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Intended Use

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (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 cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

Indications

Leg Compression

The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for:

• · Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis.
• · Treatment of pain and swelling related to venous stasis
• · Circulation enhancement

The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for:

· Deep Vein Thrombosis Prophylaxis.

Foot Compression

The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for:

• · Circulation Enhancement
• · Deep Vein Thrombosis Prophylaxis
• · Edema Acute
• · Edema Chronic
• · Extremity Pain Incident to Trauma or Surgery
• · Leg Ulcers
• · Venous Stasis

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (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 cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.

The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

This document is an FDA 510(k) clearance letter for the Kendall SCD SmartFlow Controller and related components. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...""
• "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a device performance study report.

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