NIPRO PUREFLUX-L HEMODIALYZER

K122952 · Nipro Medical Corporation · FJI · Dec 4, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K122952
• Device Name: NIPRO PUREFLUX-L HEMODIALYZER
• Applicant: Nipro Medical Corporation
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Dec 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

PUREFLUX-L hemodialyzer functions as artificial kidney for patients with renal failure or intoxication. Device consists of polyethersulfone fiber membrane. During treatment, patient blood circulates through blood compartment while dialysate solution flows countercurrent through dialysate compartment. Toxins and fluid transfer across membrane from blood to dialysate. Used in clinical settings; operated by trained healthcare professionals. Output is purified blood returned to patient; clinical decision-making relies on clearance of urea, creatinine, phosphate, and Vitamin B12. Benefits include removal of metabolic waste and toxins.

Clinical Evidence

Bench testing only. Studies evaluated analyte clearance (urea, creatinine, phosphate, Vitamin B12), ultrafiltration coefficient, and pressure drop. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Polyethersulfone fiber membrane; countercurrent flow hemodialyzer; available in various sizes based on membrane surface area; single-use; non-sterile (implied by standard manufacturing requirements).

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate; also indicated for treatment of patients intoxicated with poisons or drugs. Prescription use only; single use only.

Regulatory Classification

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.

Predicate Devices

• Baxter Xenium Hemodialyzer (K062079)
• Fresenius Hemoflow (K926005)
• Fresenius Optiflux (K043244)

Submission Summary (Full Text)

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# K122952
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# 510(k) Summary per 21 CFR 807.92

| Submitter | Nipro Medical Corporation<br>3150 NW 107th Avenue<br>Miami, FL 33172<br>FDA Establishment #: 1056186 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Jessica Oswald-McLeod<br>Phone: [phone]<br>Fax: [phone] | DEC 0 4 2013 |
| Date of Preparation | November 18, 2013 | |
| Device Trade Names | Nipro PUREFLUXTM-L Hemodialyzer | |
| Device Classification<br>Name | Conventional Dialyzer<br>per 21CFR 876.5820 | |
| Common Name | Hemodialyzer | |
| Substantial Equivalence | K062079 Baxter Xenium Hemodialyzer<br>K926005 Fresenius Hemoflow<br>K043244 Fresenius Optiflux | |
| Device Description | The PUREFLUXTM-L hemodialyzer is a medical<br>device used as an artificial kidney system for the<br>treatment of patients with renal failure. During<br>treatment. blood is circulated from the patient through<br>the hemodialyzer's blood compartment, while the<br>dialysate solution flows countercurrent through the<br>dialysate compartment. In this process, toxins and/or<br>fluid are transferred across the membrane from the<br>blood to the dialysate compartment.<br><br>The PUREFLUXTM-L hemodialyzer is composed of<br>polyethersulfone fiber and is available in various sizes,<br>which are differentiated by membrane surface area. | |

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| Intended Use | Hemodialysis with a PUREFLUXTM-L dialyzer is<br>indicated for patients with acute or chronic renal<br>failure when conservative therapy is judged to be<br>inadequate. It also may be indicated in the treatment<br>of patients intoxicated with poisons or drugs. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is for prescription use only. This product<br>is intended for single use only. The performance<br>properties of reused dialyzers have not been<br>established. |
| Technological Aspects | Both the PUREFLUX-L dialyzer and the Baxter<br>Xenium predicate dialyzer are composed of<br>polyethersulfone fiber. The hemodialyzer design and<br>membrane composition are equivalent between the<br>PUREFLUX-L dialyzer and the predicate device. |
| | Non-clinical studies included those for analyte<br>clearance (urea, creatinine, phosphate. Vitamin B12).<br>ultrafiltration coefficient and pressure drop. Results of<br>these studies establish substantial equivalence to<br>Fresenius hemodialyzer performance and<br>PUREFLUX-L results are included in product<br>labeling. |
| Conclusion | Testing performed on the PUREFLUXTM-L dialyzer<br>indicates that it is safe, effective and performs as well<br>as the predicate devices, when used in accordance with<br>the instructions for use. |

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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.

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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 [phone] or [phone] 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

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K122952

# 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'

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