(62 days)
Not Found
No
The description focuses on mechanical components and manual control, with no mention of AI/ML terms or functionalities.
No
The device is described as assisting, manipulating, and maintaining a seal around other diagnostic/interventional devices, rather than directly treating a medical condition.
No
The device is described as assisting in interventional angioplasty procedures by maintaining a seal around other diagnostic/interventional devices. Its function is to facilitate the use of other devices, not to diagnose.
No
The device description clearly details physical components like Y-connectors and silicone valves, indicating it is a hardware device, not software-only.
Based on the provided information, the SEDAT MYSHELL LITE is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "assisting, manipulating, and maintaining a seal around diagnostic/interventional devices... used in interventional angioplasty procedures." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a Y-connector with a haemostatic valve for controlling access during interventional procedures. This aligns with a surgical or procedural accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SEDAT MYSHELL LITE does not fit this description.
N/A
Intended Use / Indications for Use
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.
0
Special 510(k) Premarket Notification Myshell Lite
VII. 510(k) Summary
APR 2 3 2008
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 8807.92, the following summary of information is provided:
A. Submitted by
Catherine Charles Director of Regulatory Affairs and Quality Assurance Sedat 135, Route Neuve 69540 Irigny - France Telephone: +33 472 397 414 Fax: +33 478 518 967
B. Device Name
Trade or Proprietary Name: Sedat Myshell Lite Common or Usual Name: Myshell Lite Y Connector Classification Name: Cardiopulmonary Bypass Adaptor, Stopcock, Mannifold, or Fitting Device Class: Class II Classification: 870.4290 Product Code: DTL
C. Predicate Devices
The subject device is substantially equivalent to the Myshell device cleared under K040498.
D. Device Description
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.
E. Intended Use
The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter