(108 days)
The DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness.
The membrane used in this device which is substantially equivalent to the membranes utilized in the Cobe CentrySystem 160E and Baxter CF25 Dialyzers, which have been previously approved under a 510(k) Notification (K8G4831).
Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalent in design to the previously approved Cobe CentrySystem 160E Dialyzers. The wall thickness of the hollow fibers in Cobe CentrySystem 160)E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameller of hollow fibers in both Baxter CF25 Dialyzers and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
The provided text describes the 510(k) submission for the DYNAMIC Hollow Fiber Dialyzer DC-Series. The study conducted is an in vitro performance comparison to predicate devices, not a clinical study involving human patients or detailed statistical analysis for AI model validation. As such, many of the requested categories are not applicable to this type of device submission.
Here's the information based on the provided text, with clarifications where data is not available or relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DYNAMIC Hollow Fiber Dialyzer DC-Series appear to be substantial equivalence to existing predicate devices (Cobe CentrySystem 160E, Baxter CF25, and Terumo Clirans T175 dialyzers) in terms of in vitro performance. The table below presents the reported performance of the DYNAMIC DC-160 and DC-190 models alongside the predicate devices. The implicit acceptance criterion is that the DYNAMIC devices' performance values are comparable to or better than those of the predicate devices.
| Metric | DYNAMIC DC-160 (Reported Performance) | DYNAMIC DC-190 (Reported Performance) | TERUMO CLIRANS T1.75 (Predicate Performance) | Baxter CF25 (Predicate Performance) | COBE CentrySystem 160E (Predicate Performance) | Acceptance Criteria (Implicit) |
|---|---|---|---|---|---|---|
| BUN Clearance (ml/min) | 185 | 190 | 192 | 191 | - | Comparable to predicate devices (e.g., 191-192 ml/min for Terumo/Baxter) |
| Creatinine Clearance (ml/min) | 167 | 179 | 177 | 170 | 130 | Comparable to predicate devices (e.g., 130-177 ml/min) |
| Phosphate Clearance (ml/min) | 155 | 155 | 151 | 159 | - | Comparable to predicate devices (e.g., 151-159 ml/min) |
| Vitamin B12 Clearance (ml/min) | 67 | 73 | 79 | 62 | 35 | Comparable to predicate devices (e.g., 35-79 ml/min) |
| In Vitro Ultrafiltration Coefficient (ml/hr/mmHg) | 7.5 | 8.5 | 8.3 | 6.5 | 4.3 | Comparable to predicate devices (e.g., 4.3-8.3 ml/hr/mmHg) |
| Effective Surface Area (m²) | 1.6 | 1.9 | 1.75 | 1.6 | 0.9 | Comparable to predicate devices (e.g., 0.9-1.75 m²) |
| Number of Fibers | 10,300 | 12,000 | 11,800 | 12,000 | 6,240 | Comparable to predicate devices (e.g., 6,240-12,000) |
| Inner Diameter (µm) | 200 | 200 | 200 | 200 | - | Comparable to predicate devices (e.g., 200 µm) |
| Wall Thickness (µm) | 8 | 8 | 9 | 8 | 8 | Comparable to predicate devices (e.g., 8-9 µm) |
| Sterilization Method | ETO | ETO | ETO | ETO | ETO | Same sterilization method as predicate devices (ETO) |
| Priming Volume (ml) | 91 | 104 | 123 | 112 | 42 | Comparable to predicate devices (e.g., 42-123 ml) |
| Max. TMP (mmHg) | 500 | 500 | 500 | 500 | - | Comparable to predicate devices (e.g., 500 mmHg) |
The conclusion states: "The result indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 for in vitro performance." This indicates that the reported values were determined to be within an acceptable range of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of dialyzers tested. The data presented are reported performance metrics, likely averages or representative values from multiple measurements.
- Data Provenance: The study was an "in vitro performance" study conducted by Dynamic Technology Corporation, located in Hsinchu, Taiwan, R.O.C. The data are therefore laboratory-generated, not from patient studies. It is retrospective in the sense that it compares new device data to established data from predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved in vitro performance testing of a physical device, not an AI model or clinical assessment requiring expert human interpretation for "ground truth." The "ground truth" here is the measured physical performance parameters of the device as per standard laboratory protocols for dialyzer testing.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the study measured objective physical parameters in an in vitro setting.
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, and no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device or algorithm. The performance described is of the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on in vitro measurements and established engineering/medical device performance standards for clearance rates, ultrafiltration, and physical characteristics of dialyzers. This is an objective measurement of device function in a laboratory setting. The comparison is made against the reported performance of predicate devices which would have been established through similar in vitro testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device, so there is no training set or associated ground truth establishment process in the context of machine learning.
§ 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.