(221 days)
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.
The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.
The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer.
The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer.
The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.
I am sorry, but the provided text focuses on the regulatory clearance of a medical device (SoundBite® Crossing System XS Peripheral) and its substantial equivalence to a predicate device. It describes the device, its intended use, and a comparison of its characteristics with the predicate.
The document includes a "Summary of Non-Clinical Testing" section that lists various tests performed to assess the safety and performance of the device. However, this section does not provide specific acceptance criteria or the reported device performance in a quantitative manner that would allow for the creation of the requested table. It also does not delve into the details of study design, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance. While tests are listed, the specific criteria and performance values are not provided.
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- Whether a MRMC comparative effectiveness study was done, or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document confirms that non-clinical testing was conducted, but the specifics required to answer your questions are not present in the provided text.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).