(116 days)
The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
- · Aid in the prevention of DVT
- · Enhance blood circulation
- · Diminish post-operative pain and swelling
- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies.
The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.
This document, a 510(k) Premarket Notification for the Devon 24 Deep Vein Thrombosis Prevention Therapy System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested sections regarding the study design and results cannot be fully addressed from the provided text.
Based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance tests conducted, but it does not explicitly state quantitative acceptance criteria or the specific numerical results for each test. Instead, it offers a general conclusion that "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate."
| Test Name | Acceptance Criteria (Not explicitly stated with values) | Reported Device Performance (General Conclusion) |
|---|---|---|
| Pressure Accuracy Test | Would typically involve a target pressure range and tolerance (e.g., ±X mmHg) | "Device is performing as intended" |
| Pressure Sensor Calibration Test | Would involve accuracy and linearity requirements for the sensor | "Device is performing as intended" |
| Cycle Time Test | Specific duration for inflation/deflation cycle (e.g., 50 seconds ±Y seconds) | "Device is performing as intended" (document states 50-second cycle time) |
| Alarm Function Test | Alarms activate under specified fault conditions | "Device is performing as intended" |
| Battery Life Test | Specific duration of operation on a full charge | "Device is performing as intended" |
| Garment Burst Testing | Withstand a certain pressure without bursting (e.g., >X mmHg) | "Device is performing as intended" |
| Biocompatibility | Pass cytotoxicity, sensitization, irritation tests | Passed; uses same material as predicate, which previously passed these tests. |
| Electrical Safety & EMC | Conformity to IEC 60601 series standards | Conforms to IEC 60601-1, -1-2, -1-6, -1-11. |
| Software Verification & Validation | Meet "moderate" level of concern V&V requirements | Documentation provided, considered adequate for "moderate" level of concern. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "samples of the device" for performance and mechanical testing, but the number of units tested is not provided.
- Data Provenance: The tests were conducted internally by Devon Medical Products (Jiangsu) Ltd. in China. The document does not specify if the data involved human subjects or was entirely bench-top testing. Given the type of tests listed, they appear to be primarily bench-top (in-vitro) engineering and functional tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For the engineering and functional tests performed (pressure, cycle time, alarms, battery, burst, electrical safety, software V&V), ground truth is established through measurement instruments and compliance with technical standards and specifications, not through expert human interpretation as would be the case for diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in clinical studies or when human interpretation of data is required to establish a consensus ground truth. The tests described are objective engineering and functional measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "No animal study or clinical study was conducted." MRMC studies are clinical studies involving human readers/observers.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical device (intermittent pneumatic compression system), not an algorithm or AI software for diagnosis or image analysis. Its "standalone" performance refers to its functional operation as demonstrated by the engineering tests for pressure, cycle time, etc., which were reported as "performing as intended."
7. The Type of Ground Truth Used:
- Engineering Specifications and Standard Compliance. For the performance tests, the "ground truth" is defined by the device's design specifications (e.g., target pressure, cycle time) and adherence to recognized international standards for electrical safety and electromagnetic compatibility (IEC 60601 series). For biocompatibility, the ground truth was the results of previously conducted biocompatibility tests on the predicate device's materials, per FDA Good Laboratory Practice.
8. The Sample Size for the Training Set:
- Not Applicable. This information pertains to machine learning algorithms. The Devon 24 is a mechanical/electronic device, not an AI or imaging device that uses a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See 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).