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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2020

Bellco Srl % Michele Gust Sr. Regulatory Affairs Director, Renal Care Solutions Medtronic, Inc. 710 Medtronic Parkway (LT140) Minneapolis, MN 55432

Re: K193542

Trade/Device Name: Clearum HS Family Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: September 4, 2020 Received: September 8, 2020

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.

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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 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 mediation-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.

Carolyn Y. Neuland, Ph.D. 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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Indications for Use

510(k) Number (if known)

K193542

Device Name Clearum™ HS Family

Clearum™ HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Indications for Use (Describe)

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

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

X 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, 1
	41037 Mirandola MO, Italy

CONTACT PERSON: Michele Gust Telephone: 763-505-4016
DATE PREPARED: Aug 14, 2020

Clearum™ HS family TRADE NAMES:

Clearum™ HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

COMMON NAMES: Hollow fiber dialyzers
REGULATION and CLASS: 21 CFR §876.5860, Class II

PRODUCT CODE: KDI

Gastroenterology / Urology (78) CLASSIFICATION PANEL:

CLASSIFICATION NAMES: High permeability hemodialysis system
PREDICATE DEVICES: Polyflux H models: 140H, 170H, 210H (K030592, cleared on May 23 2003, manufactured by Gambro now Baxter Healthcare Corporation)

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5.1. Device Description

The Clearum™ HS dialyzers are substantially equivalent to Polyflux H models manufactured by Gambro now Baxter Healthcare Corporation (K030592, cleared on May 23, 2003).

The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.

5.2. Indication for Use

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

5.3. Technological Characteristics

The main design features, operating principle and basic function of the Clearum™ HS dialyzers are substantially equivalent to the predicate device, Polyflux H dialyzers family.

Both the test and predicate devices have a cylindrical housing containing a bundle of microporous hollow fiber membranes.

For both devices, blood and dialysate flow in a countercurrent in their respective compartments, thus resulting in the transfer of toxins and fluid across the semipermeable membrane from the blood to the dialysate compartment.

The table below compares the Clearum™ HS family to the predicate device for all the available information that have been retrieved from labeling information and from the FOI

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Service Inc. For clarity an indication "not av." has been added when an information was not available for the competitor's devices.

Parameter	Clearum™ HSDialyzer Family	PolyFlux H Dialyzer FamilyPredicate device(K030592)
Intended Use	The Clearum™ HS dialyzerfamily is intended for use inacute or chronic renal failurepatients requiringhemodialysis.	The capillary dialyzer/filter isintended for use inHemodialysis,Hemodiafiltration,Hemofiltration for thetreatment of chronic or acuterenal failure.
Potting Resin forFibers	Polyurethane	Polyurethane
Dialysate portcaps	Polypropylene	Polypropylene
Blood port caps	Polypropylene	Polypropylene
Headers	Polypropylene	Polycarbonate
O-rings	Silicone Rubber	Silicone Rubber
Housing	Polypropylene	Polycarbonate
Fiber ChemicalComposition	Clearum GmbHPolyethersulfone (PES),Polyvinyl-pyrrolidone (PVP)	Polyamix™Polyarylethersulfone (PAES),Polyvinyl-pyrrolidone (PVP)
Fiber InternalDiameter(measuredaverage) (µm)	200 (for all the models)	215
Parameter	Clearum™ HSDialyzer Family	PolyFlux H Dialyzer FamilyPredicate device(K030592)
Wall Thickness(µm)	40 (for all the models)	50
Number of fibers	HS 13: 8600HS 15: 9900HS 17: 11150HS 20: 10400HS 22: 11200	Polyflux 140H: 7500Polyflux 170H: 9300Polyflux 210H: 12000
Effective fiberlength(mm)	HS 13: 246HS 15: 246HS 17: 246HS 20: 308HS 22: 308	Polyflux 140H: 270Polyflux 170H: 270Polyflux 210H: 270
Effectivemembranesurface area(m2)	HS 13: 1.3HS 15: 1.5HS 17: 1.7HS 20: 2.0HS 22: 2.2	Polyflux 140H: 1.4Polyflux 170H: 1.7Polyflux 210H: 2.1
Configuration:Outer housingHeight (mm)	HS 13: 306HS 15: 306HS 17: 306HS 20: 366HS 22: 366	Not av.
Configuration:Maximumoutside diameter(mm)	55 (for all the models)	Not av.
Parameter	Clearum™ HSDialyzer Family	PolyFlux H Dialyzer FamilyPredicate device(K030592)
Configuration:Minimum insidediameter (mm)	HS 13: 36.75HS 15: 36.75HS 17: 39.40HS 20: 39.40HS 22: 39.40	Not av.
Configuration:overall casinggeometry	Cylindrical body	Cylindrical body
Priming volume(ml)	HS 13: 84HS 15: 95HS 17: 105HS 20: 120HS 22: 126	Polyflux 140H: 94Polyflux 170H: 115Polyflux 210H: 125
Sterilizationmethod	Moist heat with saturatedsteam	Moist heat with saturatedsteam

Table 5-1: Comparison Clearum™ HS Dialyzers Family vs. PolyFlux H Dialyzers Family

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5.4. Non-Clinical Test Results

Applicable tests were conducted in accordance with the requirements of ISO 10993-1.

The Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and its guidelines was also considered limited to external communicating device, circulating blood, prolonged contact duration.

5.5. In-Vitro Test Results

In vitro testing was conducted on the entire Clearum™ HS dialyzers family. The tests performed demonstrate the predicate device 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 - Hemodialysers, hemodiafilters, hemofilters and hemoconcentrators".

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Device performance testing included:

Priming Volume
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
. Hemo-compatibility (mechanical hemolysis)

For comparative purposes, the same testing, was also conducted on the Polyflux H predicate device, when applicable.

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

5.6. Conclusions

The results on in vitro studies demonstrate the Clearum™ HS dialyzers perform as per design specifications and are 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.”