(73 days)
The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System. Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.
The provided text is a 510(k) summary for the Twister™ Side-Firing Fiber Optic Delivery System. It describes the device, its intended use, and its technological characteristics. However, it explicitly states that no performance testing was included in the submission because the performance of the device on soft tissue is "well established and documented."
Therefore, based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented in the document.
- Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was analyzed.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no performance data was collected.
- The sample size for the training set: Not applicable as this is a physical medical device.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing substantial equivalence to a predicate device (Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System, K112987) based on technological characteristics and identical components/patient contact materials. The key difference noted is a change in the numerical aperture (NA) of the fiber for better coupling efficiency, which is presented as an improvement rather than a factor requiring new performance testing for soft tissue applications.
§ 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.