NxStage Cartridge Express with Speedswap

K183158 · Nxstage Medical, Inc. · KDI · Aug 9, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183158
• Device Name: NxStage Cartridge Express with Speedswap
• Applicant: Nxstage Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Aug 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Single-use extracorporeal blood circuit and fluid management device; used with NxStage System One. Features 'Speedswap' mechanism allowing manual exchange of clotted/clogged filter during treatment. Kit includes replacement filter, tubing for manual priming, and waste bag. Operated by trained/qualified personnel in acute care facilities. Facilitates continuity of therapy when filter flow is disrupted; allows filter replacement without disposing of entire cartridge. Output is maintained extracorporeal blood flow and solute removal via diffusion/convection. Benefits patient by reducing treatment interruptions and potential blood loss associated with full circuit replacement.

Clinical Evidence

Bench testing only. Performance testing per ISO 8638:2010 included cartridge integrity (pressure leak, bond tensile), simulated use, kink resistance, ship testing, priming volume, and waste bag integrity. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, pyrogenicity, genotoxicity, hemocompatibility, and chemical characterization. Human factors summative evaluation confirmed safety and effectiveness for intended users and environments.

Technological Characteristics

Disposable extracorporeal circuit with pre-attached detachable high-permeability hollow-fiber dialyzer (1.6m²). Materials include valve connectors tested for biocompatibility. Sterilization via Gamma radiation (10-6 SAL). Connectivity: Standalone accessory for NxStage System One. No software/algorithm components.

Indications for Use

Indicated for patients with acute or chronic renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration in acute care facilities. Used for filter replacement when flow is compromised. Contraindications not specified.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• NxStage System One Cartridge Express (K061837)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

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

| Permissive Use (Part 91 CFR 901 Subpart D) | <span style="text-decoration: overline;">☒</span> |
|-----------------------------------------------|---------------------------------------------------|
| 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 Information<br>Name: | NxStage Medical, Inc. |
| Phone: | 978-450-5275 |
| Fax: | 978-687-4750 |
| Email address: | [e-mail]<br>[e-mail] |
| Manufacturer | NxStage Medical, Inc. 350<br>Merrimack Street<br>Lawrence, MA 01843 |
| FDA Establishment<br>Registration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix<br>1000 S. Sarah Place<br>Ontario, CA 91761 |
| | Sterigenics Fort Worth 3125<br>Wichita Ct.<br>Fort Worth, TX 76140USA |
| | Steris<br>1435 Isomedix Place<br>El 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:

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.

# 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.

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.

# 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 Speedswap<br>Proposed Device | NxStage Cartridge Express<br>K061837 - Predicate | COMPARISON |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | For treatment of renal failure or fluid overload using<br>hemofiltration, hemodialysis, and/or ultrafiltration | For treatment of renal failure or fluid overload using<br>hemofiltration, hemodialysis, and/or ultrafiltration | SAME |
| Therapies<br>Indicated | Continuous/intermittent hemofiltration and/or<br>ultrafiltration Continuous/intermittent hemodialysis and/or<br>ultrafiltration and slow continuous<br>ultrafiltration | Continuous/intermittent hemofiltration and/or<br>ultrafiltration Continuous/intermittent hemodialysis<br>and/or ultrafiltration and slow continuous ultrafiltration | SAME |
| Principal of<br>Operation | 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 |
| Sterilization<br>Method | Gamma; 10-6 SAL | Gamma; 10-6 SAL | SAME |
| Product<br>Configuration | Disposable extracorporeal circuit with pre-attached<br>detachable filter for use with the NxStage System One. This<br>Cartridge is configured with connections to<br>allow the filter to be exchanged. | Disposable extracorporeal circuit with pre-attached filter<br>for use with the NxStage System One. | MODIFIED |
| Indications<br>for Use | The NxStage System One is indicated for the treatment of<br>acute and chronic renal failure or fluid overload using<br>hemofiltration, hemodialysis, and/or ultrafiltration, in an<br>acute care facility.<br><br>The NxStage Cartridge Express with Speedswap is an<br>optional accessory device to be used exclusively with the<br>NxStage System One for facilitating the removal and<br>replacement of a flow-compromised filter during<br>treatment of acute and chronic renal failure or fluid<br>overload. The device would be used when hemofiltration,<br>hemodialysis, and /or ultrafiltration may become<br>disrupted.<br><br>All treatments must be administered under a physician's<br>prescription and must be observed by a trained and<br>qualified person, considered to be competent in the use of<br>this device by the prescribing physician. | The NxStage System One is indicated for the treatment of<br>acute and chronic renal failure or fluid overload using<br>hemofiltration, hemodialysis, and/or ultrafiltration, in an<br>acute or chronic care facility. The System is also indicated for<br>hemodialysis with or without ultrafiltration in the home.<br><br>All treatments must be administered under a physician's<br>prescription, and must be observed by a trained and qualified<br>person, considered to be competent in the use of this device<br>by 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.