(119 days)
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.
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.
Here's an analysis of the provided text regarding the NxStage Connected Health System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) Premarket Notification for a telemedicine system, not a diagnostic AI device with specific performance metrics like sensitivity or specificity. Therefore, the "acceptance criteria" discussed are related to the system's ability to reliably collect, store, and transmit medical data, and its substantial equivalence to a predicate device. The performance is assessed through functional testing rather than clinical diagnostic accuracy.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Functional Performance | Software readiness | All predetermined acceptance criteria were met. |
| Software design review | All predetermined acceptance criteria were met. | |
| Usability | All predetermined acceptance criteria were met. | |
| Data Handling | Collect medical information (flowsheet data, vital signs, blood pressure, weight, dialysis data) | System collects, stores, and transmits medical information as intended. |
| Store medical information | System collects, stores, and transmits medical information as intended. | |
| Transmit medical information to healthcare practitioner at another facility | System collects, stores, and transmits medical information as intended. | |
| System Capabilities | Online labeling | System provides online labeling. |
| Treatment status | System provides treatment status. | |
| Trending | System provides trending. | |
| Supports education and messaging | System supports education and messaging. | |
| Safety & Compatibility | Not intended for time-sensitive data or alarms | Stated as a device limitation. |
| Does not control NxStage System One Cycler | Stated as a device limitation. | |
| Not a substitute for direct medical intervention or emergency care | Stated as a device limitation. | |
| Requires clinical judgment by an experienced medical professional for interpretation | Stated as a device limitation/requirement. | |
| Substantial Equivalence | Similar in design, function, and operation to predicate device (BL Healthcare TCx-I-DV) | Device demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (like for an AI diagnostic algorithm). The testing described is non-clinical bench testing for functional performance, software readiness, design review, and usability. Therefore, concepts like country of origin for data or retrospective/prospective study design are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The device is a data collection and transmission system, not a diagnostic tool that requires ground truth established by experts for performance evaluation. The "ground truth" for this type of device would be its ability to accurately and reliably perform its stated functions.
4. Adjudication Method for the Test Set
This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in studies involving expert reviews for diagnostic accuracy, which is not the type of study presented for this device.
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, an MRMC comparative effectiveness study was not done. This device is a data management system, not an AI-powered diagnostic tool, so a study of human readers improving with AI assistance is not relevant to its function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself is a "standalone" system in terms of its ability to collect, store, and transmit data without continuous human intervention during the data transfer process. However, this is not a standalone diagnostic algorithm performance study. The system's function is to facilitate data flow to human healthcare practitioners for their interpretation.
7. The Type of Ground Truth Used
For this device, the "ground truth" is its functional correctness and reliability in performing its stated tasks: collecting, storing, and transmitting the specified medical information. This is verified through non-clinical bench testing (software readiness, design review, usability). There is no "pathology" or "outcomes data" ground truth in the traditional sense for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable. This device is a data management and communication system, not an AI/machine learning algorithm that requires a "training set" of data to learn from.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device.
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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 StreetLawrence, MA 01843United States |
| FDA Establishment | 9045797 |
OCT 10 2013
Phone:
Fax:
Number:
Mary Lou Stroumbos Regulatory Affairs Manager (978) 687-4872
(978) 687-4750
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 DeliverySystem; e-Health Device |
| Classification Name: | Hemodialysis System and Accessories |
| Regulation Number: | 21 CFR 876.5820 |
| Product Code: | 78 FKP - System, dialysate delivery, singlepatient |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-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 FORUSE | ||
|---|---|---|
| The NxStage Connected Health System is foruse by chronic hemodialysis patients remotelyin combination with the NxStage System Oneand a variety of devices such as bloodpressure monitor and weight scale upon theprescription of a licensed physician orhealthcare practitioner. The Connected HealthSystem serves as the data repository andcommunication link to the server softwarewhich is utilized by the healthcare facility. Thehealthcare facility may include the physicianor licensed healthcare practitioner, otherclinicians, or a disease management center. | The TCx-I-DV Remote Care ManagementSystem is for use by patients remotely incombination with a variety of monitoringdevices such as blood pressure monitor.NxStage System One Hemodialysis Systemand weight scale upon the prescription of alicensed physician or healthcare provider. TheTCx-I-DV Remote Care management Systemserves as the communication link between thecompatible devices and the server software ata compatible healthcare facility. Thehealthcare facility may include healthcareprovider, other caregivers, or a diseasemanagement center. | |
| The purpose of the system is to collect,accumulate, store and transmit medicalinformation such as flowsheet data, vitalsigns, blood pressure, weight and dialysistreatment and transmit these results to theirhealthcare practitioner at another facility. Thesystem also provides online labeling,treatment status, trending and supportseducation and messaging. | The purpose of the system is to collect andtransmit medical information such as weight,blood pressure and pulse rate, and dialysisdate from the patients on completion of theirtesting of their testing and transmit theseresults to their healthcare provider at anotherfacility. | |
| INDICATIONS FORUSE CONT. | The device is not intended to provide timesensitive data or alarms and does not controlthe System One Cycler. This system may notbe used as a substitute for direct medicalintervention or emergency care. | The system is installed by or with supportfrom trained professionals. |
| Interpretation of the information collected andtransmitted requires clinical judgment by anexperienced medical professional. | The device is not intended to provide timesensitive data or alarms. This system may notbe used as a substitute for direct medicalintervention or emergency care. | |
| Interpretation of the information collected andtransmitted requires clinical judgment by anexperienced medical professional. | ||
| INTENDED USE | Accessory to Hemodialysis Delivery System;e-Health Device | Telemedicine System |
| INTENDED USERS | Home Users, Healthcare Practitioners | Home Users |
| SITE OF USE | Home, Clinic | Home, Clinic |
| DATA COLLECTIONSOFTWARE | Proprietary Software | Proprietary Software |
| COMMUNICATIONMETHOD WITHDEVICES | Secure Wi-Fi Connection | Wireless RF Protocol |
| COMMUNICATIONMETHOD WITHREMOTE CAREMANAGEMENT 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 (800) 638-2041 or (301) 796-7100 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
Image /page/8/Picture/11 description: The image shows the text "Glenn Bell -S" in a bold, sans-serif font. The letters are black against a white background, and the text appears to be slightly distorted or stylized. The text is likely a name or a brand name.
§ 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.