(122 days)
The SCD Express" system is designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.
Indications for use:
- · Circulation Enhancement
- · Deep Vein Thrombosis Prophylaxis
- Edema Acute
- Edema Chronic
- · Extremity Pain Incident to Trauma or Surgery
- · Leg Ulcers
- · Venous Stasis / Venous Insufficiency
The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.
The use of the SCD EXPRESS Compression System with Foot Cuffs is also indicated for: (a) circulation enhancement, (b) edema -- acute, (c) edema -- chronic, (d) extremity pain incident to trauma or surgery, (e) leg ulcers, and (f) venous stasis /venous insufficiency.
The SCD Express™ Controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of Deep Vein Thrombosis (DVT). This new SCD Express™ system has the potential to provide uninterrupted DVT prophylaxis as it is used throughout the hospital, and it can be worn and used continuously by the patient during the entire period of risk.
The SCD Express" system has been designed to be more compact, quieter, lightweight, and offer battery power. Additional features also include the ability to provide sequential, gradient compression to each limb individually and the flexibility to provide compression to various sleeves consisting of up to three bladders each.
The SCD Express™ Controller will also have the potential to be used as a compression foot device. A new feature for an SCD-based system, the SCD Express™ Foot Cuff will provide DVT prophylaxis in situations that allow for a wrap only on the foot due to obstacles on the leg (e.g., surgery). In addition, the product has been designed to have the capability of providing high pressure, compression to a foot garment. In this configuration, the SCD Express™ system would still include the controller and a pair of tubing sets, but a pair of single patient use, single bladder disposable foot garments would be used in place of the aforementioned sleeves. The SCD Express " system will also allow for mixed configurations where a foot garment could be used on one limb while a sleeve was used on the other.
The provided text is related to a 510(k) premarket notification for the SCD Express™ Portable Compression System (PCS). Unfortunately, the document does not contain the specific information required to complete the requested table and answer the study-related questions.
This document primarily focuses on:
- Device Description: What the device is, how it works, and its features.
- Intended Use and Indications for Use: The medical conditions the device is designed to treat or prevent.
- Substantial Equivalence: Comparing the new device to previously cleared predicate devices.
- Regulatory Information: Classification, contact details, and FDA's clearance letter.
There is no mention of:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Any studies conducted to demonstrate device performance against such criteria.
- Details about sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader studies.
- Standalone algorithm performance.
Therefore, I cannot populate the table or answer the questions as the necessary information is not present in the provided text.
In summary: The document is a regulatory submission for device clearance based on substantial equivalence, not a detailed report of performance studies against pre-defined 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).