(14 days)
The Cirona™ 6200 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.
The Cirona™ 6200 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.
The Cirona™ 6200 Series system consists of a device and a pair of soft compression garment(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device-supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf and calf-thigh treatments, where a pressure of 120mmHg is used for the foot treatment.
The acceptance criteria and device performance for the Cirona™ 6200 Deep Vein Thrombosis Prevention Therapy System are summarized below based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes "Performance Testing" which consists primarily of bench and laboratory tests to assure the product meets its specifications. The specific acceptance criteria (target tolerances, passing thresholds) for each test are not explicitly detailed in the summary. However, the summary states that the product meets its specifications and that the manufacturer believes its technological characteristics are substantially equivalent to predicate devices. The "reported device performance" is essentially that the device passed these tests.
| Test Name | Acceptance Criteria (Not Explicitly Stated, Implied as 'Meets Specifications') | Reported Device Performance |
|---|---|---|
| Cirona 6200 System Level Software Test | Implied: Software functions as designed, without critical errors. | Meets specifications |
| Cirona 6200 Pressure Accuracy | Implied: Delivers specified pressures (40mmHg for calf/thigh, 120mmHg for foot) with acceptable accuracy. | Meets specifications |
| Cirona 6200 Cycle, Time Test | Implied: Maintains specified inflation (12 seconds) and deflation (48 seconds) cycle times accurately. | Meets specifications |
| Cirona 6200 Alarm Function Test | Implied: All alarms (e.g., pressure faults, system errors) activate correctly under defined conditions. | Meets specifications |
| Cirona 6200 Foot Bladder Burst | Implied: Foot bladders withstand expected operational pressures and do not burst prematurely under stress. | Meets specifications |
| Cirona 6200 Battery Depreciation Test | Implied: Battery life/performance meets design specifications over time or usage cycles. | Meets specifications |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Bench and laboratory testing" for performance.
- Sample Size for Test Set: Not explicitly stated. The testing listed ("Test 1" through "Test 6") appears to be a series of engineering/design verification tests on the device's components and system functionality, rather than a clinical study with a patient test set.
- Data Provenance: The tests are described as "Bench and laboratory testing," suggesting they were conducted in a controlled lab environment by Devon Medical Products or a contracted testing facility. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as it does not appear to be human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the described testing does not involve human subject data or diagnostics requiring expert ground truth establishment. The "ground truth" for these engineering performance tests would be the device's design specifications.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a therapeutic pneumatic compression device, not an imaging or diagnostic AI tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable in the typical AI sense. This device is a physical medical device (pneumatic compression system), not an algorithm-only diagnostic or predictive tool. Its "standalone" performance is assessed through the functional bench tests mentioned.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests is the device design specifications and relevant engineering standards. For example, for the "Pressure Accuracy" test, the ground truth is the specified pressure of 40mmHg or 120mmHg. For the "Cycle, Time Test," the ground truth is the 12-second inflation and 48-second deflation times.
8. Sample Size for the Training Set:
Not applicable. This device is hardware with embedded control logic, not a machine learning model that requires a "training set" in the context of AI/ML. Its operational parameters are designed and engineered, not learned from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8. The device's functionality is based on engineering design and established physiological principles of pneumatic compression, not on ground truth established from a training dataset.
§ 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).