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510(k) Data Aggregation
(234 days)
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(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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(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.
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(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.
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