(172 days)
No
The document describes an electromechanical control unit and a sterile circuit for hemodialysis and ultrafiltration. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic interventions aimed at managing and treating specific medical conditions.
No
The device is indicated for the treatment of renal failure and fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are treatment modalities, not diagnostic functions.
No
The device description explicitly states that the NxStage System One is comprised of both an electromechanical control unit (NxStage Cycler) and a sterile, single-use extracorporeal blood and fluid management circuit (NxStage Cartridge), indicating it is a hardware-based medical device with software components, not a software-only device.
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 hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic procedures performed directly on the patient's blood, not tests performed on samples outside the body to diagnose or monitor a condition.
- Device Description: The description details an electromechanical control unit and a blood and fluid management circuit. This aligns with a system designed for extracorporeal blood treatment, not for analyzing samples.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples (like blood, urine, or tissue) for diagnostic purposes. There is no mention of reagents, assays, or any components typically associated with IVD devices.
- Clinical Study Focus: The clinical studies described focus on the effectiveness and safety of the treatment delivery (hemodialysis) and compare different treatment regimens, not on the diagnostic accuracy of any test.
Therefore, the NxStage System One is a therapeutic medical device used for treating renal conditions, not an IVD device used for diagnosis or monitoring through in vitro testing.
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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis. All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Product codes (comma separated list FDA assigned to the subject device)
ODN
Device Description
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal 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
18 years of age
Intended User / Care Setting
Acute or chronic care facility, home. Must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
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)
Clinical testing included 2 crossover studies with a total of 58 patients. There were 38 in the first study and 20 in the second study. Results were provided separately and pooled together to show substantial equivalence of nocturnal hemodialysis to daily hemodialysis in the home setting.
Pivotal Studies: NxStage conducted a US prospective, multi-center, two-treatment, twophase, open-label, cross-over Investigational Device Exemption clinical study titled "Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One." The objective of the study was to determine whether or not NHD (6-10 hours) was substantially equivalent to DHD (2-4 hours) on a per treatment basis, using the NxStage System One (NSO) in the home setting. The first phase (DHD) consisted of 2 to 4 hour treatments, and the second phase (NHD) consisted of 6 to 10 hour treatments. Both phases consisted of either 5 or 6 treatments per week over an 8 week period (40 or 48 treatments in total) using the NSO in the home environment. A 4 week training/transition period took place between the two phases. A total of 58 End Stage Renal Disease (ESRD) patients >18 years of age who were currently stable on home DHD were enrolled, of which 39 completed the study period and 19 discontinued.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary effectiveness endpoint: The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).
Primary safety endpoint: The primary safety endpoint was the composite intradialytic and interdialytic adverse event (AE) profile.
Effectiveness: For the ITT population, the probability of a successful treatment was 90.9% in the DHD phase versus 91.7% in the NHD phase. The upper limit of the confidence interval (2.9%) was less than the protocol-specified limit (10%). Hence, the treatment success rates were similar and the protocol specified noninferiority criterion was attained.
Safety: For the ITT population, the composite AE rate per 100 treatments was 8.3 in the DHD phase versus 6.9 in the NHD phase. The event profiles were similar for both phases. The rate of severe AEs per 100 treatments was 0.9 for DHD vs. 0.3 for NHD. Hypotension occurred at a rate of 1.9 vs. 0.2 per 100 treatments. The rate of muscle cramping was 1.1 per 100 treatments for both study phases.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K043436, K060296, K090919, K111174, K140571
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Re:
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
NxStage Medical, Inc. Mary Lou Strombos Director, Regulatory Affairs 350 Merrimack Street Lawrence. MA 01843
K141752 Trade/Device Name: NxStage System One Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: ODN Dated: November 20, 2014 Received: November 21, 2014
Dear Mary Lou Strombos,
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background. In the background, there is a faint, stylized logo that appears to be the letters "FDA".
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K141752
NxStage® System One™ Device Name:
- 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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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
| A. Date Prepared: | June 27, 2014 |
|---|---|
| B. Submitter's Information: | |
| Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack Street |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Owner/Operator | |
| Number: | 9045797 |
| Contact Person: | Mary Lou Stroumbos |
| Director, Regulatory Affairs | |
| Phone: | |
| Fax: | (978) 687-4872 |
| (978) 687-4750 | |
| Manufacturer: | NxStage Medical, Inc. |
| 350 Merrimack Street | |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Registration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix (NxStage Cartridge |
| Express) | |
| 1000 S. Sarah Place | |
| Ontario, CA 91761 |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
A.
4
NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
- C. Device Name: Trade/Proprietary NxStage System One Name: Common/Usual Name: Hemodialysis System Classification Name: High Permeability Hemodialysis System Regulation Number: 876.5860 Product Code: ODN Device Classification: Class II Device Panel: Gastroenterology/Urology
D. Substantial Equivalence:
The NxStage System One has the same intended use and utilizes the same fundamental technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate device as cleared through K140526 (May 19, 2014) and was found to be substantially equivalent.
E. Device Description/Indications for Use:
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.
5
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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
F. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The proposed device is designed with similar software, components and features also used in the predicate device.
| Table 1
| Device Technological Characteristics Comparison Table | ||
|---|---|---|
| Parameter | Proposed Device | |
| NxStage System One | Predicate Device | |
| NxStage System One | ||
| (K140526) | ||
| Intended Use | ||
| Hemodialysis | Yes | Yes |
| Hemofiltration | Yes | Yes |
| Ultrafiltration | Yes | Yes |
| Technology / Components: | ||
| Pumps | Same | 4 peristaltic pumps |
| Valves (clamps) | Same | 2 solenoid actuated pinch clamps |
| Same | 8 cam driven pinch clamps | |
| Air / fluid detectors | Same | 3 ultrasonic air/ fluid detectors |
| Blood leak detector | Same | 1 optical blood leak detector |
| Pressure transducers | Same | 5 electronic pressure transducers |
| Temperature sensors | Same | 1 electronic temperature sensor |
6
NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
| Table 1
| Device Technological Characteristics Comparison Table | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Proposed Device | |||||||
| NxStage System One | Predicate Device | |||||||
| NxStage System One | ||||||||
| (K140526) | ||||||||
| Flow Rates: | ||||||||
| Blood | Same | 10-600 ml/min | ||||||
| Prescription Fluid /Dialysate | ||||||||
| Flow | Same | 0-18000 ml/hr | ||||||
| Ultrafiltration | Same | 0-2400 ml/hr | ||||||
| Transmembrane Pressure | ||||||||
| Monitoring Specification | Same | Yes | ||||||
| Venous Pressure Monitor | Same | 0 to 400 mmHg | ||||||
| Effluent fluid Pressure Monitor | Same | 0 to 500 mmHg | ||||||
| Air Detector | Same | Reduction of detector signal lasting 6 ms | ||||||
| minimum (Approximates a 60 micro liter | ||||||||
| bubble at 400 mmHg venous pressure and | ||||||||
| 600 ml/min blood flow) | ||||||||
| Blood Leak Detector | Same | 15% reduction in detector signal lasting 20 | ||||||
| seconds minimum. Signal reduction % | ||||||||
| based on a 0.35 ml/min leak rate of 32 Hct | ||||||||
| blood. | ||||||||
| Effluent Volume Accuracy | Same | Greater of 300 ml/ 12 hr or 3% of exchange | ||||||
| volume (For software versions 4.7 and | ||||||||
| below) | ||||||||
| For software versions 4.8 and higher: | ||||||||
| Therapy Fluid Flow Rate L/hr) Specification greater of > 3 $\pm$ 100 ml/hr* | ||||||||
| or |
- 5% UF* ≤ 3 $\pm$ 25 ml/hr* *Representing 95/90 tolerance interval
established under controlled laboratory
testing conditions. | | | | | | |
| IV Prescription Fluid | Same | Off-line, sterile- physician prescribed,
indicated for infusion | | | | | | |
| Dialysate | Same | Dialysate available as pre-packaged pre-
mixed sterile fluids or via the PureFlow SL
(K043436 K060296, K090919, K111174 &
K140571) | | | | | | |
| Compatible Blood Tubing Set | Same | NxStage Standard Cartridge | | | | | | |
| Software | Software version 4.10 | Software version 4.9 | | | | | | |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
7
Summary of Non-Clinical Test/Performance Testing – Bench and G. Clinical Testing
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. Performance, verification and validation; and clinical testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria were met.
The following non-clinical testing was conducted:
- . System Verification and Software Validation
- Software verification & validation o
- Regression testing o
- Safety systems verification o
- Labeling verification testing O
- Simulated dialysis treatments O
The following clinical testing was conducted:
Clinical testing included 2 crossover studies with a total of 58 patients. There were 38 in the first study and 20 in the second study. Results were provided separately and pooled together to show substantial equivalence of nocturnal hemodialysis to daily hemodialysis in the home setting.
Pivotal Studies:
NxStage conducted a US prospective, multi-center, two-treatment, twophase, open-label, cross-over Investigational Device Exemption clinical study titled "Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One." The objective of the study was to determine whether or not NHD (6-10 hours) was substantially equivalent to DHD (2-4 hours) on a per treatment basis, using the NxStage System One (NSO) in the home setting. The first phase (DHD) consisted of 2 to 4 hour treatments, and the second phase (NHD) consisted of 6 to 10 hour treatments. Both phases consisted of either 5 or 6 treatments per week over an 8 week period (40 or 48 treatments in total) using the NSO in the home environment. A 4 week training/transition period took place between the two phases. A total of 58 End Stage Renal Disease (ESRD)
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
8
patients >18 years of age who were currently stable on home DHD were enrolled, of which 39 completed the study period and 19 discontinued.
Primary effectiveness endpoint:
The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).
Primary safety endpoint:
The primary safety endpoint was the composite intradialytic and interdialytic adverse event (AE) profile.
Effectiveness:
The primary endpoint for the study focused on the ability to deliver the clinically prescribed amount of therapy (success or failure). For the ITT population, the probability of a successful treatment was 90.9% in the DHD phase versus 91.7% in the NHD phase. The upper limit of the confidence interval (2.9%) was less than the protocol-specified limit (10%). Hence, the treatment success rates were similar and the protocol specified noninferiority criterion was attained.
Safety:
For the ITT population, the composite AE rate per 100 treatments was 8.3 in the DHD phase versus 6.9 in the NHD phase. The event profiles were similar for both phases. Results were similar for the PP population.
The study reported one death not related to study participation or the study device and no unanticipated adverse device effects. In the DHD phase there were 21 severe AEs reported, and in the NHD phase there were 6 severe AEs reported. Device relatedness was recorded as cannot be ruled out for one of the severe AEs: patient was unable to self-cannulate due to a non-dialysis related surgery. The remaining 26 severe AEs were considered not related to the device. The rate of severe AEs per 100 treatments was 0.9 for DHD vs. 0.3 for NHD.
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
9
The most commonly occurring AEs were OTH-other, hypotension, and muscle cramping. OTH-other included non-dialysis related injuries and surgeries (e.g. broken ankle, knee surgery, toe infection, etc.), out of range blood laboratory values, access related events, episodes of depression, infection, kidney stone, and other isolated events. OTH-other occurred at a rate of 1.3 vs. 1.6 per 100 treatments in DHD vs. NHD, respectively. Hypotension occurred at a rate of 1.9 vs. 0.2 per 100 treatments. The rate of muscle cramping was 1.1 per 100 treatments for both study phases.
The rates of adverse events were similar in the DHD and NHD phases, and the events experienced were typical of those commonly reported for dialysis patients, including episodes of hypotension and muscle cramping.
Summary
Based on the clinical performance as documented in the pivotal clinical studies, the NxStage System One in the home setting delivers NHD therapy that is substantially equivalent to DHD therapy on a per treatment basis.
Conclusion: Results of the non-clinical testing and clinical data have documented that the proposed NxStage System One is substantially equivalent to the predicate device and is suitable for the labeled indications for use.