(72 days)
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are portable, ambulatory, sequential. intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment.
These devices are indicated for use in:
- Preventing Deep Vein Thrombosis (DVT)
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) (Venous Thromboembolism (VTE))
- Treatment of venous stasis
- Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- Enhancing blood circulation
- Treatment of chronic venous insufficiency
- Reducing edema
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow.
The ActiveCare+DTx and ActiveCare+S.F.T. Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing patient mobility and ease of use. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf – single or double, compression of the thigh – single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool.
The provided text is a 510(k) summary for the Medical Compression System (DBN) Ltd.'s ActiveCare+S.F.T. and ActiveCare+DTx devices. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or any detailed study data that proves the device meets specific performance criteria.
The "Performance Data" section merely states: "Testing referenced in support of this submission includes: Electrical Safety, EMC, Usability, Software Validation, Risk Analysis, internal testing and published Clinical Literature. The data provided demonstrates that the modified ActiveCare+S.F.T. and ActiveCare+DTx Systems are substantially equivalent to its predicates, and raises no new safety or effectiveness issues."
This is a general statement and does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance data.
- Types of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
Therefore, I cannot fulfill your request for this specific information based on the provided document. The document focuses on demonstrating substantial equivalence through a summary of regulatory and general testing, rather than presenting detailed performance efficacy data against specific acceptance 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).