Search Results
Found 5 results
510(k) Data Aggregation
(55 days)
ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare
The ActiveCare+S.F.T.® and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment and can be provided directly to the patient for home use.
These devices are indicated for use in:
- . Preventing Deep Vein Thrombosis (DVT)
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) ● (Venous Thromboembolism (VTE))
- Treatment of venous stasis ●
- Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- Enhancing blood circulation
- Treatment of chronic venous insufficiency ●
- Reducing edema ●
The ActiveCare+S.F.T. and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing full patient mobility and ease of use. 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.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool.
The provided text is a 510(k) summary for the ActiveCare+S.F.T. and ActiveCare+DTx Systems. It describes the device, its intended use, and states its substantial equivalence to a previously cleared device (K142728). However, it does not contain the specific details about acceptance criteria or a dedicated study demonstrating the device's performance against such criteria in the manner requested.
The "Performance Data" section mentions a "Human Factors and Usability Study" to validate usability for direct-to-home use, and states that its results "substantiated the acceptability of the risks identified during the risk assessment activities." It also lists other referenced testing such as "Electrical Safety, Electromagnetic Compatibility, Usability/Environmental, Software Validation, Internal testing and Risk Analysis."
Despite these mentions of testing, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for the test set ground truth.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Details on standalone (algorithm only) performance.
- The type of ground truth used (e.g., pathology, outcomes data) for clinical performance.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than detailing a de novo performance study with specific metrics and ground truth. The listed "performance data" appears to refer more to safety and general usability testing rather than a clinical effectiveness study against predefined acceptance criteria for its therapeutic claims (e.g., preventing DVT, reducing edema).
Ask a specific question about this device
(72 days)
ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are portable, ambulatory, sequential. intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment.
These devices are indicated for use in:
- Preventing Deep Vein Thrombosis (DVT)
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) (Venous Thromboembolism (VTE))
- Treatment of venous stasis
- Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- Enhancing blood circulation
- Treatment of chronic venous insufficiency
- Reducing edema
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow.
The ActiveCare+DTx and ActiveCare+S.F.T. Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing patient mobility and ease of use. 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.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool.
The provided text is a 510(k) summary for the Medical Compression System (DBN) Ltd.'s ActiveCare+S.F.T. and ActiveCare+DTx devices. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or any detailed study data that proves the device meets specific performance criteria.
The "Performance Data" section merely states: "Testing referenced in support of this submission includes: Electrical Safety, EMC, Usability, Software Validation, Risk Analysis, internal testing and published Clinical Literature. The data provided demonstrates that the modified ActiveCare+S.F.T. and ActiveCare+DTx Systems are substantially equivalent to its predicates, and raises no new safety or effectiveness issues."
This is a general statement and does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance data.
- Types of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
Therefore, I cannot fulfill your request for this specific information based on the provided document. The document focuses on demonstrating substantial equivalence through a summary of regulatory and general testing, rather than presenting detailed performance efficacy data against specific acceptance criteria.
Ask a specific question about this device
(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.
Ask a specific question about this device
(63 days)
ACTIVECARE DVT ACTIVECARE+SFT
The ActiveCare DVT and ActiveCare+SFT Systems are prescription 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 DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - 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.
The provided text describes a 510(k) submission for minor modifications to the ActiveCare DVT and ActiveCare+SFT Systems. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain safety and efficacy after minor modifications. | "A series of performance testing, including risk analysis, electrical safety, software validation and field testing were performed to demonstrate that the modified ActiveCare DVT and ActiveCare+SFT Systems with the described modifications do not raise any new questions of safety and efficacy." |
| Substantial Equivalence to predicate devices (K023573 and K060146). | "The ActiveCare DVT and ActiveCare+SFT Systems are substantially equivalent in all aspects, e.q., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s ActiveCare DVT and ActiveCare+SFT Systems, previously cleared under K023573 and K060146, respectively." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for a "test set" in the context of clinical or performance data for the modified device. The testing described focuses on demonstrating that the modifications themselves do not raise new safety or efficacy concerns, rather than re-proving the device's original clinical effectiveness.
The document indicates "field testing" was performed, but no details on sample size, data provenance (country of origin, retrospective/prospective), or type of data are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for modifications to an existing device, and the testing described does not involve establishing ground truth for a diagnostic or predictive algorithm. There's no mention of experts being used in this capacity.
4. Adjudication method for the test set
Not applicable. As noted above, this type of testing is not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The submission focuses on demonstrating the safety and equivalence of minor hardware and software modifications.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a pneumatic compression system, not an AI or algorithm-based diagnostic tool. The "software updates" mentioned are likely related to the control unit's operational logic, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The testing described involves performance, electrical safety, risk analysis, and software validation for the device's functionality, not a diagnostic accuracy assessment against a ground truth.
8. The sample size for the training set
Not applicable. This document pertains to modifications of an existing physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
Ask a specific question about this device
(113 days)
ACTIVECARE SFT
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is 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+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides 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 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.
Acceptance Criteria and Device Performance Study for ActiveCare+SFT® System (K110159)
The submission for the ActiveCare+SFT® System (K110159) focuses on demonstrating substantial equivalence to a previously cleared device (K060146) with an added software module. Therefore, the acceptance criteria and performance data specifically address the new "Venous Obstruction Detection software module" rather than the core functionality of the compression system itself. As a result, the information provided in the document is limited for a detailed breakdown of acceptance criteria and a comprehensive study that proves all aspects of device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (modifying an already cleared device with a new software module), the "acceptance criteria" appear to be focused on ensuring the new software module does not raise new questions of safety and efficacy and performs as intended. Specific quantitative acceptance criteria are not explicitly stated in the provided text, but rather implied by the overall goal of demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software performs as intended and correlates data to detect possible venous flow obstruction. | "Lab 003 — Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" was performed. |
| The modified system does not raise any new questions of safety and efficacy. | "A series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy." |
| Compliance with general safety and electromagnetic compatibility standards. | The ActiveCare+SFT® System complies with voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 14971. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical comparison in healthy volunteers." However, it does not specify the sample size for this clinical comparison or the "Lab 003" validation study.
- Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "healthy volunteers," implying the study was prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth related to the "Venous Obstruction Detection software module." The nature of the device (a pneumatic compression system) and the added software's function (detecting potential obstruction) suggest that objective physiological measurements might have been used as ground truth rather than expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a physical compression system with an added software module for detection, not an imaging AI diagnostic aid that would typically involve multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance evaluation of the algorithm was conducted. The "Lab 003 - Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" explicitly refers to validating the software module itself, implying an evaluation of the algorithm's performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the "Venous Obstruction Detection software module." Given the nature of detecting "venous flow obstruction," it is likely that objective physiological measurements (e.g., Doppler ultrasound, plethysmography, or other forms of vascular assessment) were used to establish the presence or absence of venous obstruction as ground truth in the healthy volunteers, rather than expert consensus on visual assessment or pathology.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set for the "Venous Obstruction Detection software module."
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given the validation study involved "healthy volunteers," it's possible that the initial development (training) of the software module might have used data from a different cohort or internally generated data, or a portion of the "healthy volunteers" data was used for development and another for validation.
Ask a specific question about this device
Page 1 of 1