(79 days)
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
The Dornier Medilas D Family Lasers are continuous-wave diode laser emitting laser radiation in the invisible range of 940 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D Family Lasers incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D Family Lasers feature several operating modes, including Standard, Fibertom, LITT and LPS. The lasers can be used in contact or non-contact open surgery with or without handpieces.
The provided document is a 510(k) summary for the Dornier Medilas D Family Lasers. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel device proving its efficacy or accuracy.
Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, are not explicitly present in this type of regulatory submission. This document describes the device, its intended use, and its technological characteristics as compared to a predicate device, ultimately stating its compliance with established electrical and laser safety standards rather than clinical performance metrics.
Here is a summary of what can be extracted from the document, with explanations for the missing information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness through Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective. | The submission concludes that the Dornier Medilas D Family Lasers and the predicate device (Biolitec Ceralas Diode 100 W 980 nm Laser System K050824) are "substantially equivalent" from a clinical perspective and based on design specifications. "No significant differences exist between the proposed diode lasers and the predicate devices." |
| Compliance with Safety Standards: Compliance with relevant international electrical and laser safety standards. | The lasers are in compliance with Class IV performance standards for light-emitting products promulgated under the Radiation Control for Health and Safety Act of 1968 (21 C.F.R. §1040.10 and §1040.11). They also comply with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE). |
| Technological Characteristics Comparison: The new device's technological characteristics should not raise new issues of safety or effectiveness compared to the predicate device. | The "minor differences" between the Medilas D Family Lasers and its predicates "should not raise any concerns regarding the overall 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)
This information is not provided. As this is a 510(k) for a laser system built on substantial equivalence to an existing device, it relies on design comparisons and compliance with safety standards rather than new clinical outcome data or a specific "test set" in the context of AI/diagnostic device performance.
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)
This information is not provided. This type of detail is relevant for diagnostic devices or those requiring expert interpretation for ground truth, which is not the primary focus of this laser system's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. See point 3.
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 information is not provided. MRMC studies are typically for evaluating the impact of AI on human diagnostic performance, which is not applicable to a laser system device focused on tissue manipulation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This refers to AI algorithm performance and is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not specified because the submission relies on the established safety and efficacy of the predicate device and compliance with general device standards, not on a new clinical study generating specific ground truth. The "ground truth" for this type of submission is essentially the proven safety record and performance of the predicate device and the adherence to recognized safety standards.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/provided. See point 8.
§ 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.