(293 days)
No
The device description and performance studies focus on the physical components and in vitro performance of a hemodialyzer, with no mention of AI or ML technologies.
Yes
Hemodialyzers like the Clearum™ HS family remove toxins and fluid from the blood, serving as a therapeutic intervention for patients with renal failure.
No
The device is a dialyzer used for treating renal failure patients by filtering toxins and fluid from their blood, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical medical device (dialyzer) made of polypropylene and polyethersulfone hollow fibers, with specific dimensions and sterilization methods. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute or chronic renal failure patients requiring hemodialysis." This describes a therapeutic treatment applied directly to the patient's blood, not a test performed on a sample outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical device (a dialyzer) that filters blood. This is a therapeutic device, not a diagnostic one.
- Mechanism of Action: The device works by transferring toxins and fluid across a membrane from blood to dialysate. This is a physical process of filtration and diffusion, not a chemical or biological test to detect substances or markers.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the dialyzer (priming volume, pressure drop, ultrafiltration, sieving, clearance, hemo-compatibility), which are relevant to its therapeutic function, not its diagnostic capabilities.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly interacts with the patient's blood for treatment.
N/A
Intended Use / Indications for Use
The Clearum™ HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.
Product codes
KDI
Device Description
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 Clearum™ HS dialyzers are substantially equivalent to Polyflux H models manufactured by Gambro now Baxter Healthcare Corporation (K030592, cleared on May 23, 2003).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Non-Clinical Test Results, In-Vitro Test Results.
Sample Size: Not specified.
AUC: Not specified.
MRMC: Not specified.
Standalone Performance: Not specified.
Key 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. 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". 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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.
1
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
2
Indications for Use
510(k) Number (if known)
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 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 Clearum™ HS dialyzers are substantially equivalent to Polyflux H models manufactured by Gambro now Baxter Healthcare Corporation (K030592, cleared on May 23, 2003).
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.
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
5
Service Inc. For clarity an indication "not av." has been added when an information was not available for the competitor's devices.
| Parameter | Clearum™ HS
Dialyzer Family | PolyFlux H Dialyzer Family
Predicate device
(K030592) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Clearum™ HS dialyzer
family is intended for use in
acute or chronic renal failure
patients requiring
hemodialysis. | The capillary dialyzer/filter is
intended for use in
Hemodialysis,
Hemodiafiltration,
Hemofiltration for the
treatment of chronic or acute
renal failure. |
| Potting Resin for
Fibers | Polyurethane | Polyurethane |
| Dialysate port
caps | Polypropylene | Polypropylene |
| Blood port caps | Polypropylene | Polypropylene |
| Headers | Polypropylene | Polycarbonate |
| O-rings | Silicone Rubber | Silicone Rubber |
| Housing | Polypropylene | Polycarbonate |
| Fiber Chemical
Composition | Clearum GmbH
Polyethersulfone (PES),
Polyvinyl-pyrrolidone (PVP) | Polyamix™
Polyarylethersulfone (PAES),
Polyvinyl-pyrrolidone (PVP) |
| Fiber Internal
Diameter
(measured
average) (µm) | 200 (for all the models) | 215 |
| Parameter | Clearum™ HS
Dialyzer Family | PolyFlux H Dialyzer Family
Predicate device
(K030592) |
| Wall Thickness
(µm) | 40 (for all the models) | 50 |
| Number of fibers | HS 13: 8600
HS 15: 9900
HS 17: 11150
HS 20: 10400
HS 22: 11200 | Polyflux 140H: 7500
Polyflux 170H: 9300
Polyflux 210H: 12000 |
| Effective fiber
length
(mm) | HS 13: 246
HS 15: 246
HS 17: 246
HS 20: 308
HS 22: 308 | Polyflux 140H: 270
Polyflux 170H: 270
Polyflux 210H: 270 |
| Effective
membrane
surface area
(m2) | HS 13: 1.3
HS 15: 1.5
HS 17: 1.7
HS 20: 2.0
HS 22: 2.2 | Polyflux 140H: 1.4
Polyflux 170H: 1.7
Polyflux 210H: 2.1 |
| Configuration:
Outer housing
Height (mm) | HS 13: 306
HS 15: 306
HS 17: 306
HS 20: 366
HS 22: 366 | Not av. |
| Configuration:
Maximum
outside diameter
(mm) | 55 (for all the models) | Not av. |
| Parameter | Clearum™ HS
Dialyzer Family | PolyFlux H Dialyzer Family
Predicate device
(K030592) |
| Configuration:
Minimum inside
diameter (mm) | HS 13: 36.75
HS 15: 36.75
HS 17: 39.40
HS 20: 39.40
HS 22: 39.40 | Not av. |
| Configuration:
overall casing
geometry | Cylindrical body | Cylindrical body |
| Priming volume
(ml) | HS 13: 84
HS 15: 95
HS 17: 105
HS 20: 120
HS 22: 126 | Polyflux 140H: 94
Polyflux 170H: 115
Polyflux 210H: 125 |
| Sterilization
method | Moist heat with saturated
steam | Moist heat with saturated
steam |
Table 5-1: Comparison Clearum™ HS Dialyzers Family vs. PolyFlux H Dialyzers Family
6
7
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".
8
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.