(27 days)
The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 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 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 SCD 700 Series Compression System with Leg Sleeves is indicated for:
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Deep vein thrombosis and pulmonary embolism prophylaxis. .
The use of the Kendall SCD 700 Series Compression System with Foot Cuffs is indicated for: -
Circulation enhancement. .
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Deep vein thrombosis prophylaxis. .
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Edema Acute. .
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Edema Chronic. .
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Extremity pain incident to trauma or surgery. .
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. Leg Ulcers.
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Venous stasis / venous insufficiency.. .
The Kendall SCD™ 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).
Device Acceptance Criteria and Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Outcome |
|---|---|---|---|
| Electric Safety | Compliance with IEC 60601-1 and UL60601-1 | Testing performed according to specified standards. | Passed |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 and EN55011 | Testing performed according to specified standards. | Passed |
| Enclosure Protection | Compliance with IEC 60529 | Testing performed according to specified standards. | Passed |
| General Controller Features | Verification and Validation of features to match predicate device. | Design Verification and Validation testing performed. | Substantially Equivalent |
| Compression Cycle Operation | Verification and Validation of compression parameters and function to match predicate device. | Design Verification and Validation testing performed. | Substantially Equivalent |
| Controller Alarm and Test Modes | Verification and Validation of alarm and test mode functionality to match predicate device. | Design Verification and Validation testing performed. | Substantially Equivalent |
| Battery Operations | Verification and Validation of battery performance and functionality to match predicate device. | Design Verification and Validation testing performed. | Substantially Equivalent |
| Biocompatibility | All components comprised of materials in accordance with ISO Standard 10993-1. | Statement of compliance with ISO Standard 10993-1. | Compliant |
| Intended Use | Device's intended use matches predicate device: intermittent pneumatic compression for DVT and PE prevention. | Device is identical to predicate device in terms of intended use. | Identical |
| Mode of Function | Device's mode of function matches predicate device. | Device is identical to predicate device in terms of mode of function. | Identical |
Note: The reported device performance indicates that the Kendall SCD™ 700 Controller met all specified criteria, demonstrating substantial equivalence to the predicate device (Kendall SCD Express™ Portable Compression System, K040511).
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the individual tests (Electric Safety, Electromagnetic Compatibility, Enclosure Protection, Design Verification and Validation testing). It only states that "Testing was performed" for each category.
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be prospective as they involved performance testing on the proposed Kendall SCD 700 Controller to compare it to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary does not mention using experts to establish ground truth for the performance testing. The evaluation primarily relies on engineering and technical standards compliance (IEC, UL, EN, ISO) and functional verification against a predicate device.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method. Given the nature of the testing (compliance with standards and functional verification), adjudication by multiple external reviewers is typically not applicable in the same way it would be for a clinical trial evaluating diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this submission. The device is a physical medical device (sequential compression controller), not an AI-powered diagnostic tool.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a hardware system, not an algorithm. The "performance data" refers to the device's physical and functional attributes, not algorithmic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the Kendall SCD™ 700 Sequential Compression Controller relies on:
- Engineering and Safety Standards: Compliance with established international and national standards such as IEC 60601-1, UL60601-1, IEC 60601-1-2, EN55011, and IEC 60529.
- Predicate Device Performance: The functional behavior (General Controller Features, Compression Cycle Operation, Controller Alarm and Test Modes, Battery Operations) of the legally marketed predicate device (Kendall SCD Express™ Portable Compression System, K040511) serves as the benchmark for substantial equivalence.
- Biocompatibility Standards: Compliance with ISO Standard 10993-1 for materials.
No "expert consensus," "pathology," or "outcomes data" in a clinical diagnostic sense was used as ground truth for this device's engineering performance evaluation.
8. The Sample Size for the Training Set
This question is not applicable to the Kendall SCD™ 700 Sequential Compression Controller. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 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).