OLPUR DIALYZER, MODEL HD 190

K050603 · Nephros, Inc. · KDI · Jun 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050603
• Device Name: OLPUR DIALYZER, MODEL HD 190
• Applicant: Nephros, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

Device Story

The OLpūr™ HD 190 Dialyzer is a sterile, single-use, high-permeability hemodialyzer. It functions by circulating blood through polyethersulfone (PES) hollow fibers while dialysate flows counter-currently on the outside of the fibers. Toxin removal and excess plasma water removal occur via diffusion (concentration gradients) and convection (transmembrane pressure differential). The device is designed for use with UF-controlled dialysis equipment in clinical settings. It features a polycarbonate casing, polyurethane potting, and silicone o-rings. The device benefits patients by facilitating the removal of uremic toxins and excess fluid in renal failure cases.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, sterility, pyrogenicity, shelf-life, and in vitro performance testing.

Technological Characteristics

High-flux hollow fiber hemodialyzer. Materials: polyethersulfone (PES) membranes, polyurethane potting compound, polycarbonate casing, silicone o-rings. Connectivity: standalone, compatible with UF-controlled dialysis equipment. Sterilization: sterile, non-pyrogenic.

Indications for Use

Indicated for hemodialysis and hemodiafiltration in patients with acute or chronic renal failure.

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

• Gambro Polyflux 21S Dialyzer (K982414)
• Asahi APS 21R Dialyzer (K001250)

Submission Summary (Full Text)

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# 510(k) Summary

#### Submitter

Nephros, Inc. 3960 Broadway New York, NY 10032 USA

#### Contact:

Nadia C. Greenidge Manager of Quality Assurance and Regulatory Affairs

Phone: [phone] Fax: [phone]

#### Date summary was prepared:

3/8/05

Name(s) of the device

OLpūr™ HD 190 Dialyzer

# Identification of predicate device(s)

The OLpur HD 190 Dialyzer is substantially equivalent to the following devices:

Gambro Polyflux 21S Dialyzer, 510(k) # K982414

Asahi APS 21R Dialyzer, 510(k) # K001250

# Description of the device

The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container.

The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the

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hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port.

As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.

#### Intended Use

The OLDur™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

#### Comparison of device characteristics to predicate

The OLour HD 190 Dialyzer is substantially equivalent to the Gambro Polyflux 21S, in that they are both sterile, single use, high permeability hemodialyzers with the same intended use, of similar construction, made with the same type of membrane material and comparable in regard to their performance characteristics.

The OLDur HD 190 Dialyzer is also substantially equivalent to the Asahi APS 21R in that they are both sterile, high permeability hemodialyzers with similar intended use, of similar construction and materials, made with the same type of membrane material and comparable in regard to their performance characteristics.

#### Nonclinical testing

OLpur HD 190 Dialyzer was subjected to biocompatibility, sterility, pyrogenicity, shelf life, and in vitro performance testing to demonstrate its equivalence to the predicate devices. All of the testing supported the substantial equivalence by the test results. Both the subject devices and the predicate devices are effective as High Flux Hollow Fiber Hemodialyzers. Based on this data it was concluded that OLpur HD 190 Dialyzer is substantially equivalent to the Gambro Polyflux 21S Dialyzer and the Asahi APS 21R Dialyzer,

# Conclusion

Based on the descriptive information and performance data provided in this premarket notification, it is concluded that the OLpur HD 190 Dialyzer is substantially equivalent to the predicate devices listed above.

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JUN 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nadia Greenidge Manager QA/RA Nephros, Inc. 3960 Broadway NEW YORK NY 10032

Re: K050603

Trade/Device Name: Nephrol OLpūr™ HD 190 Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 26, 2005 Received: May 27, 2005

Dear Ms. Greenidge:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your becalled in oppy probstantially equivalent (for the indications for use stated in above and have decemined the ad predicate devices marketed in interstate commerce prior to the enclosule) to tegarry mattered produced Device Amendments, or to devices that have been May 20, 1970, the clascinonic dato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordation warmatics approval application (PMA). You may, therefore, market the do not require approval or a premiation of the Act. The general controls provisions of the Act device, subjost to the gatedal controls provinces, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (300 additional controls. Existing major regulations affecting your Apployal), it may of subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA ucvice can be round in the concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please or advised that I DA 3 issualled of a sice complies with other requirements of the Act of all Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, modulity, but hot million is regultements as set forth in the quality systems (QS) (ZF CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter with cation. The FDA finding of substantial equivalence of your device to a legally promatics notificate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot produs neve the regulation on your responsibilities under the Act from the 60 : 77). " Ca may obtain ourers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K050603

Device Name: OLpūr™ HD 190 Dialyzer

Indications For Use:

The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin m Pollard

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number.