FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Clearum™ HS 17 dialyzer is consisting of a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polyurethane resin.
The modifed Clearum™ HS 17 dialyzer is substantially equivalent to the predicate Clearum™ HS 17 dialyzer manufactured by Bellco (K193542, cleared on October 8, 2020).
The device is characterized by a membrane surface area equivalent to 1.7 m², and by an outer housing total height of 306 mm and a maximum outside diameter of 44 mm.
ldentical to the predicate Clearum™ HS 17, 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called Clearum™ HS 17, a high permeability hemodialysis system. The submission seeks to demonstrate substantial equivalence to a predicate device (also Clearum™ HS 17, K193542) despite a minor modification in fiber undulation amplitude and effective fiber length.

This document does not contain information about an AI/ML-based medical device or a study involving human readers and AI assistance. Therefore, it is impossible to extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML context.

The document focuses on the equivalence of a physical medical device (a dialyzer) based on in-vitro test results. The "study" referenced is a series of non-clinical, in-vitro tests comparing the modified device to its predicate.

To directly address your request as if it were for an AI/ML device, I would need a different source document. However, based solely on the provided text, I can only report on the non-AI/ML aspects related to the Clearum™ HS 17 dialyzer.

Here's a breakdown of what can be extracted, framed within the closest possible interpretation of your request for this non-AI/ML device:

Acceptance Criteria and Device Performance (for a physical hemodialyzer)

The document states that "The modified Clearum™ HS 17 has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device." The acceptance criterion, implicitly, is that the modified device performs comparably to the predicate device in key in-vitro performance metrics, demonstrating substantial equivalence and not raising new safety or effectiveness concerns.

Acceptance Criteria (Implicit - based on comparison to predicate)	Reported Device Performance
Maintain performance specifications as defined by relevant standards (e.g., ISO 8637-1:2017) and guidance (e.g., FDA guidance for hemodialyzers).	"The results of the testing met the performance specifications demonstrating that the modified Clearum™ HS 17 performs as intended."
Demonstrate substantial equivalence to the predicate Clearum™ HS 17 (K193542).	"The predicate device substantial equivalence was also demonstrated."
No new or increased biocompatibility concerns.	"The biocompatibility testing and/or chemical characterization followed by a toxicological risk assessment that was completed on the predicate Clearum™ HS 17 applies to the modified Clearum™ HS 17..."
Maintain or improve performance across key metrics:	In vitro testing conducted on both modified and predicate device.
- Priming Volume	Test conducted.
- Pressure Drop across Blood Compartment	Test conducted.
- Pressure Drop across Dialysate Compartment	Test conducted.
- Ultrafiltration Coefficient	Test conducted.
- Sieving Coefficient (Albumin, Myoglobin, Inulin)	Test conducted.
- Clearance (Urea, Creatinine, Phosphate, Vitamin B12)	Test conducted.
- Hemo-compatibility (mechanical hemolysis)	Test conducted.

Study Details (for a physical hemodialyzer)

1. A table of acceptance criteria and the reported device performance: (See table above)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but in-vitro testing was conducted on "both the modified and predicate Clearum™ HS 17 for comparative purpose." This implies multiple units were tested to generate the reported performance data. Specific numbers of dialyzers tested for each metric are not provided.
- Data Provenance: The tests were conducted internally by Bellco S.r.l. or a contracted lab. The country of origin is Bellco S.r.l. in Mirandola (MO), Italy. The data is from in-vitro testing, not retrospective or prospective human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a physical device's performance is established by standardized in-vitro measurements, not expert consensus or human reading. The "experts" would be the scientists and engineers conducting and interpreting the physical and chemical tests, presumably adhering to ISO standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to human interpretation or algorithm output, not to objective physical measurements of a device.
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:
- Not applicable. This is not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device, so there is no algorithm to evaluate in standalone mode.
7. The type of ground truth used:
- In-vitro performance metrics: The "ground truth" for this device's performance is derived from objective physical and chemical measurements (e.g., clearance rates, ultrafiltration coefficients, pressure drops) performed in controlled laboratory settings according to established scientific and engineering principles and international standards (ISO 8637-1:2017).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and manufacturing process are based on engineering principles and material science.
9. How the ground truth for the training set was established:
- Not applicable. As above, there's no training set for an AI/ML model.

Summary

Regulation Number and Section

§ 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.”