(63 days)
The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.
This document describes a 510(k) submission for the Dornier Medilas H Pulsed Laser. The provided text is a summary seeking clearance for the device, and as such, it does not detail a study proving the device meets specific performance acceptance criteria in the manner one might find for a diagnostic or AI-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.
Therefore, many of the requested elements regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or not present in this type of submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a laser device demonstrating substantial equivalence, explicit "acceptance criteria" for a specific disease or diagnostic task are not provided in the same way they would be for a clinical diagnostic device.
The "performance" is primarily focused on demonstrating that the device operates safely and effectively within established laser standards and is technologically similar to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar principles of operation and technological characteristics to predicate devices. | The Medilas H has the same principles of operation and similar technological characteristics as previously cleared predicates, the Dornier Medilas Fibertome 5100 and Coherent's VersaPulse 2.1. Similarities include: photoelectric power meters, automatic calibration, 2-stage foot switch, watchdog monitored microprocessor, graphic display panel for operating parameters/status, adjustable pulse durations/continuous modes, 1 mW aiming beam power, and an identical cooling system to the Medilas 5100. Minor differences (e.g., Medilas H only has a Standard operating mode while predicates offer several) do not present new issues of safety or effectiveness. |
| Compliance with Safety Standards: Adherence to established laser safety and electrical safety standards. | Complies with class IV performance standards for light emitting products under the Radiation Control Health and Safety Act of 1968 (21 C.F.R. § 1040.10 and §1040.11). Complies with applicable requirements of voluntary standards: IEC-601, IEC 825NDE 0837/2.86. |
| Safety Features: Incorporation of mechanisms to prevent unintended laser emission or hazardous operation. | Features include a single rotating magnetic shutter controlled by two parallel running microprocessors; if microprocessors run differently, a "system fault" routinely is initiated, immediately halting laser production and release. Cooling system prevents operation at excessive temperatures. |
| Intended Use: Device performs as intended for specified indications. | Intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, colonoscopes) or in open surgery (contact or non-contact) for various specialties (Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, General Surgery). The submission asserts that the technological characteristics support these uses in a manner substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable. The submission does not describe a clinical study in the traditional sense involving a "test set" of patient data. It relies on technological comparison and compliance with standards rather than clinical performance data against a specific disease outcome.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. No ground truth for a test set was established as no such study is described.
4. Adjudication Method for the Test Set
This is not applicable. No test set requiring expert adjudication is described.
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
This is not applicable. This is not an AI-assisted diagnostic device, but a surgical laser. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The submission is based on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards for laser devices, not on a ground truth related to a specific disease diagnosis or outcome in a study. The closest concept to "ground truth" here would be the established safety and efficacy profiles of the predicate devices and the regulatory standards themselves.
8. The Sample Size for the Training Set
This is not applicable. This is not a machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As above, this is not a device requiring a training set with established ground truth.
§ 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.