(82 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description and performance studies focus on electromechanical and software control systems typical of traditional medical devices.
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 for disease or injury.
No
Explanation: The device is indicated for the treatment of renal failure or fluid overload (hemofiltration, hemodialysis, and/or ultrafiltration). It is a therapy device, not a diagnostic one.
No
The device description explicitly states that the NxStage System One Plus is comprised of both an electromechanical control unit (NxStage Cycler) and a sterile, single-use extracorporeal blood and fluid management circuit (NxStage Cartridge), in addition to software. The performance studies also include extensive hardware testing (electrical standards, device performance, mechanical, thermal, etc.).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 on the patient's body, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details an electromechanical control unit and a sterile extracorporeal blood and fluid management circuit. This aligns with a system that processes blood outside the body for treatment, not a device that analyzes samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Measuring analytes or biomarkers
The NxStage System One Plus is a therapeutic device used for dialysis and ultrafiltration, which are treatments for kidney failure and fluid overload.
N/A
Intended Use / Indications for Use
The NxStage System One Plus 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
KDI
Device Description
The NxStage System One Plus 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 pre-attached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One Plus 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
Not Found
Intended User / Care Setting
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.
acute or chronic care facility, home
Description of the training set, sample size, data source, and annotation protocol
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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)
Non-clinical bench and performance testing included:
- Bench testing:
- Software testing used to characterize software performance, including: Shutdown Alarm Verification, Cycler Software Test, NSO Plus User Interface Software Verification Test, NSO Plus Alarm and Warning Verification Test, NSO Plus Data Communication Verification Test, UIC Alarm Processor SW Test, Cycler 4.12 Software Change Verification Test, NSO Plus White Box Test, NxStage System One Software White Box Test.
- Electrical standards used: ANSI / AAMI ES 60601-1: 2005 (R2012), IEC 60601-1:Ed 3.1, IEC 60601-1-2:2007, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11:2015, IEC 60601-2-16: 2012, ISO 11137-1:2006, EN ISO 14971:2007, IEC 62366:2007, 1st Ed.
- The non-invasive blood pressure measuring module meets the following standards: IEC 80601-2-30 Ed. 1.0, IEC 81060-2:2013.
- Device performance testing used to characterize device performance, including: System Performance Test, Control Subsystem Test, Safety Subsystem Test, Mechanical Fastener Verification, Pressure Subsystem Test, Electronics Subsystem Test, Operating Temperature Test, Thermal Testing on the Cycler Test, Flow Chart Test, Cycler Labeling Test, NiBP Subsystem Test, System One Chronic User Guide Warning and Precaution Verification Test, NSO Plus User Interface Subsystem Test, NX1000-10 Chronic NxStage System One, Basic Safety & Essential Performance Regulatory Test, Operating Options Test, System One NiBP Essential Performance Standards Compliance Test, Chemical Resistance Test, Ship Testing.
Results of this testing have documented that the proposed NxStage System One is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
NxStage Medical. Inc. Randall Covill Regulatory Affairs Manager 350 Merrimack Street Lawrence. MA 01843
K170469 Re:
Trade/Device Name: NxStage System One Plus Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 17, 2017 Received: February 21, 2017
Dear Randall Covill:
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.
1
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 (QS) 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.
Charles Viviano -S
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) K170469
Device Name NxStage System One Plus
Indications for Use (Describe)
The NxStage System One Plus 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
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
NxStage Medical, Inc. NxStage System One Plus Traditional 510(k) Premarket Notification
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: February 15, 2017
Submitter's Information:
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 350 Merrimack Street |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Owner/Operator Number: | 9045797 |
| Contact Person: | Randall Covill |
| Regulatory Affairs Manager | |
| Phone: | (978) 298-4163 |
| Fax: | (978) 687-4750 |
| e-mail: | rcovill@nxstage.com |
| 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 |
Device Name:
| Trade/Proprietary Name: | NxStage System One Plus |
|---|---|
| Common/Usual Name: | Hemodialysis System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 876.5860 |
| Product Code: | 78 KDI |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
Comparison to Predicate:
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 K141752 (December 19, 2014) and was found to be substantially equivalent.
Device Description:
The NxStage System One Plus is comprised of the NxStage Cycler, an electromechanical control unit;
4
NxStage Medical, Inc. NxStage System One Plus Traditional 510(k) Premarket Notification
the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One Plus is also indicated for home hemodialysis, including home nocturnal hemodialysis.
Indications for use:
The NxStage System One Plus 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 Plus 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.
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 components and features also used in the predicate device.
Summary of Non-Clinical Test/Performance Testing - Bench
Non-clinical bench and performance testing included.
- Bench testing ●
- Software testing testing used to characterize software performance O
- . Shutdown Alarm Verification
- . Cycler Software Test
- NSO Plus User Interface Software Verification Test
- NSO Plus Alarm and Warning Verification Test ■
- l NSO Plus Data Communication Verification Test
- I UIC Alarm Processor SW Test
- Cycler 4.12 Software Change Verification Test ■
- l NSO Plus White Box Test
- I NxStage System One Software White Box Test
- Electrical standards used list of electrical standards O
- ANSI / AAMI ES 60601-1: 2005 (R2012) ●
- IEC 60601-1:Ed 3.1 ●
- IEC 60601-1-2:2007 ●
- IEC 60601-1-6 ●
- IEC 60601-1-8 ●
- IEC 60601-1-11:2015 ●
- IEC 60601-2-16: 2012
- ISO 11137-1:2006
- EN ISO 14971:2007 ●
- IEC 62366:2007, 1st Ed ●
- Software testing testing used to characterize software performance O
5
NxStage Medical, Inc. NxStage System One Plus Traditional 510(k) Premarket Notification
The non-invasive blood pressure measuring module meets the following standards:
- IEC 80601-2-30 Ed. 1.0 ●
- . IEC 81060-2:2013
- o Device performance - list of testing used to characterize device performance
- System Performance Test ●
- Control Subsystem Test ●
- Safety Subsystem Test .
- Mechanical Fastener Verification ●
- Pressure Subsystem Test ●
- Electronics Subsystem Test ●
- Operating Temperature Test .
- Thermal Testing on the Cycler Test
- Flow Chart Test ●
- Cycler Labeling Test ●
- NiBP Subsystem Test ●
- System One Chronic User Guide Warning and Precaution Verification Test ●
- NSO Plus User Interface Subsystem Test ●
- NX1000-10 Chronic NxStage System One, Basic Safety & Essential ● Performance Regulatory Test
- Operating Options Test ●
- System One NiBP Essential Performance Standards Compliance Test ●
- Chemical Resistance Test .
- Ship 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. Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage System One is substantially equivalent to the predicate device and is suitable for the labeled indications for use.