NXSTAGE 1.6M2 DIALYZER

K131050 · Nxstage Medical, Inc. · KDI · Dec 27, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131050
• Device Name: NXSTAGE 1.6M2 DIALYZER
• Applicant: Nxstage Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Dec 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.

Device Story

Single-use, high-flux hollow-fiber dialyzer; removes solutes from blood via diffusion or convection. Device connects to standard blood tubing sets via ISO8637 connectors. Used in clinical settings by healthcare professionals to treat renal failure or fluid overload. Output is filtered blood returned to patient; clinical benefit is removal of waste products and excess fluid. Device is a passive component of a larger hemodialysis system.

Clinical Evidence

Bench testing only. Performance, verification, and validation testing conducted per FDA guidance for Conventional and High Permeability Hemodialyzers (1998). Testing confirmed device meets predetermined acceptance criteria for design and performance.

Technological Characteristics

High-flux hollow-fiber dialyzer; Polyethersulfone (Membrana Purema H) membrane; 1.6 m² surface area; 200 μm fiber ID; 30 μm fiber wall thickness; 91 ml priming volume; 500 mmHg max TMP; ISO8637 DIN blood/dialysate connectors; gamma sterilization.

Indications for Use

Indicated for patients with acute or chronic renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration. No known contraindications.

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

• NxStage Cartridge Express (K061837)
• NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer (K113023)
• Baxter Xenium Dialyzer (K062079)

Submission Summary (Full Text)

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K131050

#### NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92

| A. Date | April 12, 2013 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| B. Submitter's Information:<br>Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack Street<br>Lawrence, MA 01843<br>United States |
| FDA Establishment<br>Owner/Operator Number: | 9045797 |
| Contact Person: | Nnamdi Nwachukwu<br>Regulatory Affairs Engineer |
| Phone: | [phone] |
| Fax: | [phone] |
| Manufacturer: | NxStage GmbH & Co. KG<br>Anna-Vandenhoeck-Ring 24<br>37081 Goettingen<br>Bundesrepublik Deutschland |
| FDA Establishment<br>Registration Number: | An application for an establishment registration<br>number will be submitted prior to<br>commercialization. |
| Sterilization Site: | Steris Isomedix<br>1000 S. Sarah Place<br>Ontario, CA 91761 |
| C. Device Name:<br>Trade/Proprietary<br>Name: | NxStage® 1.6m2 Dialyzer |
| Common/Usual Name: | Dialyzer, High Permeability |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 21 CFR 876.5860 |
| Product Code : | 78 KDI - Dialyzer, High Permeability with or Without |

510(k) Premarket Notification NxStage Medical, Inc.

, ... .......... 2014-01-28

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#### NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission

| | Sealed Dialysis System | | |
|------------------|---------------------------------------------|--|--|
| Submission Type: | 510(k) | | |
| Device Class: | II | | |
| Device Panel: | Gastroenterology-Urology (GU)/ Gastro-Renal | | |
| | (GRDB) | | |

#### D. Predicate Devices:

NxStage Cartridge Express K061837 K113023 NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer K062079 Baxter Xenium Dialyzer

#### E. Substantial Equivalence:

The proposed NxStage® 1.6m² Dialyzer is substantially equivalent in design, function and operation to the identified predicates.

#### F. Device Description/Indications for Use:

The proposed device is a single use high flux (permeability) hollow-fiber dialyzer.

Indications for use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.

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#### G. Technological Characteristics:

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The proposed device has the same technological characteristics and is similar in design and configuration as the predicate devices.

| Parameter | NxStage 1.6m2<br>Dialyzer<br>Subject of this<br>510(k) | Predicate Device<br>NxStage Cartridge<br>Express<br>K061837 | Predicate Device<br>Streamline Airless<br>System Set with<br>Pre-attached<br>dialyzer<br>K113023 | Predicate Device<br>Baxter Xenium<br>Dialyzer 150<br>K062079 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The dialyzer is<br>indicated for the<br>treatment of acute<br>and chronic renal<br>failure or fluid<br>overload using<br>hemofiltration,<br>hemodialysis,<br>and/or<br>ultrafiltration.<br>There are no<br>known<br>contraindications. | The NxStage System<br>One is indicated for<br>the treatment of<br>acute and chronic<br>renal failure or fluid<br>overload using<br>hemofiltration,<br>hemodialysis, and/or<br>ultrafiltration, in an<br>acute or chronic care<br>facility. The System is<br>also indicated for<br>hemodialysis with or<br>without ultrafiltration<br>in the home. | The single use blood<br>tubing set with pre-<br>attached dialyzer is<br>indicated for use with<br>the B. Braun Dialog<br>Series hemodialysis<br>systems for the<br>treatment of acute<br>and chronic renal<br>failure. There are no<br>known<br>contraindications. | Hemodialysis with<br>Xenium dialyzers is<br>indicated for<br>patients with acute<br>or chronic renal<br>failure when<br>conservative<br>therapy is judged to<br>be inadequate. It<br>also may be<br>indicated in the<br>treatment of<br>patients intoxicated<br>with poisons or<br>drugs. |
| Principle of<br>Operation | Removal of<br>solutes via<br>diffusion or<br>convection | Removal of solutes<br>via diffusion or<br>convection | Removal of solutes<br>via diffusion or<br>convection | Removal of solutes<br>via diffusion or<br>convection |
| Product<br>Configuration | Single use<br>disposable<br>dialyzer with<br>standard dialysis<br>connectors that<br>are connected to<br>blood tubing sets<br>prior to use. | Single use<br>disposable consisting<br>of a pre-attached<br>dialyzer and tubing<br>set for use on the<br>NxStage System<br>One. | Single use<br>disposable consisting<br>of a pre-attached<br>dialyzer and tubing<br>set for use on the B.<br>Braun Dialog Series<br>hemodialysis<br>systems. | Single use<br>disposable dialyzer<br>with standard<br>dialysis connectors<br>that are connected<br>to blood tubing sets<br>prior to use. |
| How<br>Supplied | Individually<br>packaged dialyzer. | Dialyzer pre-<br>connected to<br>disposable NxStage<br>Cartridge tubing set. | Dialyzer pre-<br>connected to<br>disposable B. Braun<br>tubing set. | Individually<br>packaged dialyzer. |
| Device Comparison Table | | | | |
| Parameter | NxStage 1.6m²<br>Dialyzer | Predicate Device<br>NxStage<br>Cartridge<br>Express<br>(K061837) | Predicate Device<br>Streamline Airless<br>System Set with<br>Pre-attached<br>dialyzer<br>(K113023) | Predicate Device<br>Baxter Xenium<br>Dialyzer 150<br>(K062079) |
| Connectors | Standard<br>ISO8637 DIN<br>Blood and<br>Dialysate Hansen<br>Connectors | Blood and<br>dialysate lines pre-<br>bonded | Blood lines pre-<br>bonded, Standard<br>ISO8637 Dialysate<br>Hansen Connector | Standard ISO8637 DIN<br>Blood and Dialysate<br>Hansen Connector |
| Sterilization<br>Method | Gamma | Gamma | Gamma | Gamma |
| Fibers | Polyethersulfone<br>Membrana<br>Purema H | Polyethersulfone<br>Membrana<br>Purema H | Polyethersulfone<br>Membrana<br>Purema H | Polyethersulfone<br>Membrana<br>Purema H |
| Fiber ID | 200 μm | 200 μm | 200 μm | 200 μm |
| Fiber Wall<br>Thickness | 30 μm | 30 μm | 30 μm | 30 μm |
| Effective<br>Surface<br>Area | 1.6 m² | 1.6 m² | 1.6 m² | 1.5 m² |
| Priming<br>Volume | 91 ml | 91 ml | 91 ml | 91 ml |
| Max. TMP | 500 mmHg | 500 mmHg | 500 mmHg | 500 mmHg |

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#### H. Summary of Non-Clinical Test/Performance Testing - Bench

The information and data provided in this submission clearly describe the proposed device and demonstrate that the device is adequately designed for the labeled indications for use and is substantially equivalent to the predicate devices. Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

December 27, 2013

NxStage Medical, Inc. Laura F. Plath Regulatory Affairs Manager 350 Merrimack Street Lawrence, MA 01843

Re: K131050

Trade/Device Name: NxStage® 1.6m2 Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: December 6, 2013 Received: December 9, 2013

Dear Laura F. Plath,

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. 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

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 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 -S

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 (if known): K131050

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NxStage® 1.6m² Dialyzer Device Name:

Indications for Use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.

X Prescription Use _ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Benjamin R. Fisher -S 2013.12.30 09:55:53 -05'00'