(121 days)
DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
DVT-2600 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and 3 types(Non-woven, Fabric, Oxford) garments. The system offers Sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated.
The provided 510(k) summary for K112677, "The Venous Assist System DVT-2600", does not contain details about specific acceptance criteria or a study that definitively proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SCD Express™4 system, K040511) through:
- Comparison of Intended Use: Stating that the DVT-2600 has "substantial equivalent intended use" to the predicate.
- Comparison of Technological and Performance Characteristics: Claiming "substantial equivalent technological and performance characteristics," and that it is "as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns."
- Adherence to Standards: Listing several international standards (IEC, ISO) that the device complies with, which are general safety and quality management standards rather than specific performance metrics for DVT prevention efficacy. These include:
- Council Directive 93/42/EEC
- IEC 980:2003
- IEC1041:1998
- ISO 13485:2003
- ISO 14155-1:2003
- ISO 14971:2007
- IEC 60601-1
- IEC 60601-1-2
The document explicitly states "After analyzing both bench as well as laboratory testing to applicable standards," but does not provide any specific results or data from these tests, nor does it describe a clinical study measuring performance against acceptance criteria for DVT prevention efficacy. This is typical for a 510(k) submission seeking substantial equivalence for devices of this type, where performance often relies on demonstrating similar operational principles and safety to already-cleared devices, rather than a new clinical efficacy trial with detailed performance metrics.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a summary of what can be inferred or is stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate (SCD Express™4 system) | The device is as safe and effective as the predicate. |
| Few technological differences compared to predicate | Few technological differences reported. |
| No new indications for use compared to predicate | No new indications for use reported. |
| No new safety and/or effectiveness concerns compared to predicate | No new safety and/or effectiveness concerns reported. |
| Compliance with relevant international standards (e.g., IEC, ISO) | Bench and laboratory testing to applicable standards completed. (Specific results not provided) |
| Improvement of blood velocity (implied mechanism of action) | Claims to "improve the blood velocity of patients." (Specific metrics not provided) |
Missing: Specific quantitative acceptance criteria (e.g., target increase in blood velocity, DVT incidence reduction, specific pressure ranges, cycle times, etc.) and direct performance data to demonstrate meeting these criteria.
2. Sample size used for the test set and the data provenance
Missing. The document does not describe a clinical "test set" involving human subjects or data that would typically have a sample size for performance evaluation. The "bench as well as laboratory testing" mentioned likely refers to engineering tests and basic safety assessments, not a clinical study on patient outcomes or diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing. No information on experts or ground truth establishment is provided, as no clinical performance study akin to a diagnostic device trial is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Missing. No adjudication method is mentioned.
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
Missing. This device is an intermittent pneumatic compression system for DVT prophylaxis, not an AI-powered diagnostic or decision support tool for human readers. Therefore, an MRMC study is not applicable to its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Missing. This is not an algorithm-only device. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing. As no clinical performance study is described with detailed results, no ground truth type is specified. For a device like this, clinical ground truth would typically be DVT incidence or objective measures of blood flow.
8. The sample size for the training set
Missing. This device is not an AI/ML model that would have a "training set."
9. How the ground truth for the training set was established
Missing. Not applicable, as this is not an AI/ML model.
In summary: The provided 510(k) emphasizes substantial equivalence to a predicate device and adherence to general medical device safety and quality standards (e.g., ISO, IEC). It does not detail a specific clinical study with quantitative performance acceptance criteria, sample sizes, or ground truth establishment for measuring the device's efficacy in preventing DVT. This approach is common for devices demonstrating substantial equivalence where the predicate has already established clinical effectiveness.
§ 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).