(267 days)
Not Found
No
The description focuses on the mechanical and fluid management aspects of the device and its accessory, with no mention of AI or ML technologies.
Yes
The device is used with the NxStage System One for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, which are therapeutic interventions.
No
Explanation: The device is indicated for the treatment of renal failure and fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. It is an extracorporeal blood circuit and fluid management device and does not perform any diagnostic function.
No
The device description clearly states it is a "single use extracorporeal blood circuit and fluid management device with a pre-attached detachable high permeability hollow-fiber" and includes a "kit" with physical components like a filter, tubing, and a waste bag. This indicates it is a hardware device with physical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic procedures performed directly on the patient's blood, not diagnostic tests performed on samples in vitro (outside the body).
- Device Description: The device is described as an extracorporeal blood circuit and fluid management device with a filter. This aligns with devices used in dialysis and hemofiltration, which are therapeutic treatments.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, urine, etc.) to provide diagnostic information about a patient's condition. The purpose is to remove waste products and excess fluid from the blood.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is therapeutic, not diagnostic.
N/A
Intended Use / 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 flow-compromised 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.
Product codes
KDI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
acute care facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with ISO 8638:2010.
The following tests were performed to support performance: Cartridge integrity tests (Cartridge Pressure Leak Test, Solvent bond tensile tests), 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 testing was performed for 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.
Verification and Validation of the NxStage Cartridge Express with Speedswap was designed to verify and validate that it performs according to product specifications. 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 that the NxStage Cartridge Express with Speedswap and Express Speedswap kit are safe and effective for intended users, uses, and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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
2
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) | ☒ |
|---|---|
| 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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3
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 | |
| Name: | 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. 350 |
| Merrimack Street | |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Registration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix |
| 1000 S. Sarah Place | |
| Ontario, CA 91761 | |
| Sterigenics Fort Worth 3125 | |
| Wichita Ct. | |
| Fort Worth, TX 76140USA | |
| Steris | |
| 1435 Isomedix Place | |
| 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
Proposed Device | NxStage Cartridge Express
K061837 - Predicate | COMPARISON |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | For treatment of renal failure or fluid overload using
hemofiltration, hemodialysis, and/or ultrafiltration | For treatment of renal failure or fluid overload using
hemofiltration, hemodialysis, and/or ultrafiltration | SAME |
| Therapies
Indicated | Continuous/intermittent hemofiltration and/or
ultrafiltration Continuous/intermittent hemodialysis and/or
ultrafiltration and slow continuous
ultrafiltration | Continuous/intermittent hemofiltration and/or
ultrafiltration Continuous/intermittent hemodialysis
and/or ultrafiltration and slow continuous ultrafiltration | SAME |
| Principal of
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
Method | Gamma; 10-6 SAL | Gamma; 10-6 SAL | SAME |
| Product
Configuration | Disposable extracorporeal circuit with pre-attached
detachable filter for use with the NxStage System One. This
Cartridge is configured with connections to
allow the filter to be exchanged. | Disposable extracorporeal circuit with pre-attached filter
for use with the NxStage System One. | MODIFIED |
| 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 flow-compromised 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. | The NxStage System One is indicated for the treatment of
acute and chronic renal failure or fluid overload using
hemofiltration, hemodialysis, and/or ultrafiltration, in an
acute or chronic care facility. The System is also indicated for
hemodialysis with or without ultrafiltration in the home.
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. | MODIFIED |
6
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
7
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.