(29 days)
The DVTcare™ CA5 is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
The DVTcare™ CA5 system is a light weight, portable, prescriptive device that helps stimulate blood flow in the legs through the use of pneumatically controlled, single chamber leg cuff(s), actuated by an electronically controlled pump unit and solenoid valves. All pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 plastic quick disconnects for air tube connection, and an external power supply input jack. The option exists for the unit to be used in single leg or double leg modes.
During operation, the pump unit provides air to one cuff through flexible plastic tubing, inflating it to a specified pressure, to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the current set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. To provide maximum flexibility, the CA5 also provides adjustable cycle times. System software prevents users from entering a cycle time, for any one limb, to be less than 60 seconds. This is done to prevent excessive stimulation of the limb.
In single leg mode, this cycle repeats until the unit is turned off. In double leg mode the first and second leg cuffs do not fill simultaneously. The second leg begins its fill once the first leg has reached the midpoint of the overall cycle time for both legs. In double leg mode, air flow is directed to fill the second bladder cuff using the same cycle profile as the initial leg. After completing the fill, exhaust and rest period of leg 1, the control unit directs air flow to the second leg and fills that bladder cuff until the set pressure is reached and exhausted. The cycle repeats, reverting air flow to the initial leg.
The control unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for mains connection.
The provided document is a 510(k) summary for the DVTcare™ CA5 device, an intermittent pneumatic compression device. It details the device's substantial equivalence to predicate devices but does not contain typical acceptance criteria and study information for AI/ML-based diagnostic devices.
Specifically, the document states:
- "No clinical testing was performed on the DVTCare CA5" (page 5).
- The device is an electromechanical pump and sleeve system, not an AI/ML diagnostic.
Therefore, many of the requested categories for AI/ML device evaluation (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for AI models) are not applicable to this submission.
However, based on the information provided, I can construct a table for the non-clinical testing performed and describe how "equivalence" was established, which serves a similar purpose to acceptance criteria in this context for non-AI devices.
Acceptance Criteria and Device Performance for DVTcare™ CA5 (Non-AI Device)
The DVTcare™ CA5 is an intermittent pneumatic compression device, not an AI/ML diagnostic algorithm. Therefore, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to predicate devices through non-clinical validation and comparison to published clinical studies of predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device characteristics/standards) | Reported Device Performance (DVTcare™ CA5) |
|---|---|
| Electrical Safety Standards Compliance | Validated to UL 60601-1, CSA C22.2 NO 601.1, and CENELEC EN 60601-1. Confirmed by an accredited test lab. |
| Electromagnetic Compatibility (EMC) | Demonstrated substantially equivalent or superseding performance to listed predicate devices. |
| Mechanical Integrity | Demonstrated substantially equivalent or superseding performance to listed predicate devices. |
| Environmental & Life Cycle Testing | Demonstrated substantially equivalent or superseding performance to listed predicate devices. |
| Vibrational Integrity (for portability) | Tested to MIL-STD 810D, section 514.3-1. |
| Pressure Delivery | Bench tested to verify equivalent pressure delivery as predicate devices. |
| Adjustable pressure set point (20-65 mmHg) with default similar to predicate (40mmHg). | |
| Cuff (Garment) Fill Time | Bench tested to verify equivalent cuff fill time as predicate devices. |
| Default fill time approximately 10-12 seconds, similar to predicate (approximately 10 seconds). | |
| Cycle Time | Bench tested to verify equivalent cycle time as predicate devices. |
| Adjustable cycle time (60-75 seconds) with default similar to predicate (approximately 60 seconds). System software prevents cycle time less than 60 seconds. | |
| System Operation (overall functionality) | Bench tested to verify equivalent system operation as predicate devices. |
| Combines features of predicate devices: portability, adjustable pressure, and cycle time capabilities. | |
| Uses single bladder PVC chambers in soft Nylon material, similar to Flowtron Excel. | |
| Microprocessor control, internal battery, and mains power similar to WizAir DVT and TravelAir. | |
| Alarms for system monitoring and fault recognition similar to Flowtron Excel. | |
| Hemodynamic Effect (Indirect, via predicate device studies) | "Significant equivalence is concluded" based on comparison to published clinical studies of predicate devices (e.g., Venodyne model producing a mean blood flow velocity of 76.2 ± 23.77 using similar parameters). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML diagnostic test set. For the non-clinical bench testing, no specific sample sizes are mentioned, but it implies multiple cycles and components were tested to verify performance.
- Data Provenance: The "clinical testing" referenced for comparison was from published studies of predicate devices. These included two studies:
- One study used five healthy individuals aged 21-35 years old.
- Another study used ten patients about to undergo primary unilateral knee arthroplasty, with a mean age of 68 years and mean weight of 85kg.
- These data are retrospective in relation to the DVTcare™ CA5 device, as they are from previously published studies on different, but similar, devices. The country of origin is not specified but is implied to be academic/research settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML diagnostic device requiring expert-established ground truth. The "ground truth" for the device's operational performance was against engineering specifications and the performance of established predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic test set requiring human adjudication.
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:
- No MRMC study was done, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML algorithm. The device's "standalone" performance refers to its electromechanical operation as described in the non-clinical testing section.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical validation of the DVTcare™ CA5 device itself, the "ground truth" was engineering specifications, compliance with recognized safety and performance standards (UL, CSA, CENELEC, MIL-STD), and the established performance parameters of the predicate devices.
- For the clinical effectiveness claims, the "ground truth" for efficacy was based on the outcomes and blood flow velocity measurements reported in the published clinical studies of the predicate devices. These studies reported outcomes such as "decreasing the risk of postoperative DVT" and measured "mean blood flow velocity."
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device that requires a training set with established ground truth.
§ 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).