(184 days)
Not Found
No
The document describes a standard hemodialysis system and its components, focusing on the physical mechanism of filtration and performance metrics related to clearance and ultrafiltration. There is no mention of AI, ML, or any computational analysis of data for decision-making or control beyond basic system operation.
Yes
The device is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, which are medical treatments.
No
Explanation: The device is indicated for the treatment of renal failure and fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. It removes waste products from the patient's blood. This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states that the system consists of an "electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit," which are hardware components.
Based on the provided information, the NxStage System One is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of renal failure and fluid overload using techniques like hemofiltration, hemodialysis, and ultrafiltration. These are direct treatments applied to the patient's blood, not tests performed on samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a system that filters blood and removes waste products. This is a therapeutic process, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention analyzing samples, detecting analytes, or providing diagnostic information. The performance metrics listed (clearance rates) relate to the device's ability to perform its filtering function, not to the accuracy of a diagnostic test.
In summary, the NxStage System One is a therapeutic device used for blood purification, not a device used to perform tests on samples outside the body for diagnostic purposes.
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 or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.
All treatments must be administered under 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 is the subject of this 510(k) and is available in two (2) configurations as shown in Table 1.
Table 1: Model Numbers and Description
| Description | Model Number |
|---|---|
| NxStage Cartridge Express | CAR-170-E |
| NxStage Cartridge Express with needleless access sites | CAR-172-E |
The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express". The NxStage Cartridge Express is a gammasterilized, single-use device. The dialyzer is provided with the blood pathway sterile and nonpyrogenic.
The NxStage System One dialysis system consists of an electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit (NxStage Cartridge). The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express".
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.
The NxStage Cartridge Express filter is made up of a fiber bundle maintained within a polyethylene terephthalate glycol (PETG) dialyzer housing. The polysulfone fiber bundle is a semipermeable, hollow fiber membrane through which water molecules and smaller molecular weight solutes pass from the blood to the dialysate, but larger molecular weight solutes (such as proteins) do not. Uremic toxins and waste products are removed from the patient's blood by means of diffusion during hemodialysis.
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
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Intended User / Care Setting
acute or chronic care facility.
home.
Must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
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 8637-1 First Edition 2017-11 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. The following testing was conducted to support the determination of substantial equivalence:
- Performance testing clearance testing, ultrafiltration performance and membrane
• performance - Structural integrity testing - positive and negative pressure decay testing and blood compartment integrity (membrane integrity)
All testing met predetermined acceptance criteria and demonstrated that, like the predicate device, the NxStage Cartridge Express is safe and effective for its intended use.
Biocompatibility Testing was performed in accordance with ISO 10993-1:2018 to support the biological safety of the dialyzer fiber change:
- Chemical analysis extractables and leachables
- Cytotoxicity, ISO Neutral Red Uptake
- Sensitization, ISO Guinea Pig Maximization
- ISO Intracutaneous Irritation
- Systemic Toxicity (i.e., Acute Systemic Toxicity and Material Mediated Pvrogenicity)
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect Extract)
- Hemocompatibility, Complement Activation - SC5b-9
- Hemocompatibility, Platelet, WBC, RBC Counts
- Hemocompatibility, Mechanical Hemolysis
- Hemocompatibility, Thrombin-antithrombin III complex (TAT)
A toxicological risk assessment was also performed. No new biocompatibility concerns were raised as a result of using the alternate fiber discussed in this submission.
No Human Factors testing was required.
Not applicable for Electrical Safety and EMC.
Not applicable for Software Verification and Validation Testing.
No animal studies were performed.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key Performance Specifications and Characteristics:
Urea, Creatinine, and Vitamin B12 clearance are key performance indicators for dialyzers due to the variety of their molecule sizes. Molecules are used to exhibit movement across the membrane. Table 2 exhibits the clearance information provided in the instructions for use (IFU) for these molecules. Figure 1 provides ultrafiltration information.
Table 2: In vitro Clearance Performance Data
| Clearance in mL/min, QUF1 = 0 mL/min | |||||
|---|---|---|---|---|---|
| QD2 in mL/min | 100 | 100 | 100 | 200 | 200 |
| QB3 in mL/min | 200 | 300 | 400 | 400 | 500 |
| Urea | 100 | 100 | 100 | 195 | 199 |
| Creatinine | 97 | 100 | 99 | 182 | 186 |
| Vitamin B12 | 84 | 92 | 95 | 138 | 143 |
QUF = Ultrafiltration rate
QD = Dialysate flow rate
QB = Blood flow rate
Figure 1: Ultrafiltration Rate graph.
In Vitro Test Results with bovine blood. Inlet conditions: Hct. 32%; Total Protein 6 gm/dL; Temperature 37° C.
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 shows 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.
March 14, 2024
NxStage Medical Inc. Denise Oppermann VP Regulatory Affairs North America 350 Merrimack Street Lawrence, Massachusetts 01843
Re: K232803
Trade/Device Name: NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: February 12, 2023 Received: February 12, 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Gema Gonzalez -S
Maura Rooney, MS 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
3
Indications for Use
510(k) Number (if known) K232803
Device Name
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
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 or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.
All treatments must be administered under 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there are three blue chevrons stacked on top of each other, pointing downwards. To the right of the chevrons, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
1. 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.
Submitter's Information 1.1.
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 350 Merrimack St. |
| Lawrence, MA 01843 USA | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Vice President |
| Preparation Date: | 11 September 2023 |
1.2. Device Name
| Trade Name: | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) |
|---|---|
| Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate 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 Sealed Dialysate System |
| FDA Review Panel: | Gastroenterology/Urology |
1.3. Legally Marketed Predicate Device
The legally marketed predicate device is the NxStage System One with Cartridge Express cleared under K061837. This predicate has not been subject to a design-related recall.
1.4. Device Description
Device Identification 1.4.1.
The NxStage Cartridge Express is the subject of this 510(k) and is available in two (2) configurations as shown in Table 1.
Table 1: Model Numbers and Description
| Description | Model Number |
|---|---|
| NxStage Cartridge Express | CAR-170-E |
| NxStage Cartridge Express with needleless access sites | CAR-172-E |
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Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name in blue text on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text reads "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
1.4.2. Device Characteristics
The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express". The NxStage Cartridge Express is a gammasterilized, single-use device. The dialyzer is provided with the blood pathway sterile and nonpyrogenic.
1.4.3. Environment of Use
The NxStage Cartridge Express is used in environments where hemodialysis is performed.
Brief Written Description of the Device 1.4.4.
The NxStage System One dialysis system consists of an electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit (NxStage Cartridge). The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express".
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.
The NxStage Cartridge Express filter is made up of a fiber bundle maintained within a polyethylene terephthalate glycol (PETG) dialyzer housing. The polysulfone fiber bundle is a semipermeable, hollow fiber membrane through which water molecules and smaller molecular weight solutes pass from the blood to the dialysate, but larger molecular weight solutes (such as proteins) do not. Uremic toxins and waste products are removed from the patient's blood by means of diffusion during hemodialysis.
1.4.5. Materials of Use
The NxStage Cartridge Express dialyzer is made up of a fiber bundle maintained within a PETG dialyzer housing. The fiber bundle located within the dialyzer housing is made of polysulfone.
1.4.6. Kev Performance Specifications and Characteristics
Urea, Creatinine, and Vitamin B12 clearance are key performance indicators for dialyzers due to the variety of their molecule sizes. Molecules are used to exhibit movement across the membrane. Table 2 exhibits the clearance information provided in the instructions for use (IFU) for these molecules. Figure 1 provides ultrafiltration information.
| Clearance in mL/min, QUF1 = 0 mL/min | |||||
|---|---|---|---|---|---|
| QD2 in mL/min | 100 | 100 | 100 | 200 | 200 |
| QB3 in mL/min | 200 | 300 | 400 | 400 | 500 |
| Urea | 100 | 100 | 100 | 195 | 199 |
| Creatinine | 97 | 100 | 99 | 182 | 186 |
Table 2: In vitro Clearance Performance Data
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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other.
| Clearance in mL/min, QUF1 = 0 mL/min | |||||
|---|---|---|---|---|---|
| Vitamin B12 | 84 | 92 | 95 | 138 | 143 |
| 1 QUF = Ultrafiltration rate |
Quif 2 QD = Dialysate flow rate
3 QB = Blood flow rate
Image /page/6/Figure/5 description: The image is a graph titled "Ultrafiltration rate". The x-axis is labeled "TMP (mmHg)" and ranges from 0 to 600. The y-axis is labeled "Quf (ml/min)" and ranges from 0 to 250. There are 5 lines on the graph, each representing a different variable: Quf @ Qb200, Quf @ Qb300, Quf @ Qb400, Quf @ Qb500, and Quf @ Qb600.
Ultrafiltration Rate Figure 1:
In Vitro Test Results with bovine blood. Inlet conditions: Hct. 32%; Total Protein 6 gm/dL; Temperature 37° C.
1.5. Intended Use
The NxStage System One and its related components is used to treat patients with renal insufficiency and/or fluid overload by delivering hemofiltration, hemodialysis, ultrafiltration, or a combination of hemofiltration/ultrafiltration or hemodialysis/ultrafiltration.
1.6. 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 or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.
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Image /page/7/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS" in large, bold, blue letters, with the words "MEDICAL CARE" underneath in the same style.
All treatments must be administered under 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.
1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the proposed NxStage Cartridge Express remain unchanged when compared to the predicate device, the NxStage Cartridge Express cleared under K061837:
- Intended use including the same indications for use ●
- Fundamental Scientific Technology / Operating Principle ●
- Essential performance requirements
- . Materials, aside from the alternate dialyzer fiber (subject of this submission)
- Sterilization method, packaging, and sterility label claims ●
1.8. Performance Data
Performance testing was conducted in accordance with ISO 8637-1 First Edition 2017-11 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. The following testing was conducted to support the determination of substantial equivalence:
- Performance testing clearance testing, ultrafiltration performance and membrane ● performance
- . Structural integrity testing - positive and negative pressure decay testing and blood compartment integrity (membrane integrity)
All testing met predetermined acceptance criteria and demonstrated that, like the predicate device, the NxStage Cartridge Express is safe and effective for its intended use.
Biocompatibility Testing 1.8.1.
The following testing was performed in accordance with ISO 10993-1:2018 to support the biological safety of the dialyzer fiber change:
- Chemical analysis extractables and leachables ●
- Cytotoxicity, ISO Neutral Red Uptake
- Sensitization, ISO Guinea Pig Maximization
- ISO Intracutaneous Irritation
- . Systemic Toxicity (i.e., Acute Systemic Toxicity and Material Mediated Pvrogenicity)
8
Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the text "FRESENIUS MEDICAL CARE" is written in a bold, blue font. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect Extract) ●
- . Hemocompatibility, Complement Activation - SC5b-9
- Hemocompatibility, Platelet, WBC, RBC Counts
- Hemocompatibility, Mechanical Hemolysis ●
- Hemocompatibility, Thrombin-antithrombin III complex (TAT)
A toxicological risk assessment was also performed. No new biocompatibility concerns were raised as a result of using the alternate fiber discussed in this submission.
1.8.2. Human Factors Validation Testing
Not applicable. No Human Factors testing was required. The structural properties of the dialyzer and cartridge remain unchanged, and there is no change in how the device is set up or used. Therefore, there is no impact on usability.
Electrical Safety and Electromagnetic Compatibility (EMC) 1.8.3.
Not applicable. The NxStage Cartridge Express does not have an electrical component.
1.8.4. Software Verification and Validation Testing
Not applicable. The NxStage Cartridge Express does not contain software.
1.8.5. Animal Studies
No animal studies were performed in support of the fiber change.
Clinical Studies 1.8.6.
No clinical studies were performed in support of the fiber change.
1.9. Conclusion
The information provided in this submission demonstrates that the subject NxStage Cartridge Express functions as intended and supports the determination of substantial equivalence to the predicate device.
The results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns regarding safety or effectiveness.
The Indications for Use, technological characteristics, design, and performance requirements of the NxStage Cartridge Express 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 NxStage Cartridge Express is safe and effective for its intended use.