(62 days)
No
The summary describes a system for collecting, storing, and transmitting patient data, providing basic trending and alerts based on predefined criteria. There is no mention of AI, ML, or any advanced analytical techniques that would typically be associated with these technologies. The interpretation of data is explicitly stated to require clinical judgment.
No.
Explanation: The device is a data repository and communication link, collecting and transmitting medical information without providing direct medical intervention or control over treatment. It requires clinical judgment for interpretation and is not intended to provide time-sensitive data or alarms.
No
The device collects, stores, and transmits medical information. It explicitly states it is "not intended to provide time sensitive data or alarms" and "may not be used as a substitute for direct medical intervention or emergency care." Interpretation of the information requires clinical judgment by an experienced medical professional, indicating it acts as a data conduit rather than performing diagnostic analysis.
No
The device description explicitly states it collects data from "a variety of devices such as blood pressure monitor and weight scale" and the NxStage System One. While the Connected Health System itself might be primarily software, its function is dependent on and integrated with external hardware devices, making it a system that includes hardware components.
Based on the provided information, the NxStage Connected Health System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NxStage Connected Health System Function: The description clearly states the system's purpose is to collect, store, and transmit medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis data. It acts as a data repository and communication link.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens. It is collecting data from other devices (blood pressure monitor, weight scale, System One) and patient input (flowsheet data).
- Focus on Data Management: The core function is data management, transmission, and presentation to healthcare professionals for interpretation.
Therefore, the NxStage Connected Health System falls under the category of a medical device that supports patient management and communication, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
FKP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Patient, Healthcare Professional / Home, Clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench studies, Verification Testing, Simulated Use Testing, Design Validation Testing. All predetermined acceptance criteria were met. The proposed device is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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.