(293 days)
The Clearum™ HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.
The Clearum™ HS family consists of dialyzers comprised by a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polvurethane resin.
The devices are available in different models which differentiate by membrane surface area, ranging from 1.3 to 2.2 m², and for the dimensions of the outer cylindrical body in terms of length and height (306 x 41 mm for the surface areas in the range 1.3-1.5 m², 306 x 44 mm for the surface area 1.7 m² and 366 x 44 mm for the surface areas in the range 2.0-2.2 m²).
Similar to other commercially available hemodialyzers, blood and dialysate flow in a countercurrent in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment.
The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.
The provided text describes the Clearum™ HS family of dialyzers and their comparison to a predicate device, the Polyflux H models, to demonstrate substantial equivalence for FDA 510(k) clearance. This report does not describe acceptance criteria for an AI/ML powered medical device, but rather for a physical medical device. It focuses on in-vitro test results and comparison to a predicate device.
Here's an analysis of the provided information, noting where specific requested details (like those for AI/ML studies) are not available in this physical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" in a table format for each performance metric, but rather states that "The results of the testing met the performance specifications demonstrating that the Clearum™ HS family performs as intended." It also aims to demonstrate substantial equivalence to the predicate device.
The "performance specifications" are implicitly derived from the established performance characteristics of the predicate device and the industry standards (ISO 8637-1:2017).
| Performance Metric | Clearum™ HS Family Performance (Implicit) | Predicate Device Performance (Polyflux H) (Implicit) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Priming Volume | Met performance specifications; demonstrated substantial equivalence to predicate. | Polyflux 140H: 94 ml; Polyflux 170H: 115 ml; Polyflux 210H: 125 ml (These are the predicate's reported values, implying the Clearum™ HS values are comparable and within acceptable variation for substantial equivalence). | |
| Clearum™ HS: HS 13: 84ml, HS 15: 95ml, HS 17: 105ml, HS 20: 120ml, HS 22: 126ml | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. | ||
| Pressure Drop (Blood Compartment) | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. |
| Pressure Drop (Dialysate Compartment) | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. |
| Ultrafiltration Coefficient | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. |
| Sieving Coefficient (Albumin, Myoglobin, Inulin) | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. |
| Clearance (Urea, Creatinine, Phosphate, Vitamin B12) | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017. |
| Hemocompatibility (mechanical hemolysis) | Met performance specifications; demonstrated substantial equivalence to predicate. | Not explicitly stated for predicate in summary, but comparative testing was done. | Performance must meet established design specifications and demonstrate substantial equivalence to the predicate device, consistent with ISO 8637-1:2017 and ISO 10993-1. |
| Sterility | Effectiveness of production techniques to assure sterility demonstrated. | Moist heat with saturated steam. | Must be sterile. |
| Non-pyrogenicity | Effectiveness of production techniques to assure non-pyrogenicity demonstrated. Device has a non-pyrogenic fluid path. | Not explicitly stated for predicate in summary. | Must be non-pyrogenic. |
| Biocompatibility | In accordance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (limited to external communicating device, circulating blood, prolonged contact duration). | Not explicitly stated for predicate in summary for comparison, but predicate would have met similar standards. | Must comply with ISO 10993-1 for biological evaluation, specific to external communicating (circulating blood, prolonged contact). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "In vitro testing was conducted on the entire Clearum™ HS dialyzers family" and "For comparative purposes, the same testing, was also conducted on the Polyflux H predicate device, when applicable." However, the exact number of units tested (sample size) for each model or for the overall family is not specified in the provided text.
- Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting. There is no mention of human subject data, retrospective or prospective studies in the context of device performance. The manufacturer, Bellco S.r.l., is located in Mirandola MO, Italy, suggesting the tests were likely conducted there or at an affiliated lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. For physical medical devices like dialyzers, "ground truth" is established through physical and chemical testing against recognized standards (e.g., ISO, FDA guidance) and comparison to the predicate device's established performance. It does not involve expert adjudication of clinical data in the way an AI/ML device would.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data, typically in AI/ML validation studies. For this physical device, performance is measured objectively through lab tests.
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
This information is not applicable. This is a submission for a physical medical device (hemodialyzer), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-assisted human reader improvement metrics are relevant or discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" is based on:
- Industry Standards: Compliance with ISO 8637-1:2017 ("Cardiovascular implants and extracorporeal systems - Hemodialysers, hemodiafilters, hemofilters and hemoconcentrators") and ISO 10993-1 ("Biological evaluation of medical devices").
- FDA Guidance: "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers" (1998) and "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
- Predicate Device Performance: The established, legally marketed performance characteristics of the Polyflux H dialyzer family. The new device demonstrates "substantial equivalence" to the predicate.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for an algorithm.
§ 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.”