(135 days)
The CAPIOX Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used during and after surgical procedures requiring cardiopulmonary bypass (up to 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.
CAPIOX® Hemoconcentrator consists of Glycerin-free polysulfone fibers, casing, blood port, O-ring and adhesives.
The hemoconcentrator is available in two model has a total membrane area I he nemoconcentrator is a valuable in a 1.08 m² surface area.
Three types of blood ports are available in each model: ¼" slip, 3/16" slip, and 3/16" The ports are transparent allowing easy observation of air bubbles passing through the ports when priming.
Dimensions of filtrate ports meet the requirements specified in ISO 8637 which permits connection of fast couplings.
The CAPIOX Hemoconcentuator provides high ultra filtration rates which permits the The CAPIOX Hemoval of excess fluid by a slight hydrostatic pressure differential across the membrane without loss of essential plasma proteins
The provided text describes the CAPIOX® Hemoconcentrator, a device intended to remove excess fluid from blood during and after cardiopulmonary bypass. The document is a Summary of Safety and Effectiveness Information submitted as part of a 510(k) submission (K973516) to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
- Acceptance Criteria for Device Performance: The acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device (Minntech Hemocor HPH Hemoconcentrator) across several key characteristics. The study proving this substantial equivalence is a comparative analysis, rather than a traditional clinical trial with a defined test set and ground truth in the context of AI/machine learning.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit by Predicate Device Specs) | CAPIOX® Hemoconcentrator (Reported Performance) | Minntech Hemocor (Predicate Device) |
|---|---|---|
| Intended Use | Used during and after surgical procedures requiring cardiopulmonary bypass when the removal of excess fluid is required. (Should not be used as a dialyzer, hemofilter or for any other function.) | Used during and after surgical procedures requiring cardiopulmonary bypass when the removal of excess fluid is required. |
| Membrane technology | Hollow Fiber | Hollow Fiber |
| Membrane material | Glycerin-free polysulfone | Glycerin-free polysulfone |
| Blood flow relative to fiber | Inside | Inside |
| Effective surface area | HC11: 1.08m², HC05: 0.5 m² | HPH1000: 1.1m², HPH400: 0.3m² |
| Blood Ports | ¼" slip, 3/16" slip, 3/16" luer lock | ¼" slip |
| Filtrate ports | ½" Hansen quick connect | ¼" slip |
| Maximum Blood Flow | 500 mL/min | 500 mL/min |
| Maximum transmembrane pressure | 500 mmHg | 500 mmHg |
| Priming volume | HC11: 70 mL, HC05: 35 mL | HPH1000: 88 mL, HPH400: 34 mL |
| Priming | No rinse required | No rinse required |
| Sterilization method | Ethylene oxide | Ethylene oxide |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an AI/ML test set. The study demonstrating substantial equivalence is a comparison of specifications and design, not an evaluation on a patient-data test set.
- Data Provenance: Not applicable. The "data" here are the specifications and design features of the device itself and the predicate device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable for establishing ground truth in an AI/ML sense. The "ground truth" is the established performance and safety profile of the predicate device, which is implied to be acceptable based on its prior market clearance. The comparison was conducted by the manufacturer, Terumo Medical Corporation, with regulatory oversight by the FDA.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This was a direct comparison of specifications and design, not a judgment of performance on a data set.
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:
- MRMC Study/Effect Size: No. This document describes a medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a standalone medical device, not an algorithm.
7. The type of ground truth used:
- Ground Truth: The "ground truth" used for this submission is the established performance and safety profile of the legally marketed predicate device (Minntech Hemocor HPH Hemoconcentrator). The acceptance criteria essentially state that the new device must be sufficiently similar to the predicate device such that it does not raise new questions of safety or effectiveness. This is determined by comparing intended use, design and materials, technology/principles of operation, specifications, and performance.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.
§ 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.”