(118 days)
The Caremed Supply Inc. VASOPOUSE® SQS and IPCS Decp Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
VASOPOUSE® that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT) - a potentially life threatening condition which can lead to pulmonary embolism. VASOPOUSE® is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.
VASOPOUSE® is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VASOPOUSE® is identified as a compressible limb sleve.
This document describes the 510(k) notification for the VASOPOUSE® DVT Compression Device Model: IPCS/SQS by Caremed Supply Inc. The submission aims to demonstrate substantial equivalence to a predicate device, the VESOFLOW (K110977), also manufactured by Caremed Supply Inc.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The document states that "All the test results demonstrate VASOPOUSE® meets the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative or qualitative acceptance criteria for each test performed are not explicitly provided in the document. The reported device performance is generally stated as meeting these unspecified requirements.
The non-clinical testing performed includes:
- Function Test
- Vibration Test
- Shock Test
- Free Fall Drop
- Life Test
Additionally, the device was tested in accordance with several safety and biocompatibility standards:
- EN/IEC60601-1-2:2007 (Electromagnetic compatibility for medical electrical equipment)
- ISO10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)
- ISO10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- ISO10993-10:2002/AMD.1:2006(E) (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- IEC60068-2-06 (Environmental testing - Part 2-6: Tests - Test Fc: Vibration, sinusoidal)
- IEC60068-2-27 (Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock)
- ISO14971:2007 (Medical devices - Application of risk management to medical devices)
The document asserts that these non-clinical tests confirmed the device's safety and effectiveness and its substantial equivalence to the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary) |
|---|---|---|
| Function Test | Not specified | Meets requirements, functions as intended |
| Vibration Test | Not specified | Meets requirements |
| Shock Test | Not specified | Meets requirements |
| Free Fall Drop | Not specified | Meets requirements |
| Life Test | Not specified | Meets requirements, demonstrates satisfactory operational lifespan |
| EN/IEC 60601-1-2:2007 Testing | Not specified | Meets standard requirements (EMC) |
| ISO 10993 series Testing | Not specified | Meets standard requirements (Biocompatibility) |
| IEC 60068-2-06 Testing | Not specified | Meets standard requirements (Vibration) |
| IEC 60068-2-27 Testing | Not specified | Meets standard requirements (Shock) |
| ISO 14971:2007 Testing | Not specified | Meets standard requirements (Risk Management) |
Additional Requested Information:
Since this 510(k) pertains to a DVT compression device (mechanical, non-diagnostic), many of the detailed aspects typically associated with AI/software-as-a-medical-device (SaMD) validations (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not relevant or provided in this type of submission. This document focuses on demonstrating physical and functional equivalence to a predicate device, primarily through non-clinical bench testing.
Therefore, for the remaining points, the answer is "Not Applicable" based on the provided document, as the submission does not involve an AI/software component that would require such studies.
- Sample size used for the test set and the data provenance: Not Applicable (Bench testing of physical device, not data-driven software).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (Bench testing, not expert-adjudicated data).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable.
- 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: Not Applicable (No AI component).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (No algorithm/AI).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Applicable (Performance evaluated against engineering specifications and industry standards for physical device functioning, not clinical ground truth in the context of diagnoses or outcomes).
- The sample size for the training set: Not Applicable (No training set as it's not a machine learning device).
- How the ground truth for the training set was established: Not Applicable.
§ 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).