(53 days)
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that pre-treats and purifies water that mixes with concentrate to produce dialysate meeting the requirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis treatments.
The provided text describes a Special 510(k) Device Modification for the NxStage Dialysate Preparation Module, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance, or a study that uses a test set, ground truth, or expert review in the way a typical AI/ML medical device submission would.
Therefore, the following information is based on the provided text, and many sections will indicate that the information is "Not applicable" or "Not provided" for this type of device modification.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The modified NxStage Dialysate Preparation Module was compared to the baseline device (K043436) and found to be substantially equivalent based on device indications for use, comparison of descriptive and technological characteristics, and design control certification. |
| Meeting Design Specifications | Design validation testing was performed to ensure that the modified device meets design specifications. |
| Compliance with ANSI/AAMI Standards | The device produces dialysate meeting the requirements of ANSI/AAMI Standards, RD52:2004 and RD62:2001. |
| Compliance with Design Control Requirements | Certification of compliance to 21 CFR 820.30 Design Control requirements was provided. |
| Intended Use | The device meets the minimum requirements considered acceptable for its intended use (preparing dialysate for hemodialysis with the NxStage System One). |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. This was a Special 510(k) Device Modification focusing on design validation and substantial equivalence, not a clinical study on a test set in the context of an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) was not established for this type of device modification.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 Dialysate Preparation Module, not an AI-assisted diagnostic or interpretative device that would involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical device, not an AI algorithm. Its performance is evaluated based on its physical and functional characteristics to prepare dialysate.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance would be the physical and chemical properties of the dialysate it produces, validated against established standards (ANSI/AAMI RD52:2004 and RD62:2001) and its design specifications. It is based on objective measurements and engineering principles, not expert consensus on medical images or pathology.
- The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
- How the ground truth for the training set was established: 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.