(119 days)
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.
The provided document (K080807) for the NxStage Medical, Inc. Blood Tubing Sets is a Special 510(k) Device Modification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with detailed performance metrics. As such, information regarding acceptance criteria, specific device performance numbers, and detailed study parameters (like sample sizes for test and training sets, expert qualifications, MRMC studies, or standalone performance) are not detailed in this type of submission.
The document indicates "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, it does not present the specific acceptance criteria or the reported performance data from these tests.
Based on the provided text, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document states that "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, the specific acceptance criteria and the numerical results of these tests are not disclosed in this summary. The goal was to demonstrate substantial equivalence, implying that the modified device met performance expectations similar to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided. The document states that "Performance, verification and validation testing was conducted," but it does not specify the sample sizes used for these tests. The nature of this 510(k) being a "Special 510(k) Device Modification" suggests that the testing likely focused on bench testing to confirm the modified device's performance against the predicate, rather than large-scale clinical trials. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission relies on bench testing and comparison to a predicate device for substantial equivalence, not typically on expert-established ground truth for a test set in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
Not applicable. As above, a formal adjudication method for establishing ground truth from experts is not described for this type of device and submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe a MRMC comparative effectiveness study. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a blood tubing set re-submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission pertains to a physical medical device (blood tubing sets), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
Not applicable in the traditional sense. For a physical device like blood tubing sets, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., flow rates, pressure resistance, sterility). The document implies that the device's performance was characterized against a "basis of comparison to the predicate device," meaning the predicate's established performance served as a de-facto ground for equivalence.
8. The Sample Size for the Training Set
Not applicable. This submission relates to a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.
§ 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.