(70 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware, software, and a disposable cartridge for renal treatment.
Yes
The device is indicated for the treatment of renal failure or fluid overload, which directly administers medical therapy to patients.
No
The device description and intended use state that it is "indicated for treatment of renal failure or fluid overload," which implies a therapeutic rather than a diagnostic function. There is no mention of diagnosing conditions or providing diagnostic information.
No
The device description explicitly states that the NxStage System One consists of "hardware, software and a sterile disposable cartridge," indicating it is not a software-only device.
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 directly on the patient's blood, not diagnostic tests performed on samples in vitro (outside the body).
- Device Description: The description reinforces the therapeutic nature of the device, focusing on the hardware, software, and disposable cartridge used for treatment.
- Lack of IVD Characteristics: The description does not mention any activities typical of IVDs, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information.
Therefore, the NxStage System One is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 prescription.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, 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 prescription.
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
health care provider
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)
Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage System One has been compared to the predicate device and found to be substantially equivalent.
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.
Not Found
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.
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.”
0
K040696
Page 1 of 2
Section 7 510(K) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR 807.92.
| Date: | March 16, 2004 |
|---|---|
| Common/Usual Name: | Hemodialysis System |
| Trade/Proprietary Name: | NxStage System One |
| Classification Name & | |
| Device Classification: | Dialyzer, High Permeability with or without |
| Dialysate System; Class II | |
| Product Code: | KDI |
| 21 CFR Ref.: | 876.5860 |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal |
| (GRDB) | |
| 510(k) Sponsor & | |
| Owner/Operator: | NxStage Medical, Inc |
| 439 South Union St, Suite 501 | |
| South Lawrence, MA 01843 | |
| Owner/Operator No. 9045797 | |
| Contact Person: | Norma LeMay |
| Manager, Regulatory Affairs |
Device Description:
The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, 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 prescription.
Confidential
1
Substantial Equivalence:
This submission is a Special 510(k) Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Pre-Market Notifications." In support of this 510(k), NxStage has provided certification of compliance to 21 CFR 820.30 Design Control requirements. Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage System One has been compared to the predicate device and found to be substantially equivalent.
Conclusion:
Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage System One has been shown to meet the minimum requirements that are considered acceptable for its intended use.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is a prominent symbol, representing the United States government. The seal is likely used on official documents and communications from the HHS.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2004
Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union St., 5th Floor LAWRENCE MA 01843
Re: K040696
Trade/Device Name: NxStage System One Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: May 6, 2004 Received: May 7, 2004
Dear Ms. LeMay:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 5 I 0(k) This letter will allow you to ocgin marteeing your antial equivalence of your device to a legally premarket notification. The PDA miding of cassification 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 If you desire specific advice tor your dones on 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 Additionally, Tor questions on the promotion on the regulation entitled, "Misbranding Office of Compliance at (101) 37 1 1057. Part 807.97) you may obtain. Other general by recence to premarked nonitodion (21 or Act may be obtained from the Division of Small information on your responsionalites and Consumer Assistance at its toll-free number (800) 638-2041 or Mandiacturers, International and Collisation of the Collection of Schools of School
Sincerely yours,
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
4
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): _ KO40696
NxStage System One Device Name:
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 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
Nancyc brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
002