(84 days)
The NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called the "NEO-2 Meter". It indicates that the device has been found substantially equivalent to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The text only states:
- Device Name: NEO-2 Meter
- Intended Use: To test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems, and the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
- Regulatory Class: II (21 CFR §876.5820/Product Code: 78 FIZ)
- Date of Clearance: October 13, 1999
Therefore, I cannot provide the requested information regarding acceptance criteria and studies because it is not present in the provided text. The output will reflect this lack of information for each requested point.
Acceptance Criteria and Study Information for NEO-2 Meter
Based on the provided document, the following information regarding acceptance criteria and supporting studies for the NEO-2 Meter is not available:
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Table of acceptance criteria and reported device performance:
- No acceptance criteria are mentioned in the document.
- No device performance data is reported.
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Sample size used for the test set and the data provenance:
- No information about a test set or its sample size is provided.
- No data provenance (country of origin, retrospective/prospective) is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information regarding experts or ground truth establishment is provided.
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Adjudication method for the test set:
- No information regarding a test set or adjudication method is provided.
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Multi-reader multi-case (MRMC) comparative effectiveness study and effect size:
- No MRMC study or comparative effectiveness data is mentioned.
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Standalone (algorithm-only) performance:
- The NEO-2 Meter is a physical measurement device, not an AI/algorithm-based device in the context typically described by "standalone performance." Therefore, this question is not applicable, and no such study is mentioned anyway.
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Type of ground truth used:
- No information about the type of ground truth is provided.
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Sample size for the training set:
- This question is typically relevant for machine learning models. As the NEO-2 Meter is a measurement device, a "training set" in this context is not applicable. No information about any training data is provided.
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How the ground truth for the training set was established:
- As with point 8, this is not applicable for this type of device, and no relevant information is provided.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.