Who is the manufacturer of NxStage Connected Health System?

Nxstage Medical, Inc. filed the 510(k) submission for NxStage Connected Health System (K181991).

What is the FDA product code for NxStage Connected Health System?

FKP. It is classified under 21 CFR 876.5820 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for NxStage Connected Health System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NxStage Connected Health System?

NxStage Connected Health System (K131739).

Who can help prepare an FDA 510(k) submission like NxStage Connected Health System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NxStage Connected Health System

K181991 · Nxstage Medical, Inc. · FKP · Sep 26, 2018 · Gastroenterology, Urology

Device Facts

Record ID	K181991
Device Name	NxStage Connected Health System
Applicant	Nxstage Medical, Inc.
Product Code	FKP · Gastroenterology, Urology
Decision Date	Sep 26, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5820
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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 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 medical data (flowsheet, vitals, BP, weight, dialysis parameters) from home/remote settings to healthcare facilities. Inputs include manual/device-linked data; system enables clinician remote access to treatment snapshots, trending, and alert monitoring. Operates via secure Wi-Fi/broadband to server software. Used by patients and clinicians (physicians, nurses, disease management centers) to track treatment status and variances. Does not control dialysis cycler or provide real-time alarms. Benefits include improved remote monitoring and clinical oversight of home dialysis therapy.

Clinical Evidence

Bench testing only. Verification and validation included software verification, simulated use testing (end-to-end system, GUI, customer scenarios), and design validation for 'Link' and 'Remote View' features. All predetermined acceptance criteria met.

Technological Characteristics

Proprietary software-based e-Health system. Connectivity via secure Wi-Fi and broadband internet. Components include Nx2me App and Nx2me Clinician Portal. No hardware materials or sterilization applicable.

Indications for Use

Indicated for chronic hemodialysis patients using NxStage System One with peripheral devices (BP monitor, weight scale) under physician prescription. Not for time-sensitive alarms, emergency care, or direct cycler control.

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 Connected Health System (K131739)

Related Devices

K131739 — NXSTAGE CONNECTED HEALTH SYSTEM · Nxstage Medical, Inc. · Oct 10, 2013
K093379 — TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM · Bl Healthcare, Inc. · Feb 9, 2010
K073038 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B · Carematix, Inc. · Jan 11, 2008
K052608 — TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) · Bl Healthcare, Inc. · Feb 1, 2006
K100508 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B · Carematix, Inc. · May 5, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 26, 2018 NxStage Medical, Inc Christina Marabella Associate Director, Regulatory Affairs 350 Merrimack Street Lawrence. Massachusetts 01843 Re: K181991 > Trade/Device Name: NxStage Connected Health System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: FKP Dated: July 25, 2018 Received: July 26, 2018 Dear Christina Marabella: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Carolyn Y. Neuland -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181991 #### Device Name NxStage Connected Health System #### Indications for Use (Describe) The NxStage Connected Health System is for use by chronic hemotialysis 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 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. Type of Use (Select one or both, as applicable) | <div> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> <line stroke="black" stroke-width="2" x1="0" x2="15" y1="0" y2="15"></line> <line stroke="black" stroke-width="2" x1="0" x2="15" y1="15" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 18, 2018 | |----|---------------------------------------------|--------------------------------------------------------------------------------------| | B. | Submitter's Information: Name: | NxStage Medical, Inc. | | | Address: | 350 Merrimack Street Lawrence, MA 01843 United States | | | FDA Establishment Owner/Operator Number: | 9045797 | | | Contact Person: | Christina Marabella Associate Director, Regulatory Affairs | | | Phone: Fax: | (978) 450-5275 (978) 687-4750 | | | Manufacturer: | NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843 United States | | | FDA Establishment Registration Number: | 3003464075 | | | Sterilization Site: | Not Applicable | {4}------------------------------------------------ # C. Device Name: | Trade/Proprietary Name: | NxStage Connected Health System | |-------------------------|----------------------------------------------------------------| | Common/Usual Name: | Accessory to Hemodialysis Delivery System; e- Health Device | | Classification Name: | Hemodialysis System and Accessories | | Regulation Number: | 21 CFR 876.5820 | | Product Code: | 78 FKP - System, dialysate delivery, single patient | | Device Classification: | Class II | | Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal (GRDB) | # C. Predicate Devices: The predicate device is the cleared and currently marketed Connected Health System, K131739. # 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 treatment data from the patient and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education, has the ability to add picture attachments through the notes in a flowsheet, and the ability for the Clinician to remotely access snapshots of patient's treatment data while the treatment is taking place. 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. {5}------------------------------------------------ # Proposed 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 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, same design and same configuration as the predicate device. {6}------------------------------------------------ | Table 1 - Device Comparison Table | | | | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | NxStage Connected Health System Proposed Device | NxStage Connected Health System – K131739 (Predicate) | COMPARISON | | 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 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 | 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 | Modified - the proposed Indications for Use statement does not include the words "on the completion of their dialysis treatment". All other language remains the same. | | Table 1 - Device Comparison Table | | | | | Feature | NxStage Connected Health System Proposed Device | NxStage Connected Health System – K131739 (Predicate) | COMPARISON | | | Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional. | Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional. | | | Intended Use | Accessory to Hemodialysis Delivery System; e-Health Device | Accessory to Hemodialysis Delivery System; e-Health Device | SAME | | Intended Users | Patient, Healthcare Professional | Patient, Healthcare Professional | SAME | | Location Of Use | Home, Clinic | Home, Clinic | SAME | | Data Collection Software | Proprietary Software | Proprietary Software | SAME | | Communication Method With Devices | Secure Wi-Fi Connection | Secure Wi-Fi Connection | SAME | | Communication Method With Remote Care Management Sys. | Secure Broadband Internet Connection | Secure Broadband Internet Connection | SAME | 510(k) Premarket Notification NxStage Medical, Inc. {7}------------------------------------------------ {8}------------------------------------------------ # G. Summary of Non-Clinical Test/Performance Testing - Bench The information and data provided in this submission 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. 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. # H. Discussion of Software Verification and Validation Verification and Validation activities were divided into the following three categories: # Verification Testing Verification of the Nx2me App and the Nx2me Clinician Portal has been designed to validate the system and verify that it performs according to the product specifications. The approved protocols included pass/fail criteria for each of the tests performed. Software verification testing was accomplished by Software Quality Engineering personnel that were not directly involved in the design of the software. Any new risk control measures identified in Risk Management activities or Usability requirements identified in the Usability Engineering file traced to requirements that were verified. # Simulated Use Testing A Simulated Use validation procedure using an approved protocol was executed to validate end to end system testing (Nx2me App - Nx2me Clinician Portal), GUI functionality, general use and customer use scenarios. # Design Validation Testing Design Validation testing was performed on the new functional areas of "Link" and "Remote View". This testing was performed using Clinicians at Dialysis Clinics and NxStage Technical Support personnel with assistance from R&D, and Software Quality Engineering groups. #### l. Conclusions Drawn from Non-Clinical Tests Results of the verification testing demonstrate that the NxStage Connected Health system performs as intended and is safe and effective for its intended use. The testing and data provided sufficiently demonstrates that the NxStage Connected Health system has been successfully validated and performs as intended. Predetermined acceptance criteria were met. In summary, the information and data submitted in support of this Traditional 510(k) Premarket Notification, demonstrate that the NxStage Connected Health system does not introduce any new technologies, materials, manufacturing processes, or new/increased risks as compared to the predicate device K131739 and is adequately designed for the proposed labeled indications for use. There is no change to the fundamental scientific technology employed or the intended use of the device. The results of the verification and validation testing supports that the modified system is substantially equivalent to the predicate device, K131739.