(252 days)
Compression Therapy Device (Model: LGT-2201DVT) is intended to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients.
LGT-2201DVT is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
Compression Therapy Device LGT-2201DVT a compression therapy device comprised of intermittent pneumatic controller, sleeves and connectable hose. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body. Squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly.
The provided documentation is a 510(k) premarket notification for a medical device called the "Compression Therapy Device (Model: LGT-2201DVT)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a study involving AI.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The information provided is primarily related to:
- Regulatory clearance: FDA's notification of substantial equivalence.
- Device identification: Trade name, regulation number, product code, etc.
- Intended use/indications for use.
- Comparison to a predicate device: Highlighting similarities and minor differences in specifications (size, weight, input power, battery, pressure range) and noting that these differences do not affect safety or effectiveness.
- Compliance with general safety and performance standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62133-2.
In summary, none of the requested information regarding acceptance criteria, study design for proving device performance (especially in the context of AI), sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is present in this document. This device is a physical, non-AI medical device, and its clearance process relied on demonstrating equivalence to an existing device through bench testing and standard compliance, not a clinical performance study with AI.
§ 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).