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510(k) Data Aggregation
(18 days)
The Cirona™ DVT Prevention Therapy Foot Garment 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™ deep vein thrombosis prevention therapy foot garment is intended to be used with Devon Cirona™ 6100 deep vein thrombosis prevention system (K130571). The Cirona™ deep vein thrombosis prevention foot garment is a pair of single patient reusable soft compression garment(s) (sleeves), that consists of a brushed nylon outer material bonded to a foam inner liner. An inflatable polyvinylchloride (PVC) pressure bladder is encapsulated in an additional foam material. The patient contact material is polyurethane foam and the extension tubing set connects to the garment on one end through quick connectors and to the pump on the other end. It is intended to be used noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.
The FDA cleared Cirona™ 6100 system (K130571) consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. This submission is for the new Cirona DVT Foot Garment which will be used in conjunction with the Cirona 6100 system. 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 40mm Hg is used for all applications. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
Here's a breakdown of the acceptance criteria and study information for the Cirona™ DVT Foot Garment, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | The device accurately delivers/maintains the specified pressure of 40mmHg. | Passed. "no significant difference in the inflation, deflation and pressure hold time when used in conjunction with previously FDA cleared Devon Cirona 6100 DVT Prevention Therapy System (K130571)." |
| Cycle Time Test | The device adheres to the specified cycle time (12-second inflation, 48-second relaxation, 60-second total). | Passed. "no significant difference in the inflation, deflation and pressure hold time when used in conjunction with previously FDA cleared Devon Cirona 6100 DVT Prevention Therapy System (K130571)." |
| Alarm Function Test | Alarm functions operate correctly. | Passed. (Explicit statement of passing, but no specific details about the alarm criteria are given.) |
| Sleeve Bladder Burst Test | Sleeves maintain structural integrity at the highest pressure setting for anticipated maximum treatment time. | Passed. "all samples continued to function in the original and intended manner and structure integrity was well maintained. This indicates that the Foot Garment is safe to use." |
2. Sample Size Used for the Test Set and Data Provenance
The document provides very limited information regarding sample sizes for human subjects or specific details of the "test set" for performance evaluation. The "Sleeve Bladder Burst Test" mentions "all samples," implying a sample size greater than one for that specific bench test.
Data provenance: The tests are described as "bench and laboratory testing," suggesting an in-house, prospective testing environment rather than clinical data. No country of origin for the data is specified, but the submission is to the FDA, implying testing relevant to US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided regarding the use of human experts or establishing ground truth in the context of the described performance testing. The performance tests appear to be objective, engineering-focused benchmarks rather than clinical evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The described tests are bench tests with objective pass/fail criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes bench and laboratory performance testing against specifications, not a clinical comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The device is a physical medical device (compression garment) and does not involve an algorithm in the sense of AI. The performance testing is for the physical attributes and functionality of the device itself.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on the device's own specifications (e.g., 40mmHg pressure, 12-second inflation, structural integrity). This is a form of objective engineering specification compliance rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied, as this device is not an AI/machine learning product requiring training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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