NXSTAGE CONNECTED HEALTH SYSTEM

K131739 · Nxstage Medical, Inc. · FKP · Oct 10, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131739
• Device Name: NXSTAGE CONNECTED HEALTH SYSTEM
• Applicant: Nxstage Medical, Inc.
• Product Code: FKP · Gastroenterology, Urology
• Decision Date: Oct 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center. The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging. The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

Device Story

System collects, stores, and transmits patient dialysis data (flowsheet, vitals, BP, weight) from home/remote settings to healthcare facilities. Inputs include data from NxStage System One and peripheral monitors (BP, scale). Data transmitted via secure Wi-Fi/broadband to server software for clinician review. Provides trending, treatment status, and messaging. Used by patients at home and clinicians at facilities. Does not control dialysis cycler; not for emergency use. Benefits include remote monitoring and improved data accessibility for clinical decision-making.

Clinical Evidence

Bench testing only. Performance, verification, and validation testing conducted, including software design review and usability testing. All predetermined acceptance criteria were met.

Technological Characteristics

Proprietary software; secure Wi-Fi communication with peripheral devices; secure broadband internet connection to remote server; data repository and communication link architecture.

Indications for Use

Indicated for chronic hemodialysis patients for remote collection, storage, and transmission of dialysis-related data (flowsheet, vitals, BP, weight) to healthcare practitioners. Used with NxStage System One and peripheral monitoring devices. Not for time-sensitive alarms or emergency care.

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

• BL Healthcare TCx-I-DV Remote Care Management System (K093379)

Submission Summary (Full Text)

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

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 | September 9, 2013 |
|-----------------------------------|-------------------------------------------------------------|
| B. Submitter's Information: Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack Street<br>Lawrence, MA 01843<br>United States |
| FDA Establishment | 9045797 |

**OCT 10 2013**

Phone:

Fax:

Number:

Mary Lou Stroumbos Regulatory Affairs Manager [phone]

[phone]

Manufacturer:

Owner/Operator

Contact Person:

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

FDA Establishment Registration Number: 3003464075

Sterilization Site:

Not Applicable

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## NxStage Medical. Inc. NxStage Connected Health System 510(k) Premarket Notification

## C. Device Name:

| Trade/Proprietary Name: | NxStage Connected Health System |
|-------------------------|---------------------------------------------------------------|
| Common/Usual Name: | Accessory to Hemodialysis Delivery<br>System; e-Health Device |
| Classification Name: | Hemodialysis System and Accessories |
| Regulation Number: | 21 CFR 876.5820 |
| Product Code: | 78 FKP - System, dialysate delivery, single<br>patient |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-<br>Renal (GRDB) |

## C. Predicate Devices:

BL Healthcare TCx-I-DV Remote Care Management System K093379

## D. Substantial Equivalence:

The NxStage Connected Health device is substantially equivalent in design, function and operation to the identified predicate.

## E. Device Description/Indications for Use:

## Device Description:

The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis data from the patients on the completion of their dialysis treatment and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.

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

## Indications for Use:

The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.

The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.

Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

## F. Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as the predicate device. Refer to Table 1 for a device comparison.

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#

| INDICATIONS FOR<br>USE | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The NxStage Connected Health System is for<br>use by chronic hemodialysis patients remotely<br>in combination with the NxStage System One<br>and a variety of devices such as blood<br>pressure monitor and weight scale upon the<br>prescription of a licensed physician or<br>healthcare practitioner. The Connected Health<br>System serves as the data repository and<br>communication link to the server software<br>which is utilized by the healthcare facility. The<br>healthcare facility may include the physician<br>or licensed healthcare practitioner, other<br>clinicians, or a disease management center. | The TCx-I-DV Remote Care Management<br>System is for use by patients remotely in<br>combination with a variety of monitoring<br>devices such as blood pressure monitor.<br>NxStage System One Hemodialysis System<br>and weight scale upon the prescription of a<br>licensed physician or healthcare provider. The<br>TCx-I-DV Remote Care management System<br>serves as the communication link between the<br>compatible devices and the server software at<br>a compatible healthcare facility. The<br>healthcare facility may include healthcare<br>provider, other caregivers, or a disease<br>management center. | |
| The purpose of the system is to collect,<br>accumulate, store and transmit medical<br>information such as flowsheet data, vital<br>signs, blood pressure, weight and dialysis<br>treatment and transmit these results to their<br>healthcare practitioner at another facility. The<br>system also provides online labeling,<br>treatment status, trending and supports<br>education and messaging. | The purpose of the system is to collect and<br>transmit medical information such as weight,<br>blood pressure and pulse rate, and dialysis<br>date from the patients on completion of their<br>testing of their testing and transmit these<br>results to their healthcare provider at another<br>facility. | |
| INDICATIONS FOR<br>USE CONT. | The device is not intended to provide time<br>sensitive data or alarms and does not control<br>the System One Cycler. This system may not<br>be used as a substitute for direct medical<br>intervention or emergency care. | The system is installed by or with support<br>from trained professionals. |
| | Interpretation of the information collected and<br>transmitted requires clinical judgment by an<br>experienced medical professional. | The device is not intended to provide time<br>sensitive data or alarms. This system may not<br>be used as a substitute for direct medical<br>intervention or emergency care. |
| | | Interpretation of the information collected and<br>transmitted requires clinical judgment by an<br>experienced medical professional. |
| INTENDED USE | Accessory to Hemodialysis Delivery System;<br>e-Health Device | Telemedicine System |
| INTENDED USERS | Home Users, Healthcare Practitioners | Home Users |
| SITE OF USE | Home, Clinic | Home, Clinic |
| DATA COLLECTION<br>SOFTWARE | Proprietary Software | Proprietary Software |
| COMMUNICATION<br>METHOD WITH<br>DEVICES | Secure Wi-Fi Connection | Wireless RF Protocol |
| COMMUNICATION<br>METHOD WITH<br>REMOTE CARE<br>MANAGEMENT SYS. | Secure Broadband Internet Connection | Secure Broadband Internet Connection |

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##

510(k) Premarket Notification
NxStage Medical, Inc.

.

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

## G. 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 substantially equivalent to predicate device. Performance, verification and validation testing was conducted to characterize performance of the proposed device. This included testing for software readiness, software design review, and usability.

All predetermined acceptance criteria were met. Results of this testing also document that the proposed NxStage Connected Health System is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol consisting of three curved shapes, resembling a person embracing another person.

### Public Health Service

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

ﺎﺭ

## October 10, 2013

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

Re: K131739

> Trade/Device Name: NxStage Connected Health System Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKP Dated: September 9, 2013 Received: September 10, 2013

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. You must comply with all the Act's requirements, including, but not limited to: registration and I da mast ochip; march 807); labeling (21 CFR Part 801); medical device reporting (reporting of

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Page 2 - Mary Lou Stroumbos

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,

## Glenn ByBell -S

Acting for: 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): K131739

NxStage Connected Health System Device Name:

The NxStage Connected Health System is for use by Indications for Use: chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.

> The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.

Interpretation of the information collected and transmitted requires clinical judgment by an experienced madical professional.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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) Page 1 of 1

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