The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.

All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Device Description

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.

AI/ML Overview

This document is a 510(k) Premarket Notification for the NxStage System One, a high permeability hemodialysis system. It seeks to demonstrate substantial equivalence to a previously cleared predicate device (K141752).

Based on the provided document, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of technological characteristics between the proposed device and the predicate device in Table 1. However, this table does not directly state acceptance criteria in terms of performance metrics (e.g., minimum accuracy, maximum allowable deviation) against which the proposed device was tested. Instead, it states that the "Proposed Device (NxStage System One)" is "Same" for most parameters compared to the "Predicate Device (NxStage System One)".

The closest the document comes to defining acceptance criteria is under "Effluent Volume Accuracy" for the predicate device, where specifications for different software versions are provided. However, it only states that the proposed device is "Same," implying it meets these same specifications without explicitly presenting the proposed device's performance against them.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text as the explicit acceptance criteria and quantitative performance results for the proposed device are not detailed, beyond stating they were "met."

Inference of Acceptance Criteria (from Predicate Device Specifications as implied by "Same"):

Parameter	Acceptance Criteria (from Predicate)	Reported Device Performance (Implied)
Flow Rates: Blood	10-600 ml/min	Same (Implied to meet 10-600 ml/min)
Flow Rates: Prescription Fluid /Dialysate	0-18000 ml/hr	Same (Implied to meet 0-18000 ml/hr)
Flow Rates: Ultrafiltration	0-2400 ml/hr	Same (Implied to meet 0-2400 ml/hr)
Transmembrane Pressure	Yes (Implies capability)	Same (Implied to have capability)
Monitoring: Venous Pressure	0 to 400 mmHg	Same (Implied to monitor 0 to 400 mmHg)
Monitoring: Effluent Fluid Pressure	0 to 500 mmHg	Same (Implied to monitor 0 to 500 mmHg)
Monitoring: Air Detector	Reduction of detector signal lasting 6 ms minimum (Approximates a 60 microliter bubble at 400 mmHg venous pressure and 600 ml/min blood flow)	Same (Implied to meet this specification)
Monitoring: Blood Leak Detector	15% reduction in detector signal lasting 20 seconds minimum. Signal reduction % based on a 0.35 ml/min leak rate of 32 Hct blood.	Same (Implied to meet this specification)
Effluent Volume Accuracy (Software versions 4.7 and below)	Greater of 300 ml/12 hr or 3% of exchange volume	Same (Implied to meet this specification)
Effluent Volume Accuracy (Software versions 4.8 and higher)	Therapy Fluid Flow Rate (L/hr) > 3 ml/hr: +100 or +5% UF; ≤ 3 ml/hr: +25 ml/hr* (*Representing 95/90 tolerance interval established under controlled laboratory testing conditions)	Same (Implied to meet this specification)
IV Prescription Fluid	Off-line, sterile- physician prescribed, indicated for infusion	Same (Implied to handle this type)
Dialysate	Available as pre-packaged pre-mixed sterile fluids or via the PureFlow SL	Same (Implied to be compatible with these types)
Compatible Blood Tubing Set	NxStage Standard Cartridge	Same (Implied to be compatible)
Software	Software version 4.10	Same (Implied to use or be compatible with 4.10)

2. Sample Size Used for the Test Set and Data Provenance

The document states: "No Clinical testing was conducted." All testing mentioned is "Non-Clinical Test/Performance Testing - Bench."

Sample Size: Not explicitly stated for bench testing. The document refers to "Simulated treatments" but does not give a number of simulations or samples used.
Data Provenance: Not applicable as no clinical data was used. All testing appears to be in-house bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Since no clinical testing was conducted and all testing was "Non-Clinical Test/Performance Testing - Bench," there was no need for expert ground truth establishment in a clinical context. The "ground truth" for bench testing would be established by the engineering specifications and validated test methods.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with human subjects or expert review was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a 510(k) for a medical device (hemodialysis system), not an AI-powered diagnostic or interpretive device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an "algorithm only" performance that would typically compare to human clinicians. This device is a treatment system. The "Non-Clinical Test/Performance Testing - Bench" can be considered a form of standalone performance assessment against engineering specifications, but it's not "algorithm only" in the sense of a software-as-a-medical-device (SaMD) context. It's the performance of the integrated electromechanical control unit with its software and cartridge.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" would be established by:

Engineering specifications and design requirements: The device's performance was measured against these predefined technical standards and parameters (e.g., flow rates, pressure monitoring ranges, accuracy for effluent volume).
Physical measurements and simulated conditions: The testing simulates treatment conditions and measures the device's output against expected physical and chemical outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. The "training" for a traditional medical device involves its design, development, and iterative testing/refinement against engineering principles and specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's design and development (analogous to a training process for an AI) comes from established medical standards for hemodialysis, regulatory requirements, risk analysis, and engineering principles.

Summary

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

June 4, 2015

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

Re: K150472

Trade/Device Name: NxStage System One Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: ODN Dated: May 4, 2015 Received: May 5, 2015

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

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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) K150472

Device Name NxStage System One

Indications for Use (Describe)

The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.

Type of Use (Select one or both, as applicable)
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X 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 Prepared:	February 20, 2015
B. Submitter's Information:Name:	NxStage Medical, Inc.
Address:	350 Merrimack StreetLawrence, MA 01843
FDA EstablishmentOwner/OperatorNumber:	9045797
Contact Person:	Mary Lou StroumbosDirector, Regulatory Affairs
Phone:Fax:	(978) 687-4872(978) 687-4750
Manufacturer:	NxStage Medical, Inc.350 Merrimack StreetLawrence, MA 01843
FDA EstablishmentRegistration Number:	3003464075
Sterilization Site:	Steris Isomedix (NxStage CartridgeExpress)1000 S. Sarah PlaceOntario, CA 91761

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NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification

C. Device Name: NxStage System One Trade/Proprietary Name: Common/Usual Name: Hemodialysis System Classification Name: High Permeability Hemodialysis System Requlation Number: 876.5860 Product Code: ODN Device Classification: Class II Device Panel: Gastroenterology/Urology

D. Substantial Equivalence:

The NxStage System One has the same intended use and utilizes the same fundamental technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate device as cleared through K141752 (December 19, 2014) and was found to be substantially equivalent.

E. Device Description/Indications for Use:

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Indications for use:

The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.

F. Technological Characteristics:

The proposed device has the same technological characteristics and is identical in design and configuration as compared to the predicate device. The proposed device is designed with similar software, components and features also used in the predicate device.

Table 1Device Technological Characteristics Comparison Table
Parameter	Proposed DeviceNxStage System One	Predicate DeviceNxStage System One(K141752)
Intended UseHemodialysis	Yes	Yes
Hemofiltration	Yes	Yes
Ultrafiltration	Yes	Yes
Technology / Components:
Pumps	Same	4 peristaltic pumps
Valves (clamps)	Same	2 solenoid actuated pinch clamps
	Same	8 cam driven pinch clamps
Air / fluid detectors	Same	3 ultrasonic air/ fluid detectors
Blood leak detector	Same	1 optical blood leak detector
Pressure transducers	Same	5 electronic pressure transducers
Temperature sensors	Same	1 electronic temperature sensor

Special 510(k) Premarket Notification NxStage Medical, Inc.

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NxStage Medical, Inc.

NxStage System One 510(k) Premarket Notification

Table 1Device Technological Characteristics Comparison Table
Parameter	Proposed DeviceNxStage System One	Predicate DeviceNxStage System One(K141752)
Flow Rates:BloodPrescription Fluid /DialysateFlowUltrafiltrationTransmembrane Pressure	SameSameSameSame	10-600 ml/min0-18000 ml/hr0-2400 ml/hrYes
Monitoring SpecificationVenous Pressure MonitorEffluent fluid Pressure MonitorAir Detector	SameSameSame	0 to 400 mmHg0 to 500 mmHgReduction of detector signal lasting 6 ms
Blood Leak Detector	Same	minimum (Approximates a 60 micro literbubble at 400 mmHg venous pressure and600 ml/min blood flow)15% reduction in detector signal lasting 20seconds minimum. Signal reduction %based on a 0.35 ml/min leak rate of 32 Hctblood.
Effluent Volume Accuracy	Same	Greater of 300 ml/ 12 hr or 3% of exchangevolume (For software versions 4.7 andbelow)For software versions 4.8 and higher:Specification greater ofTherapyFluid FlowRate L/hr)+100> 3ml/hr+ 5% UFor+ 25≤ 3ml/hr**Representing 95/90 tolerance intervalestablished under controlled laboratorytesting conditions.
IV Prescription Fluid	Same	Off-line, sterile- physician prescribed,indicated for infusion
Dialysate	Same	Dialysate available as pre-packaged pre-mixed sterile fluids or via the PureFlow SL(K043436 K060296, K090919, K111174 &K140571)
Compatible Blood Tubing Set	Same	NxStage Standard Cartridge
Software	Same	Software version 4.10

Special 510(k) Premarket Notification NxStage Medical, Inc.

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Summary of Non-Clinical Test/Performance Testing - Bench and G. Clinical Testing

NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria were met.

The following non-clinical testing was conducted:

Simulated treatments o

The following clinical testing was conducted:

No Clinical testing was conducted

Conclusion: Results of the non-clinical testing have documented that the proposed NxStage System One is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”