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

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

June 14, 2023

Bellco S.r.l. % Michele Gust VP, Regulatory and Ouality Mozarc Medical 710 Medtronic Parkway (LT140) Minneapolis, Minnesota 55432

Re: K231406

Trade/Device Name: Clearum™ HS 17 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 15, 2023 Received: May 15, 2023

Dear Michele Gust:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gema Gonzalez -S

Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231406

Device Name Clearum™ HS 17

Indications for Use (Describe)

The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

SUBMITTER:	Bellco S.r.l.Via Camurana, 141037 Mirandola (MO) Italy
CONTACT PERSON:	Michele GustTelephone: 763-505-4016E-mail: michele.gust@medtronic.com
DATE PREPARED:	May 11, 2023
DEVICE TRADE NAME:	Clearum™ HS 17
COMMON NAMES:	Hollow fiber dialyzers
CLASSIFICATION NAME:	High permeability hemodialysis system
PREDICATE DEVICES:	Clearum™ HS 17 (K193542)

DEVICE DESCRIPTION:

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.

INDICATION FOR USE:

The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis.

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TECHNOLOGICAL CHARACTERISTICS:

The modified Clearum™ HS 17 has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device.

As compared to the predicate device, the modified Clearum™ HS 17 is characterized by a different fiber undulation amplitude that has been increased from 0.5 to 0.6 millimeters. As a consequence, the effective fiber length also increases from 246 to 247 millimeters.

The design has not been changed. No modification described in the present 510(k) applies to other device components except for the fiber.

No change to the intended use has been made as a result of the modifications.

The modified and the predicate Clearum™ HS 17 devices share fundamental technological characteristics and the same device function.

The increased fiber undulation amplitude does not raise any new issues of safety and effectiveness.

The modified device is substantially equivalent to the predicate device with respect to intended use, function, sterilization method, operating principles, control mechanisms, manufacturing process and fundamental scientific technology.

There are no differences in packaging type and material between predicate and modified device.

The Clearum™ HS 17 is sterilized using moist heat with saturated steam and have a nonpyrogenic fluid path. The device is for single use only.

The table below compares the modified Clearum™ HS 17 to the predicate Clearum™ HS 17.

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Comparison of Modified Clearum™ HS 17 vs. Predicate Clearum™ HS 17

Parameters	Clearum ™ HS 17Predicate device(K193542)	Clearum ™ HS 17Modified device
Intended use	The Clearum™ HS 17 is intendedfor use in acute or chronic renalfailure patients requiringhemodialysis	Same
Fiber ChemicalComposition	Clearum GmbHPolyethersulfone (PES), Polyvinyl-pryrrolidone (PVP)	Same
Potting Resin forFibers	Polyurethane	Same
Dialysate port caps	Polypropylene	Same
Blood port caps	Polypropylene	Same
Headers	Polypropylene	Same
O-rings	Silicone Rubber	Same
Housing	Polypropylene	Same
Fiber InternalDiameter (measuredaverage)	200 μm	Same
Fiber undulationamplitude (mm)	0.5	0.6
Fiber undulationwavelength (mm)	0.8	Same
Wall Thickness	40 μm	Same
Number of fibers	11150	Same
Effective fiber length(mm)	246	247
Outer housing Height(mm)	306	Same
Maximum outsidediameter (mm)	55	Same
Minimum insidediameter (mm)	39.40	Same
Priming Volume(ml)	105	Same
Blood Connector	luer-type	Same
Dialysate Connector	Hansen-type	Same
Casing geometry	Cylindrical body	Same
Packaging type	Single/Multi unit box	Same
Packaging material	Plastic pouch/carton box	Same
Shelf life	3 Years	6 months
Method ofSterilization	Moist heat with saturated steam	Same
Manufacturer	Bellco S.r.l.	Same

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NON CLINICAL TEST RESULTS

The raw materials have not been modified as a result of this change. The modified Clearum™ HS 17 is manufactured with the same biocompatible materials as the predicate device. Also, the manufacturing flow is fully identical. The processing of the materials, manufacturing methods and steps have not been changed.

The are no new or increased biocompatibility concerns as there is no change to the raw materials nor the processing agents/steps that the fiber is subjected to: therefore, biocompatibility testing was not repeated. 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 in accordance with the requirements of ISO 10993-1 and the quidelines of the Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

IN-VITRO TEST RESULTS

In vitro testing was conducted on both the modified and predicate Clearum™ HS 17 for comparative purpose. The test results demonstrated the substantial equivalence.

Testing was conducted in accordance with the relevant requirements of "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, issued on August 7, 1998" as well as the related ISO 8637-1:2017 - "Cardiovascular implants and extracorporeal systems - Hemodiafilters, hemodiafilters and hemoconcentrators". Device performance testing included:

Priming Volume l
Pressure Drop across Blood Compartment (Resistance to Flow) -
Pressure Drop across Dialysate Compartment (Resistance to Flow) -
Ultrafiltration Coefficient |
Sieving Coefficient: Albumin, Myoglobin, Inulin —
Clearance: Urea, Creatinine, Phosphate, and Vitamin B12 —
l Hemo-compatibility (mechanical hemolysis)

The results of the testing met the performance specifications demonstrating that the modified Clearum™ HS 17 performs as intended. The predicate device substantial equivalence was also demonstrated.

CONCLUSIONS

The results on in vitro studies demonstrate the modified Clearum™ HS 17 performs as per design specifications and is equivalent to the predicate device with respect to device function. Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and non-pyrogenic.

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.”