(85 days)
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is 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), and in the treatment and/or removal of vascular lesions (tumors).
The Dornier Medilas D 1064 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1064 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 1064 Laser incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D 1064 Laser features several operating modes, including Standard, Fibertom, LITT and LPS. The laser 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 1064 Laser. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets specific de novo acceptance criteria through rigorous clinical studies for performance metrics like sensitivity, specificity, etc.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/diagnostic device.
Here's why and what information is available:
- Type of Device: The Medilas D 1064 Laser is a surgical laser, not an AI or diagnostic device that would typically have performance metrics like those for image analysis, disease detection, or treatment efficacy quantified by sensitivity, specificity, F1-score, etc.
- Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a device already on the market.
- Performance Data (as presented): 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 1064 Laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968... The laser also complies 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 safety and electrical standards for laser devices, not clinical performance metrics on patient outcomes or AI accuracy.
In summary, the requested information (performance acceptance criteria, study details, sample sizes, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable to this type of device and regulatory submission.
The document confirms that:
- The Medilas D 1064 Laser emits laser radiation at 1064 nm.
- It operates in continuous-wave mode.
- It is calibrated during manufacturing and service.
- It has a graphic display and several operating modes (Standard, Fibertom, LITT, LPS).
- It can be used in contact or non-contact open surgery, with or without handpieces.
- Its intended use is for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties, including with endoscopic equipment, and for treating/removing vascular lesions.
§ 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.