(87 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 for use in the treatment of incompetence and reflux of superficial veins in the lower extremity.
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.
This submission describes the Dornier Medilas D Family Lasers. The provided text indicates that the device's performance was evaluated against technological characteristics and overall performance, rather than specific quantitative acceptance criteria or a clinical study demonstrating statistically significant improvements.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No significant differences existing between the proposed diode lasers and the predicate devices (Diomed D15 plus and D30 plus) | Dornier MedTech America, Inc. believes that no significant differences exist and that minor differences should not raise concerns regarding overall safety or effectiveness. |
| Compliance with Class IV performance standards for light-emitting products (promulgated under the Radiation Control for Health and Safety Act of 1968) | The Dornier Medilas D Family Lasers are in compliance with 21 C.F.R. §1040.10 and §1040.11. |
| Compliance with applicable voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE). | The lasers also comply with these standards. |
| Substantial Equivalence for Safety and Effectiveness (compared to predicate devices) | Dornier MedTech America, Inc. believes the devices are substantially equivalent, and differences are minor, not raising new issues of safety or effectiveness. |
Study Information
The provided text does not describe a clinical study with a test set, ground truth, or expert review for the device's performance in its intended clinical applications. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and compliance with regulatory and voluntary standards.
Here's what can be inferred or stated as absent based on your questions:
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned for device performance.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
- 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 system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (laser system), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission revolves around compliance with engineering and safety standards, and technological similarity to predicate devices, rather than clinical outcomes verified by independent means.
- The sample size for the training set: Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary is for a medical laser system and focuses on demonstrating substantial equivalence to predicate devices through a review of technological characteristics and compliance with established safety and performance standards. It does not contain information about a clinical study involving a test set, ground truth, or expert review in the manner typically associated with submissions for diagnostic or AI-driven devices.
§ 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.