(104 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on electromechanical components and a user interface for displaying information and instructions.
Yes
The device is indicated for the treatment of acute and chronic renal failure, fluid overload, and Therapeutic Plasma Exchange, which are all therapeutic interventions.
No
The device is indicated for treatment of renal failure and fluid overload, and for therapeutic plasma exchange, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly states that the NxStage System One is comprised of a cycler (electromechanical control unit), a cartridge (sterile, single-use circuit), and NxView (a touch screen interface). While NxView is a software component, the overall device includes significant hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NxStage System One is described as a system for treating renal failure and fluid overload using hemofiltration, hemodialysis, and ultrafiltration. It is also used for Therapeutic Plasma Exchange. These are all procedures performed on the patient's blood or plasma outside the body, but the primary function is treatment and fluid management, not diagnostic testing of a sample.
- Lack of Diagnostic Claims: The intended use and device description focus on treatment and fluid management, not on analyzing a sample to provide diagnostic information.
Therefore, the NxStage System One is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
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 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.
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
acute or chronic 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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
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 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 C |
| Express) | |
| 1000 S. Sarah Place | |
| Ontario, 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 1
| Device Technological Characteristics Comparison Table | ||
|---|---|---|
| Parameter | Proposed Device | |
| NxStage System One | ||
| with NxView | Predicate Device | |
| NxStage System One | ||
| (K122051) | ||
| Intended Use | ||
| Hemodialysis | Yes | Yes |
| Hemofiltration | Yes | Yes |
| Ultrafiltration | Yes | Yes |
| Technology / Components: | ||
| Pumps | Same | 4 peristaltic pumps |
| Valves (clamps) | Same | |
| Same | 2 solenoid actuated pinch clamps | |
| 8 cam driven pinch clamps |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
Confidential
3
| Table 1
| Device Technological Characteristics Comparison Table | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Proposed Device | |||||||
| NxStage System One with | ||||||||
| NxView | Predicate Device | |||||||
| NxStage 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 /Dialysate | ||||||||
| Flow | 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 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 | 15% reduction in detector signal | |||||||
| lasting 20 seconds minimum. Signal | ||||||||
| reduction % based on a 0.35 ml/min | ||||||||
| leak rate of 32 Hct blood. | 15% reduction in detector signal lasting | |||||||
| 20 seconds minimum. Signal reduction | ||||||||
| % based on a 0.45 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 ±100 ml/hr* | ||||||||
| or + 5% UF* ≤ 3 ± 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 |
Traditional 510(k) Premarket Notification
NxStage Medical, Inc.
Confidential
・
4
. '
| Table 1
| Device Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Parameter | Proposed Device | |||
| NxStage System One with | ||||
| NxView | Predicate Device | |||
| NxStage System One | ||||
| (K122051) | ||||
| Dialysate | Same | Dialysate available as pre-packaged | ||
| pre-mixed sterile fluids or via the | ||||
| PureFlow 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 interface | |||
| included as standard with NxStage | ||||
| System One | OneView (K040074) touch screen | |||
| interface 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
5
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.
6
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
7
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