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

The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that pre-treats and purifies water that mixes with concentrate to produce dialysate meeting the requirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis treatments.

AI/ML Overview

The provided text describes a Special 510(k) Device Modification for the NxStage Dialysate Preparation Module, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance, or a study that uses a test set, ground truth, or expert review in the way a typical AI/ML medical device submission would.

Therefore, the following information is based on the provided text, and many sections will indicate that the information is "Not applicable" or "Not provided" for this type of device modification.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	The modified NxStage Dialysate Preparation Module was compared to the baseline device (K043436) and found to be substantially equivalent based on device indications for use, comparison of descriptive and technological characteristics, and design control certification.
Meeting Design Specifications	Design validation testing was performed to ensure that the modified device meets design specifications.
Compliance with ANSI/AAMI Standards	The device produces dialysate meeting the requirements of ANSI/AAMI Standards, RD52:2004 and RD62:2001.
Compliance with Design Control Requirements	Certification of compliance to 21 CFR 820.30 Design Control requirements was provided.
Intended Use	The device meets the minimum requirements considered acceptable for its intended use (preparing dialysate for hemodialysis with the NxStage System One).

Study Details

Sample size used for the test set and the data provenance: Not applicable. This was a Special 510(k) Device Modification focusing on design validation and substantial equivalence, not a clinical study on a test set in the context of an AI/ML device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) was not established for this type of device modification.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a Dialysate Preparation Module, not an AI-assisted diagnostic or interpretative device that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical device, not an AI algorithm. Its performance is evaluated based on its physical and functional characteristics to prepare dialysate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance would be the physical and chemical properties of the dialysate it produces, validated against established standards (ANSI/AAMI RD52:2004 and RD62:2001) and its design specifications. It is based on objective measurements and engineering principles, not expert consensus on medical images or pathology.
The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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MAR 3 1 2006

K060296
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SECTION 7

510(K) Summary of Safety Effectiveness

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 1807.92.

Date:	February 3, 2006
Common/Usual Name:	Subsystem, proportioning
Trade/Proprietary Name:	NxStage Dialysate Preparation Module
Classification Name:	Hemodialysis Systems & Accessories21CFR 876.5820
Device Classification:	Class II
Product Code:	78 FKR
Device Panel:	Gastroenterology-Urology (GU)/Gastro-Renal(GRDB)
510(k) Sponsor &Owner/Operator:	NxStage Medical, Inc439 South Union St, Suite 501Lawrence, MA 01843Owner/Operator No. 9045797Establishment Registration #3003464075
Contact Person:	Norma LeMayManager, Regulatory Affairs

Device Description:

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K060296
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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 Premarket 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 Dialysate Preparation Module has been compared to the baseline as cleared in K043436 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 Dialysate Preparation Module has been shown to meet the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to the baseline device.

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Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird-like figure in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text, which appears to be the name of an organization or department. The text is arranged along the inner edge of the circle, following its curvature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2006

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

Re: K060296

Trade/Device Name: NxStage Dialysate Preparation Module Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: FKR and KPO Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Product Code: FIP Regulatory Class: II Dated: March 9, 2006 Received: March 10, 2006

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 (Premarket Approval), it may be subject to such 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.

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This letter will allow you to begin marketing your device as described in your Section 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:

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
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Ando, promo not regaral information on your responsibilities under the Act from the 001:57). I For may overnment 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/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

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K060296

Indications for Use

510(k) Number (if known): K060296/S'

Device Name:

NxStage Dialysate Preparation Module

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

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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. Burgdon

and Radiologic 510(k) Number

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Regulation Number and Section

§ 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.