(373 days)
The DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.
The proposed devices, DORA Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as two accessories which are recirculate connector and drainage bag. They are available in five (5) models, following very similar design principles, and has some differences in dimensions and configurations. The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
This document is a 510(k) premarket notification for DORA Tubing Sets for Hemodialysis. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and study design for performance metrics that would typically be found in a clinical study report or a more comprehensive performance evaluation for an AI-powered medical device.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria for performance metrics in a table format, nor does it provide quantitative performance data like sensitivity, specificity, or accuracy. Instead, it refers to conformity with established international standards for medical devices.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ISO 8638:2010 (Cadiovascular Implants And Extracorporeal Blood Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters) | Conforms to ISO 8638:2010 |
| ISO 594-2:1998 (Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings) | Conforms to ISO 594-2:1998 |
| ISO 10993-5:2009 (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity) | Biocompatibility tests conducted (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemolysis, Partial Thromboplastin Time, Complement System, In vitro Chromosomal Aberration, Bacterial Reverse Mutation, Mouse Bone Marrow Micronucleus) |
| ISO 10993-11:2006 (Biological evaluation of medical devices -- Part 11: Tests for systemic A toxicity) | Biocompatibility tests conducted (see above) |
| ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | Biocompatibility tests conducted (see above) |
| ISO 10993-4:2002 (Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood) | Biocompatibility tests conducted (see above) |
| ASTM F 756-08 (Standard practice for assessment of hemolytic properties of material) | Biocompatibility tests conducted (see above) |
| ASTM F88/F88M-09 (Standard Test Method for Seal Strength of Flexible Barrier Materials) | Non-clinical tests conducted to verify design specifications and substantial equivalence |
| Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6 through e-beam sterilization |
2. Sample size used for the test set and the data provenance
This document describes non-clinical laboratory testing and does not involve patient data or a "test set" in the context of an AI/algorithm study. The testing was performed on the device itself. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not involve AI or an algorithm requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This document does not involve AI or an algorithm requiring ground truth adjudication.
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
No such study was conducted or is mentioned in this document. The device is a physical medical device (tubing sets), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This is a physical medical device. The "ground truth" for its performance is adherence to established engineering and biocompatibility standards.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning algorithm.
§ 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.