(84 days)
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are 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 Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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 text describes the 510(k) summary for the Dornier Medilas D Family Lasers. It outlines the device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond regulatory compliance.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, a common pathway for medical device clearance in the US.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance Study for Dornier Medilas D Family Lasers
This submission for the Dornier Medilas D Family Lasers (including Medilas D Litebeam, Medilas D Litebeam +, Medilas D Urobeam, Medilas D Multibeam, and Medilas D FlexiPulse) relies on demonstrating substantial equivalence to predicate devices rather than independent performance studies with specific acceptance criteria. Therefore, a table of acceptance criteria and reported device performance, in the typical sense of quantitative clinical or analytical performance, cannot be extracted directly from this document.
The "acceptance criteria" can be inferred as compliance with existing regulatory standards and the demonstration of equivalent technological characteristics and overall performance to the identified predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from Submission) |
|---|---|
| Regulatory Compliance | Complies with Class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11). Complies with voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE). |
| Technological Characteristics | "From a clinical perspective and comparing design specifications, the Dornier Medilas D Family Lasers and the predicate devices are substantially equivalent." Minor differences exist that "should not raise any concerns regarding the overall safety or effectiveness." |
| Overall Performance | "Based on the technological characteristics and overall performance of the devices... no significant differences exist between the proposed diode lasers and the predicate devices." Implied performance is equivalent to predicate devices for stated indications. |
| Safety and Effectiveness | Believed to be "substantially equivalent" to predicate devices, and differences "do not raise new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" for a performance study as it relies on substantial equivalence. It does not mention any sample sizes for tests, nor does it specify data provenance in terms terms of country of origin or retrospective/prospective nature. The assessment is based on a comparison of design specifications and regulatory compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as there is no described test set or ground truth establishment relevant to the performance metrics of an AI/algorithm-based device. The submission focuses on the engineering and regulatory equivalence of a laser system.
4. Adjudication Method for the Test Set
This information is not provided as there is no described test set that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported for this device, as it is a laser hardware system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study, as understood for AI/algorithmic devices, was not conducted or reported. The device is an energy-based surgical tool. Its performance is assessed through compliance with electrical, laser radiation, and medical device safety standards, and by demonstrating equivalence in its operational specifications to previously cleared devices.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI image analysis or diagnostic algorithms is not relevant or discussed in this 510(k) submission. The "truth" in this context is the fulfillment of regulatory standards and the demonstration that the device's technical specifications and intended uses are analogous to legally marketed predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided as this submission is for a laser surgical instrument, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated in 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.