(90 days)
The DYNAMIC Hollow Fiber Dialyzer DH-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.
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 which is substantially equivalent to the fibers utilized in the Focus R-Series Hollow Fiber Dialyzers (K914790) and Gambro GFS plus Series Hemodialyzer (K902481), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Focus R-Series Hollow Fiber Dialyzers and the proposed device is 8 microns. The inner diameter of hollow fibers in both Focus R-Series Hollow Fiber Dialyzers, Gambro GFS plus Series Hemodialyzer 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 a 510(k) submission for a medical device, the DYNAMIC Hollow Fiber Dialyzer DH-Series. The primary purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the device performs at least as well as the predicate device in relevant performance metrics.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as numerical thresholds that must be met. Instead, the approach is to demonstrate substantial equivalence to predicate devices. The "performance" is reported by stating that the device is substantially equivalent to these predicates.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Urea Clearance | Substantially equivalent to predicate devices | "proposed device is substantially equivalent to Focus R-Series Hollow Fiber Dialyzers 120H-R(K914790) , Gambro GFS plus 20 Hemodialyzer (K902481), and DYNAMIC Hollow Fiber Dialyzer DC-Series (K973291) for in vitro performance." |
| Creatinine Clearance | Substantially equivalent to predicate devices | Same as above. |
| Phosphate Clearance | Substantially equivalent to predicate devices | Same as above. |
| Vitamin B12 Clearance | Substantially equivalent to predicate devices | Same as above. |
| Ultrafiltration Coefficient | Substantially equivalent to predicate devices | Same as above. |
| Construction, Design, Intended Use, Function | Substantially equivalent to predicate devices | "substantially equivalent in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States." |
| Materials | Similar to predicate devices | "similarities are noted in the design and materials employed to accomplish the same intended use." |
| Sterilization Method | Substantially equivalent to predicate devices | "sterilized by ethylene oxide gas," which is also used by predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "In vitro testing was performed on the proposed device".
- Sample Size: The document does not specify the sample size for the in vitro testing. It only mentions that testing was performed on "the proposed device."
- Data Provenance: The data is from in vitro testing. The country of origin for the data is implied to be Taiwan, R.O.C., where the submitter (DYNAMIC TECHNOLOGY CORP.) is located. It is prospective data as it was generated to support this 510(k) submission for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for hollow fiber dialyzers in this context refers to the measured performance characteristics (clearances, ultrafiltration) of the device itself and its comparison to predicate devices, not subjective expert assessment of images or clinical outcomes. The performance is measured directly in a lab setting.
4. Adjudication Method for the Test Set
This is not applicable. As stated above, the performance metrics are objective laboratory measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This document describes a hollow fiber dialyzer, which is a therapeutic device, not an imaging device.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. This device is a physical medical device (dialyzer), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the performance claims are the objective, measurable results of in vitro laboratory tests (urea, creatinine, phosphate, vitamin B12 clearances, and ultrafiltration coefficient). The comparison is then made against the established performance characteristics of the predicate devices.
8. Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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.