(35 days)
The ZOE Fluid Status Monitor is intended for patients: With fluid management problems - Taking diuretic medication - . Living with Heart Failure - Living with End-stage Renal Disease - Recovering from Coronary Artery Disease related event . - Suffering from Recurrent Dehydration . This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
The ZOE Fluid Status Monitor is a non-invasive; battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems. The ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
This document is a 510(k) premarket notification for the ZOE Fluid Status Monitor (Model ZOE 2b-5k). It addresses the safety and effectiveness of the device by establishing its substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document does not detail specific quantitative acceptance criteria or a dedicated study showing the device meets such criteria in terms of accuracy, sensitivity, or specificity for diagnosing fluid status. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a previously cleared predicate device.
The reported "device performance" is based on the claim of functional equivalence and identical indications for use as the predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Method of operation is the same as the predicate device. | The ZOE Fluid Status Monitor has the same method of operation as the predicate device (K112830). |
| Indications for Use | Indications for use are identical to the predicate device. | The ZOE Fluid Status Monitor has identical indications for use as the predicate device (K112830). |
| Safety and Effectiveness Issues | Does not raise any new issues of safety, effectiveness, or performance. | The ZOE Fluid Status Monitor does not raise any new issues of safety, effectiveness, or performance compared to the predicate device. |
| Electrical Safety | Compliance with UL 2601-1 / CSA C22.2 No. 60601. | The ZOE Fluid Status Monitor complies with UL 2601-1 / CSA C22.2 No. 60601. |
| EMC/EMI Compliance | Compliance with EN 60601-1-2 and EN 60601-1:2003. | The ZOE met all electrical and electromagnetic compatibility (EMI) safety requirements, including EN 60601-1:2003 and EN 60601-1-2. |
| Quality Management System | Manufactured under a certified Quality Management System. | Noninvasive Medical Technology is certified to ISO13485 2003. |
Study Details:
The document describes a 510(k) premarket notification process, not a clinical study in the traditional sense that generates new performance data to prove efficacy. The "study" here is the comparative analysis against the predicate device to demonstrate substantial equivalence.
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Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical test set with human subjects for performance evaluation. The "test set" for this 510(k) is the comparison of device characteristics (design, materials, operating principles, indications for use, safety standards) to the predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense (e.g., diagnosis of a condition) is not established in this document. The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate device (K112830).
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Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. An MRMC study was not described or performed for this 510(k) submission. The document focuses on device characteristics and regulatory compliance, not on human reader performance with or without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The ZOE Fluid Status Monitor is a hardware device (impedance plethysmograph) that measures electrical impedance. It does not appear to involve an AI algorithm that would have standalone performance in the way a diagnostic imaging algorithm might. Its "performance" revolves around accurate impedance measurement, which is addressed by electrical safety and EMC testing, not standalone algorithmic evaluations.
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The type of ground truth used: For the purposes of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device (ZOE Fluid Status Monitor K112830), as previously cleared by the FDA. The current device is deemed "substantially equivalent" based on direct comparison of its attributes to those of the predicate. Compliance with electrical safety and EMC standards (UL 2601-1 / CSA C22.2 No. 60601, EN 60601-1, EN 60601-1-2) serves as "ground truth" for those specific engineering performance aspects.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
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How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.