levels) | "The major performance parameters (energy transmission levels and beam quality) of the OmniGuide Sterile WaveGuide Adapter System are similar or equivalent to the characteristics of above mentioned legally marketed devices." |
| Compliance with FDA Guidance on Medical Lasers | "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) and is similar to the predicate device tests." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for clinical performance. The submission states, "Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate device."
The testing performed was non-clinical (laser power output and beam quality), and details about the sample sizes for these engineering tests are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was established for this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was established.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study was not performed. The device is a physical instrument, not an AI or software algorithm that would typically be evaluated in an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a CO2 laser accessory, not an algorithm.
7. The Type of Ground Truth Used
Not applicable for clinical ground truth. The "ground truth" for the non-clinical performance evaluation appears to be established by engineering measurements against established laser performance standards and comparison to the predicate device's measured performance.
8. The Sample Size for the Training Set
Not applicable. This device is a physical instrument, not a machine learning model, so there is no concept of a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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