(177 days)
To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.
The ClearMedical/Kendall SCDs are an accessory device to a SCD System which is used for the prevention of deep vein thrombosis and pulmonary embolism. The SCD Sleeve is designed with inflatable bladders that fill with air to provide compression to the legs. A connector tubing system attaches the SCD to the Controller system. The SCD Sleeves are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, three bladders and molded polyethylene tubing with a polypropylene snap-lock connector. Kendall has recently changed the device from the color blue to white. ClearMedical will designate the white SCDs with a "w" after the part number (i.e. 5330W).
This 510(k) summary describes a reprocessed medical device, the ClearMedical/Kendall Sequential Compression Device (SCD) Sleeves, which are intended to be substantially equivalent to the Kendall SCD Sleeves. The submission focuses on demonstrating that the reprocessed devices maintain the same safety and performance characteristics as the original, legally marketed predicate devices.
Here's an analysis of the provided information, focusing on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of numerical acceptance criteria with corresponding performance data in the typical format of a clinical study report. Instead, it relies on a qualitative assessment of "technological indicators of substantial equivalence" and bench testing results. The acceptance criterion is essentially "equality in safety and performance" compared to the predicate device.
| Acceptance Criteria Category | Specific Indicators/Tests | Reported Device Performance (Summary) |
|---|---|---|
| Overall Equivalence | In all relevant safety and performance indicators | ClearMedical devices demonstrated equality in safety and performance. |
| Technological Characteristics | Methods of infection control | ClearMedical's methods meet or exceed CDC standards. |
| Fit/attachment | Same as predicate device. | |
| Bladder function | Same as predicate device (functionally inflate with air to control circulation). | |
| Velcro adhesion | Implied as same/equivalent to predicate. | |
| Connector function | Implied as same/equivalent to predicate. | |
| Physical Form | Form factor | Same as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "bench tests" and "non-clinical performance data" but does not quantify the number of reprocessed sleeves or components tested.
- Data Provenance: The data is generated from bench testing and "non-clinical performance data" conducted by ClearMedical, Inc. This is internal company data. The country of origin of the data is the USA (Bellevue, WA, where ClearMedical is located). The data is retrospective in the sense that it evaluates the reprocessed devices against the established characteristics of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The submission appears to rely on internal engineering and quality control expertise within ClearMedical for evaluating the bench test results against the predicate device's characteristics. There is no mention of independent clinical experts or a consensus panel.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or specified. Given the nature of bench testing for substantial equivalence, there isn't a "ground truth" to be adjudicated by multiple readers in the traditional sense of a diagnostic medical device. The comparison is against engineering specifications and the known characteristics of the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physical, accessory compression sleeve, not an imaging or diagnostic device that would typically involve human readers interpreting cases.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This is a physical, non-electronic device. There is no algorithm involved. "Standalone" performance would refer to the device's physical function by itself, which is what the bench tests were designed to assess.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this substantial equivalence determination is the established characteristics and performance of the legally marketed predicate device (Kendall SCD Sleeves). This includes its technical labeling, promotional materials, and assumed baseline performance for safety and efficacy. The reprocessed device's performance benchmarks were derived from the predicate device's specifications and behavior.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a reprocessed physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).