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 care facility.

The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during to acute and chronic renal failure or fluid overload. The device would be used when hemodialysis, and /or ultrafiltration may become disrupted.

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

Device Description

The NxStage Cartridge Express with Speedswap is a single use extracorporeal blood circuit and fluid management device with a pre-attached detachable high permeability hollow-fiber. The proposed feature, "Speedswap" is a feature in the cartridge design that will allow the user to exchange the filter that is becoming clotted or clogged with a new filter that has been manually primed.

A kit will be required to perform the filter exchange. The proposed optional kit will consist of a filter with tubing connections for manual priming along with a waste bag to collect used saline. The nurse has the option of using the proposed cartridge without using the Speedswap feature. The functionality of the proposed cartridge is the same as the predicate Cartridge. Exchanging a used filter is optional and the facility can choose to dispose of the entire cartridge instead of exchanging the Filter.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: NxStage Cartridge Express with Speedswap

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantitative performance acceptance criteria with numerical targets. However, the testing performed implicitly aims to meet the regulatory and safety standards expected for such a device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	The NxStage Cartridge Express with Speedswap has the same intended use and utilizes the same fundamental scientific technology as the identified predicate (NxStage System One Cartridge Express, K061837). It is substantially equivalent in design, function, and operation to the predicate.
Safety - Manufacturing	Cartridge Integrity: Passed Cartridge Pressure Leak Test and Solvent bond tensile tests.
	Sterilization: Gamma sterilization at 10-6 SAL, same as predicate.
Safety - Use	Biocompatibility: Passed Cytotoxicity, Guinea Pig Sensitization, Rabbit Intracutaneous Reactivity, USP Rabbit Pyrogen, Bacterial Reverse Mutation, Genotoxicity (Mouse Lymphoma), Hemocompatibility (Coagulation and Hematology), ASTM Hemolysis, ASTM Partial Thromboplastin Time, SC5b-9 Complement Activation, Chemical Characterization, Chronic Toxicity, Carcinogenicity. All tests performed to support safety of valve connectors.
	Simulated Use: Demonstrated performance in a simulated use environment.
	Kink Resistance: Passed Kink Resistance Test.
	Waste Bag Integrity: Passed Waste Bag Integrity test.
Performance - General	System and Subsystem Performance: Performed.
	Blood Line Priming Volume: Assessed.
	Chemical Resistance: Passed Disposable Component Chemical Resistance Test.
Usability/ Human Factors	Human Factors Validation (Summative Evaluation): Critical tasks associated with Speedswap features were evaluated. Results, coupled with post-evaluation risk analysis, indicate the device is safe and effective for intended users, uses, and use environments.
Shipping/Durability	Ship Testing: Performed.
Overall Verification & Validation	All testing passed, confirming the device performs according to product specifications and meets predetermined acceptance criteria. Any new risk control measures or usability requirements were traced to requirements and verified.

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

The document does not explicitly state the sample sizes for the individual performance, biocompatibility, or human factors tests. It refers to "testing" and "studies" but doesn't quantify the number of units or participants.

The data provenance is industrial testing, likely conducted in a laboratory setting by the manufacturer (NxStage Medical, Inc. in Lawrence, MA), and is therefore considered retrospective to the submission date. There is no information about country of origin for specific test data beyond the manufacturer's location.

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

This type of information is not applicable to the studies described. The "ground truth" here is based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and established biological/chemical safety protocols, rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective measurements against defined criteria (e.g., pass/fail for leak tests, adherence to ISO standards, or clear results for biocompatibility). There is no ambiguity or subjective interpretation that would require an adjudication method.

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:

Not applicable. This device is a medical accessory for a hemodialysis system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies related to human reader performance with or without AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the various tests relies on established scientific principles, engineering standards, and regulatory guidelines:

Engineering Specifications: For integrity, kink resistance, priming volume, chemical resistance, and system performance.
International Standards (e.g., ISO 8638:2010): For performance testing.
Biocompatibility Standards (e.g., ISO 10993 series implicitly): For cytotoxicity, sensitization, reactivity, pyrogenicity, genotoxicity, hemocompatibility, etc.
Risk Analysis and Usability Engineering Principles: For human factors validation.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dataset.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 9, 2019

NxStage Medical, Inc. Christina Marabella Associate Director, Regulatory Affairs 350 Merrimack Street Lawrence, MA 01843

Re: K183158

Trade/Device Name: NxStage Cartridge Express with Speedswap Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: July 11, 2019 Received: July 12, 2019

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 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

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statutes and regulations administered by other Federal agencies. 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 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 (QS) 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 medical devices and radiation-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,

Carolyn Y. Neuland, Ph.D. Assistant Division 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) K183158

Device Name NxStage Cartridge Express with Speedswap

Indications for Use (Describe)

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 care facility.

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

Permissive Use (Part 91 CFR 901 Subpart D)	☒
On-The-Ground Use (Part 91 CFR 901 Subpart E)	□

|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

DATE:	August 9, 2019
Submitter's InformationName:	NxStage Medical, Inc.
Phone:	978-450-5275
Fax:	978-687-4750
Email address:	cmarabella@nxstage.com christina.marabella@fmc-na.com
Manufacturer	NxStage Medical, Inc. 350Merrimack StreetLawrence, MA 01843
FDA EstablishmentRegistration Number:	3003464075
Sterilization Site:	Steris Isomedix1000 S. Sarah PlaceOntario, CA 91761
	Sterigenics Fort Worth 3125Wichita Ct.Fort Worth, TX 76140USA
	Steris1435 Isomedix PlaceEl Paso, TX 79936
Device Name:
Trade/Proprietary Name:	NxStage Cartridge Express with Speedswap
Common/Usual Name:	Dialyzer with High Permeability Hemodialysis System
Classification Name	High Permeability Hemodialysis System
Regulation Number:	21 CFR 876.5860
Product Code:	KDI
Device Classification:	Class II
Device Panel:	Gastroenterology-Urology (GU)/Gastro-Renal (GRDB)

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Predicate Device:

The predicate device is the currently marketed NxStage System One Cartridge Express, K061837 FDA cleared on July 31, 2006.

Substantial Equivalence:

The NxStage Cartridge Express with Speedswap has the same intended use and utilizes the same fundamental scientific technology as the identified predicate. The proposed cartridge has been compared to the legally marketed predicate cartridge and is substantially equivalent in design, function, and operation to the identified predicate, K061837.

Device Description/Indications for Use:

Device Description:

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 care facility.

The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flowcompromised filter during treatment of acute and chronic renal failure or fluid overload. The device would be used when hemofiltration, hemodialysis, and /or ultrafiltration may become disrupted.

Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device with a minor difference to allow for the used filter to be exchanged. The proposed device is designed with similar components and features also used in the predicate device.

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NxStage Medical, Inc. Cartridge Express with Speedswap Traditional 510(k) Premarket Notification

Feature	NxStage Cartridge Express with SpeedswapProposed Device	NxStage Cartridge ExpressK061837 - Predicate	COMPARISON
Intended Use	For treatment of renal failure or fluid overload usinghemofiltration, hemodialysis, and/or ultrafiltration	For treatment of renal failure or fluid overload usinghemofiltration, hemodialysis, and/or ultrafiltration	SAME
TherapiesIndicated	Continuous/intermittent hemofiltration and/orultrafiltration Continuous/intermittent hemodialysis and/orultrafiltration and slow continuousultrafiltration	Continuous/intermittent hemofiltration and/orultrafiltration Continuous/intermittent hemodialysisand/or ultrafiltration and slow continuous ultrafiltration	SAME
Principal ofOperation	Removal of solutes via diffusion and/or convection	Removal of solutes via diffusion and/or convection	SAME
Filter (Dialyzer)	NxStage® 1.6m² Dialyzer	NxStage® 1.6m² Dialyzer	SAME
SterilizationMethod	Gamma; 10-6 SAL	Gamma; 10-6 SAL	SAME
ProductConfiguration	Disposable extracorporeal circuit with pre-attacheddetachable filter for use with the NxStage System One. ThisCartridge is configured with connections toallow the filter to be exchanged.	Disposable extracorporeal circuit with pre-attached filterfor use with the NxStage System One.	MODIFIED
Indicationsfor Use	The NxStage System One is indicated for the treatment ofacute and chronic renal failure or fluid overload usinghemofiltration, hemodialysis, and/or ultrafiltration, in anacute care facility.The NxStage Cartridge Express with Speedswap is anoptional accessory device to be used exclusively with theNxStage System One for facilitating the removal andreplacement of a flow-compromised filter duringtreatment of acute and chronic renal failure or fluidoverload. The device would be used when hemofiltration,hemodialysis, and /or ultrafiltration may becomedisrupted.All treatments must be administered under a physician'sprescription and must be observed by a trained andqualified person, considered to be competent in the use ofthis device by the prescribing physician.	The NxStage System One is indicated for the treatment ofacute and chronic renal failure or fluid overload usinghemofiltration, hemodialysis, and/or ultrafiltration, in anacute or chronic care facility. The System is also indicated forhemodialysis with or without ultrafiltration in the home.All treatments must be administered under a physician'sprescription, and must be observed by a trained and qualifiedperson, considered to be competent in the use of this deviceby the prescribing physician.	MODIFIED

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Summary of Non-Clinical Test / Performance Testing - Bench

Performance Testing

Performance testing was conducted in accordance with ISO 8638:2010.

The following tests were performed to support performance

Cartridge integrity tests:
- o Cartridge Pressure Leak Test
- Solvent bond tensile tests o
Simulated use test
Kink Resistance Test ●
Ship Testing
Blood Line Priming Volume Assessment
Waste Bag Integrity
System and Subsystem Performance Testing ●
Disposable Component Chemical Resistance Test

Biocompatibility

The following biocompatibility testing was performed to support the safety of the valve connectors:

Cytotoxicity Study Using the ISO Elution Method
Guinea Pig Maximization Sensitization Test ●
Rabbit Intracutaneous Reactivity
USP Rabbit Pyrogen Study
Bacterial Reverse Mutation Study
Genotoxicity: Mouse Lymphoma Assay
Hemocompatibility Assay for Coagulation and Hematology Parameters ●
ASTM Hemolysis Study
ASTM Partial Thromboplastin Time
SC5b-9 Complement Activation Assay
Chemical Characterization ●
Chronic Toxicity
Carcinogenicity

Discussion of Verification and Validation

Verification and Validation Testing

Verification and Validation of the NxStage Cartridge Express with Speedswap was designed to verify and validate that it performs according to product specifications. The approved protocols included pass/fail criteria for each of the tests performed. Any new risk control measures identified in the Risk Management activities or usability requirements identified in the Usability Engineering file traced to requirements that were verified. All testing passed.

Human Factors Validation

The critical tasks associated with the new Speedswap features for the proposed cartridge and proposed kit were evaluated during Summative Evaluation (Human Factors Validation). The Summative Evaluation results in conjunction with a post-evaluation risk analysis indicate

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that the NxStage Cartridge Express with Speedswap and Express Speedswap kit are safe and effective for intended users, uses, and use environments.

Conclusion:

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. Verification and validation were conducted to characterize the proposed device and the predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage Cartridge Express with Speedswap Kit 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.”