(256 days)
The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.
The Hemofeel-CH Hemofilter consists of highly permeable polymethylmethacrylate (PMMA) hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. Blood enters the device through the arterial inlet port, passes through the hollow fibers and exits at the opposite end through the venous outlet port. The Hemofeel-CH hemofilter is provided in a range of sizes based on the surface area of the hollow fiber membrane. Hemofilter size should be selected by the physician according to the patient's body weight and medical condition. The device is gamma-ray sterilized and intended for single use only.
Toray Industries (America), Inc.'s Hemofeel™-CH Hemofilter study:
1. Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In Vitro Testing | Not Specified | All samples met the acceptance criteria. |
| - Ultrafiltration Coefficient | Not Specified | Met acceptance criteria. |
| - Water Permeability | Not Specified | Met acceptance criteria. |
| - Pressure Drop | Not Specified | Met acceptance criteria. |
| - Hemolysis | No Hemolysis | No hemolysis seen. |
| Shelf Life (3 years) | Not Specified | Biological, sterility, leak, and water permeability characteristics maintained. |
| Clinical (Safety and Efficacy) | Not Specified | No complications related to use; safe and effective for continuous hemofiltration. |
2. Sample Size and Data Provenance:
- Test Set (Clinical Study): 8 anuric critically ill patients.
- Data Provenance: The document does not specify the country of origin, but the clinical study was "in the clinical setting", suggesting a prospective clinical trial.
3. Number of Experts and Qualifications:
- Not Applicable. The document describes a medical device's performance, not an AI or diagnostic system requiring expert interpretation for ground truth. The "experts" involve the physicians overseeing the clinical study.
4. Adjudication Method:
- Not Applicable. This is a performance study for a medical device, not a diagnostic system requiring adjudication of interpretations. Outcomes were assessed in the clinical setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an MRMC comparative effectiveness study. It's a study evaluating the performance of a medical device (hemofilter).
6. Standalone (Algorithm Only) Performance:
- No. The device is a physical medical device (hemofilter) and does not involve an algorithm with standalone performance.
7. Type of Ground Truth Used:
- Clinical Outcomes/Observations and In-Vitro Measurements:
- For the clinical study, the ground truth was based on patient outcomes and observations regarding fluid and electrolyte management, and the occurrence of complications.
- For in-vitro testing, the ground truth was based on laboratory measurements of various performance parameters (ultrafiltration coefficient, water permeability, pressure drop, hemolysis) against established scientific or engineering benchmarks.
8. Sample Size for the Training Set:
- Not Applicable. This is a medical device, not an AI or machine learning algorithm requiring a training set in that context. The device's design and manufacturing process would involve internal testing and development data, but not a "training set" as understood in AI studies.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The design and validation of the hemofilter would have involved engineering specifications, material science data, and pre-clinical testing, which serve a similar function to inform product development.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”