(129 days)
A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.
A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE.
Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.
The provided document is a 510(k) Pre-Market Notification for the DVT-4000S device. It does not contain a study demonstrating acceptance criteria for the device's performance in terms of its intended use (preventing DVT/PE by increasing venous blood flow).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.
Therefore, many of the requested details about acceptance criteria, device performance against those criteria, sample sizes, expert involvement, and ground truth establishment are not present in this document.
Here's what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria for DVT/PE prevention or venous blood flow increase, nor does it report performance metrics against such criteria. The "specifications" listed are more about the device's operational parameters rather than clinical outcomes.
| Metric/Characteristic | Acceptance Criteria (Not explicitly stated for clinical outcomes) | Reported Device Performance (Operational Specifications for DVT-4000S) |
|---|---|---|
| Intended Use | Device prevents DVT/PE by increasing venous blood flow | A device designed to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE. (This is the intended use, not a performance metric.) |
| Power Source | N/A (for clinical outcome) | 100-240VAC, 50/60Hz, 90VA |
| Pressure (LEG) | N/A (for clinical outcome) | 20-60mmHg |
| Pressure (FOOT) | N/A (for clinical outcome) | 120-140mmHg |
| Battery | N/A (for clinical outcome) | 3500mAh |
| Number of chambers | N/A (for clinical outcome) | 3 |
| Electrical Safety | Compliance with IEC 60601:2005/A1:2012 | Complies with IEC 60601:2005/A1:2012 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 |
| Biocompatibility (in vitro cytotoxicity) | Compliance with ISO 10993-5:2009 | Complies with ISO 10993-5:2009 |
| Biocompatibility (irritation and skin sensitization) | Compliance with ISO 10993-10:2010 | Complies with ISO 10993-10:2010 |
2. Sample size used for the test set and the data provenance:
- Clinical Test Set: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-4000S to its predicate device." Therefore, there is no clinical test set mentioned, and thus no sample size or data provenance for such a test.
- Non-Clinical Test Set: For electrical safety, EMC, and biocompatibility, the sample size is not specified, but these are typically tested on a representative number of devices (e.g., a small batch) during product development and regulatory submission. The provenance would be from laboratory testing performed by the manufacturer or a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring ground truth establishment by experts was conducted or reported.
4. Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication was conducted or reported.
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:
Not applicable. This device is a mechanical compression device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical compression device, not an algorithm.
7. The type of ground truth used:
Not applicable, as no clinical test involving ground truth for disease detection/prevention was performed. The ground truth for electrical safety or biocompatibility would be defined by the standards themselves (e.g., does it conduct electricity safely, does it cause cell death).
8. The sample size for the training set:
Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.
Summary of Study (as presented in the document):
The "study" presented is a substantial equivalence comparison to a legally marketed predicate device (DVT-2600). The manufacturer asserts that the DVT-4000S is substantially equivalent to the DVT-2600 based on:
- Identical Indications for Use: Both devices are intended to prevent DVT/PE by increasing venous blood flow.
- Similar Technological Characteristics: The operating principle (sequential inflation of air chambers) is the same. Key specifications like pressure range and number of chambers are identical.
- Minor Differences Justified: The differences (power consumption and inclusion of a battery in DVT-4000S) were deemed not to raise new questions of safety or effectiveness. Performance tests confirmed that the device functions equivalently when using AC power or battery.
- Compliance with Voluntary Standards: The DVT-4000S complies with recognized standards for electrical safety (IEC 60601-1:2012), electromagnetic compatibility (IEC 60601-1-2:2014), and biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).
The basis for market clearance, in this case, is not a clinical study demonstrating performance against specific clinical acceptance criteria, but rather a demonstration of substantial equivalence to an already cleared device and compliance with relevant safety and performance standards.
§ 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).