(48 days)
The Dornier Medilas D 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, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties:
- Urology
- Plastic Surgery
- General Surgery
- Dermatology
- Gynecology
- Pulmonary Surgery
- Gastroenterology
- ENT
- Radiology
The Dornier Medilas D laser is a 50 W diode laser that emits laser radiation in the invisible range of 940 nm. It offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps, and offers adjustable pulse duration. It has software controlled operating modes including Standard, Fibertom, LITT and LPS. It uses a 0.1mW Diode laser aiming beam with a wavelength of 645 nm. It incorporates a graphic display showing laser operating parameters, application modes, time functions, system status and messages for the user. It has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system. It is based on a single shutter with two parallel running microprocessors.
The provided text describes a 510(k) submission for the Dornier Medilas D Laser, which asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study.
Therefore, most of the requested information regarding acceptance criteria, study details, and data provenance cannot be extracted from this document, as such a study was not conducted or reported for this 510(k) submission.
Here's what can be inferred for the relevant points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics from a dedicated study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The reported "performance" is a comparison of technological characteristics to those predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Comparison to Predicates) |
|---|---|
| Intended Use Equivalence: The intended use of the Medilas D Laser must be the same as the predicate devices. | The Dornier Medilas D Laser has the same intended use as the Dornier 5100 Laser and Indigo's 830e Laser: cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties (Urology, Plastic Surgery, Dermatology, Radiology, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery). |
| Technological Characteristics Equivalence: The Medilas D Laser must have similar principles of operation and technological characteristics to the predicate devices, with any differences not raising new safety or effectiveness concerns. | Principles of Operation: Same as Dornier 5100 (continuous-wave laser). |
| Wavelength: 940 nm (Medilas D) vs. 1064 nm (5100). Both invisible ranges. | |
| Power Output: 0-50 W (Medilas D) vs. 2-100 W (5100). Both adjustable in 1 W steps. | |
| Pulse Duration: Adjustable (same as 5100). | |
| Calibration: Medilas D calibrated during manufacturing and service calls (end-user does not calibrate fibers). 5100 has automatic calibration with photoelectric power meter. | |
| Safety Features: Both have 2-stage waterproof/explosion-proof switch and watchdog-monitored microprocessor. | |
| Aiming Beam: Medilas D: 0.1mW Diode, 645 nm. 5100: 2 mW Diode, 630 nm. Max power for both at aperture is 1 mW. Differences do not affect tissue. | |
| Graphic Display: Both incorporate graphic displays for operating parameters, modes, time, status, and messages. | |
| Operating Modes: Medilas D shares "Standard, Fibertom, LITT and LPS" modes with 5100. 5100 has additional modes not on Medilas D. | |
| Cooling System: Both have air-cooled, temperature-controlled internal closed circuit water system. | |
| Microprocessor Control: Both use a single shutter with two parallel running microprocessors; "system fault" routine for discrepancies. | |
| Laser Medium: Medilas D is a diode laser, similar to Indigo's 830e (diode laser). 5100 is an Nd:YAG laser (though not explicitly stated, implied by 1064 nm wavelength). Differences in laser medium (diode vs. Nd:YAG) are acknowledged but deemed not to raise new safety/effectiveness issues, especially by referencing the Indigo 830e. | |
| Safety and Effectiveness: Any minor differences from predicate devices should not present new issues of safety or effectiveness. | The submitter states: "There are minor differences between the Medilas D laser and the predicate 5100 laser, none of which present new issues of safety or effectiveness." and "The minor differences in the aiming beam, software controlled operating modes, do not present new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" or clinical study data were provided in this 510(k) submission to demonstrate performance against specific criteria. The submission relies on a comparison of technological characteristics to already cleared devices.
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)
Not applicable. No "ground truth" establishment by experts was detailed as no specific performance study was presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" was detailed as no specific performance study was presented.
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
Not applicable. This device is a laser for surgical procedures, not an AI-assisted diagnostic tool, and no MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser, not an algorithm, and performance was established by demonstrating substantial equivalence to predicate devices, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate devices as previously determined by the FDA. The Medilas D Laser's "performance" is its similarity in function and safety profile to these established devices.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this 510(k) is not for an AI algorithm or a device requiring a training phase from data.
9. How the ground truth for the training set was established
Not applicable. As no training set was used, no ground truth needed to be established for it.
§ 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.