Predicate Devices

K061387, K100364, K032431, K071298, K923312

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a single-use extracorporeal blood circuit and fluid management device with a filter, focusing on its physical characteristics and performance in dialysis. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is indicated for the treatment of acute and chronic renal failure or fluid overload, which are therapeutic interventions.

Diagnostic

No
The device is used for treatment (hemofiltration, hemodialysis, and/or ultrafiltration) of renal failure or fluid overload, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter," which are physical hardware components. The performance studies also describe testing of physical properties like strength, volume, tensile strength, and hemocompatibility.

IVD (In Vitro Diagnostic)

Based on the provided information, 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/or ultrafiltration. These are therapeutic procedures performed directly on the patient's blood, not tests performed on samples outside the body to diagnose or monitor a condition.
Device Description: The device is described as an extracorporeal blood circuit and fluid management device with a filter. This aligns with devices used for blood purification treatments, not diagnostic testing.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, etc.) to provide diagnostic information.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat a condition by processing the patient's blood externally.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One, in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Product codes (comma separated list FDA assigned to the subject device)

78 KDI

Device Description

The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler.

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

adult patients

Intended User / Care Setting

chronic care dialysis facility or acute care unit.
trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

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 testing for the integrity of the strength between connections (pressure leak testing); priming volume assessment; tensile testing of joints and materials of tubing segments; tubing clamps testing; kink resistance testing; hemocompatibility testing; pressure drop, ultrafiltration rates, clearance determination, and sieving coefficients testing, as well as simulated use testing. All predetermined acceptance criteria were met. Results of this testing also document that the proposed NxStage System One Low Volume Cartridge Express device is substantially equivalent to the predicate devices and is suitable for the labeled indications 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.

K061387, K100364, K032431, K071298, K923312

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

Regulation Number and Section

§ 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.”

Summary

0

510K Summar

K123395

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

MAR 0 7 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

A. Date:	March 4, 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:	Mary Lou Stroumbos
Regulatory Affairs Manager
Phone:	(978) 687-4872
Fax:	(978) 687-4750
Manufacturer:	NxStage Medical, Inc.
350 Merrimack Street
Lawrence, MA 01843
United States
FDA Establishment
Registration Number:	3003464075
Sterilization Site:	Steris Isomedix
1000 S. Sarah Place
Ontario, CA 91761

510(k) Premarket Notification NxStage Medical, Inc.

Page 1 of 7

1

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

C. Device Name:

| Trade/Proprietary Name: | NxStage System One Low Volume
Cartridge Express |
|-------------------------|---------------------------------------------------------------------------------|
| Common/Usual Name: | Dialyzer with High Permeability
Hemodialysis System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 21 CFR 876.5860 |
| Product Code: | 78 KDI – Dialyzer, High Permeability with
or without Sealed Dialysate System |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-
Renal (GRDB) |

D. Predicate Devices:

NxStage Cartridge Express	K061387
Gambro Cartridge Blood Set Low Weight - Low Volume Set	K100364
Gambro Prisma M60 Set	K032431
Minntech HF Junior Hemofilter	K071298
Minntech High Permeability Dialyzer	K923312

E. Substantial Equivalence:

The NxStage System One Low Volume Cartridge Express device is substantially equivalent in design, function and operation to the identified predicates.

F. Device Description/Indications for Use:

The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler.

2

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

Indications for use:

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One, in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

G. Technological Characteristics

The proposed device has the same technological characteristics and is similar in design and configuration as the predicate devices.

Device Comparison Table
Parameter	NxStage System
One Low
Volume
Cartridge
Express	Predicate
Device
NxStage
Cartridge
Express
K061837	Predicate
Device
*Gambro
Cartridge
Blood Set Low
Weight Low
Volume
K100364	Predicate
Device Gambro
Prisma M60
Disposable Set
K032431
PRODUCT	Disposable
extracorporeal
circuit for use with
the NxStage
System One.
Consists of
dialyzer and
disposable
NxStage
Cartridge.	Disposable
extracorporeal
circuit for use
with the NxStage
System One.
Consists of
dialyzer and
disposable
NxStage
Cartridge.	Disposable,
extracorporeal
circuit for use
with the Phoenix
Dialysis Delivery
System	Disposable,
extracorporeal
circuit for use with
the Prismaflex
system. Consists
of AN69 hollow
fiber hemofilter
dialyzer and
tubing lines.
Device Comparison Table
Parameter	NxStage System
One Low Volume
Cartridge
Express	Predicate
Device
NxStage
Cartridge
Express
K061837	Predicate
Device
*Gambro
Cartridge
Blood Set Low
Weight Low
Volume
K100364	Predicate
Device Gambro
Prisma M60
Disposable Set
K032431
INDICATIONS
FOR USE	The NxStage
System One Low
Volume Cartridge
Express is
indicated for use
only with the
NxStage System
One in a chronic
care dialysis facility
or acute care unit.
It is indicated for
use in adult
patients for the
treatment of acute
and chronic renal
failure or fluid
overload using
hemofiltration,
hemodialysis,
and/or
ultrafiltration.	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 our without
ultrafiltration in
the home.	The Gambro
Cartridge Blood
Set Low Weight-
Low Volume is
intended for
single use in a
hemodialysis
treatment using
the Phoenix
Dialysis Delivery
System.

The Low-Weight
Low Volume
model is used
when a low
extra-corporeal
blood volume is
recommended.
The Low Weight-
Low Volume
model with a
priming volume
of 40 ml is
indicated for
patients with a
body weight
greater than 15
kg and lower or
equal to 20 kg. | Indicated for use
with the Prisma
control unit in
providing
continuous fluid
management and
renal replacement
therapies for
patients who
have acute renal
failure, fluid
overload, or both. |
| | All treatments must
be administered
under a physician's
prescription, and
must be performed
by a trained and
qualified person,
considered to be
competent in the
use of this device
by the prescribing
physician. | All treatments
must be
administered
under a
physician's
prescription, and
must be
performed by a
trained and
qualified person,
considered to be
competent in the
use of this
device by the
prescribing
physician. | | |
| Device Comparison Table | | | | |
| Parameter | NxStage System
One Low
Volume
Cartridge
Express | Predicate
Device
NxStage
Cartridge
Express
K061837 | Predicate
Device
*Gambro
Cartridge
Blood Set Low
Weight Low
Volume
K100364 | Predicate
Device Gambro
Prisma M60
Disposable Set
K032431 |
| THERAPIES
INDICATED | Continuous/
intermittent
hemofiltration
and/or
ultrafiltration.
Continuous/
intermittent
hemodialysis
and/or
ultrafiltration and
slow continuous
ultrafiltration | Continuous/
intermittent
hemofiltration
and/or
ultrafiltration.
Continuous/
intermittent
hemodialysis
and/or
ultrafiltration and
slow continuous
ultrafiltration | Hemodialysis | SCUF-slow
continuous
ultrafiltration
CVVH-continuous
venovenous
hemofiltration
CVVHD-
continuous
hemodialysis
CVVHDF-
continuous
venovenous
hemodiafiltration |
| PRINCIPLE
OF
OPERATION | Removal of
solutes via
diffusion or
convection | Removal of
solutes via
diffusion or
convection | Removal of
solutes via
diffusion | Removal of
solutes via
diffusion and/or
convection |
| HOW
SUPPLIED | Dialyzer pre-
connected to
disposable
NxStage Cartridge | Dialyzer pre-
connected to
disposable
NxStage
Cartridge | Sterile non
pyrogenic blood
pathway is
supplied sealed
in plastic
package | The Prismaflex
M60 set consists
of an AN69
hollow fiber
hemofilter
dialyzer and
tubing lines |
| PRIMING
VOLUME | 15 mL (filter)
70 mL (cartridge
set total) | 91 mL (filter)
175 – 200 mL
(cartridge set
total) | 40 mL (blood
tubing set) | 42mL ± 10%
(filter)
93 mL (Set total) |

3

K123395

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

510(k) Premarket Notification NxStage Medical, Inc.

4

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

*Note: K100364 does not feature a pre-attached dialyzer.

:

5

K123395

NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

Device Comparison Table
Parameter	NxStage
System One
Low Volume
Cartridge
Express	Predicate
Device
NxStage
Cartridge
Express
K061837	Predicate
Device
Gambro
Prisma M60
Disposable
Set
K032431	Predicate
Device
Minntech
HF Junior
Hemofilter
K071298	Predicate
Device
Minntech
High
Permeability
Dialyzer
K923312
FIBERS	Polyethersulfone	Polyethersulfone	Acrylonitrile
and sodium
methallyl
sulfonate
copolymer	Polysulfone	Polysulfone
FIBER
INTERNAL
DIAMETER	200 μm	200 μm	240 μm	200 μm	200 μm
FIBER WALL
THIICKNESS	30 μm	30 μm	50 μm	Not
available	Not available
FIBER
LENGTH	10 cm	23 cm	27 cm
overall
dimension	15 cm
overall
dimension	9.42 cm
EFFECTIVE
SURFACE
AREA	0.21 m²	1.6 m²	0.60 m²	0.09 m²	0.30 m²
PRIMING
VOLUME	15 ml (filter)
70 ml
(cartridge)	91 ml (filter)
175 – 200 ml
(cartridge)	42 ml ± 10%
(blood
priming
volume in
filter)
(93 ml blood
volume in
set)	8 ml (filter)	28 ml (filter)
MAX. TMP	500 mmHg	500 mmHg	450 mmHg	500 mmHg	500 mmHg

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 substantially equivalent to predicate devices. Performance, verification and validation testing was conducted to characterize performance of the proposed device. This included testing for the integrity of the strength between connections (pressure leak testing); priming volume assessment; tensile testing of joints and materials of tubing segments; tubing clamps testing; kink resistance testing; hemocompatibility

6

NxStage Medical, Inc. . NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification

testing; pressure drop, ultrafiltration rates, clearance determination, and sieving coefficients testing, as well as simulated use testing. All predetermined acceptance criteria were met. Results of this testing also document that the proposed NxStage System One Low Volume Cartridge Express device is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.

7

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2013

NxStage Medical, Inc. % Ms. Mary Lou Stroumbos Regulatory Affairs Manager 350 Merrimack Street LAWRENCE MA 01843

Re: K123395

Trade/Device Name: NxStage System One Low Volume Cartridge Express Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 31, 2013 Received: February 5, 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. Isting 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.

8

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/8/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a stylized font. The name is written in black ink and is easily readable. The letters "R" and "F" are stylized with a geometric design.

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

9

Indications for Use

510(k) Number (if known): K123395

Device Name: NxStage System One Low Volume Cartridge Express

Indications for Use:

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed 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 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. 2013.03.07 16:

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123395 510(k) Number ________________________________________________________________________________________________________________________________________________________________