(256 days)
Not Found
No
The summary describes a physical medical device (a dialyzer) and its performance testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used for the "treatment of acute and chronic renal failure or fluid overload," which directly addresses and treats a medical condition.
No
The device description clearly states "The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "single use high flux (permeability) hollow-fiber dialyzer," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of renal failure and fluid overload using hemofiltration, hemodialysis, and ultrafiltration. These are therapeutic procedures performed on a patient's blood outside the body, but the device itself is not used to diagnose a condition by examining a sample in vitro.
- Device Description: It's a hollow-fiber dialyzer, which is a component of a dialysis system used to filter blood.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) to provide information about a patient's health status.
- Detecting or measuring specific substances or markers in a sample.
- Providing diagnostic, prognostic, or screening information.
This device is a therapeutic medical device used in the treatment of a condition, not a diagnostic device used to identify or characterize a condition.
N/A
Intended Use / Indications for Use
The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The proposed device is a single use high flux (permeability) hollow-fiber dialyzer. It is a single use disposable dialyzer with standard dialysis connectors that are connected to blood tubing sets prior to use. It is supplied individually packaged. The sterilization method is Gamma. The fibers are Polyethersulfone Membrana Purema H, with a Fiber ID of 200 μm and Fiber Wall Thickness of 30 μm. The Effective Surface Area is 1.6 m² and Priming Volume is 91 ml. The Max. TMP is 500 mmHg.
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)
Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed device 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): 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.
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
NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission
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
| A. Date | April 12, 2013 |
|---|---|
| B. Submitter's Information: | |
| Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack Street |
| Lawrence, MA 01843 | |
| United States | |
| FDA Establishment | |
| Owner/Operator Number: | 9045797 |
| Contact Person: | Nnamdi Nwachukwu |
| Regulatory Affairs Engineer | |
| Phone: | (978) 332-8477 |
| Fax: | (978) 687-4750 |
| Manufacturer: | NxStage GmbH & Co. KG |
| Anna-Vandenhoeck-Ring 24 | |
| 37081 Goettingen | |
| Bundesrepublik Deutschland | |
| FDA Establishment | |
| Registration Number: | An application for an establishment registration |
| number will be submitted prior to | |
| commercialization. | |
| Sterilization Site: | Steris Isomedix |
| 1000 S. Sarah Place | |
| Ontario, CA 91761 | |
| C. Device Name: | |
| Trade/Proprietary | |
| Name: | NxStage® 1.6m2 Dialyzer |
| Common/Usual Name: | Dialyzer, High Permeability |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 21 CFR 876.5860 |
| Product Code : | 78 KDI - Dialyzer, High Permeability with or Without |
510(k) Premarket Notification NxStage Medical, Inc.
, ... .......... 2014-01-28
.
1
NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission
| Sealed Dialysis System | |||
|---|---|---|---|
| Submission Type: | 510(k) | ||
| Device Class: | II | ||
| Device Panel: | Gastroenterology-Urology (GU)/ Gastro-Renal | ||
| (GRDB) |
D. Predicate Devices:
NxStage Cartridge Express K061837 K113023 NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer K062079 Baxter Xenium Dialyzer
E. Substantial Equivalence:
The proposed NxStage® 1.6m² Dialyzer is substantially equivalent in design, function and operation to the identified predicates.
F. Device Description/Indications for Use:
The proposed device is a single use high flux (permeability) hollow-fiber dialyzer.
Indications for use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
2
G. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as the predicate devices.
| Parameter | NxStage 1.6m2
Dialyzer
Subject of this
510(k) | Predicate Device
NxStage Cartridge
Express
K061837 | Predicate Device
Streamline Airless
System Set with
Pre-attached
dialyzer
K113023 | Predicate Device
Baxter Xenium
Dialyzer 150
K062079 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The dialyzer is
indicated for the
treatment of acute
and chronic renal
failure or fluid
overload using
hemofiltration,
hemodialysis,
and/or
ultrafiltration.
There are no
known
contraindications. | 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 single use blood
tubing set with pre-
attached dialyzer is
indicated for use with
the B. Braun Dialog
Series hemodialysis
systems for the
treatment of acute
and chronic renal
failure. There are no
known
contraindications. | Hemodialysis with
Xenium dialyzers is
indicated for
patients with acute
or chronic renal
failure when
conservative
therapy is judged to
be inadequate. It
also may be
indicated in the
treatment of
patients intoxicated
with poisons or
drugs. |
| Principle of
Operation | Removal of
solutes via
diffusion or
convection | Removal of solutes
via diffusion or
convection | Removal of solutes
via diffusion or
convection | Removal of solutes
via diffusion or
convection |
| Product
Configuration | Single use
disposable
dialyzer with
standard dialysis
connectors that
are connected to
blood tubing sets
prior to use. | Single use
disposable consisting
of a pre-attached
dialyzer and tubing
set for use on the
NxStage System
One. | Single use
disposable consisting
of a pre-attached
dialyzer and tubing
set for use on the B.
Braun Dialog Series
hemodialysis
systems. | Single use
disposable dialyzer
with standard
dialysis connectors
that are connected
to blood tubing sets
prior to use. |
| How
Supplied | Individually
packaged dialyzer. | Dialyzer pre-
connected to
disposable NxStage
Cartridge tubing set. | Dialyzer pre-
connected to
disposable B. Braun
tubing set. | Individually
packaged dialyzer. |
| Device Comparison Table | | | | |
| Parameter | NxStage 1.6m²
Dialyzer | Predicate Device
NxStage
Cartridge
Express
(K061837) | Predicate Device
Streamline Airless
System Set with
Pre-attached
dialyzer
(K113023) | Predicate Device
Baxter Xenium
Dialyzer 150
(K062079) |
| Connectors | Standard
ISO8637 DIN
Blood and
Dialysate Hansen
Connectors | Blood and
dialysate lines pre-
bonded | Blood lines pre-
bonded, Standard
ISO8637 Dialysate
Hansen Connector | Standard ISO8637 DIN
Blood and Dialysate
Hansen Connector |
| Sterilization
Method | Gamma | Gamma | Gamma | Gamma |
| Fibers | Polyethersulfone
Membrana
Purema H | Polyethersulfone
Membrana
Purema H | Polyethersulfone
Membrana
Purema H | Polyethersulfone
Membrana
Purema H |
| Fiber ID | 200 μm | 200 μm | 200 μm | 200 μm |
| Fiber Wall
Thickness | 30 μm | 30 μm | 30 μm | 30 μm |
| Effective
Surface
Area | 1.6 m² | 1.6 m² | 1.6 m² | 1.5 m² |
| Priming
Volume | 91 ml | 91 ml | 91 ml | 91 ml |
| Max. TMP | 500 mmHg | 500 mmHg | 500 mmHg | 500 mmHg |
3
.... ----------
.
4
H. Summary of Non-Clinical Test/Performance Testing - Bench
The information and data provided in this submission clearly describe the proposed device and demonstrate that the device is adequately designed for the labeled indications for use and is substantially equivalent to the predicate devices. Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
NxStage Medical, Inc. Laura F. Plath Regulatory Affairs Manager 350 Merrimack Street Lawrence, MA 01843
Re: K131050
Trade/Device Name: NxStage® 1.6m2 Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: December 6, 2013 Received: December 9, 2013
Dear Laura F. Plath,
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. 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
6
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
7
Indications for Use
510(k) Number (if known): K131050
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NxStage® 1.6m² Dialyzer Device Name:
Indications for Use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 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
Benjamin R. Fisher -S 2013.12.30 09:55:53 -05'00'