(103 days)
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
TCx-I-DV Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
The provided text is a 510(k) submission summary for the "TCx-I-DV Remote Care Management system." This device is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, dialysis data) from patients remotely to their healthcare providers.
The document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness. Instead, the submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices.
Here's a breakdown based on your request, highlighting what is (and isn't) present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document does not specify quantitative acceptance criteria (e.g., accuracy percentages, precision metrics) for the device's performance in collecting or transmitting medical data. | Not provided. The document states "Verification activities including substantial equivalence testing demonstrates that this system is substantially equivalent to the predicate devices in terms of functionality and intended use," but does not present specific performance metrics or data. It emphasizes that the device functions to "collect and transmit measurement information." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "Verification activities including substantial equivalence testing," but provides no details on the sample size used for this testing.
- Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable/not provided in this submission. The device is a data transmission system, not a diagnostic or interpretive device requiring expert ground truth for its performance evaluation in the context of this 510(k). The document notes, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional," implying that the device itself is not making interpretations that would need expert ground truth for its own validation.
4. Adjudication method for the test set
- Not applicable/Not provided. As stated above, the submission focuses on functional equivalence rather than clinical performance 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, an MRMC comparative effectiveness study was not done. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. The device's primary function is to collect and transmit data; it is not presented as an algorithmic diagnostic tool that would have standalone performance measured in this context. Its function is to facilitate communication, with interpretation explicitly stated to require a human experienced medical professional.
7. The type of ground truth used
- Not applicable/Not provided. Given the nature of the device (data transmission), the concept of "ground truth" for clinical outcomes or diagnostic accuracy is not directly relevant to this 510(k) submission, which focuses on functional equivalence and safe transmission of data.
8. The sample size for the training set
- Not applicable/Not provided. This device is not described as utilizing a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no mention of a machine learning algorithm or training set, this information is not relevant to the provided text.
In summary: The provided 510(k) document emphasizes the functional equivalence of the TCx-I-DV Remote Care Management system to existing predicate devices. It clearly states the device's purpose is to collect and transmit data and that interpretation requires clinical judgment. It does not present a study with specific acceptance criteria, performance metrics, or ground truth establishment as would be seen for a diagnostic or AI-powered device. The "study" referenced is "Verification activities including substantial equivalence testing," which confirmed its functionality and intended use were comparable to predicate devices.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”