Search Results
Found 1 results
510(k) Data Aggregation
(301 days)
The DYNAMIC Hollow Fiber Dialyzer DS-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 40 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, and the proposed device is 40 microns. The inner diameter of hollow fibers in predicate devices 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.
Here's an analysis of the provided text regarding the DYNAMIC Hollow Fiber Dialyzer DS-Series, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" with specific numerical thresholds for each performance metric. Instead, the study aims to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of achievement of this equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Urea Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Creatinine Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Phosphate Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Vitamin B12 Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Ultrafiltration Coefficient | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Sieving Coefficient | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Safety and Effectiveness | Safe and effective as predicate devices | Device is safe, effective, and performs as well as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the in vitro performance testing (test set). It only states that "In vitro testing was performed on the proposed device."
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a medical device prior to market, it's highly likely the in vitro testing was prospective.
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 the reported study. The "ground truth" for hollow fiber dialyzers in this context is established by the functional performance characteristics (clearances, ultrafiltration, sieving coefficients) as measured by laboratory equipment and standardized protocols, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable to the in vitro performance testing of a dialyzer. Performance metrics are measured objectively, not adjudicated by human review.
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 MRMC study was performed. This device is a medical device (dialyzer), not an AI-based diagnostic or imaging device, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical hemodialyzer, not an algorithm. The "standalone" performance refers to the in vitro performance of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the in vitro performance testing consisted of measured functional performance characteristics such as urea, creatinine, phosphate, and vitamin B12 clearances, ultrafiltration coefficient, and sieving coefficient. These measurements were then compared against the established performance of the predicate devices.
8. The Sample Size for the Training Set
There is no "training set" in the context of this 510(k) submission for a physical medical device. The device's design and manufacturing processes are based on established engineering principles and materials, not on a machine learning training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1