(104 days)
NxStage System One: 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 Therapeutic Plasma Exchange in a clinical environment. 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. NxView: NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment.
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: and NxView, a flat panel touch screen interface which is mounted on top of the cycler and provides online instructions for use, summarized system information, and remote viewing of treatment information. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.
The provided text describes a 510(k) premarket notification for the "NxStage System One with NxView," a hemodialysis system. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to showcase a new device's performance against detailed acceptance criteria using a study.
Therefore, much of the requested information regarding acceptance criteria and performance studies (like sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not applicable or not available in this document.
However, I can extract information related to the device's technical characteristics and how its performance is compared to the predicate device.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating that the "NxStage System One with NxView" has the same technological characteristics or comparable specifications to its predicate device (NxStage System One (K122051)). Therefore, the "acceptance criteria" are implicitly defined by the predicate device's established performance and specifications. The "reported device performance" for the proposed device is its sameness or similarity to these predicate specifications.
| Parameter | Predicate Device (K122051) Specification/Performance (Implicit Acceptance Criteria for Proposed Device) | Proposed Device (NxStage System One with NxView) Performance |
|---|---|---|
| Intended Use | Hemodialysis, Hemofiltration, Ultrafiltration | Yes (Same) |
| Pumps | 4 peristaltic pumps | Same |
| Valves (Clamps) | 2 solenoid actuated pinch clamps, 8 cam driven pinch clamps | Same |
| Air / fluid detectors | 3 ultrasonic air/ fluid detectors | Same |
| Blood leak detector | 1 optical blood leak detector | Same |
| Pressure transducers | 5 electronic pressure transducers | Same |
| Temperature sensors | 1 electronic temperature sensor | Same |
| Blood Flow Rates | 10-600 ml/min | Same |
| Prescription Fluid /Dialysate Flow | 0-12000 ml/hr (NX1000-1 & NX1000-2), 0-18000 ml/hr (NX1000-3) | 0-12000 ml/hr (NX1000-5) - Note: This is a specific model reference in the proposed device, while the predicate lists multiple models/ranges. Implies general equivalence within range. |
| Ultrafiltration | 0-2400 ml/hr | Same |
| Transmembrane Pressure Monitoring | Yes | Same |
| Venous Pressure Monitor | 0 to 400 mmHg | Same |
| Effluent fluid Pressure Monitor | 0 to 500 mmHg | Same |
| Air Detector | Reduction of detector signal lasting 6 ms minimum (Approximates a 60 microliter bubble at 400 mmHg venous pressure and 600 ml/min blood flow) | Same |
| Blood Leak Detector | 15% reduction in detector signal lasting 20 seconds minimum (based on a 0.45 ml/min leak rate of 32 Hct blood) | 15% reduction in detector signal lasting 20 seconds minimum (based on a 0.35 ml/min leak rate of 32 Hct blood) - Note: Proposed device states a lower leak rate for the same signal reduction, implying potentially better or at least equivalent detection. |
| Effluent Volume Accuracy | 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 ±100 ml/hr* or + 5% UF*; ≤ 3 ± 25 ml/hr* (*Representing 95/90 tolerance interval established under controlled laboratory testing conditions.) | Same (refers to same complex specification as predicate) |
| IV Prescription Fluid | Off-line, sterile- physician prescribed, indicated for infusion | Same |
| Dialysate | Available as pre-packaged pre-mixed sterile fluids or via the PureFlow SL | Same |
| Compatible Blood Tubing Set | NxStage Standard Cartridge | Same |
| Software | Software version 4.8 | Software version 4.9 |
| NxView (Interface) | OneView (K040074) touch screen interface is an optional accessory | NxView touch screen interface included as standard with NxStage System One |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document refers to "Performance, verification and validation testing" (G. Summary of Non-Clinical Test/Performance Testing - Bench) to characterize the proposed device. However, specific sample sizes, study designs, or data provenance (e.g., country of origin, retrospective/prospective) for this testing are not detailed. It is bench testing, suggesting in-lab rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnoses). This submission is for a hemodialysis system based on technological characteristics and bench testing.
4. Adjudication method for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-based diagnostic device undergoing human-in-the-loop evaluation. The NxView is a user interface, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not in the context of an "algorithm-only" performance for diagnostic accuracy. The "testing" mentioned is to verify the hardware and software functionality of the hemodialysis system against engineering specifications.
7. The type of ground truth used
- For the non-clinical testing ("bench testing"), the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device and internal design requirements. The device's performance observed in testing was compared against these predefined physical and functional benchmarks.
8. The sample size for the training set
- Not applicable. This submission describes a medical device, not a machine learning model that undergoes "training."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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MAR - 3 2014
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 Prepared: | November 18, 2013 |
|---|---|
| Submitter's Information:Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack StreetLawrence, MA 01843 |
| FDA EstablishmentOwner/OperatorNumber: | 9045797 |
| Contact Person: | Mary Lou StroumbosDirector, Regulatory Affairs |
| Phone:Fax: | (978) 687-4872(978) 687-4750 |
| Manufacturer: | NxStage Medical, Inc.350 Merrimack StreetLawrence, MA 01843 |
| FDA EstablishmentRegistration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix (NxStage CExpress)1000 S. Sarah PlaceOntario, CA 91761 |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
A.
B.
Confidential
Cartridge
{1}------------------------------------------------
- C. Device Name:
Trade/Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Classification: Device Panel:
NxStage System One with NxView
Hemodialysis System High Permeability Hemodialysis System 876.5860 78 KDI Class II Gastroenterology/Urology
D. Substantial Equivalence:
The NxStage System One with NxView has the same intended use and utilizes the same fundamental technology as the predicate NxStage System One. The NxStage System One with NxView has been compared to the legally marketed predicate devices as cleared through K122051 (April 23, 2013) and K040074 (April 8, 2004) 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 Cvcler: and NxView, a flat panel touch screen interface which is mounted on top of the cycler and provides online instructions for use, summarized system information, and remote viewing of treatment information. The combined svstem is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
Confidential
{2}------------------------------------------------
Indications for use:
NxStage System One:
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 Therapeutic Plasma Exchange in a clinical environment.
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.
NxView:
Nx/iew is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access.
NxView is contraindicated as the sole method of monitoring a patient during treatment.
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 1Device Technological Characteristics Comparison Table | ||
|---|---|---|
| Parameter | Proposed DeviceNxStage System Onewith NxView | Predicate DeviceNxStage System One(K122051) |
| Intended Use | ||
| Hemodialysis | Yes | Yes |
| Hemofiltration | Yes | Yes |
| Ultrafiltration | Yes | Yes |
| Technology / Components: | ||
| Pumps | Same | 4 peristaltic pumps |
| Valves (clamps) | SameSame | 2 solenoid actuated pinch clamps8 cam driven pinch clamps |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
Confidential
{3}------------------------------------------------
| Table 1Device Technological Characteristics Comparison Table | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Proposed DeviceNxStage System One withNxView | Predicate DeviceNxStage System One(K122051) | ||||||
| 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 | ||||||
| Flow Rates: | ||||||||
| Blood | Same | 10-600 ml/min | ||||||
| Prescription Fluid /DialysateFlow | 0-12000 ml/hr (NX1000-5) | 0-12000 ml/hr (NX1000-1 & NX1000-2)0-18000 ml/hr (NX1000-3) | ||||||
| Ultrafiltration | Same | 0-2400 ml/hr | ||||||
| Transmembrane PressureMonitoring 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 6ms minimum (Approximates a 60 microliter bubble at 400 mmHg venouspressure and 600 ml/min blood flow) | ||||||
| Blood Leak Detector | 15% reduction in detector signallasting 20 seconds minimum. Signalreduction % based on a 0.35 ml/minleak rate of 32 Hct blood. | 15% reduction in detector signal lasting20 seconds minimum. Signal reduction% based on a 0.45 ml/min leak rate of32 Hct blood. | ||||||
| Effluent Volume Accuracy | Same | Greater of 300 ml/ 12 hr or 3% ofexchange volume (For softwareversions 4.7 and below)For software versions 4.8 and higher:Therapy Fluid Flow Rate L/hr) Specification greater of > 3 ±100 ml/hr*or + 5% UF* ≤ 3 ± 25 ml/hr* *Representing 95/90 tolerance intervalestablished under controlled laboratorytesting conditions. | ||||||
| IV Prescription Fluid | Same | Off-line, sterile- physician prescribed,indicated for infusion |
Traditional 510(k) Premarket Notification
NxStage Medical, Inc.
Confidential
・
{4}------------------------------------------------
. '
| Table 1Device Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Parameter | Proposed DeviceNxStage System One withNxView | Predicate DeviceNxStage System One(K122051) | ||
| Dialysate | Same | Dialysate available as pre-packagedpre-mixed sterile fluids or via thePureFlow SL (K043436 K060296,K090919 & K111174) | ||
| Compatible Blood Tubing Set | Same | NxStage Standard Cartridge | ||
| Software | Software version 4.9 | Software version 4.8 | ||
| NxView | NxView touch screen interfaceincluded as standard with NxStageSystem One | OneView (K040074) touch screeninterface is an optional accessory |
G. Summary of Non-Clinical Test/Performance Testing - Bench 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 testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with NxView is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
Confidential
Page 27
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The central image is a stylized representation of a human figure embracing a globe.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002
March 3, 2014
NxStage Medical, Inc. Mary Lou Stroumbos Director, Regulatory Affairs 350 Merrimack Street Lawrence, MA 01843
Re: K133547
Trade/Device Name: NxStage® System One™ with NxView™ Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 24, 2014 Received: January 27, 2014
Dear Mary Lou Stroumbos,
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.
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Page 2 - Mary Lou Stroumbos
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
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INDICATIONS FOR USE
510(k) Number (if known): K133547
...
NxStage® System One™ with NxView™ Device Name:
Indications for Use: NxStage System One: 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 Therapeutic Plasma Exchange in a clinical environment.
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.
NxView:
NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access.
NxVlew is contraindicated as the sole method of monitoring a patient during treatment.
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)
Benjamin R=Fishër -S 2014.03 02 18:23:28 -05'00'
Page 1 of 1
Page 21
§ 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.”