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WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 532nm - 2200mm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are indented for endovascular of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radially.

Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement.

WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W.

They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.

The provided document is a 510(k) summary for a medical device (WONTECH Surgical Optic Fibers) seeking clearance from the FDA. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical characteristics, rather than clinical studies or studies proving device performance against specific acceptance criteria in a clinical context.

Therefore, the information required to fully answer your request regarding a study proving the device meets acceptance criteria, including details on acceptance criteria with reported performance, sample sizes, expert involvement, ground truth establishment, and MRMC studies, is not present in the provided text.

Specifically:

• No acceptance criteria or reported device performance table is provided. The document focuses on showing the new device is similar enough to a legally marketed predicate device (K220189) that it doesn't raise new questions of safety or effectiveness.
• No details on sample sizes for a test set (clinical data), data provenance, or expert involvement are available. The document states "No clinical studies were considered necessary and performed."
• Adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance are not applicable as this is not a software-based AI device and no clinical studies were performed.
• The type of ground truth used is not applicable since clinical studies were not conducted.
• Training set size and ground truth establishment for a training set are not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense.

The document highlights the following non-clinical tests to demonstrate substantial equivalence:

• Sterilization: Bench tests demonstrated compliance with numerous ISO and EN standards related to ethylene oxide sterilization, biological indicators, and packaging sterility. No performance metrics are given beyond "complies."
• Software Validation: "There is no software available for this device," so no software validation was performed.
• Biocompatibility: The material (Silica Core) for the fiber is stated to be biocompatible for limited contact (

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