(140 days)
The Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
The Caremed Vesoflow® SQS and IPCS Deep Vein Thrombosis (DVT) Compression Systems are electrically powered, non-invasive mechanical compression devices designed for use by patients for whom external compression therapy is indicated. Their intended function and use is to increase venous blood flow and help prevent Deep Vein Thrombosis (DVT), by applying intermittent, controlled pressure to the calf, thigh or foot.
The Vesoflow product will be available in two (2) models. These are the Vesoflow SQS and the Vesoflow IPCS. They differ in that the SQS delivers sequential compression therapy while the Vesoflow IPCS delivers intermittent compression therapy.
The provided 510(k) summary for the Caremed Supply Vesoflow SQS and IPCS Deep Vein Thrombosis Device does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices.
Instead, the submission focuses on:
- Substantial Equivalence: The primary method for FDA clearance for this type of device (compression therapy) is by demonstrating substantial equivalence to predicate devices (Huntleigh Healthcare Universal Flowtron (K010744) and Tyco/Kendall SCD Express (K040511)). This means demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Performance Data (Safety Standards): The only "performance data" mentioned is compliance with the IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety. This is a general electrical safety standard, not a clinical performance or diagnostic accuracy study.
- Internal Garment Testing: It states that "Garments were tested internally by Caremed and met their specified requirements." This is vague and does not provide details of the requirements, test methods, or results.
Therefore, many of the requested sections below cannot be populated from the provided text because a clinical performance study with acceptance criteria, ground truth, expert readers, and statistical analysis (as typically done for diagnostic AI/ML products) was not included or required for this type of device submission.
Here is an attempt to address your request based only on the provided text, with many N/A or "Not Provided" entries due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (Based on provided text) |
|---|---|
| Implied from Substantial Equivalence and Safety Standards | |
| Safety: Device meets applicable electrical safety standards. | Device has been tested to and meets IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety. |
| Functional Performance: Garments meet specified requirements. | Garments were tested internally by Caremed and met their specified requirements. (Specific requirements, test methods, and results are not provided). |
| Effectiveness: Similar effectiveness to predicate devices in increasing venous blood flow and helping prevent DVT. | Demonstrated substantial equivalence to Huntleigh Healthcare Universal Flowtron (K010744) and Tyco/Kendall SCD Express (K040511) for the intended use and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable (N/A) – No clinical performance test set or study detailed for efficacy. The primary "test" was for electrical safety (IEC 60601-1) and internal garment testing, for which sample sizes are not specified.
- Data Provenance: Not applicable (N/A) – No clinical data is described. The IEC 60601-1 testing is a laboratory-based safety standard, not a clinical study with patient data. Internal garment testing details are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable (N/A) – No clinical performance study requiring expert ground truth for a test set is described.
4. Adjudication Method for the Test Set
- Not applicable (N/A) – No clinical performance study requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study focuses on diagnostic performance compared to human readers, which is not relevant for this mechanical compression therapy device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A) – This is a mechanical compression device, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Not applicable (N/A) – No clinical performance study requiring a specific type of ground truth (like expert consensus, pathology, or outcomes data) is described. The "ground truth" for the device's substantial equivalence relates to its functional characteristics and safety compliance compared to existing devices and standards.
8. The Sample Size for the Training Set
- Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A) – This is not an AI/ML device; therefore, there is no "training set" or associated ground truth establishment.
§ 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).