(87 days)
Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications:
General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology
Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic
The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console.
The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe.
Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device.
Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged.
This document describes a 510(k) submission for the E3 MicroProbe, a medical device. Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The design of the E3 MicroProbe has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied." However, it does not provide specific acceptance criteria or an enumerated list of reported device performance metrics. The primary "performance" being evaluated is its substantial equivalence to predicate devices, particularly regarding its increased power output and expanded indications for use.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| General System Specifications | "All system specifications are satisfied." (No specific criteria detailed) |
| Power Output (E3 MicroProbe - 60W model) | Achieves 60 Watts at the output port. (Implied, as this is the primary modification) |
| Safety and Functionality | "The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate prior to the modifications." |
| Indications for Use (Expanded) | Supports contact and non-contact ablation, incision, excision, coagulation, and vaporization for: General Surgery, Ophthalmology/Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary/Thoracic, Dermatology/Plastic Surgery, Neurosurgery, Orthopedic. (This is a statement of intended use, verified as substantially equivalent). |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "The design of the E3 MicroProbe has been thoroughly validated at the unit and system level." but does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). This submission is a 510(k) for a modified device (increased power), and the "testing" described appears to be internal validation rather than a clinical trial with a defined test set of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The submission focuses on device characteristics and substantial equivalence to predicate devices rather than direct clinical performance data established by expert ground truth on a test set.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the nature of a 510(k) for a modified device with internal validation, a formal adjudication method for a clinical test set is not described as being part of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study is mentioned or appears to have been performed for this 510(k) submission. The document relies on demonstrating substantial equivalence to existing devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the E3 MicroProbe is a surgical laser and endoscope system, not an algorithm or AI-driven device.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is substantial equivalence to legally marketed predicate devices. The testing described ("thoroughly validated at the unit and system level") would likely involve engineering specifications, safety testing (e.g., laser power output accuracy, thermal management, electrical safety), and functional verification against the existing MicroProbe and other predicate devices. It relies on the understanding that if the new device performs similarly and safely to established predicate devices within its increased power range, it is considered safe and effective.
8. The Sample Size for the Training Set:
This information is not provided and is likely not relevant as this is a physical medical device, not an AI/machine learning model that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable for the reasons stated above.
§ 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.