NXSTAGE SYSTEM ONE

K140526 · Nxstage Medical, Inc. · KDI · May 19, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140526
• Device Name: NXSTAGE SYSTEM ONE
• Applicant: Nxstage Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Device Story

NxStage System One is an electromechanical hemodialysis system for acute/chronic renal failure or fluid overload. System comprises a cycler control unit and a sterile, single-use extracorporeal blood/fluid management cartridge. Operates via 4 peristaltic pumps, 10 pinch clamps (solenoid/cam-driven), 3 ultrasonic air/fluid detectors, 1 optical blood leak detector, 5 electronic pressure transducers, and 1 temperature sensor. Used in clinical facilities or home settings; operated by trained/qualified personnel under physician prescription. System monitors blood flow, dialysate flow, ultrafiltration, and pressures (transmembrane, venous, effluent). Output provides real-time therapy control and monitoring; alerts clinicians/users to deviations (e.g., air bubbles, blood leaks, pressure limits). Benefits include flexible treatment settings (home vs. facility) and automated fluid management to support renal replacement therapy.

Clinical Evidence

Bench testing only. Performance verification and validation testing characterized the device, including flow rate accuracy, pressure monitoring, and alarm sensitivity (air/fluid and blood leak detection). Results demonstrated that the device meets all predetermined acceptance criteria and performs equivalently to the predicate.

Technological Characteristics

Electromechanical hemodialysis system. Components: 4 peristaltic pumps, 10 pinch clamps, 3 ultrasonic air/fluid detectors, 1 optical blood leak detector, 5 electronic pressure transducers, 1 temperature sensor. Connectivity: Standalone. Software: Version 4.9. Sterilization: Provided via sterile single-use cartridge. Flow rates: 10-600 ml/min blood flow; 0-18000 ml/hr dialysate/fluid flow.

Indications for Use

Indicated for patients with acute or chronic renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration. Treatment must be physician-prescribed and observed by a trained, competent individual in acute/chronic care facilities or the home.

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 System One (K122051)

Reference Devices

• PureFlow SL (K043436)
• PureFlow SL (K060296)
• PureFlow SL (K090919)
• PureFlow SL (K111174)

Submission Summary (Full Text)

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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 Prepared: | February 28, 2014 |
|-----------------------------|-----------------------|
| B. Submitter's Information: | |
| Name: | NxStage Medical, Inc. |

Address:

IC.

350 Merrimack Street Lawrence, MA 01843

FDA Establishment Owner/Operator Number: Contact Person:

9045797

Mary Lou Stroumbos Director, Regulatory Affairs

Phone: Fax:

Manufacturer:

NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843

FDA Establishment Registration Number:

Sterilization Site:

3003464075

[phone]

[phone]

Steris Isomedix (NxStage Cartridge Express) 1000 S. Sarah Place Ontario, CA 91761

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- C. Device Name:
Trade/Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Classification: Device Panel:

NxStage System

Hemodialysis System High Permeability Hemodialysis System 876.5860 78 KDI Class II Gastroenterology/Urology

# D. Substantial Equivalence:

The NxStage System One has the same intended use and utilizes the same fundamental technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate devices as cleared through K122051 (April 23, 2013) and was found to be substantially equivalent.

# E. Device Description/Indications for Use:

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cvcler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.

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### NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification

### Indications for use:

The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home

All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

### F. Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The · proposed device is designed with similar software, components and features also used in the predicate device.

| Table 1<br>Device Technological Characteristics Comparison Table | | |
|------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------|
| Parameter | Proposed Device<br>NxStage System One | Predicate Device<br>NxStage System One<br>(K122051) |
| Intended Use<br>Hemodialysis | Yes | Yes |
| Hemofiltration<br>Ultrafiltration | Yes<br>Yes | Yes<br>Yes |
| Technology / Components: | | |
| Pumps | Same | 4 peristaltic pumps |
| Valves (clamps) | Same | 2 solenoid actuated pinch clamps<br>8 cam driven pinch clamps |
| Air / fluid detectors | Same | 3 ultrasonic air/ fluid detectors |
| Blood leak detector | Same | 1 optical blood leak detector |
| Pressure transducers | Same | 5 electronic pressure transducers |
| Temperature sensors | Same | 1 electronic temperature sensor |

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.

# NxStage Medical, Inc.

| Table 1<br>Device Technological Characteristics Comparison Table | | | | | | | | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Parameter | Proposed Device<br>NxStage System One | Predicate Device<br>NxStage System One<br>(K122051) | | | | | | |
| Flow Rates:<br>Blood<br>Prescription Fluid /Dialysate<br>Flow<br>Ultrafiltration | Same<br>0-18000 ml/hr (NX1000-4)<br>Same | 10-600 ml/min<br>0-18000 ml/hr (NX1000-3)<br>0-2400 ml/hr | | | | | | |
| Transmembrane Pressure<br>Monitoring Specification | Same | Yes | | | | | | |
| Venous Pressure Monitor | Same | 0 to 400 mmHg | | | | | | |
| Effluent fluid Pressure Monitor | Same | 0 to 500 mmHg | | | | | | |
| Air Detector | Same | Reduction of detector signal lasting 6 ms<br>minimum (Approximates a 60 micro liter<br>bubble at 400 mmHg venous pressure and<br>600 ml/min blood flow) | | | | | | |
| Blood Leak Detector | 15% reduction in detector signal<br>lasting 20 seconds minimum.<br>Signal reduction % based on a 0.35<br>ml/min leak rate of 32 Hct blood. | 15% reduction in detector signal lasting 20<br>seconds minimum. Signal reduction %<br>based on a 0.45 ml/min leak rate of 32 Hct<br>blood. | | | | | | |
| Effluent Volume Accuracy | Same | Greater of 300 ml/ 12 hr or 3% of exchange<br>volume (For software versions 4.7 and<br>below)<br>For software versions 4.8 and higher:<br>Therapy<br>Fluid Flow<br>Rate L/hr) Specification greater of > 3 ±100 ml/hr*<br>+ 5% UF*<br>or ≤ 3 ± 25 ml/hr* *Representing 95/90 tolerance interval<br>established under controlled laboratory<br>testing conditions. | | | | | | |
| IV Prescription Fluid | Same | Off-line, sterile- physician prescribed,<br>indicated for infusion | | | | | | |
| Dialysate | Same | Dialysate available as pre-packaged pre-<br>mixed sterile fluids or via the PureFlow SL<br>(K043436 K060296, K090919 & K111174) | | | | | | |
| Compatible Blood Tubing Set | Same | NxStage Standard Cartridge | | | | | | |
| Software | Software version 4.9 | Software version 4.8 | | | | | | |

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#### NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification

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

NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.

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Image /page/5/Picture/1 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 that resemble a human figure.

#### Public Health Service

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

May 19, 2014

NxStage Medical, Inc. Mary Lou Stroumbos Director, Regulatory Affairs 350 Merrimack Street Lawrence, MA 01843

Re: K140526

> Trade/Device Name: NxStage® System One™ Regulation Number: 21 CFR& 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 4, 2014 Received: March 5, 2014

Dear Mary Lou Stroumbos,

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 - Mary Lou Stroumbos

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 (OS) 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,

Image /page/6/Picture/6 description: The image shows the text "Benjamin Fisher -S". The words are written in a simple, bold font. The text is arranged horizontally, with "Benjamin" on the left, followed by "Fisher" and then "-S" on the right.

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): K140526

NxStage® System One TM Device Name:

The NxStage System One is indicated for the Indications for Use: treatment of acute and chronic renal failure, or fluid overload using hemofitration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

> The NxStage System One is also indicated for hemodialysis with our without ultrafiltration in the home.

All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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 Fisher -S
2014.05.19 13:21:21 -04'00'