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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 text is a 510(k) premarket notification for the DVT-2600 device, a compressible limb sleeve intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, the information required for a detailed description of acceptance criteria and a study proving those criteria are met is not available in the provided text.

Here's an explanation based on the available text:

1. A table of acceptance criteria and the reported device performance:

   • The document does not provide a table of specific performance acceptance criteria (e.g., minimum pressure levels, pulsation rates, blood flow increase percentages, etc.) that the DVT-2600 device was tested against.
   • Instead, it compares the technological characteristics of the DVT-2600 to a predicate device (also named DVT-2600, K112677 from DAESUNG MAREF CO., LTD.) to establish substantial equivalence. The performance listed relates to general specifications like pressure ranges and number of chambers, which are compared to the predicate device, not against predefined acceptance criteria from a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-2600 to its predicate device." This means there was no clinical "test set" in the context of a performance study to prove new acceptance criteria.
   • The non-clinical tests mentioned (electrical safety, EMC, biocompatibility) are general compliance tests for standards, not performance studies against specific clinical acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable, as no clinical test set for performance evaluation was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as no clinical test set for performance evaluation was conducted.

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. The DVT-2600 is a physical medical device (compressible limb sleeve), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as it's not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable, as no clinical performance study was conducted to establish ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device based on similar technological characteristics and non-clinical safety/EMC standards compliance.

8. The sample size for the training set:

   • Not applicable, as no machine learning or AI model was developed for this device that would require a training set.

9. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

Summary from the provided text:

The DVT-2600 received 510(k) clearance based on "substantial equivalence" to a predicate device (K112677, also named The Venous Assist System DVT-2600 from DAESUNG MAREF CO., LTD.).

• Acceptance Criteria & Performance: The document provides a comparison of specifications between the proposed device and the predicate device, claiming they are largely identical except for the inclusion of a battery in the proposed device. The "performance" assessment is based on this comparative technical specification rather than a dedicated study with defined acceptance criteria.
  • Proposed Device (DVT-2600):
    • Power Source: 100-240VAC, 50/60Hz
    • Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
    • Number of chambers: 3
    • Battery: 3200mAh, 3350mAh
  • Predicate Device (DVT-2600 / The Venous Assist System):
    • Power Source: 100-240VAC, 50/60Hz
    • Pressure: LEG: 20-60mmHg, FOOT: 120-140mmHg
    • Number of chambers: 3
    • Battery: -
  • Justification for Substantial Equivalence: The battery difference was deemed not to affect performance, confirmed by a product performance test report (though the report itself is not included in the provided text).
• Study Data: No clinical performance study data against specific "acceptance criteria" is provided or stated to have been conducted. The submission relies on non-clinical tests for electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility for the sleeves (ISO 10993-5, ISO 10993-10). These are compliance tests to standards, not performance studies against medical efficacy acceptance criteria.
• Ground Truth: The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the legally marketed predicate device, to which the new device is substantially equivalent.
• Sample Size: Not applicable for performance studies.
• Experts: Not applicable for performance studies.
• Adjudication/MRMC/Standalone AI: Not applicable as the device type does not involve these methodologies.

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