(258 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.
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 text describes a 510(k) premarket notification for the Dornier Medilas D Family Lasers. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria.
The document primarily focuses on:
- Intended Use and Indications for Use: Delineating the medical specialties and specific procedures for which the lasers are intended.
- Technological Characteristics: Stating that the device is substantially equivalent to predicate devices.
- Regulatory Compliance: Listing the performance standards and voluntary standards with which the device complies (e.g., 21 C.F.R. §1040.10 and §1040.11, IEC 60601-1, etc.). These are regulatory compliance standards, not performance acceptance criteria from a clinical study.
- Administrative Information: Submitter details, device trade names, common names, classification, and predicate devices.
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices based on the information provided.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.
The document does not include any details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance studies.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Data" section explicitly states: "While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D Family 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. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE)."
This indicates compliance with electrical safety and laser product performance standards, which are different from acceptance criteria for clinical efficacy or diagnostic accuracy that would be proven in a clinical study.
§ 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.