NXSTAGE EXPRESS FLUID WARMER

K140623 · Nxstage Medical, Inc. · FLA · Jun 16, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140623
• Device Name: NXSTAGE EXPRESS FLUID WARMER
• Applicant: Nxstage Medical, Inc.
• Product Code: FLA · Gastroenterology, Urology
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

Device Story

The NxStage Express Fluid Warmer is an electro-mechanical accessory for the NxStage System One Cycler. It warms dialysate prior to administration using an aluminum plate heated by electrical resistance. The system includes a single-use disposable set. It is operated in a clinical or home setting as part of the dialysis workflow. A microcontroller manages temperature control via thermistors, maintaining fluid between 31°C and 38°C. Audible and visual alarms trigger if temperatures reach 41°C. A secondary hardware safety circuit cuts power if the fluid temperature remains ≥41°C for more than 5 seconds. The device ensures dialysate is at an appropriate temperature for patient comfort and therapy efficacy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance, verification, and validation testing demonstrated that the device is adequately designed for its labeled indications and performs equivalently to the predicate device.

Technological Characteristics

Electro-mechanical warming unit; aluminum heating plate; electrical resistance heating; thermistor-based temperature control; microcontroller-based system; 100-120/230 VAC auto-ranging power; audible/visual alarms; secondary hardware safety circuit (power cutoff at ≥41°C for >5s); materials: PVC, ABS; single-use disposable set; gamma sterilization (SAL 10^-6).

Indications for Use

Indicated for use as an accessory to the NxStage System One Cycler to warm dialysate prior to administration. Not for use with blood or blood products.

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

• NxStage Travel Warmer (K071263)

Submission Summary (Full Text)

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JUN 1 6 2014

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 of Preparation

May 21, 2014

B. Submitter's Information: Name:

NxStage Medical, Inc.

Address:

Phone:

Fax:

350 Merrimack Street Lawrence, MA 01843

FDA Establishment Owner/Operator Number: Contact Person:

9045797

Mary Lou Stroumbos Director, Regulatory Affairs [phone]

[phone]

Manufacturer:

FDA Establishment Registration Number:

ﺎ

Sterilization Site:

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

3003464075

Steris Isomedix 1000 S. Sarah Place Ontario, CA 91761

510(k) Device Modification N×Stage Medical, Inc.

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#### B. Device Name:

| Trade Name: | NxStage Express Fluid Warmer |
|----------------------|---------------------------------------------------------------------------|
| Common/Usual Name: | Monitor, Temperature, Dialysis |
| Classification Name: | Hemodialysis System and Accessories<br>(876.5820)<br>Product Code: 78 FLA |

#### C. Substantial Equivalence/Predicate Devices:

The proposed NxStage Express Fluid Warmer is substantially equivalent to the NxStage Travel Warmer cleared through K071263 on August 24, 2007.

## D. Device Description/Indications for Use:

The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm dialysate prior to administration. The Express Fluid Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Express Fluid Warmer consists of an electro-mechanical warming unit and a single-use disposable.

#### Indications for use:

The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

#### E. 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 as shown in Table 1.

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| Table 1:<br>Device Technological Characteristics Comparison Table | | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Proposed Device<br>NxStage Express<br>Fluid Warmer | Predicate Device<br>NxStage Travel<br>Warmer<br>(K071263) |
| Indications for<br>Use | The NxStage Express<br>Fluid Warmer and<br>Express Fluid<br>Warmer Disposable<br>Set are accessories<br>to the NxStage<br>System One Cycler<br>used to warm<br>dialysate prior to<br>administration. | The NxStage Travel<br>Warmer and Travel<br>Warmer Disposable<br>set are accessories to<br>the NxStage System<br>One used to warm<br>dialysate prior to<br>administration |
| Heating<br>Method | Same | One Aluminum plate<br>heated by electrical<br>resistance |
| Fluid<br>Temperatures | Same | 31°C – 38°C<br>Adjustable |
| Temperature<br>Control | Same | Thermistors |
| Alarm Logic<br>a) Upper limit | Same | Alarms activate when<br>temperature reaches<br>41°C |
| b) Lower Limit | N/A | N/A |
| Alarms | Same | Audible and Visual |
| Table 1<br>Device Technological Characteristics Comparison Table | | |
| Parameter | Proposed Device<br>NxStage Express<br>Fluid Warmer | Predicate Device<br>NxStage Travel<br>Warmer<br>(K071263) |
| Secondary<br>Safety<br>Mechanism | Same | Hardware safety<br>circuit cuts the power<br>to the heater if the<br>fluid temperature is ≥<br>41°C for more than 5<br>seconds |
| Fluid Flow<br>Rates | Same | 0 - 200 ml/min |
| Control<br>System | Same | Microcontroller |
| Voltage | 100-120/230 VAC<br>Auto ranging | 110 -240 VAC |
| Power | Same | 400 VA |
| Frequency | Same | 50/60 Hz |
| Mounting<br>Method | Same | Top Mount with IV<br>pole support |
| Dimensions | Same | 13"W X 10"L X 1 ½<br>"H |
| Material | Same | PVC, ABS |
| Table 1<br>Device Technological Characteristics Comparison Table | | |
| Parameter | Proposed Device<br>NxStage Express<br>Fluid Warmer | Predicate Device<br>NxStage Travel<br>Warmer<br>(K071263) |
| Fluid warming<br>Method | Same | 5L Dialysate Bag with<br>connectors to MLA<br>and therapy fluid<br>outlet line |
| Method of air<br>removal | Same | Air entrapment in bag<br>– release not required<br>due to large bag<br>capacity |
| Priming<br>Volume | Same | 100 ml |
| Method of<br>Sterilization | Same | Gamma<br>SAL 10 $^{-6}$ |
| Pyrogenicity | Same | Non-pyrogenic |
| Packaging | Same | Packaged in<br>polyethylene bags |
| Single/ Multiple<br>Use | Same | Single Use only |

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# F. 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 NxStage Express Fluid Warmer to provide a basis of comparison to the predicate device. Results of the all testing have documented that the proposed NxStage Express Fluid Warmer is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

510(k) Device Modification NxStage Medical, Inc.

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

June 16, 2014

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

Re: K140623

> Trade/Device Name: NxStage Express Fluid Warmer Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FLA Dated: May 21, 2014 Received: May 22, 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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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 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): K140623

NxStage Express Fluid Warmer Device Name:

The NxStage Express Fluid Warmer and Express Indications for Use: Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

Prescription Use × (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)

Benjamin 2014.06.1

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