(62 days)
The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter
The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.
Here's an analysis of the provided text regarding the Sedat Myshell Lite device's acceptance criteria and the study used to demonstrate it:
Disclaimer: This device is a medical device (Y-connector with a double silicone haemostatic valve) and NOT an AI/algorithm-powered device. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable or cannot be extracted from the provided 510(k) summary. I will highlight what information is present and what is missing based on the nature of this particular device approval.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence in Indications for Use (to predicate device K040498) | The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter |
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.