(268 days)
The Venera 608 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 Venera™ 608 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 Venera™ 608 Series system consists of a device and a pair of soft compression cuff(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two cuffs 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, calf-thigh, and 120mmHg for foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
This document is a 510(k) summary for the Venera 608 Deep Vein Thrombosis (DVT) Prevention System. This device is an intermittent pneumatic compression device.
Here's an analysis of the acceptance criteria and the study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| System Level Software Test | Performed; conclusions demonstrate the device is performing as intended. |
| Pressure Accuracy Test | Performed; conclusions demonstrate the device is performing as intended. |
| Cycle Time Test | Performed; conclusions demonstrate the device is performing as intended. |
| Alarm Function Test | Performed; conclusions demonstrate the device is performing as intended. |
| Charge and Discharge Test | Performed; conclusions demonstrate the device is performing as intended. |
| Cuff Burst Testing (incl. Leak Testing) | Performed; conclusions demonstrate the device is performing as intended. |
| Electrical Safety (IEC 60601-1) | Conducted according to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020. |
| EMC (IEC 60601-1-2) | Conducted according to IEC 60601-1-2:2014+A1:2020. |
| Usability (IEC 60601-1-6, IEC 62366-1) | Conducted according to IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010/AMD2:2020; IEC 62366-1:2015/AMD1:2020. |
| Biocompatibility (ISO 10993-5) | Conducted according to ISO 10993-5: 2009 for In Vitro Cytotoxicity. |
| Biocompatibility (ISO 10993-23) | Conducted according to ISO 10993-23:2021 for irritation. |
| Biocompatibility (ISO 10993-10) | Conducted according to ISO 10993-10: 2021 for skin sensitization. |
| Software Verification and Validation | Performed; documentation provided. Software level of concern: Moderate. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the functional and performance tests (e.g., Pressure Accuracy Test, Cycle Time Test). It generically states "samples of the device underwent function and mechanical testing."
The data provenance is from tests conducted by the manufacturer, Suzhou Minhua Medical Apparatus Supplies Co. Ltd. (China). The document does not specify if the testing was performed retrospectively or prospectively, but standard device verification and validation testing is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The device performance tests are primarily engineering and technical validations against defined specifications, not expert-adjudicated clinical outcomes.
4. Adjudication method for the test set
This information is not applicable/not provided as the performance tests listed are objective engineering and technical validations, not clinical studies requiring adjudication of results by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted. The document explicitly states: "No animal study or clinical study was conducted." This device is a mechanical DVT prevention system, not an AI diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the context of this device. The Venera 608 is a physical medical device (intermittent pneumatic compression device) with embedded software for control, not a standalone algorithm used for diagnostic or predictive purposes without human intervention as implied by the question. The software verification and validation section confirms the software's performance, but not in a "standalone algorithm" context for clinical decision-making.
7. The type of ground truth used
For the functional and performance tests (e.g., pressure accuracy, cycle time, alarm function), the "ground truth" would be the established engineering specifications and regulatory standards for the device's operational parameters. For biocompatibility, the ground truth is established by the specified ISO standards. For electrical safety and EMC, the ground truth is established by the specified IEC standards.
8. The sample size for the training set
Not applicable. This document describes a physical medical device (pneumatic compression system), not an AI/ML-based system that requires a "training set" in the conventional sense. The "software verification and validation" mentioned refers to traditional software testing, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable for the same reasons as #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).