(21 days)
The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "MSI Pressure Infusor" device, dated October 29, 1997. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.
The document does not include any details about:
- Acceptance criteria for performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used.
- How ground truth for a training set was established.
This type of information is typically found in a detailed device submission, clinical study report, or a summary of safety and effectiveness, which are not part of this clearance letter.
§ 880.5420 Pressure infusor for an I.V. bag.
(a)
Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.