(192 days)
The hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.
DHF and SH Hemoconcentrators are single-use, non-toxic and nonpyrogenic fluid path devices; they are supplied sterile and individually packaged. The devices are made of plastic materials and are recommended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit: The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device can be used up to 6 hours.
The DHF and SH hemoconcentrators are the modified version of the disposables currently marketed in the Dideco DHF hemoconcentrators (K021732) and the SH 14 hemoconcentrators (K081313).
The provided FDA 510(k) clearance letter for the DHF and SH Hemoconcentrators does not describe a study that proves the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic device.
Instead, this document details a change to an existing, cleared medical device (hemoconcentrators used in cardiopulmonary bypass circuits). The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against new, quantitative clinical acceptance criteria as one would find for a novel diagnostic or AI-powered system.
The "study" described here is a non-clinical performance evaluation focused on demonstrating that a material change (from Santoprene to Silicone for O-rings) does not introduce new questions of safety or effectiveness.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance.
Here's an analysis based on the provided document, highlighting what is (and isn't) present:
Analysis of Acceptance Criteria and Device Performance for DHF and SH Hemoconcentrators
The information provided describes a 510(k) clearance for hemoconcentrators, which are physical medical devices, not an AI/ML or diagnostic software. The "acceptance criteria" and "study" are therefore framed around demonstrating substantial equivalence to existing predicate devices, particularly after a material change to a component, rather than performance metrics for a diagnostic algorithm.
This document explicitly states: "No clinical testing was conducted in support of the DHF and SH hemoconcentrators, as the indications for use and technical characteristics are unchanged with respect to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
The "study" instead focuses on non-clinical performance data to ensure that the device still complies with applicable standards and performs as expected after the specified design change.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission, acceptance criteria are generally met through compliance with recognized standards and demonstrating that the device's fundamental characteristics and performance are maintained despite the change. The document does not list specific quantitative performance criteria in a table format, but rather states compliance.
| Acceptance Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|
| Material Biocompatibility and Safety: | New silicone O-ring material demonstrated to be safe and biocompatible. (Implied by clearance) |
| Mechanical Integrity/Functionality: | Device continues to function as intended (e.g., maintain integrity, proper fluid path, non-pyrogenic). "Passed all testing in accordance with national and international standards." |
| Sterility: | Ethylene Oxide sterilized; non-pyrogenic fluid path maintained. |
| Substantial Equivalence: | The DHF and SH hemoconcentrators are deemed substantially equivalent to their predicate devices, raising no new questions of safety or effectiveness. |
| Compliance with Voluntary Standards: | Complies with all applicable voluntary standards related to Dialyzers. |
| Intended Use Maintained: | Intended for use in cardiopulmonary bypass circuits for hemoconcentration and restoring physiological hematocrit, for 6 hours or less. (Unchanged from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" because this was non-clinical performance testing (e.g., bench testing of prototypes or manufacturing samples), not a clinical study on patient data.
- Data Provenance: The testing was conducted by Sorin Group Italia S.R.L. and is "non-clinical," implying laboratory or bench testing. The country of origin would be Italy (where Sorin Group Italia S.R.L. is located). It is not retrospective or prospective in the sense of a clinical trial; it is product performance verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is a physical device, and the testing involved demonstrating compliance with engineering and safety standards, not establishing a "ground truth" for diagnostic purposes by human experts.
4. Adjudication Method for the Test Set
Not Applicable. There was no human adjudication process involved in assessing diagnostic performance. The evaluation was based on engineering and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess how human readers perform with and without AI assistance. This device is a hemoconcentrator, not an imaging or diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm. Performance was assessed for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for dialyzers), and performance parameters (e.g., filtration rates, material integrity, biocompatibility, sterility assurance). It is not based on expert consensus, pathology, or outcomes data from patients in the context of a new diagnostic claim. The "ground truth" is that the device, with the new material, still meets the same performance and safety requirements as the predicate device.
8. The Sample Size for the Training Set
Not Applicable. This device is not an AI/ML algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.”