(201 days)
The Hemodialysis Arterial Blood Tubing Set is intended for use as the extra corporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Arterial Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
The proposed hemodialysis arterial blood tubing sets raise no new issues of safety or efficacy. Sterilization method and packaging are essentially the same. The arterial bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided.
This document is a 510(k) submission, specifically K971313, for a Hemodialysis Arterial Blood Tubing Set. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new device's performance against specific acceptance criteria through a formal study with detailed statistical analysis as would be required for a novel device or AI/software.
Based on the provided text, the device in question is a hemodialysis arterial blood tubing set, which is a physical medical device, not a software or AI algorithm. Therefore, many of the requested elements of your query related to AI/software validation (e.g., test set, training set, ground truth, MRMC study, standalone performance) are not applicable to this submission.
Here's an attempt to answer the relevant questions based on the provided text, and explaining why others are not applicable:
Acceptance Criteria and Device Performance (Based on provided text)
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| No new issues of safety or efficacy compared to predicate. | The proposed hemodialysis arterial blood tubing sets raise no new issues of safety or efficacy. |
| Sterilization method is essentially the same as predicate. | Sterilization method is essentially the same. |
| Packaging is essentially the same as predicate. | Packaging is essentially the same. |
| Functionally tested. | These bloodlines have been functionally tested and data provided. |
| Biocompatible for blood contact materials. | The blood contact materials... have been tested for biocompatibility and data provided. |
| Integrity of bonded connections tested. | The integrity of the bonded connections... have been tested and data provided. |
| Substantially equivalent to legally marketed bloodlines. | The arterial bloodlines are substantially equivalent to legally marketed bloodlines. |
1. A table of acceptance criteria and the reported device performance
See table above. The acceptance criteria are "implied" because 510(k) submissions focus on demonstrating substantial equivalence to a predicate device rather than setting new, explicit, quantitative performance acceptance criteria in the same way a de novo device might. The "performance" here largely refers to the device meeting the same safety and efficacy profile as the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a physical medical device (blood tubing set), not a software or AI device. The text indicates "functional testing" and "biocompatibility testing," but does not provide details on sample sizes or data provenance for these tests. These are standard engineering and materials tests, not clinical studies in the typical sense that would have test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of "experts" to establish "ground truth" for a "test set" as would be relevant for an AI/software device. The validation involves standard engineering and biocompatibility testing for a physical component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as this is not an AI/software device with a medical imaging or diagnostic component.
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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of AI/software. For a physical device, "ground truth" would be established by validated test methods for functionality, material properties, and sterility, compared against established standards or predicate device performance. The text mentions "functional testing" and "biocompatibility testing" data were provided.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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.