(435 days)
No
The document describes a standard hemodialyzer and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat patients with acute or chronic renal failure and can also be used to treat patients intoxicated with poisons or drugs, which are therapeutic interventions.
No
Explanation: The device description clearly states it is a medical device used as an artificial kidney system for treatment, not for diagnosis. It performs a therapeutic function (removing toxins and/or fluid) rather than identifying a medical condition.
No
The device description clearly describes a physical hemodialyzer composed of polyethersulfone fiber, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a process of hemodialysis, which is a treatment for renal failure. This involves circulating blood through a device to remove toxins and excess fluid. This is a therapeutic procedure performed on the patient's body, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical components and function of the hemodialyzer as an "artificial kidney system." This reinforces its role in treatment rather than diagnosis.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (like blood, urine, etc.) to provide diagnostic information. It focuses on the physical process of filtration and fluid removal.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's purpose is to treat a condition by filtering blood, not to diagnose or monitor it through sample analysis.
N/A
Intended Use / Indications for Use
Hemodialysis with a PUREFLUXTM-L dialyzer 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.
The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.
Product codes
FJI
Device Description
The PUREFLUXTM-L hemodialyzer is a medical device used as an artificial kidney system for the treatment of patients with renal failure. 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 PUREFLUXTM-L hemodialyzer is composed of polyethersulfone fiber and is available in various sizes, which are differentiated by membrane surface area.
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
The device is for prescription use only.
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 studies included those for analyte clearance (urea, creatinine, phosphate. Vitamin B12). ultrafiltration coefficient and pressure drop. Results of these studies establish substantial equivalence to Fresenius hemodialyzer performance and PUREFLUX-L results are included in product labeling.
Testing performed on the PUREFLUXTM-L dialyzer indicates that it is safe, effective and performs as well as the predicate devices, when used in accordance with the instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062079 Baxter Xenium Hemodialyzer, K926005 Fresenius Hemoflow, K043244 Fresenius Optiflux
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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K122952
Page 1 of 2
・
510(k) Summary per 21 CFR 807.92
| Submitter | Nipro Medical Corporation
3150 NW 107th Avenue
Miami, FL 33172
FDA Establishment #: 1056186 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Jessica Oswald-McLeod
Phone: 305-599-7174
Fax: 305-592-4621 | DEC 0 4 2013 |
| Date of Preparation | November 18, 2013 | |
| Device Trade Names | Nipro PUREFLUXTM-L Hemodialyzer | |
| Device Classification
Name | Conventional Dialyzer
per 21CFR 876.5820 | |
| Common Name | Hemodialyzer | |
| Substantial Equivalence | K062079 Baxter Xenium Hemodialyzer
K926005 Fresenius Hemoflow
K043244 Fresenius Optiflux | |
| Device Description | The PUREFLUXTM-L hemodialyzer is a medical
device used as an artificial kidney system for the
treatment of patients with renal failure. 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 PUREFLUXTM-L hemodialyzer is composed of
polyethersulfone fiber and is available in various sizes,
which are differentiated by membrane surface area. | |
1
ﺎ ﺗﻌ
| Intended Use | Hemodialysis with a PUREFLUXTM-L dialyzer 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. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is for prescription use only. This product
is intended for single use only. The performance
properties of reused dialyzers have not been
established. |
| Technological Aspects | Both the PUREFLUX-L dialyzer and the Baxter
Xenium predicate dialyzer are composed of
polyethersulfone fiber. The hemodialyzer design and
membrane composition are equivalent between the
PUREFLUX-L dialyzer and the predicate device. |
| | Non-clinical studies included those for analyte
clearance (urea, creatinine, phosphate. Vitamin B12).
ultrafiltration coefficient and pressure drop. Results of
these studies establish substantial equivalence to
Fresenius hemodialyzer performance and
PUREFLUX-L results are included in product
labeling. |
| Conclusion | Testing performed on the PUREFLUXTM-L dialyzer
indicates that it is safe, effective and performs as well
as the predicate devices, when used in accordance with
the instructions for use. |
.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling a person with outstretched arms, above three wavy lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2013
Nipro Medical Corporation % Carolyn K. George Consultant Quality System Engineering 3150 NW 107th Avenue Miami, FL 33172
K122952 Re:
Trade/Device Name: PUREFLUX™-L Hemodialyzers Regulation Number: 21 CFR§ 876.5820 Regulation. Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJI Dated: November 18, 2013 Received: November 19, 2013
Dear Carolyn K. George,
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. Iisting 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.
3
Page 2 - Carolyn K. George
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name: PUREFLUX™-L Hemodialyzers
Indications for Use:
Hemodialysis with a PUREFLUXTM-L 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.
The device is for prescription use only.
This product is intended for single use only. The performance properties of reused dialyzers have not been established.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner 2013.12.04 15:48:33 -05'00'