(28 days)
The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
The DVT60 Compression Sleeves are single chamber inflatable cuffs, designed to fit around a patient's calf. They are used with the Huntleigh Flowtron Excel and Universal Pumps. When inflated, they compress the veins in the calf and expel blood out of the leg, promoting circulation and overcoming stasis.
Here's an analysis of the provided text regarding the DVT60 Limb Compression Sleeves, focusing on acceptance criteria and the supporting study:
The provided text does not contain a traditional set of acceptance criteria with quantitative metrics or a detailed study report comparing the DVT60 against specific, pre-defined performance thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Healthcare DVT10) through functional equivalence in inflation performance.
Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The "reported device performance" is a comparative statement.
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported DVT60 Device Performance |
|---|---|
| Technological Characteristics: | |
| - Design characteristics are the same. | - Design characteristics are the same as the DVT10 predicate device. |
| - Materials are the same. | - Materials are the same as the DVT10 predicate device. |
| - Method of manufacture is the same. | - Method of manufacture is the same as the DVT10 predicate device. |
| - Inflation sequence and pressures are the same. | - Inflation sequence and pressures are the same as the DVT10 predicate device. |
| Functional Equivalence (Inflation Performance Testing): | |
| - Venous blood velocity increase is similar to predicate. | - Venous blood velocity increase is similar to the DVT10 predicate device. |
| - Duration of increased venous blood velocity is similar to predicate. | - Duration of increased venous blood velocity is similar to the DVT10 predicate device. |
| - Ability to overcome venous stasis (prevents DVT). | - Helps to prevent deep vein thrombosis by increasing blood velocity and overcoming venous stasis, in the same manner as the DVT10 predicate device. |
| Intended Use: | |
| - Prevent Deep Vein Thrombosis (DVT) by increasing venous blood flow. | - Designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow (same as predicate). |
| Dimensions: | - Extended in width (compared to DVT10) to fit a patient's calf up to 28 inches circumference. (This is a difference from the predicate, but deemed acceptable within the scope of intended use and effectiveness, likely because fitting a wider range of patients is a benefit and doesn't negatively impact the core function). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "The sleeves are tested by fitting to a subject's calf..." This implies at least one subject, but a specific number is not provided. This is common for this type of equivalence testing which might involve a small number of healthy volunteers for physiological measurements.
- Data Provenance: Not explicitly stated in terms of country of origin. The testing is described as "non-clinical outcome, inflation performance testing," which strongly suggests a prospective study (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable/not mentioned. Ground truth in this context isn't established by expert consensus on clinical images or diagnoses. Instead, the "ground truth" (or performance measure) is the physiological measurement of blood flow velocity.
- Qualifications of Experts: Not applicable/not mentioned. The testing involves measuring a physiological parameter rather than expert interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned. Since the performance metric is a direct physiological measurement (blood flow velocity), expert adjudication of results, in the sense of resolving discrepancies between multiple expert opinions, is not relevant. The measurements would be taken by trained personnel using appropriate equipment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- The device is a limb compression sleeve, not an imaging or diagnostic AI device that would typically involve human reader performance. The evaluation focuses on the physiological effect of the device on blood flow.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is a physical medical device (compression sleeve), not a software algorithm. Its "performance" is its mechanical action and physiological effect on the human body.
7. Type of Ground Truth Used
- Physiological Measurement Data: The "ground truth" for the test set is established by direct physiological measurement of "the increase in velocity of the blood flow in the veins during compression" on "a subject's calf."
8. Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for this device, this question is not relevant.
In summary: The K022786 submission for the DVT60 Limb Compression Sleeves relies on demonstrating substantial equivalence to a predicate device (DVT10) through non-clinical functional performance testing. The "study" involves measuring physiological blood flow velocity increase in subjects wearing the sleeves and confirming its similarity to the predicate device. This is a common approach for Class II devices where a direct comparison to a previously cleared device's functionality is sufficient to establish safety and 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).