(223 days)
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study proving device performance:
The provided document is a 510(k) Premarket Notification for the OmniGuide Laser System with FlexGuide™ Ultra. It aims to demonstrate substantial equivalence to previously cleared devices, not to establish new performance claims against defined acceptance criteria in the traditional sense of a clinical trial. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance metrics) is not applicable or not explicitly provided in this type of regulatory submission. The focus is on demonstrating that the modified device is as safe and effective as its predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, explicit "acceptance criteria" against numerical performance metrics for a new claim are not presented. Instead, the acceptance is based on demonstrating that the modified device (FlexGuide™ Ultra handpiece) does not raise new issues of safety or effectiveness compared to its predicate. The "performance" reported is a qualitative assessment of similarity.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (FlexGuide™ Ultra) |
|---|---|
| Similar Intended Use: The modified device should have the same or very similar indications for use as the predicate device(s). | The FlexGuide™ Ultra has the same indications for use as the predicate OmniGuide BeamPath® Fiber Optic Handpiece System (K081939) regarding incision, excision, ablation, vaporization, and coagulation of body soft tissues (including intra-oral tissues) in general laparoscopic, gynecologic laparoscopic, urologic, and otorhinolaryngology surgical procedures. |
| Similar Operating Principles: The fundamental way the device functions should remain the same. | The operating principle of the FlexGuide™ Ultra, like its predicate, is "To enable precision control and to stabilize surgeon hand motion." The mechanism of action is also identical: "Handpiece is used to guide and protect BeamPath® fibers." |
| Similar Technical Characteristics: Key design features, materials, and functional aspects should be comparable. | Handpiece Lumen Material: 304 Stainless Steel (same as predicate). |
| Lumen Length: 50cm (vs. Up to 60cm for predicate, indicating a slight difference but within acceptable range for the modified design). | |
| Handpiece Design: Distal tip, handpiece body/cannula, rear sealing cap (same as predicate). | |
| Distal Tip Function: Used in either non-contact mode or contact mode, and may be used to enable tissue manipulation (same as predicate). | |
| The FELS 25A Laser and BeamPath Fibers remain unchanged from their predicate versions. The change focuses on the handpiece modification. | |
| No New Concerns of Safety or Effectiveness: Testing should demonstrate that the modifications do not introduce new risks or reduce effectiveness. | "Engineering analysis and bench testing concluded that the FlexGuide Ultra can be grasped, manipulated and confirmed the modified handpiece does not affect its purpose and performance when compared to the OmniGuide predicate handpiece." |
| "...testing was performed to confirm the modifications to the flexible handpiece when compared to its predicate device did not raise any new concerns of safety or effectiveness, alter the fundamental scientific technology of the device, nor affect its mode of use." | |
| Performance Data (Demonstrate Equivalence): Data should support the claim that the modified device performs comparably to the predicate. | "Results from the testing shows similar performance profiles when comparing the modified flexible handpiece to the original handpiece design." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of distinct "tests" or "patients." The performance testing is described as "Engineering analysis and bench testing." This implies a series of laboratory or functional tests, not a clinical trial with human subjects.
- Data Provenance: Not explicitly stated, but likely internal laboratory data from OmniGuide, Inc. (Cambridge, Massachusetts, USA). The study is retrospective in the sense that it evaluates the modified device against an existing predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. Ground truth as typically established by experts (e.g., for diagnostic accuracy) is not relevant for this type of engineering and bench testing. The evaluation is against engineering specifications and functional performance.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a study involving human interpretation of results requiring adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an AI diagnostic tool that assists human readers.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense. The "ground truth" for the engineering and bench testing would be successful operation according to the predicate's established performance parameters and the device's design specifications. This would involve objective measurements (e.g., mechanical integrity tests, energy delivery verification) rather than human interpretation or pathology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: 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.