(285 days)
Not Found
No
The document describes an electromechanical control unit and a fluid management circuit for dialysis and plasma exchange. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the treatment of acute and chronic renal failure, or fluid overload" and "for Therapeutic Plasma Exchange," which are therapeutic applications.
No
This device is used for treatment (hemofiltration, hemodialysis, ultrafiltration, and therapeutic plasma exchange) of renal failure or fluid overload, not for diagnosing conditions.
No
The device description explicitly states it is comprised of an electromechanical control unit (NxStage Cycler) and a sterile, single-use extracorporeal blood and fluid management circuit (NxStage Cartridge), which are hardware components.
Based on the provided text, the NxStage System One is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of renal failure and fluid overload through procedures like hemofiltration, hemodialysis, ultrafiltration, and therapeutic plasma exchange. These are all procedures performed directly on the patient's blood or plasma outside of the body, but the purpose is therapeutic treatment, not diagnostic testing of samples.
- Device Description: The description details an electromechanical control unit and a sterile circuit for managing blood and fluid extracorporeally (outside the body). This aligns with a therapeutic device used for blood purification or exchange.
- Lack of Diagnostic Language: There is no mention of analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's condition. The focus is on the physical process of filtering or exchanging blood/fluid.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The NxStage System One's function is therapeutic treatment, not diagnostic analysis.
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 hemodialysis with or without ultrafiltration in the home.
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.
Product codes
KDI
Device Description
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge, a sterile, singleuse 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 and is also indicated for hemodialysis with or without ultrafiltration in the home. The NxStage System One 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
"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."
"in an acute or chronic care facility" and "in the home" for hemodialysis. "in a clinical environment" for Therapeutic Plasma Exchange.
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, verification and validation testing was conducted to characterize performance of the proposed device. This included verification, safety, performance, and software testing. All predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage System One with a therapy fluid pump rate of 300 ml/min (18 L/hr) 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
510(k) Summary
K122051
page 1 of 3
NxStage Medical, Inc. NxStage System One Special 510(k) Device Modification
APR 2 3 2013
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
| 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 |
| Regulatory Affairs Manager | |
| 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 |
Cartridge Express) 1000 S. Sarah Place Ontario, CA 91761
Special 510(k) Device Modification NxStage Medical, Inc.
A.
1
K122051
page 2 of 3
NxStage Medical. Inc. NxStage System One Special 510(k) Device Modification
- B. Device Name: Trade/Proprietary Name:
Product Code:
Device Panel:
Common/Usual Name:
Classification Name:
Regulation Number:
Device Classification:
NxStage® System One™
Hemodialysis System High Permeability Hemodialysis System 876.5860 78 KDI Class II Gastroenterology/Urology
C. Substantial Equivalence:
This submission is a Special 510(k) Device Modification as described in the FDA's Guidance document entitled, "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this Special 510(k), NxStage has provided certification of compliance to 21 CFR §820.30 Design Control Requirements. Design validation testing was performed to ensure that the NxStage System One with modification to increase the therapy fluid pump rate from 200 ml/min (12 L/hr) to 300 ml/min (18 L/hr) meets design specifications. The NxStage System One has been compared to the legally marketed predicate device as cleared through K093069 (October 23, 2010) and was found to be substantially equivalent.
D. Device Description/Indications for Use:
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge, a sterile, singleuse 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 and is also indicated for hemodialysis with or without ultrafiltration in the home. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
Special 510(k) Device Modification NxStage Medical, Inc.
2
NxStage Medical, Inc. NxStage System One Special 510(k) Device Modification
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 hemodialysis with or without ultrafiltration in the home.
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.
E. 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 features a therapy fluid pump rate of 300 ml/min (18 L/hr) and is designed with similar software, components and features also used in the predicate device.
F. 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. This included verification, safety, performance, and software testing. All predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage System One with a therapy fluid pump rate of 300 ml/min (18 L/hr) is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2013
NxStage Medical, Inc. % Ms. Mary Lou Stroumbos Regulatory Affairs Manager 350 Merrimack Street LAWRENCE MA 01843
Re: K122051
Trade/Device Name: NxStage System One Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 22, 2013 Received: March 25, 2013
Dear Ms. 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.
4
Page 2 - Ms. 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 (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
5
INDICATIONS FOR USE
510(k) Number (if known): K122051
Device Name:
NxStage System One
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 hemodialysis with or without ultrafiltration in the home.
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.
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
Herbert | 2 Merner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122051 510(k) Number