(30 days)
No
The device description and performance studies focus on the physical components and filtration capabilities of a hemodialyzer, with no mention of AI or ML.
Yes
The device is described as a dialyzer intended for patients with renal failure requiring hemodialysis, and it functions by transferring toxins and fluid from the blood, which is a therapeutic action to treat a medical condition.
No
Explanation: The device, a dialyzer, is used for hemodialysis to remove toxins and fluid from the blood in patients with renal failure. This is a treatment process rather than a diagnostic one.
No
The device description clearly states it is a dialyzer consisting of a physical body, hollow fibers, and resin, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Clearum™ HS 17 is a dialyzer. Its function is to filter blood outside the body to remove waste products and excess fluid in patients with kidney failure. This is a therapeutic process, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "acute or chronic renal failure patients requiring hemodialysis." This describes a treatment, not a diagnostic test.
- Device Description: The description focuses on the physical components and how it facilitates the transfer of substances across a membrane, which is the mechanism of dialysis.
- Performance Studies: The performance studies listed (Priming Volume, Pressure Drop, Ultrafiltration Coefficient, Sieving Coefficient, Clearance, Hemo-compatibility) are all related to the physical and functional performance of the dialyzer in filtering blood, not to analyzing a sample for diagnostic purposes.
In summary, the Clearum™ HS 17 is a therapeutic device used in the treatment of kidney failure, not a diagnostic device used to analyze samples for diagnosis.
N/A
Intended Use / Indications for Use
The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis.
Product codes
KDI
Device Description
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 modified 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.
Identical 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.
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
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
- 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)
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.
Key Metrics
Not Found
Predicate Device(s)
Clearum HS 17 (K193542)
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.”
0
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
1
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
2
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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3
510(k) SUMMARY
| SUBMITTER: | Bellco S.r.l.
Via Camurana, 1
41037 Mirandola (MO) Italy |
|----------------------|-------------------------------------------------------------------------------|
| CONTACT PERSON: | Michele Gust
Telephone: 763-505-4016
E-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 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.
INDICATION FOR USE:
The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis.
4
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.
5
Comparison of Modified Clearum™ HS 17 vs. Predicate Clearum™ HS 17
| Parameters | Clearum ™ HS 17
Predicate device
(K193542) | Clearum ™ HS 17
Modified device |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Intended use | The Clearum™ HS 17 is intended
for use in acute or chronic renal
failure patients requiring
hemodialysis | Same |
| Fiber Chemical
Composition | Clearum GmbH
Polyethersulfone (PES), Polyvinyl-
pryrrolidone (PVP) | Same |
| Potting Resin for
Fibers | Polyurethane | Same |
| Dialysate port caps | Polypropylene | Same |
| Blood port caps | Polypropylene | Same |
| Headers | Polypropylene | Same |
| O-rings | Silicone Rubber | Same |
| Housing | Polypropylene | Same |
| Fiber Internal
Diameter (measured
average) | 200 μm | Same |
| Fiber undulation
amplitude (mm) | 0.5 | 0.6 |
| Fiber undulation
wavelength (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 outside
diameter (mm) | 55 | Same |
| Minimum inside
diameter (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 of
Sterilization | Moist heat with saturated steam | Same |
| Manufacturer | Bellco S.r.l. | Same |
6
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.