(230 days)
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
The VenAir Sequential Compression System is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism.
The product consists of the machine, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.
The system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow the user manual to check the error code and action as advised.
The provided text describes the VenAir Sequential Compression System (K213577) and its substantial equivalence determination to the predicate device, Kendall SCD 700 Sequential Compression Controller (K120944). Based on the text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence through non-clinical testing against pre-defined acceptance criteria derived from relevant standards and device performance requirements. Specific numerical acceptance criteria are not explicitly detailed in a consolidated table, but the results are stated as meeting the requirements.
| Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| General Safety & Performance | Meeting requirements of pre-defined acceptance criteria and intended use | "All the test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use." |
| Biocompatibility | Compliance with ISO 10993-1: 2018, ISO 10993-2: 2006, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 10993-12:2021, USP : 2020, OECD404: 2015, OECD406: 1992 (for Cytotoxicity, Skin Irritation, Skin Sensitization) | "Test results performed in biocompatibility test reports demonstrated that subject device complies with..." (listed standards). |
| Software Validation | (Implicit: Functionality, safety, and performance as per intended use) | "Software Validation" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
| Electromagnetic Compatibility & Electrical Safety | (Implicit: Compliance with relevant standards for EMC and electrical safety) | "Electromagnetic compatibility and electrical safety" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
| Performance Tests | (Implicit: Functionality of alarm, battery, cycle time, pressure resistance, accuracy, air tightness, pull force, venous refill detection) | "Alarm function test report," "Battery charging and discharging test report," "Cycle time test report," "Pressure resistance test report," "Pressure accuracy test report," "Air tightness and pull force test report," "Venous refill detection function test report" all completed, meeting requirements. |
| Usability | (Implicit: Device is safe and effective for end-users) | "Usability test" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for individual non-clinical tests (e.g., how many units were tested for shelf life, how many samples for biocompatibility). The testing described is non-clinical, involving the device itself rather than human or patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since this is a non-clinical device performance study (testing the physical device and its software), there is no mention of "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" is established by the specifications, standards, and engineering requirements for the device's functionality.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like '2+1' are typically used when comparing multiple human interpretations or human interpretations against AI outputs in clinical studies. This document describes non-clinical engineering and performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study would fall under clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While software validation was performed, the device is a physical medical device (Sequential Compression System) with integrated hardware and software. The "standalone" performance described refers to the device itself operating according to its design specifications, not an algorithm's isolated performance on a dataset in a diagnostic context. The performance tests (e.g., pressure accuracy, cycle time) represent the device's standalone operation.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is based on:
- Industry Standards: ISO 10993 series, USP , OECD404, OECD406 for biocompatibility.
- Device Specifications and Requirements: Internal engineering specifications for pressure, timing, alarms, battery performance, shelf-life, electrical safety, EMC, and usability.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The "training set" concept is relevant for AI/ML algorithms that learn from data. While the device contains software, there is no indication that it utilizes a learning algorithm that requires a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI/ML for this device.
§ 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).