(90 days)
No
The document describes an electro-mechanical device for renal failure treatment and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for "treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration," which are therapeutic interventions.
No
Explanation: The device is indicated for "treatment of renal failure or fluid overload" using various therapeutic methods, not for diagnosing conditions.
No
The device description explicitly states that the system consists of an "electro-mechanical device" (the NxStage Cycler) and a "single-use extracorporeal blood and fluid circuit" (the NxStage Cartridge), indicating significant hardware components beyond just software.
Based on the provided information, the NxStage System One is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic procedures performed on the patient's blood outside the body, not diagnostic tests performed on samples in vitro (in a lab).
- Device Description: The device is described as an electro-mechanical cycler and a single-use extracorporeal blood and fluid circuit. This aligns with a system used for blood purification treatments, not for analyzing biological samples.
- No mention of diagnostic testing: The description focuses on the process of filtering and managing blood and fluid, not on analyzing the composition or characteristics of blood or other biological samples for diagnostic purposes.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to diagnose diseases, monitor conditions, or screen for health issues. The NxStage System One's function is to treat a condition by processing the patient's blood extracorporeally.
N/A
Intended Use / Indications for Use
The System (and all components) is intended for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration in both acute and chronic environments, as prescribed by the treating physician.
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.
Product codes
78 KDI
Device Description
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.
The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollowfiber filter.
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 by a health care provider, under physician's prescription.
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 testing was conducted to characterize the performance of the NxStage Cartridge Express during hemodialysis to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the labeled indication 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 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.”
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OCT 2 8 2003
NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
Section VIII: 510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 439 South Union Street, Suite 501 |
| Lawrence, MA 01843 | |
| Phone: | (978) 687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Norma LeMay |
| Sr. Regulatory Specialist | |
| Date of Preparation: | July 29, 2003 |
B. Device Name:
| Trade Name: | NxStage System One with Cartridge Express |
|---|---|
| Common/Usual Name: | Dialyzer with High Permeability Hemodialysis |
| System | |
| Classification Name: | Dialyzer, High Permeability with or without Sealed |
| Dialysate System (21 CFR 875.5860, Product | |
| Code 78 KDI) |
C. Substantial Equivalence/Predicate Devices:
The NxStage Cartridge Express is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA:
- NxStage Cartridge Express (K014152, cleared 12/10/02) ●
- Gambro Prisma CFM System Disposable Tubing Set (K946279, cleared . 02/10/97)
1
NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
Section VIII: 510(k) Summary
KOZZ356
D. Device Description/Intended Use:
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.
The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollowfiber filter.
The System (and all components) is intended for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration in both acute and chronic environments, as prescribed by the treating physician.
Indications for use:
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.
E. Technological Characteristics:
The NxStage Cartridge Express has the same technological characteristics and is similar in design and configuration as compared to the predicate devices. There are no material changes to the NxStage Cartridge Express as described and cleared through K014152, as a result of this 510(k) submission. The only difference between the proposed Cartridge Express as compared to the predicate (K014152) is the expansion in intended use to include hemodialysis.
F. Summary of Non-Clinical Test/Performance 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 indication for use. Performance testing was conducted to characterize the performance of the NxStage Cartridge Express during hemodialysis to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, facing left, with three curved lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, framing the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2003
Ms. Norma LeMay Senior Regulatory Specialist NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA 01843
Re: K032356
Trade/Device Name: NxStage System One With Cartridge Express Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: July 29, 2003 Received: July 30, 2003
Dear Ms. LeMay:
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.
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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
INDICATION FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name:
NxStage System One with Cartridge Express
Indication for Use:
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use_
David R. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological De 510(k) Number
06.2