(160 days)
The BWF-5 Medical Laser Series are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.
BWF-5 Solid-State Medical Laser Series are highly reliable, compact and easy to operate medical laser systems. The cutting edge control technology provides user a high reliable and maintenance free system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A convenient and easy-to-use touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave mode or controlled pulse mode. The device features multiple user-programmable presets for storing frequently used treatment parameters.
The provided text is a 510(k) summary for a BWF-5 Medical Laser Series. It details the device's technical characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.
The document primarily focuses on:
- Identifying the applicant and device.
- Classifying the device and listing predicate devices.
- Describing the device's function and intended use.
- Listing warnings and cautions for its use.
- Stating that the device has the "same intended use and the same technological characteristics as the predicate devices" and that identified differences are "minor and are each within the specifications listed by the predicate device and does not raise any concerns regarding the overall safety and effectiveness of the device."
- Mentioning compliance with voluntary consensus standards (e.g., 21 C.F.R. § 1040.10 & 1040.11; IEC 60601 series; IEC 61000 series; IEC 60825-1).
Since the document does not include the requested information about acceptance criteria or a study proving device performance against such criteria, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
Therefore, the response is:
The provided document does not contain information about acceptance criteria or specific study data to prove the device meets acceptance criteria regarding clinical or analytical performance.
The document states that the device is substantially equivalent to predicate devices, implying that its safety and effectiveness are established through this comparison, rather than through new performance studies detailed in this summary. The "Technological Characteristics" section lists compliance with various voluntary consensus standards, which typically involve testing for electrical safety, electromagnetic compatibility, and laser safety, but these are not presented as performance criteria with specific results in this summary.
In summary, none of the requested information (points 1-9) regarding acceptance criteria and performance study details can be extracted from the provided text.
§ 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.