K Number
K043436
Device Name
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
Date Cleared
2005-03-17

(94 days)

Product Code
Regulation Number
876.5820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Device Description
Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.
More Information

Not Found

No
The summary describes a device that prepares dialysate by mixing concentrate, and the performance studies focus on demonstrating substantial equivalence to predicate devices based on functional performance and safety, with no mention of AI/ML technologies or related performance metrics.

No
The device prepares dialysate, which is then used by another system for hemodialysis, making it an accessory rather than a direct therapeutic device itself.

No

The device is an accessory that prepares dialysate for hemodialysis, which is a treatment process, not a diagnostic one. It mixes concentrates to produce dialysate and ensures it meets standards for use in hemodialysis therapies.

No

The device description explicitly states it is an "optional accessory" to the NxStage System One and "mixes with concentrate to produce" dialysate. This indicates a physical component involved in the preparation process, not solely software.

Based on the provided information, the NxStage Dialysate Preparation Module is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use is to prepare dialysate for use during hemodialysis. Hemodialysis is a treatment that filters blood outside the body.
  • Device Description: The device mixes concentrate to produce dialysate, which is then used with the NxStage System One during hemodialysis therapies. This is a process that happens outside the body, but the dialysate itself is a fluid used in a medical treatment, not a substance used to test a sample from the body.
  • Lack of IVD Characteristics: The description does not mention analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to diagnose, monitor, or screen for diseases or conditions.

The device is an accessory for a hemodialysis system, which is a medical device used for treatment, not diagnosis.

N/A

Intended Use / Indications for Use

The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

Product codes

78 KPO,FKR

Device Description

Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.

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

As there is no technological differences as compared to the predicate devices, performance testing was deemed appropriate and was conducted to characterize the performance of the proposed Prep Module to provide a basis of comparison to the predicate devices. The Prep Module utilizes FDA cleared devices with minor modifications, and additional components which are simple to operate using the Verification and Validation testing, which includes provided device labeling. simulated use testing, sufficiently demonstrates that the Prep Module can be used safely as intended. All testing performed is summarized in Section V of this 510(k) submission. Results of the testing presented in this 510(k) have demonstrated that the NxStage Prep Module is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.

Key Metrics

Not Found

Predicate Device(s)

K010131, K994267, K810127

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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NxStage Medical, Inc. NxStage Dialysate Prep Module MAR 1 7 2005 510(k) Premarket Notification

K043436
Page 1 of 2

Section VIII: 510(k) Summary of Safety & Effectiveness

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
Manager, Regulatory Affairs
Date of Preparation:December 10, 2004

B. Device Name:

Trade Name:NxStage Dialysate Preparation Module
Common/Usual Name:Subsystem, proportioning
Classification Name:Hemodialysis System & Accessories (Class I
medical device under 21 CFR 875.5820, (Product
Code 78 FKR)

C. Substantial Equivalence/Predicate Devices:

The NxStage Dialysate Prep Module is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA:

  • Aksys PHD System, K010131 (cleared on 03/26/02) .
  • Fresenius 2008K Hemodialysis System, K994267 (cleared on 03/16/00) .
  • Gambro Bicarbonate Module BCM-10, K810127 (cleared on 02/25/81) .

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NxStage Medical, Inc. NxStage Dialysate Prep Module 510(k) Premarket Notification

K043436
Page 2 of 2

Section VIII: 510(k) Summary of Safety & Effectiveness

D. Device Description/Indications for Use:

Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.

Indications for use:

The NxStage Dialysate Preparation Module is an optional accessory to the NxStage rne NAGtago Dialysate for use during hemodialysis, as prescribed by the physician.

There are no known contraindications with the use of the NxStage Dialysate Preparation Module.

E. Technological Characteristics:

The proposed Prep Module has the same technological characteristics and is similar in design and configuration as compared to the predicate devices. It uses purified AAMI water that mixes with AAMI concentrate to produce AAMI dialysate. The proposed device is designed and assembled with components commonly found in the predicate devices. Importantly, the NxStage Prep Module incorporates the proper safety features, such as conductivity measurement, automatic safety clamp, mix to use timer, and ultrafilters and I.V. sterilization filters to insure dialysate purity.

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.

As there is no technological differences as compared to the predicate devices, performance testing was deemed appropriate and was conducted to characterize the performance of the proposed Prep Module to provide a basis of comparison to the predicate devices. The Prep Module utilizes FDA cleared devices with minor modifications, and additional components which are simple to operate using the Verification and Validation testing, which includes provided device labeling. simulated use testing, sufficiently demonstrates that the Prep Module can be used safely as intended. All testing performed is summarized in Section V of this 510(k) submission. Results of the testing presented in this 510(k) have demonstrated that the NxStage Prep Module is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.

2

Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal features an abstract image of a bird in flight, composed of three curved lines. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2005

Ms. Norma LeMay Manager, Regulatory Affairs NxStage® Medical, Inc. 439 South Union Street, 5th Floor LAWRENCE MA 01843

Re: K043436

K043430
Trade/Device Name: NxStage® Dialysate Preparation Module Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO and FKR Dated: March 3, 2005 Received: March 4, 2005

Dear Ms. LeMay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have review of your better of substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholosate) to regary mantowa of the Medical Device Amendments, or to devices that have been ready 20, 1776, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassition in accercation in premarket approval application (PMA). You may, therefore, market the do not require upproval er a ve visions of the Act. The general controls provisions of the Act de fice, subjoct to the general 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 (Premarket It your devise is elective (t to such additional controls. Existing major regulations affecting your Applorary, the lia) 00 bely works 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 I reast of advised that 127 i our 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 I carral statues and regulations association and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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) This letter will allow you to begin marketing your actrice of your device of your device to a legally
premarket notification. The FDA finding of substantial equipand this pe premarket notification. The FDA Imaling of substantial equivalent of 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 for your device on our labering regarantists.
contact the Office of Compliance at one of the following numbers, based on the regulation number a the top of this letter:

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "onsonmants" of the sunder the Act from the 807.97). You may obtain other gelleral intornation on your respeared its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at its Division of Small 1143-6597 or at its Internet address 056-2041 or (2019/01/2019/11/industry/support/index.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

510(k) Number (if known):K043436
Device Name:NxStage Dialysate Preparation Module
Indications for Use:The NxStage Dialysate Preparation Module is an optional
accessory to the NxStage System One that prepares
dialysate for use during hemodialysis, as prescribed by the
physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)

Over-The-Counter AND/OR

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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