KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

• K Number: K120944
• Device Name: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
• Manufacturer: COVIDIEN
• Date Cleared: 2012-05-31 ( 63 days)
• Product Code: JOW
• Regulation Number: 870.5800
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K102737

Intended Use

The Kendall SCDTM 700 Sequential Compression System (hereby referenced as "Kendall SCDTM 700 Series") is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The Kendall SCDTM 700 Series is a prescription device for use in a clinical setting or in the home.

The System consists of the controller, the tubing sets (provided with the controller) and singlepatient 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 has reached set pressure, 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 Kendall SCDTM 700 Series Compression System with Leg Sleeves is indicated for:

• Deep vein thrombosis and pulmonary embolism prophylaxis. .
  The use of the Kendall SCDTM 700 Series Compression System with Foot Cuffs is indicated for:
• Circulation enhancement. .
• Deep vein thrombosis prophylaxis.
• Edema Acute.
• Edema Chronic. .
• Extremity pain incident to trauma or surgery. ●
• Leg Ulcers.
• Venous stasis / venous insufficiency.

Device Description

The Kendall SCDTM 700 Sequential Compression controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's limbs for the prevention of DVT and PE. The controller delivers air though the tubing sets to the pair of disposable garments (one for each limb).

AI/ML Overview

The Kendall SCD™ 700 Sequential Compression Controller is an intermittent pneumatic compression device intended for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for circulation enhancement, edema management, extremity pain, leg ulcers, and venous stasis/insufficiency when used with appropriate garments.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Risks related to home user operation are adequately assessed and deemed acceptable.	A Use Failure Modes and Effects Analysis (UFMEA) was conducted to assess risks for home users. The output of the UFMEA identified the need for validation testing. A Human Factors and Usability Study was conducted, which substantiates the acceptability of the risks identified during the risk assessment activities. (Specific quantitative metrics for "acceptability" are not provided in this summary, but the study's conclusion indicates the criteria were met.)
   Electrical safety in accordance with IEC 60601-1 and UL60601-1.	Electrical Safety testing was conducted according to IEC 60601-1 and UL60601-1. (The summary states it "were conducted," implying compliance, though no specific results like pass/fail are provided).
   Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2.	Electromagnetic Compatibility testing was conducted according to IEC 60601-1-2. (The summary states it "were conducted," implying compliance, though no specific results like pass/fail are provided).
   Device maintains similar technological characteristics and intended use as the predicate device (Kendall SCD™ 700 Sequential Compression Controller, K102737).	The modified device has the "same technological characteristics as compared to the predicate device." The intended use is also consistent with the predicate. (This is a qualitative acceptance criterion based on comparison to the predicate, and the submission asserts it is met).

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the sample size for the Human Factors and Usability Study.
   • Data Provenance: Not specified in the provided summary. The study validated usability "in the home environment," suggesting a prospective nature with real or simulated users.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This information is not provided in the summary. The Human Factors and Usability Study likely involved participants representative of the intended user population (e.g., patients, caregivers), and observational/interview data, rather than expert-established ground truth in the medical diagnostic sense.

4. Adjudication Method for the Test Set:

   • This information is not provided as the validation was a Human Factors and Usability Study addressing risk, not a diagnostic accuracy study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not conducted as the device is a therapeutic compression device, not an imaging or diagnostic device requiring human reader interpretation in the context of AI. The performance data focuses on safety, usability, and technical standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No, this device is an active medical device that requires human interaction (application of garments, operation of controls). Its "performance" is tied to its mechanical function, safety, and usability, not an AI algorithm performing a standalone task. The studies performed (UFMEA, Human Factors, Electrical Safety, EMC) are all relevant to the device's integrated function and human interaction.

7. The Type of Ground Truth Used:

   • For the Human Factors and Usability Study, the "ground truth" would be related to user performance, errors, task completion rates, and subjective feedback indicating safe and effective operation in a home environment. This is derived from observed user interaction and qualitative/quantitative data collected during the study, rather than a clinical ground truth like pathology for diagnosis.
   • For Electrical Safety and EMC testing, "ground truth" is adherence to the specified international standards (IEC 60601-1, UL 60601-1, IEC 60601-1-2).

8. The Sample Size for the Training Set:

   • This device is not an AI/ML device that requires a "training set." The development process would have involved engineering design, iterative testing, and risk analysis, not a data-driven training of an algorithm.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable as there is no training set for this type of device.

Regulation Number and Section

§ 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).