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 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.

AI/ML Overview

The provided documentation is a 510(k) Premarket Notification for the NxStage Connected Health System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results often seen in PMA (Premarket Approval) submissions. Therefore, the information regarding acceptance criteria and performance studies is primarily related to non-clinical verification and validation testing, and does not involve AI or human reader studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Verification Testing	Performed by Software Quality Engineering personnel not involved in design. All tests performed according to approved protocols with pass/fail criteria. All predetermined acceptance criteria were met.
Simulated Use Testing	Approved protocol executed to validate end-to-end system (Nx2me App - Nx2me Clinician Portal), GUI functionality, general use, and customer use scenarios. All predetermined acceptance criteria were met.
Design Validation Testing	Performed on new functional areas ("Link" and "Remote View") by Clinicians at Dialysis Clinics and NxStage Technical Support personnel. All predetermined acceptance criteria were met.
Overall Conclusion	The system performs as intended, is safe and effective for its intended use, and has been successfully validated. All predetermined acceptance criteria were met.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document describes non-clinical verification and validation testing, not a clinical study involving a "test set" of patient data in the sense of a dataset for AI evaluation.

Sample size: Not applicable in the context of a "test set" of patient data for AI. The testing involved various software verification tests, simulated use scenarios, and design validation activities rather than a sample of patient data.
Data provenance: Not applicable. The testing is described as internal verification and validation of software and system functionalities by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document describes non-clinical software and system validation, not a study requiring expert-established ground truth for a diagnostic AI.

Design Validation Testing (for "Link" and "Remote View" functionalities) involved "Clinicians at Dialysis Clinics and NxStage Technical Support personnel." Specific numbers or detailed qualifications are not provided beyond "Clinicians" and "Technical Support personnel."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The description refers to internal verification and validation testing with predetermined pass/fail criteria, not a clinical study with an adjudication process for ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This submission is for a data collection and communication system, not an AI-powered diagnostic device. The device does not involve "human readers" or "AI assistance" in the diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a system for collecting, storing, and transmitting medical information, not a standalone diagnostic algorithm. It explicitly states it is "not intended to provide time sensitive data or alarms and does not control the System One Cycler" and "Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic ground truth. The "ground truth" for the verification and validation described here would be the pre-defined product specifications and requirements that the system was tested against. The software functionality was verified to meet these specifications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a data collection and communication system.

9. How the ground truth for the training set was established

Not applicable. As noted above, there is no training set for this type of device.

Summary

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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

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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

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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.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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	September 18, 2018
B.	Submitter's Information:Name:	NxStage Medical, Inc.
	Address:	350 Merrimack StreetLawrence, MA 01843United States
	FDA EstablishmentOwner/Operator Number:	9045797
	Contact Person:	Christina MarabellaAssociate Director, Regulatory Affairs
	Phone:Fax:	(978) 450-5275(978) 687-4750
	Manufacturer:	NxStage Medical, Inc.350 Merrimack StreetLawrence, MA 01843United States
	FDA EstablishmentRegistration Number:	3003464075
	Sterilization Site:	Not Applicable

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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:

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Proposed Indications for Use:

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.

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Table 1 - Device Comparison Table
Feature	NxStage Connected Health SystemProposed Device	NxStage Connected Health System –K131739(Predicate)	COMPARISON
Indications for Use	The NxStage Connected Health System isfor use by chronic hemodialysis patientsremotely in combination with the NxStageSystem One and a variety of devices suchas blood pressure monitor and weight scaleupon the prescription of a licensedphysician or healthcare practitioner. TheConnected Health System serves as thedata repository and communication link tothe server software which is utilized by thehealthcare facility. The healthcare facilitymay include the physician or licensedhealthcare practitioner, other clinicians, or adisease management center.The purpose of the system is to collect,accumulate, store and transmit medicalinformation such as flowsheet data, vitalsigns, blood pressure, weight and dialysisdata from the patient and transmit theseresults to their healthcare practitioner atanother facility. The system also providesonline labeling, treatment status, trendingand supports education and messaging.The device is not intended to provide timesensitive data or alarms and does notcontrol the System One Cycler. This systemmay not be used as a substitute for directmedical intervention or emergency care	The NxStage Connected Health System isfor use by chronic hemodialysis patientsremotely in combination with the NxStageSystem One and a variety of devices suchas blood pressure monitor and weight scaleupon the prescription of a licensedphysician or healthcare practitioner. TheConnected Health System serves as thedata repository and communication link tothe server software which is utilized by thehealthcare facility. The healthcare facilitymay include the physician or licensedhealthcare practitioner, other clinicians, or adisease management center.The purpose of the system is to collect,accumulate, store and transmit medicalinformation such as flowsheet data, vitalsigns, blood pressure, weight and dialysisdata from the patient on the completion oftheir dialysis treatment and transmit theseresults to their healthcare practitioner atanother facility. The system also providesonline labeling, treatment status, trendingand supports education and messaging.The device is not intended to provide timesensitive data or alarms and does notcontrol the System One Cycler. This systemmay not be used as a substitute for direct	Modified - the proposedIndications for Use statementdoes not include the words "onthe completion of their dialysistreatment". All other languageremains the same.
Table 1 - Device Comparison Table
Feature	NxStage Connected Health SystemProposed Device	NxStage Connected Health System –K131739(Predicate)	COMPARISON
	Interpretation of the information collectedand transmitted requires clinical judgmentby an experienced medical professional.	Interpretation of the information collectedand transmitted requires clinical judgmentby an experienced medical professional.
Intended Use	Accessory to Hemodialysis DeliverySystem; e-Health Device	Accessory to Hemodialysis DeliverySystem; e-Health Device	SAME
Intended Users	Patient, Healthcare Professional	Patient, Healthcare Professional	SAME
Location Of Use	Home, Clinic	Home, Clinic	SAME
Data CollectionSoftware	Proprietary Software	Proprietary Software	SAME
CommunicationMethod WithDevices	Secure Wi-Fi Connection	Secure Wi-Fi Connection	SAME
CommunicationMethod WithRemote CareManagement Sys.	Secure Broadband Internet Connection	Secure Broadband Internet Connection	SAME

510(k) Premarket Notification NxStage Medical, Inc.

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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.

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.