(29 days)
The Legacy® IPC is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital settings.
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The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a medical device called LEGACY® IPC. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given input.
The input primarily details:
- The FDA's decision to deem the device substantially equivalent to legally marketed predicate devices.
- The regulatory classification (Class II) and product code (JOW: Compressible limb sleeve).
- General warnings and instructions regarding FDA regulations and compliance.
- The intended uses of the LEGACY® IPC device for prophylaxis of Deep Vein Thrombosis (DVT), stimulating circulation, preventing venous stasis and cutaneous ulcers, and reducing edema and compartmental pressures.
- Confirmation that it is a prescription device for both home and hospital settings.
To provide the requested information, you would need to provide a document that contains the results of performance studies for the LEGACY® IPC device, typically found in a Section 510(k) summary or a detailed clinical/pre-clinical study report.
§ 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).