(247 days)
Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)
SLK Varilymph 12 Pro Compression Therapy Device utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus, treat the symptoms of a variety of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main control contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and a rotating dis controlling air outflow. The regulated compressed air is transferred via an air distributor through a series of hoses to a sleeve garment. Each garment contains 12 pressure cells. The sleeve fits on the affected limb and can easily adjusted to any limb size within the sleeve tolerance. The devices are powered from a system supply voltage (230V / 110V).
The SLK VariLymph 12 Pro (SLK V12 Pro) consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance; and a power cord.
The user interface on the SLK VariLymph 12 Pro is a Membrane Keypad with dome switches. The settings are shown on a 3,2" LCD Screen.
The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.
The SLK VariLymph 12 Pro is a compressible limb sleeve device. The provided text indicates that its predicate device is the LYMPHA PRESS OPTIMAL MODEL 1201AP COMPRESSIBLE LIMB SLEEVE DEVICE (K082149). The justification for substantial equivalence relies on non-clinical performance data and a comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics. Instead, it describes various tests and concludes that the device performs similarly to the predicate. The overall acceptance criterion is demonstrating substantial equivalence in safety and efficacy to the predicate device.
Here's a summary of the performance claims based on the non-clinical data:
| Test/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technological Principle | Same as predicate (Intermittent pneumatic compression). | Both subject and predicate devices use intermittent pneumatic compression. |
| Biocompatibility | Complies with ISO 10993-1, 10993-5, 10993-10 for contact with intact skin ( |
§ 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).