(398 days)
The Trinity DVT System is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
Compressible Limb Sleeve and Pump, Single Chamber
I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) submission for the Trinity DVT System, which aims for substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
The document includes:
- A summary and certification by J. Harvey Knauss.
- Classification and proprietary name of the device.
- Performance standards (stating none are in effect for this type of device).
- Information about the predicate device for substantial equivalence.
- Indications for use, contraindications, and potential safety issues related to improper operation or damage.
- An FDA letter acknowledging the 510(k) notification and determining substantial equivalence.
- Confirmation of the device name and its indications for use.
Crucially, there is no mention of an acceptance criteria table, device performance data, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any study results (MRMC or standalone). The document focuses on regulatory approval process based on substantial equivalence, not on a detailed performance study against predefined criteria.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).