PUREFLUX-H HEMODIALYZER

K122343 · Nipro Medical Corporation · KDI · May 7, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K122343
• Device Name: PUREFLUX-H HEMODIALYZER
• Applicant: Nipro Medical Corporation
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hemodialysis with PUREFLUX-H 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.

Device Story

PUREFLUX-H is a high-permeability hemodialyzer acting as an artificial kidney. During treatment, blood circulates through the device's blood compartment while dialysate flows countercurrent through the dialysate compartment. Toxins and fluids transfer across a polyethersulfone fiber membrane from blood to dialysate. Used in clinical settings for patients with renal failure or intoxication; operated by trained healthcare professionals. Output is the removal of metabolic waste and excess fluid from patient blood. Benefits include restoration of fluid/electrolyte balance and toxin removal.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including analyte clearance (urea, creatinine, phosphate, Vitamin B12, myoglobin), ultrafiltration coefficient, and pressure drop measurements.

Technological Characteristics

High permeability hemodialyzer; polyethersulfone fiber membrane; six sizes based on membrane surface area; countercurrent flow principle; single-use; prescription only.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis when conservative therapy is inadequate, and for patients intoxicated with poisons or drugs.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Baxter Xenium Hemodialyzer (K062079)

Submission Summary (Full Text)

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7 TTACHMENT

MAY 0 7 2013

K122343 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

High permeability hemodialysis system

· K062079 Baxter Xenium Hemodialyzer

Contact Person

Jessica Oswald-McLeod Phone: [phone] Fax: [phone]

Date of Preparation

Nipro PUREFLUX™-H Hemodialyzer Device Trade Name

September 16, 2012

per 21CFR 876.5860

Device Classification Name

Common Name

Hemodialyzer

Substantial Equivalence

Device Description

The PUREFLUX-H 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 PUREFLUX-H dialyzers are composed of polyethersulfone fiber and are available in six sizes, which differentiate by membrane surface area.

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Intended Use

Hemodialysis with PUREFLUX-H 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

Conclusion

Both the PUREFLUX-H dialyzers and the predicate dialyzer are composed of polyethersulfone fiber. The dialyzer design and membrane composition are identical between the PUREFLUX-H dialyzers and the predicate devices.

Non-clinical studies included those for analyte clearance (urea, creatinine, phosphate, Vitamin B12 myoglobin), ultrafiltration coefficient and pressure drop. Results of these studies establish substantial equivalence and are included in product labeling.

Testing performed on the PUREFLUX-H dialyzer indicates that it is safe, effective and performs as well as the predicate device. when used in accordance with the instructions for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a person embracing or being embraced, conveying a sense of care and support. The logo is in black and white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2013

Nipro Medical Corporation % Ms. Carolyn K. George Consultant Quality System Engineering 6695 River Crest Point SUWANEE GA 30024

Re: K122343

Trade/Device Name: PUREFLUX™-H Hemodialyzers Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 17, 2013 Received: April 17, 2013

Dear Ms. 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, 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.

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Page 2 - Ms. 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,

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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# Indications for Use

#### 510(k) Number: K122343

Device Name: PUREFLUX™-H Hemodialyzers

#### Indications for Use:

Hemodialysis with a PUREFLUX-H 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)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

# Benjamin R=Eish 2013.05.07 13 36 24 04'00'

K122343