(358 days)
Not Found
No
The summary describes a blood tubing set and filter for hemofiltration/ultrafiltration, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of renal failure or fluid overload, which are therapeutic uses.
No
The device is used for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration, which are therapeutic interventions rather than diagnostic processes. It's a blood tubing set with a filter, not designed to diagnose conditions but to treat them.
No
The device description explicitly states it is an "extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration." This describes a therapeutic treatment applied directly to the patient's blood, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body) to diagnose a condition.
- Device Description: The device is described as an "extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter." This is consistent with a device used for filtering blood during a treatment, not for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, the NxStage Cartridge Express is a therapeutic device used in the treatment of renal failure and fluid overload, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The NxStage Cartridge Express is an extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber 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
Not Found
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)
In vitro testing was conducted to characterize performance of the NxStage Hemofilter to provide a basis of comparison to the predicate devices. Results of in vitro studies have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the intended use specified.
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.
K002210, K982414, K923312, K942679
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
178
510(k) Summary for the NxStage Cartridge Express Page 1 of 2
DEC 11 2002
| Submitter's Name and Address: | NxStage Medical Inc.
439 Union Street
Lawrence, MA 01483 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 978-687-4700 |
| Telefax Number: | 978-687-4800 |
| Contact Person: | Karen St. Onge, Director Quality Assurance
and Regulatory Affairs |
| Date Summary Prepared: | December 17, 2001 |
| Device Trade Name: | NxStage Cartridge Express |
| Common name: | Extracorporeal Blood Circuit w/ Hemofilter |
| Classification Name: | High Permeability Hemodialysis System (21
CFR 876.5860) |
| Substantial Equivalence: | The proposed device is substantially
equivalent to other legally marketed
hemofilters/hemodialyzers previously
cleared by the FDA via the 510(k)
Notification process such as the SYNTRA
Dialyzer (Baxter Healthcare Corporation,
K002210), Cobe Arylane Hemodialyzer
(Gambro Healthcare, K982414), Renoflo® II
Hemofilter (Minntech Corp, K923312) and to
the Prisma CFM System hemofilter (Hospal
Renal Intensive Care, K942679) also
provided preconnected to the hemofiltration
system disposable tubing set. |
| Device Description: | The NxStage Cartridge Express is an
extracorporeal blood tubing set with
preconnected high flux (permeability)
hollow-fiber filter. |
| Intended Use: | For treatment of renal failure or fluid
overload using hemofiltration and/or
ultrafiltration. |
| Technological Characteristics: | The proposed device has the same
technological characteristics and is similar
in design and configuration compared with
the predicate devices. |
lxStage Cartridge Ex
1 of 2
1
KO14152
2/2
510(k) Summary for the NxStage Cartridge Express Page 2 of 2
| Summary of Non-clinical Test: | In vitro testing was conducted to
characterize performance of the NxStage
Hemofilter to provide a basis of comparison
to the predicate devices. Results of in vitro
studies have documented that the NxStage
Cartridge Express is substantially equivalent
to the predicate devices and is suitable for
the intended use specified. |
| ------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Clinical Data:
Not applicable
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service" in a simple, sans-serif font. The text is black and appears to be the only element in the image. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Ms. Norma LeMay Senior Regulatory Affairs Specialist NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA: 01843
Re: K014152
Trade/Device Name: NxStage Cartridge Express Regulation Number: 21 CFR 8876.5860 Regulation Name: High permeability hemodialysis ·· svstem Regulatory Class: II Product Code: 78 KDI Dated: September 11, 2002 Received: September 12, 2002
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
Page 2
This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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 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
510(k) Number (if known): K014152
Device Name: NxStage Cartridge Express
Indications for Use:
The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seggern
Prescription Use
OR
Over-The-Counter
Use
(Per 21 CFR 801.109)