The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

Device Description

The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm dialysate prior to administration. The Express Fluid Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Express Fluid Warmer consists of an electro-mechanical warming unit and a single-use disposable.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the NxStage Express Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting in the same way a de novo device might.

Based on the provided document, here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative manner with corresponding performance results. Instead, it demonstrates substantial equivalence to a predicate device (NxStage Travel Warmer) through a comparison of technological characteristics and non-clinical performance testing. The "reported device performance" is essentially the determination that it functions similarly to the predicate.

Parameter	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (as stated)
Indications for Use	Same as predicate	The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.
Heating Method	Same as predicate	Same (as predicate: One Aluminum plate heated by electrical resistance)
Fluid Temperatures	Same as predicate	Same (as predicate: 31°C – 38°C Adjustable)
Temperature Control	Same as predicate	Same (as predicate: Thermistors)
Alarm Logic (Upper limit)	Same as predicate (alarms at 41°C)	Same (as predicate: Alarms activate when temperature reaches 41°C)
Alarm Logic (Lower Limit)	N/A (same as predicate)	N/A
Alarms	Same as predicate (Audible and Visual)	Same (as predicate: Audible and Visual)
Secondary Safety Mechanism	Same as predicate	Same (as predicate: Hardware safety circuit cuts the power to the heater if the fluid temperature is ≥ 41°C for more than 5 seconds)
Fluid Flow Rates	Same as predicate (0 - 200 ml/min)	Same (as predicate: 0 - 200 ml/min)
Control System	Same as predicate (Microcontroller)	Same (as predicate: Microcontroller)
Voltage	110-240 VAC	100-120/230 VAC Auto ranging (Minor difference, deemed equivalent)
Power	Same as predicate (400 VA)	Same (as predicate: 400 VA)
Frequency	Same as predicate (50/60 Hz)	Same (as predicate: 50/60 Hz)
Mounting Method	Same as predicate (Top Mount with IV pole support)	Same (as predicate: Top Mount with IV pole support)
Dimensions	Same as predicate (13"W X 10"L X 1 ½"H)	Same (as predicate: 13"W X 10"L X 1 ½"H)
Material	Same as predicate (PVC, ABS)	Same (as predicate: PVC, ABS)
Fluid warming Method	Same as predicate	Same (as predicate: 5L Dialysate Bag with connectors to MLA and therapy fluid outlet line)
Method of air removal	Same as predicate	Same (as predicate: Air entrapment in bag – release not required due to large bag capacity)
Priming Volume	Same as predicate (100 ml)	Same (as predicate: 100 ml)
Method of Sterilization	Same as predicate (Gamma SAL 10^-6)	Same (as predicate: Gamma SAL 10^-6)
Pyrogenicity	Same as predicate (Non-pyrogenic)	Same (as predicate: Non-pyrogenic)
Packaging	Same as predicate (Packaged in polyethylene bags)	Same (as predicate: Packaged in polyethylene bags)
Single/Multiple Use	Same as predicate (Single Use only)	Same (as predicate: Single Use only)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a numerical sample size for "test sets" in the context of clinical data. It states, "Performance, verification and validation testing was conducted to characterize performance of the proposed NxStage Express Fluid Warmer to provide a basis of comparison to the predicate device." These would be bench tests.
Data Provenance: The testing described is "Non-Clinical Test/Performance Testing - Bench." This indicates that the data is from laboratory (bench) experiments, not human or animal subjects, and is neither retrospective nor prospective in a clinical sense. The location of the manufacturer is given as Lawrence, MA, USA, so presumably, the bench testing was conducted there or at an approved facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this submission. The device is a fluid warmer, and the evaluation is based on engineering and performance specifications demonstrable through bench testing, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable to this submission, as it relates to expert consensus for ground truth establishment, which is not relevant for this type of device and study.

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:

This information is not applicable to this submission. The device is a medical accessory (fluid warmer), not an AI-powered diagnostic tool, so MRMC studies are irrelevant.

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

This information is not applicable to this submission. The device is not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for this device's evaluation is its measured physical performance and functional characteristics (e.g., temperature range, alarm activation, flow rates) as compared to the established specifications of the predicate device. This would be based on engineering specifications and direct measurements from bench testing.

8. The sample size for the training set:

This information is not applicable to this submission. The device does not employ machine learning or AI that requires a "training set."

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

This information is not applicable to this submission, as there is no training set for this device.

Summary

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JUN 1 6 2014

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 of Preparation

May 21, 2014

B. Submitter's Information: Name:

NxStage Medical, Inc.

Address:

Phone:

Fax:

350 Merrimack Street Lawrence, MA 01843

FDA Establishment Owner/Operator Number: Contact Person:

9045797

Mary Lou Stroumbos Director, Regulatory Affairs (978) 687-4872

(978) 687-4750

Manufacturer:

FDA Establishment Registration Number:

ﺎ

Sterilization Site:

NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843

3003464075

Steris Isomedix 1000 S. Sarah Place Ontario, CA 91761

510(k) Device Modification N×Stage Medical, Inc.

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B. Device Name:

Trade Name:	NxStage Express Fluid Warmer
Common/Usual Name:	Monitor, Temperature, Dialysis
Classification Name:	Hemodialysis System and Accessories(876.5820)Product Code: 78 FLA

C. Substantial Equivalence/Predicate Devices:

The proposed NxStage Express Fluid Warmer is substantially equivalent to the NxStage Travel Warmer cleared through K071263 on August 24, 2007.

D. Device Description/Indications for Use:

Indications for use:

The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

E. Technological Characteristics:

The proposed device has the same technological characteristics and is similar 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 as shown in Table 1.

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Table 1:Device Technological Characteristics Comparison Table
Parameter	Proposed DeviceNxStage ExpressFluid Warmer	Predicate DeviceNxStage TravelWarmer(K071263)
Indications forUse	The NxStage ExpressFluid Warmer andExpress FluidWarmer DisposableSet are accessoriesto the NxStageSystem One Cyclerused to warmdialysate prior toadministration.	The NxStage TravelWarmer and TravelWarmer Disposableset are accessories tothe NxStage SystemOne used to warmdialysate prior toadministration
HeatingMethod	Same	One Aluminum plateheated by electricalresistance
FluidTemperatures	Same	31°C – 38°CAdjustable
TemperatureControl	Same	Thermistors
Alarm Logica) Upper limit	Same	Alarms activate whentemperature reaches41°C
b) Lower Limit	N/A	N/A
Alarms	Same	Audible and Visual
Table 1Device Technological Characteristics Comparison Table
Parameter	Proposed DeviceNxStage ExpressFluid Warmer	Predicate DeviceNxStage TravelWarmer(K071263)
SecondarySafetyMechanism	Same	Hardware safetycircuit cuts the powerto the heater if thefluid temperature is ≥41°C for more than 5seconds
Fluid FlowRates	Same	0 - 200 ml/min
ControlSystem	Same	Microcontroller
Voltage	100-120/230 VACAuto ranging	110 -240 VAC
Power	Same	400 VA
Frequency	Same	50/60 Hz
MountingMethod	Same	Top Mount with IVpole support
Dimensions	Same	13"W X 10"L X 1 ½"H
Material	Same	PVC, ABS
Table 1Device Technological Characteristics Comparison Table
Parameter	Proposed DeviceNxStage ExpressFluid Warmer	Predicate DeviceNxStage TravelWarmer(K071263)
Fluid warmingMethod	Same	5L Dialysate Bag withconnectors to MLAand therapy fluidoutlet line
Method of airremoval	Same	Air entrapment in bag– release not requireddue to large bagcapacity
PrimingVolume	Same	100 ml
Method ofSterilization	Same	GammaSAL 10 $^{-6}$
Pyrogenicity	Same	Non-pyrogenic
Packaging	Same	Packaged inpolyethylene bags
Single/ MultipleUse	Same	Single Use only

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F. Summary of Non-Clinical Test/Performance Testing - Bench

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 NxStage Express Fluid Warmer to provide a basis of comparison to the predicate device. Results of the all testing have documented that the proposed NxStage Express Fluid Warmer is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

510(k) Device Modification NxStage Medical, Inc.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

June 16, 2014

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

Re: K140623

Trade/Device Name: NxStage Express Fluid Warmer Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FLA Dated: May 21, 2014 Received: May 22, 2014

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Fisher -S

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): K140623

NxStage Express Fluid Warmer Device Name:

The NxStage Express Fluid Warmer and Express Indications for Use: Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin 2014.06.1

Page 1 of 1

... . ..

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.