(263 days)
No
The summary describes a physical medical device (dialyzer) and its performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and functional properties.
Yes
The device is intended for hemodialysis, hemofiltration, and hemodiafiltration to treat conditions of acute or chronic renal failure, and in the treatment of intoxication, which are all therapeutic interventions.
No
Explanation: The device is a dialyzer used for treatment (hemodialysis, hemofiltration, hemodiafiltration), not for diagnosing conditions.
No
The device description clearly outlines physical components (cylindrical polycarbonate body, hollow fibers, polyurethane resin) and the performance studies focus on physical characteristics and mechanical integrity, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for hemodialysis, hemofiltration, and hemodiafiltration to treat renal failure and intoxication. These are treatments performed directly on the patient's blood outside the body, but the purpose is therapeutic, not diagnostic.
- Device Description: The description details a physical device (dialyzer) that filters blood. This aligns with a therapeutic device, not a device used to analyze samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the dialyzer (priming, pressure drop, ultrafiltration, sieving coefficient, mechanical integrity). These are relevant to the device's ability to perform its filtering function, not its ability to detect or measure substances in a sample for diagnosis.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to treat a condition by filtering blood, not to diagnose or monitor it through sample analysis.
N/A
Intended Use / Indications for Use
The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.
Product codes
KDI
Device Description
The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.
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
Prescription Use
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
NON CLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1. Sterility, pyrogenicity, EtO residual and package integrity testing were also conducted. The results of this testing met established specifications.
IN VITRO TEST RESULTS:
In vitro test methods were carried out where applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate devices and also compliant with safety and effectiveness requirements. The devices was aged and tested for: mechanical integrity, priming volume, pressure drop, ultrafiltration rate, sieving coefficient, hemolysis. The results of these tests met established specifications. For comparative purposes, the same testing, when applicable, was also conducted on the Xenium, Syntra and Polyflux 6H predicate devices. The shipping carton passed the basic testing and was still capable of providing adequate protection for further handling.
Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Xenium, Syntra and Polyflux6H apply to the RAPIDO BLS.
Device performance testing included: 1. Priming, 2. Blood side pressure drop, 3. Ultrafiltration rate, 4. Sieving coefficient, 5. Mechanical integrity.
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.”
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
BELLCO Srl % Barry Sall Principal Consultant PAREXEL Consulting, LLC 195 West Street Waltham, MA 02451
Re: K160558
Trade/Device Name: RAPIDO BLS HOLLOW-FIBRE DIALYZER RAPIDO BLS series: BLS 808; 812, 816, 819, 821 (high flux fiber) Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: October 14, 2016 Received: October 17, 2016
Dear Barry Sall:
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. 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
Page 2 - Barry Sall
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160558
Device Name
RAPIDO BLS HOLLOW-FIBRE DIALYZER RAPIDO BLS series: BLS 808; 812, 816, 819, 821 (high flux fiber).
Indications for Use (Describe)
The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.
| 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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3
Traditional 510(k) Premarket Notification
Bellco hemofilter/dialyzer
510(k) SUMMARY
SUBMITTER: Bellco Srl
Via Camurana 1
41037 Mirandola (MO), Italy
CONTACT PERSON: Giuseppe Tomasini
Phone: 011 39 0535 29323
Fax : 011 39 0535 29177
DATE PREPARED: November 18, 2016
DEVICE TRADE NAME: RAPIDO BLS HOLLOW-FIBRE DIALYZER
RAPIDO BLS series: BLS 808; 812, 816, 819, 821 (high flux fiber).
COMMON NAME: hemofilter/dialyzer
CLASSIFICATION NAME: High Permeability Hemodialysis System, 21 CFR 876.5860
PREDICATE DEVICE(S): Xenium Dialyzer, Models 190 and 210
(K062079) Syntra 120, 160 (K002210) and the Polyflux6H (K051520)
DEVICE DESCRIPTION:
The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.
INDICATION FOR USE:
The 800 series RAPIDO BLS HOLLOW-FIBRE DIALYZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF) and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment of patients intoxicated with poisons or drugs.
TECHNOLOGICAL CHARACTERISTICS:
4
Bellco Srl
Bellco hemofilter/dialyzer
The design, operating principles and control mechanism are exactly the same for the Rapido BLS and the Xenium Dialyzer, Model 190, and 210 (K062079) predicate devices. The basic function of all above mentioned dialyzers is similar.
They share the same design, patient population, performance characteristics, technological characteristics and manufacturing processes. The RAPIDO BLS has exactly the same materials, manufacturing processes and biocompatibility of mentioned predicate devices. The basic function of all the above mentioned devices is the same for the indication in hemofiltration: the removal of excess fluid from patient's blood.
NON CLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1. Sterility, pyrogenicity, EtO residual and package integrity testing were also conducted. The results of this testing met established specifications.
IN VITROTEST RESULTS:
In vitro test methods were carried out where applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate devices and also compliant with safety and effectiveness requirements. The devices was aged and tested for: mechanical integrity, priming volume, pressure drop, ultrafiltration rate, sieving coefficient, hemolysis. The results of these tests met established specifications. For comparative purposes, the same testing, when applicable, was also conducted on the Xenium, Syntra and Polyflux 6H predicate devices. The shipping carton passed the basic testing and was still capable of providing adequate protection for further handling.
Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Xenium, Syntra and Polyflux6H apply to the RAPIDO BLS.
Device performance testing included:
-
- Priming
-
- Blood side pressure drop
-
- Ultrafiltration rate
-
- Sieving coefficient
-
- Mechanical integrity
5
Bellco hemofilter/dialyzer
CONCLUSIONS:
The results on in vitro studies demonstrate the RAPIDO BLS performs in a manner substantially equivalent to the predicate devices. Biocompatibility studies demonstrate that the device is biocompatible according to its intended use. Additional testing has also demonstrates the effectiveness of production techniques to assure that the dialyzer is sterile and non-pyrogenic.