(40 days)
The TissueLink BPS bipolar sealer is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device
This looks like a 510(k) summary for a medical device (TissueLink Bipolar Sealer 2.3). However, this document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.
The provided text is a summary discussing:
- The application information (submitter, contacts, device name, classification).
- Claim of substantial equivalence to a predicate device.
- FDA's letter confirming substantial equivalence and market clearance.
- The indications for use statement for the device.
For a medical device like this, acceptance criteria and study details demonstrating performance would typically be found in a separate section of the 510(k) submission, often under "Performance Data," "Bench Testing," "Biocompatibility," "Sterilization," or similar headings. This summary document primarily focuses on regulatory approval and substantial equivalence.
Therefore, I cannot extract the requested information from the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.