(176 days)
The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. 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 indication statement is essentially the same as the indication statement of the predicate devices.
The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Cuprophan which is substantially equivalence to the Cuprophan membranes utilized in the cobe centry System 160E and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dialyzers are manufactured by Akzo (Enka) of Germany. Cuprophan membrane is also utilized in Baxter CF25 Dialyzers. Hemophan membrane is also manufactured by Akzo (Enka) and is also cellulose membrane but derivative from Cuprophan membrane.
Blood enters a blood inlet port where it is distributed to Cuprophan and Hemophan membrane. 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 equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns.
Blood is bumped via a roller pump from the artery of the patient into the arterial end of the dialvzer. The blood travels down through the dialyzer fibers where waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dilayzer on the outside of the hollow fibers. Blood then exits the venous end of the dilayzer back to the patient.
The provided text describes the acceptance criteria and a study for the Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Devices: Terumo Clirans T175, Baxter CF25, Cobe Centry System 160E) | Reported Device Performance (Haidylena Hollow Fiber Dialyzer - Cuprophan HL 100, 120, 130 and Hemophan HL 100H, 120H, 130H) |
|---|---|
| Physical Characteristics: | Haidylena Cuprophan: |
| Blood priming volume: ~95-120 ml (T175, CF25, 160E varied) | HL 100: 57 ml; HL 120: 68 ml; HL 130: 79 ml |
| Effective surface (S.Q.M.): ~0.9-1.75 | HL 100: 1.0; HL 120: 1.2; HL 130: 1.3 |
| Wall thickness (µm): 8-9 µm | 8 µm for all models |
| Clearance (ml/min.): | Haidylena Cuprophan: |
| Urea: ~190-192 | HL 100: 174; HL 120: 179; HL 130: 184 |
| Creatinine: ~161-177 | HL 100: 149; HL 120: 156; HL 130: 162 |
| Phosphate: ~151-159 | HL 100: 124; HL 120: 138; HL 130: 141 |
| Vitamin B12: ~61-97 (T175, CF25, 160E varied) | HL 100: 48; HL 120: 55; HL 130: 58 |
| Ultrafiltration rate (ml/hr/mmHg): ~4.3-8.8 | HL 100: 4.9; HL 120: 6.0; HL 130: 6.6 |
| Maximum TMP: 500 mmHg | 500 mmHg for all models |
| Haidylena Hemophan: | |
| Blood priming volume: ~95-120 ml | HL 100H: 57 ml; HL 120H: 68 ml; HL 130H: 79 ml |
| Effective surface (S.Q.M.): ~0.9-1.75 | HL 100H: 1.0; HL 120H: 1.2; HL 130H: 1.3 |
| Wall thickness (µm): 8-9 µm | 8 µm for all models |
| Clearance (ml/min.): | Haidylena Hemophan: |
| Urea: ~190-192 | HL 100H: 170; HL 120H: 175; HL 130H: 179 |
| Creatinine: ~161-177 | HL 100H: 149; HL 120H: 154; HL 130H: 160 |
| Phosphate: ~151-159 | HL 100H: 129; HL 120H: 140; HL 130H: 149 |
| Vitamin B12: ~61-97 | HL 100H: 46; HL 120H: 55; HL 130H: 60 |
| Ultrafiltration rate (ml/hr/mmHg): ~4.3-8.8 | HL 100H: 4.9; HL 120H: 6.0; HL 130H: 6.0 |
| Maximum TMP: 500 mmHg | 500 mmHg for all models |
| Sterilization: Consistent with BS EN 550 and AAMI guidelines for SAL of 10^-6 | Validated according to BS EN 550 and AAMI guidelines to provide a Sterility Assurance Level of 10^-6. Ethylene oxide residuals not exceeding maximum limits. |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the "in vitro performance" testing. It presents consolidated results for multiple models of the Haidylena dialyzer (Cuprophan HL 100, 120, 130 and Hemophan HL 100H, 120H, 130H).
- The data provenance is from "in vitro testing" performed on the proposed devices. No country of origin for this specific test data is mentioned, but the submitter is Haidylena Medical, located in Cairo, Egypt. It is not specified if the data is retrospective or prospective, but in vitro tests are typically prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for in vitro performance data is typically based on standardized testing protocols and measurements, not expert consensus in the way a diagnostic image might be.
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Adjudication method for the test set:
- This information is not applicable/provided for the type of in vitro performance study described. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, primarily in clinical or image-based studies.
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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, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, usually in a diagnostic context. The provided study is an in vitro performance assessment of a medical device (a dialyzer), not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance assessment was done. The study evaluates the device's intrinsic physical and clearance performance (Urea, Creatinine, Phosphate, Vitamin B12 clearance, and ultrafiltration coefficient) in a laboratory setting ("In Vitro Performance") without human interaction influencing the core measurement results. It is important to note that this is not an "algorithm" in the sense of AI, but rather the performance of the physical device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the in-vitro performance testing is based on direct physical and chemical measurements of the dialyzer's function in a controlled laboratory environment. This includes quantitative measurements of:
- Blood priming volume
- Effective surface area
- Wall thickness
- Clearance rates for specific solutes (Urea, Creatinine, Phosphate, Vitamin B12)
- Ultrafiltration rate
- Maximum Transmembrane Pressure (TMP)
- Sterilization efficacy is based on standardized validation protocols (BS EN 550 and AAMI guidelines) to achieve a specified Sterility Assurance Level (SAL).
- The ground truth for the in-vitro performance testing is based on direct physical and chemical measurements of the dialyzer's function in a controlled laboratory environment. This includes quantitative measurements of:
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The sample size for the training set:
- This study does not involve a training set. The described study is an in vitro performance test of a physical medical device (blood dialyzer), not a machine learning or AI model that requires training data.
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How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of device and study.
§ 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.