(63 days)
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems. The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications. The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off. The software is designed to be logical and easy to use for the user either safe and precise in measurement.
Here's an analysis of the provided text regarding the HDM97 Dialysis Meter, focusing on acceptance criteria and supporting studies:
Based on the provided document, the HDM97 Dialysis Meter’s acceptance criteria and studies are primarily focused on substantial equivalence to a predicate device, rather than explicit performance metrics or clinical efficacy studies with human subjects or pathology.
Acceptance Criteria and Device Performance
The document does not explicitly list numerical acceptance criteria for the HDM97. Instead, the acceptance is based on achieving "substantial equivalence" to a predicate device, the Neo2 meter (510(k) Number: K992431). The study proving this substantial equivalence is a comparison of technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Predicate Device (Neo2 meter) | HDM97 Performance | Acceptance Status |
|---|---|---|---|
| Measuring: | |||
| Conductivity | Yes | Yes | Met (Identical) |
| Temperature | Yes | Yes | Met (Identical) |
| Pressure | Yes | Yes | Met (Identical) |
| pH | Yes | Yes | Met (Identical) |
| Microprocessor controlled | Yes | Yes | Met (Identical) |
| RS232-Interface | No | Yes | Met (Enhanced, but deemed equivalent) |
| Power supply | Battery | Rechargeable Battery | Met (Enhanced, but deemed equivalent) |
The document states: "The technological characteristics of the HDM97 and the predicate device are completely identical." This statement considers the RS232-Interface and Rechargeable Battery as enhancements that do not alter the fundamental safety or effectiveness sufficiently to negate substantial equivalence.
Study Proving Device Meets Acceptance Criteria
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" in this case refers to the characteristics of the device itself rather than data from patient samples or clinical trials. The comparison is between the specifications and design of the HDM97 and the predicate device.
- Data Provenance: The data provenance is the design and manufacturing specifications of the HDM97 device, compared against the known specifications of the Neo2 meter. This is not retrospective or prospective in the sense of clinical data but rather a comparative analysis of device features. The manufacturer is IBP Instruments GmbH, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated for establishing a "ground truth" for a test set. The review and determination of substantial equivalence are performed by the FDA (specifically, the Division of Reproductive, Abdominal, and Radiological Devices, Office of Device Evaluation), who act as the regulators evaluating the submitted comparison.
- Qualifications of Experts: The FDA personnel, such as Nancy C. Brogdon (Director of the relevant division), are experts in medical device regulation and evaluation, but they are not "experts establishing ground truth" in the sense of clinical or pathology review. The "ground truth" for the comparison is the established specifications of the predicate device and the submitted specifications of the HDM97.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. There is no "test set" in the traditional sense requiring adjudication by multiple readers or experts. The assessment is a regulatory review process comparing device specifications.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The HDM97 is a diagnostic/metering device, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The HDM97 is a physical meter with internal software for its functions (conductivity, temperature, pressure, pH measurement). It is not an algorithm performing a diagnostic task in isolation. Its "standalone performance" is its accuracy and reliability in measuring the specified parameters, which is implicitly accepted by the FDA's clearance based on substantial equivalence. Further details on the accuracy of these measurements are not provided in this summary.
7. The type of ground truth used:
- Type of Ground Truth: The "ground truth" for the substantial equivalence determination is the specifications and functional capabilities of the legally marketed predicate device (Neo2 meter). The HDM97's performance is accepted as equivalent if its specifications, intended use, and technological characteristics are deemed sufficiently similar to the predicate device, or if any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable.
§ 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.