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510(k) Data Aggregation
(43 days)
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. The Systems are intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.
The ActiveCare+DTx, ActiveCare+SFT and ActiveCare DVT Systems are prescriptive, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
This 510(k) summary describes modifications to an existing device, the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTx Systems. The submission is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device where the modifications do not require scientific review of clinical data to determine substantial equivalence. Therefore, the information provided below will reflect the nature of a Special 510(k) rather than a de novo submission requiring extensive new performance data.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for minor modifications to an already cleared device, detailed performance metrics (like sensitivity, specificity, accuracy) and corresponding acceptance criteria are not typically presented in the same way as for a novel device. The acceptance criteria here are implicitly that the modified device performs demonstrably equal to or better than the predicate device and does not raise new questions of safety or efficacy.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device continues to perform its intended physiological function (e.g., provide pneumatic compression for DVT prevention, enhance blood circulation) as effectively as the predicate device. | The submission states that the modified systems have the "same intended use and similar indications, principles of operation, and technological characteristics as the previously cleared systems." |
| Safety Equivalence: Modified components (hardware, software) and design changes do not introduce new safety risks (e.g., electrical safety, mechanical integrity). | "Testing, including risk analysis, electrical safety, software validation and internal testing were performed to demonstrate that the modified systems with the described modifications do not raise any new questions of safety and efficacy." |
| Efficacy Equivalence: The modified device is as effective for its intended uses as the predicate device. | "Performance data demonstrates that the ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are as safe and effective as their predicates." |
| Compliance with Recognized Standards: Device adheres to relevant industry and regulatory standards. | "Electrical Testing updates per recognized Standards." |
| Software Validation: Minor software changes maintain intended functionality and do not introduce errors. | "Software validation" was performed. |
| Labeling Equivalence: Labeling remains accurate and reflects the device's capabilities and uses. | "Minor labelling changes" were made, implying these were reviewed for accuracy. |
2. Sample Size Used for the Test Set and Data Provenance
No external test set with human subjects or real-world data is described for this Special 510(k). The "testing" mentioned is primarily internal verification and validation against design specifications and safety standards for the modified components. This type of submission relies on demonstrating that the minor changes do not alter fundamental performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As described above, no external test set requiring expert-established ground truth was part of this particular submission. The "ground truth" for a Special 510(k) is the performance of the legally marketed predicate device, and the evaluation focuses on whether the modifications deviate from that established performance.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as #3.
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 pneumatic compression system, not an imaging or diagnostic AI-assisted device. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic diagnostic device. The "standalone" performance here refers to the device's ability to mechanically deliver compression according to its design specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this Special 510(k) is the established performance and safety of the legally marketed predicate devices (K113525, K110159). The submission aims to demonstrate that the modifications maintain this existing ground truth. The "Performance Data" section explicitly states that "Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are substantially equivalent to the previously cleared ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems without raising new safety and/or effectiveness issues."
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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