The NxStage system 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 and solo home hemodialysis during waking hours.

All treatments must be administered under a 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 VersiHD with GuideMe Software is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge (disposable) extracorporeal blood and fluid management circuit (with or without a pre-attached 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. It is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

AI/ML Overview

Based on the provided text, the device in question is the VersiHD with GuideMe software, which is a modification to an existing hemodialysis system (specifically, a software-only modification to the graphical user interface). This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness from scratch.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating safety, effectiveness, and non-inferiority compared to the predicate device, especially regarding the software modification and its human factors.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail table format, nor does it provide numerical "reported device performance" against those criteria in the way one might see for a diagnostic algorithm. Instead, it details that testing was conducted to demonstrate compliance with specifications and equivalence to the predicate.

The closest equivalent to "acceptance criteria" derived from the text are the regulatory and engineering requirements that the device must meet, and the "reported device performance" is indicated by the statement that these requirements were met.

Feature/Requirement	Acceptance Criteria (Implied from text)	Reported Device Performance/Conclusion
Software Functionality	Software requirements verified against pre-determined performance specifications.	"Software requirements were verified according to pre-determined performance specifications." "Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software and to confirm operation of the machine."
System Performance	System requirements verified against pre-determined performance specifications.	"System requirements were verified according to pre-determined performance specifications."
Human Factors/Usability	Safe and effective use in accordance with FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016)".	"The VersiHD with GuideMe Software was validated for safe and effective use in accordance with FDA guidance document..."
Electrical Safety & EMC	Compliance with IEC 60601-1-2:2014 (4th Edition) and adherence to FDA guidance on EMC.	"Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014 (4th Edition)." "Electromagnetic Compatibility information within this submission is provided in accordance with FDA guidance document..."
Overall Equivalence	No new concerns with regard to safety or effectiveness compared to the predicate device. Functions as intended.	"Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness." "The information provided in this submission demonstrates the VersiHD with GuideMe Software functions as intended and supports the determination of substantial equivalence to the predicate device."

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

Sample Size: The document does not specify a numerical sample size for "test sets" in terms of patient data or case numbers. The testing described (simulated treatments, software V&V, system V&V, human factors validation) are engineering and usability tests, not clinical performance studies with patient cohorts.
Data Provenance: Not applicable in the context of patient data. The origin of the testing itself would be the manufacturer (NxStage Medical, Inc.). The simulated treatments were described as "Simulated home hemodialysis treatments were performed in a simulated use environment (dialysis center/clinic or home setting)." This indicates a lab-based simulation rather than real patient data collection. The study specifically states "N/A. No clinical studies were conducted," and "N/A. No animal studies were conducted."

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

This information is not provided in the document. Given that no clinical studies or animal studies were conducted, and the device is a software modification (GUI change) to an existing system, the "ground truth" would likely relate to engineering specifications, safety standards, and usability engineering principles, rather than clinical diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical imaging studies to establish ground truth from multiple expert reads. Since no clinical studies were performed with patient data, such a method would not be relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Was it done?: No. The document explicitly states: "N/A. No clinical studies were conducted." MRMC studies are clinical studies involving human readers interpreting cases.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed. The "GuideMe" software appears to be an instructional aid, not an AI for diagnostic interpretation.

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

Was it done?: This concept isn't directly applicable in the same way it would be for a diagnostic AI algorithm. The "GuideMe" software is described as a "new optional 'Guide Me' feature in which step-by-step instructions are available for users if they press the 'Guide Me' button on the updated user interface." It assists the human operator, rather than performing an independent task that could be evaluated in isolation like a diagnostic algorithm.
The software's performance was verified and validated as part of the overall system and human factors testing, demonstrating its functionality and safety within the human-in-the-loop context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" relevant to this submission is primarily:

Engineering specifications and pre-determined performance specifications: For software and system verification and validation.
International standards (e.g., IEC 60601 series): For electrical safety and EMC.
FDA Human Factors guidance: For usability and safe interaction.

There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data, as no clinical studies were conducted.

8. The Sample Size for the Training Set

Not applicable / Not provided. This device is not described as a machine learning or AI model trained on a data set in the typical sense for image interpretation or diagnosis. The "GuideMe" feature is a software modification providing step-by-step instructions. Therefore, there wouldn't be a "training set" like for a deep learning model.

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

Not applicable / Not provided. As there's no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant here. The software's functionality and content (the "Guide Me" instructions) would have been developed based on existing procedural knowledge for operating the hemodialysis system and validated through engineering and human factors testing.

Summary

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August 11, 2023

NxStage Medical, Inc. Denise Oppermann VP Regulatory Affairs North America 350 Merrimack St. Lawrence, Massachusetts 01843

Re: K230632

Trade/Device Name: VersiHD with GuideMe software Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: July 14, 2023 Received: July 14, 2023

Dear Denise Oppermann:

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. Although this letter refers to your product as a device, please be aware 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Anil K. Kochhar -S

Acting for: Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230632

Device Name VersiHD with GuideMe Software

Indications for Use (Describe)

The system is also indicated for home hemodialysis. including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(K) SUMMARY

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

5.1. Submitter's Information

Name:	NxStage Medical, Inc.
Address:	350 Merrimack St.
	Lawrence, MA 01843 USA
Phone:	(781) 996-9103
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, VP Regulatory Affairs NorthAmerica
Preparation Date:	March 2, 2023

5.2. Device Name

Trade Name:	VersiHD with GuideMe Software
Common Name:	Dialyzer, High Permeability With Or Without SealedDialysate System
Regulation Name:	High permeability hemodialysis system
Regulatory Class:	Class II per 21 CFR § 876.5860
Product Code:	KDI
Product Code Name:	Dialyzer, High Permeability With Or Without SealedDialysate System

FDA Review Panel: Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the NxStage System One Plus cleared under K170469. This predicate has not been subject to a design-related recall.

Device Description 5.4.

The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. It is also indicated for home

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hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

5.4.1. Device Identification

The Model Numbers for subject to this submission are listed in Table 1.

Table 1. VersiHD with GuideMe Software Model Numbers and Description

Model Number	Description
NX1000-10-E	VersiHD with GuideMe software

VersiHD units that get serviced will be assigned NX1000-10-F or NX1000-16-F when upgraded to include VersiHD with GuideMe Software.

5.4.2. Device Characteristics

The VersiHD with GuideMe Software system is software driven, consisting of the cycler (machine) and a Cartridge (disposable). Depending on the use environment and materials used with the system, the VersiHD is able to perform a variety of renal therapy types as required by the health care provider including nocturnal and solo dialysis.

5.4.3. Environment of Use

The intended environments are Dialysis center or Dialysis Clinic (health care facility), Home, and Community at Large (such as Travel Use (e.g. Hotel)).

Brief Written Description of the Device 5.4.4.

The VersiHD with GuideMe Software includes a cycler and disposable NxStage Cartridge. The system components are described in Table 2.

Component	Description
Control Panel	All user inputs and informational readouts arecommunicated via the control panel
Pumps	The NxStage Cycler houses four peristalticpumps: the blood pump, ultrafiltration pump, wastefluid pump and therapy fluid pump
Balance Chambers	Volumetric fluid management is controlled by thebalance chamber subsystem, which ensures thatthe volume of waste fluid removed from the patientis equivalent to the volume of sterile replacementfluid infused into the patient for hemofiltration; orensures flow rate and volume control of dialysatein hemodialysis.
Pressure Transducers	Electronic pressure transducers monitor thepressures in the Cartridge blood and fluidpathways.
Pinch Clamp Actuators	Solenoid and cam-driven pinch clamp actuatorscontrol the flow of blood and fluids in theCartridge.
Air Detection Sensor	An ultrasonic air detector monitors for air in thevenous blood return line.
Blood Leak Detector	An optical blood leak sensor monitors for blood inthe waste fluid pathway.
Fluid TemperatureSensor	An additional, redundant safety feature whichmonitors the dialysate fluid temperature.
Software	There are two separate microprocessors: theControl Processor and the Safety Processor. Thetwo processors communicate with each other viathe Serial Communications Interface. The ControlProcessor controls the functions of the Cycler. TheSafety Processor monitors the Cycler, createsalarms, and alerts when necessary

Table 2. VersiHD with GuideMe Software Components Description

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The Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cycler performs the following functions:

Loads and primes the NxStage Cartridge and filter .
Performs pressure tests and alarms tests .

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Pumps blood from the patient, through the filter, and returns the filtered . blood to the patient.
Controls net fluid removal from the patient (ultrafiltration) .
Balances the removal of waste fluid with the infusion of sterile . replacement fluid (hemofiltration).
o Balances and maintains the dialysate flow (hemodialysis)
Monitors critical operating parameters relating to patient safety. It also . monitors treatment parameters and alerts the operator for possible intervention.
Rinses back blood to the patient at the conclusion of treatment. .

Key Performance Specifications/Characteristic 5.4.5.

The VersiHD with GuideMe Software performance requirements are provided in Table 3.

Feature	Specification
Technology / Components:
Hemodialysis	Yes
Hemofiltration	Yes
Ultrafiltration	Yes
Pumps	4 peristaltic pumps
Valves (clamps)	2 solenoid actuated pinch clamps8 cam driven pinch clamps
Air / fluid detectors	3 ultrasonic air/ fluid detectors
Blood leak detector	1 optical blood leak detector
Pressure transducers	5 electronic pressure transducers
Flow Rates:

Table 3. VersiHD with GuideMe Software performance requirements

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Feature	Specification
Blood	10-600 ml/min
Prescription Fluid /Dialysate Flow	0-18000 ml/hr
Ultrafiltration	0-2400 ml/hr
Transmembrane Pressure Monitoring Specification	Yes
Venous Pressure Monitor	0 to 400 mmHg
IV Prescription Fluid	Off-line, sterile- physician prescribed, indicated for infusion
Dialysate	Dialysate available as pre-packaged pre- mixed sterile fluids or via the PureFlow SL (K043436, K060296, K080919, K111174 & K140571)
Compatible Blood Tubing Set	NxStage Standard Cartridge
User Interface	Touch Screen
Alarms	75 dB
Software	VersiHD with GuideMe Software version 2.0

5.5. Intended Use

The VersiHD with GuideMe software is intended 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 intended for hemodialysis with or without ultrafiltration in the home.

5.6. Indications for Use

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The system is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the VersiHD with GuideMe Software remain unchanged when compared to the predicate device, NxStage System One Plus (K170469).

. Intended Use
Fundamental Scientific Technology/Operating Principle ●
. Energy Source
Materials
Essential Performance Requirements .

The VersiHD with GuideMe Software is a software only modification to the current, in market, VersiHD cycler's graphical user interface (GUI) touch screen. The VersiHD with GuideMe Software is utilizing a new optional "Guide Me" feature in which step-by-step instructions are available for users if they press the "Guide Me" button on the updated user interface .

5.8. Performance Data

Testing conducted to support the determination of substantial equivalence is summarized in Table 4.

Test Conducted	Test Method Description
Simulated Treatments(Intended Users, Usesand Use Environment)	Simulated home hemodialysis treatments wereperformed in a simulated use environment (dialysiscenter/clinic or home setting).
Software V&V	Software requirements were verified according to pre-determined performance specifications.
System V&V	System requirements were verified according to pre-determined performance specifications.

Table 4. Performance Testing Summary

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Test Conducted	Test Method Description
Basic Safety andEssential Performance	Complies with IEC 60601-1 standards and IEC60601-2-16

5.8.1. Human Factors Validation Testing

The VersiHD with GuideMe Software was validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016).

5.8.2. Electrical Safety and Electromagnetic Compatibility (EMC)

Electromaqnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014 (4th Edition). Note: The IEC 60601-1-2:2007 (3rd Edition), Model NX1000-16-F and NX1000-10-F (4th edition), serviced cyclers will be upgraded with the VersiHD with GuideMe Software. Electromagnetic Compatibility information within this submission is provided in accordance with FDA quidance document Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (11 July 2016).

Software Verification and Validation Testing 5.8.3.

Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software and to confirm operation of the machine. Software verification information within this submission is provided in accordance with the following FDA guidance documents:

o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (11 May 2005)
Content of Premarket Submissions for Management of . Cybersecurity in Medical device (02 October 2014)

5.8.4. Animal Studies

N/A. No animal studies were conducted.

5.8.5. Clinical Studies

N/A. No clinical studies were conducted.

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5.9. Conclusion

The information provided in this submission demonstrates the VersiHD with GuideMe Software functions as intended and supports the determination of substantial equivalence to the predicate device.

Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness.

The Indications for Use, technological characteristics, design, and performance requirements of the VersiHD with GuideMe Software are substantially equivalent to those of the predicate device. NxStage Medical, Inc. concludes that within the meaning of the Medical Device Amendments Act of 1976, the VersiHD with GuideMe Software is safe and effective for the intended 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.”