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510(k) Data Aggregation
(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.
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(194 days)
The Centrysystem 600 HG can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.
The membrane used in this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany.
Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus hemodialyzers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Hemophane membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
The provided 510K K960474 notification describes a hemodialyzer, the Cobe Centrysystem 600 HG. This submission is for a medical device that performs a physical function (blood filtration) rather than a diagnostic function (e.g., image analysis or disease detection). Therefore, many of the requested categories in the prompt (e.g., 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size') are not applicable to this type of device and its regulatory submission.
Here's an analysis based on the provided text, focusing on applicable points and noting where the information is not relevant to this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in a tabular format as might be seen for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical in vitro testing. The performance is "accepted" if it is shown to be substantially equivalent.
| Performance Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood side priming volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Dialysate side priming volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Dialysate and blood flow resistance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Ultrafiltration coefficient | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Urea clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Creatinine clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Phosphate clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Vitamin B12 clearance | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
| Residual blood volume | Substantially equivalent to predicate device (Gambro GFS Plus 20) | Confirmed substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance
The document refers to "in vitro testing" to determine various parameters. It does not specify the sample size (e.g., number of devices tested) for these in vitro tests. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for in vitro device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a physical medical device and its performance is evaluated through measurable physical characteristics in an in vitro setting, not by human expert assessment of a "ground truth" like in diagnostic imaging.
4. Adjudication method for the test set
Not applicable for in vitro physical device testing.
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 a diagnostic AI device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The in vitro testing represents the "standalone" performance of the device without patient involvement.
7. The type of ground truth used
The "ground truth" in this context is the established, measurable physical and chemical properties of the device and its performance in a controlled in vitro environment. For example, "urea clearance" is measured directly, rather than being an expert consensus or pathology finding. The established performance of the predicate device serves as the benchmark for "substantial equivalence."
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Study Proving Acceptance Criteria are Met:
The study proving the acceptance criteria are met is the "Summary of Non-Clinical Tests".
- Study Design: This was an in vitro test series.
- Purpose: To determine the blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, and clearances for urea, creatinine, phosphate, and vitamin B12 at varying blood flows, as well as residual blood volume.
- Methodology: The specific tests performed were standard in vitro measurements for hemodialyzers. The document mentions "varying blood flows" for clearance measurements, indicating different operational conditions were tested.
- Results/Conclusion: "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." This statement indicates that for all the measured parameters, the Cobe Centrysystem 600 HG performed comparably to the predicate device, the Gambro GFS Plus 20 Hemodialyzer.
Key Takeaway: The entire submission for the Cobe Centrysystem 600 HG relies on demonstrating substantial equivalence to an already approved predicate device (Gambro GFS Plus 20). This is a common pathway for physical medical devices, where the "acceptance criteria" are implicitly met if the new device performs within acceptable bounds of the predicate device's established performance for critical functional parameters. Clinical testing was explicitly not performed, further solidifying the reliance on in vitro evidence of equivalence.
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