(132 days)
The C-Boot™ is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.
The C-Boot™ is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including:
- Prevention of deep vein thrombosis (DVT)
- Enhancement of blood circulation
- Reduction of post-operative pain and swelling
- Reduction of wound-healing time
- Stasis dermatitis
- Treatment and assist healing of cutaneous ulceration
- Venous stasis ulcers
- Leg ulcers
- Chronic venous insufficiencies
- Reduction of edema
- Prevent pooling of fluids in limbs
- Lymphedema
C-Boot Ltd. introduces a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph distorders patients.
C-Boot's solution integrates the technological advantages of dynamic compression pumps, that enable preset sequential pressure control to individualize treatment regimes, with the mobility benefit of static compression stockings, that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return.
The device relates to a self-powered compression devices and methods for promoting circulation and therapeutic compression: It is comprising a pump, a plurality of sleeves or limb massager, which utilizes sequential, cyclical pressure, energy or vector forces, to aid circulation in a body part such as the limbs. The inflatable sleeves are filled with air by the pump and transmit massaging movement to the vessel walls whenever the patient wearing the device - walks or transmits body's weight from one leg to another. The pressure generated is a function of the user's body weight and gravitational force. The device provides methods to harness energy generated during movement and weight transfer and uses the energy for compressing to create a massaging effect on the circulation and the muscular-skeletal system.
The C-Boot™ - Lymph and Venous-Insufficiency System's 510(k) summary (K041659) does not contain sufficient information to fill out the requested table and details regarding acceptance criteria and a specific study proving device performance against those criteria.
The document indicates that the C-Boot™ is found substantially equivalent to predicate devices, namely the "WizAir™ Ambulant Pneumatic Compression System" (K002287) and the "Lympha Press®" (K810338). The rationale for substantial equivalence is based on similar technological characteristics and the claim that C-Boot™ functions within the same boundaries of performance as the predicate devices, without raising new safety or effectiveness issues.
However, the submission does not detail specific acceptance criteria for the C-Boot™ itself, nor does it present a study with quantitative results of the C-Boot™'s performance against such criteria. The document states:
- "A series of functional, performance and safety testing, including comparative analysis to Mego-Afek® and WizAir™ - demonstrates that C-Boot™ is substantially equivalent to Mego-Afek® and WizAir™, without raising new safety and/or effectiveness issues." (Page 3, Section 12. Performance Data)
This statement indicates that testing was performed, but it does not provide the results of these tests, any acceptance criteria used, or the methodology (sample size, ground truth, etc.) of these tests. Without this information, the requested table and details cannot be completed.
Therefore, I cannot provide the requested information based on the provided text.
§ 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).