(357 days)
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No
The summary describes a physical hemodialyzer device and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is described as an "artificial kidney system" for treating patients with renal failure, which directly addresses a health condition.
No
The device description clearly states it is an artificial kidney system for treatment, where toxins and fluid are transferred. It is a therapeutic device, not one for diagnosis.
No
The device description clearly describes a physical hemodialyzer, which is a hardware component used in dialysis. The performance studies also focus on physical characteristics and performance of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The description clearly states that the Nipro FB-U hemodialyzer is a medical device used as an "artificial kidney system." It circulates blood from the patient, through the device, and back to the patient. Its function is to remove toxins and fluid directly from the blood within the device, not to analyze a specimen taken from the body.
- Intended Use: The intended use is for hemodialysis in patients with renal failure or intoxication. This is a treatment process, not a diagnostic test performed on a specimen.
The device is a therapeutic medical device used for extracorporeal blood purification.
N/A
Intended Use / Indications for Use
Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into 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.
Mentions image processing
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Mentions AI, DNN, or ML
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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, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests submitted:
Dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop.
Other test items include: Transportation tests, biocompatibility, and shelf-life testing. These tests along with their associated results and conclusions are included in this submission.
Clinical tests:
This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro FB-U Dialyzer performs equivalent to the predicate device and is safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nipro Elisio-M (K131935), Baxter Exeltra (K030974)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2017
Nipro Medical Corporation Jessica Oswald-Mcleod Director, Quality and Regulatory 3150 NW 107th Avenue Doral, FL 33172
Re: K160444 Trade/Device Name: Nipro FB-U Hemodialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: January 5, 2017 Received: January 9, 2017
Dear Jessica Oswald-Mcleod:
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.
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.
1
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,
Charles Viviano -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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
Device Name Nipro FB-U Hemodialyzer
Indications for Use (Describe)
Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."FORM FDA 3881 (8/14)
K160444/S001
Page 1 of 1
(301) 443-6740 EF Page 5 of 20
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
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510(k) Summary: Nipro FB-U Hemodialyzer
| Applicant: | Nipro Medical Corporation
3150 NW 107th Ave.
Miami FL 33172
Tel: 305-599-7174 |
|-------------------------------------------------|----------------------------------------------------------------------------------------|
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod
Director, Quality Assurance & Regulatory Affairs |
| Date of summary preparation: | September 29, 2016 |
| Description of Device | |
| Trade Name: | NIPRO FB-U Hemodialyzer |
| Common Name: | Dialyzer |
| Classification Name: | dialyzer, high permeability with or without sealed dialysate system |
| Regulation Number: | 21 CFR part 876.5860 |
| Regulatory Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KDI |
| Legally marketed substantial equivalent device: | Nipro Elisio-M (K131935)
Baxter Exeltra (K030974) |
| Description of device: | |
The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into 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.
Indications for Use:
Hemodialysis with the Nipro FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
4
Comparison of technological characteristics:
The dialyzer is substantially equivalent to the predicate device in the following technological characteristics:
| Element of
| Comparison | Proposed | Predicate/s |
|---|---|---|
| Materials | Housing: Polypropylene | |
| Membrane: Cellulose Triacetate | Housing: | |
| Polypropylene/polycarbonate | ||
| Membrane: Polyether sulfone/ | ||
| Cellulose Triacetate | ||
| Design | Mechanical device consisting of a | |
| cylindrical rigid housing enclosing | ||
| hollow fibers | same | |
| Intended | ||
| Use | Intended to be used as part of an | |
| artificial kidney system for the | ||
| removal of toxins and excess water | ||
| from the blood | same | |
| Energy | ||
| Source | To be used with dialysis machines | |
| equipped with an ultrafiltration | ||
| controller or an accurate fluid | ||
| balancing system | same |
Non-clinical tests submitted:
Dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop.
Other test items include: Transportation tests, biocompatibility, and shelf-life testing. These tests along with their associated results and conclusions are included in this submission.
Clinical tests:
This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro FB-U Dialyzer performs equivalent to the predicate device and is safe and effective when used as intended.