The NxStage PureFlow Solution with bicarbonate (NxStage PureFlow-B Solution) is a non-pyrogenic dialysis solution provided in single use flexible bags. The PureFlow-B Solution is intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.

AI/ML Overview

This is a 510(k) summary for the NxStage PureFlow-B Solution, a premixed dialysate for hemodialysis. This device is classified as a Class II medical device under 21 CFR 876.5820. The submission is a Special 510(k) Device Modification, indicating that the device has undergone modifications from a previously cleared device (K033386) and seeks to demonstrate substantial equivalence to it.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary and associated documents do not include a table of acceptance criteria nor specific reported device performance metrics in numerical form.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K033386) through compliance with design control requirements and design validation testing. The conclusion states that the modified device "has been shown to meet the minimum requirements that are considered acceptable for its intended use" based on:

Device indications for use
Comparison of descriptive and technological characteristics
Design control certification

This typically means that the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device, especially considering it's a device modification where the fundamental intended use remains the same. The "acceptance criteria" here therefore refer to the device's ability to maintain the safety and effectiveness profile established by the predicate device after modifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set. It mentions "Design validation testing has been performed to ensure that the modified device meets design specifications." However, it doesn't detail the nature of this validation testing, whether it involved clinical data, bench testing, or a combination, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since clinical data or a "test set" requiring expert ground truth is not explicitly described, this information is not provided in the document. For a fluid solution like a dialysate, "ground truth" would more likely relate to chemical composition, efficacy in solute removal (measured in-vitro or in-vivo), and safety (pyrogenicity, sterility), rather than expert consensus on image interpretation, for example.

4. Adjudication Method for the Test Set

As there is no mention of a test set requiring adjudication from experts, this information is not applicable/provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance to measure improvement in accuracy or efficiency. A dialysate solution does not typically involve human interpretation of outputs in the same way.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop) Was Done

No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop performance is not applicable here. The device is a physical solution (dialysate), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for a dialysate would primarily be based on:

Chemical/Physical Specifications: Meeting established purity, concentration, pH, and electrolyte balance standards (e.g., USP monographs, ISO standards, internal specifications).
Sterility and Endotoxin Testing: Ensuring the solution is non-pyrogenic and sterile.
Performance in Dialysis Systems: Demonstrating effectiveness in removing waste products and maintaining fluid/electrolyte balance when used with compatible renal replacement therapy systems.

While the document doesn't explicitly state "type of ground truth," the concept of "design specifications" and compliance to "21 CFR 820.30 Design Control requirements" implies that the device was validated against pre-defined, measurable specifications. This would involve laboratory testing and performance evaluations against established chemical and biological criteria.

8. The Sample Size for the Training Set

As this is a physical medical device (a dialysate solution) and not an AI/ML algorithm that requires a "training set" of data, the concept of a training set sample size is not applicable and therefore not provided in the document.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set," this information is not applicable and not provided.

Summary of Key Takeaways from the document:

The submission is for a device modification of a previously cleared dialysate.
The primary method of demonstrating acceptability is through substantial equivalence to the predicate device (K033386), compliance with design control requirements (21 CFR 820.30), and performance of design validation testing.
Specific quantitative acceptance criteria or detailed results of performance testing are not included in this summary document, which is typical for a 510(k) summary relying on substantial equivalence and design control certification for a non-AI/diagnostic device.
The concepts of "test set," "expert ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not relevant or applicable to this type of device and submission as presented.

Summary

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Ko42045 R275/ of.

AUG 27 2004

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 807.92.

Date:	July 29, 2004
Common/Usual Name:	Premixed Dialysate for Hemodialysis
Trade/Proprietary Name:	NxStage PureFlow-B Solution
Classification Name:	Hemodialysis systems and accessories(21 CFR 876.5820)
Device Classification:	Class II
Product Code:	78 KPO - Dialysate Concentrate for Hemodialysis(Liquid or Powder)
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:

Special 510(k) Premarket Notification Device Modification NxStage Medical, Inc. NxStage PureFlow-B Solution

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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 Pre-Market 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 PureFlow Solution has been compared to the baseline as cleared in K033386 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 PureFlow Solution has been shown to meet the minimum requirements that are considered acceptable for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 2004

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

Re: K042045

KU42045
Trade/Device Name: NxStage PureFlow Solution with Bicarbonate (PureFlow-B) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: July 29, 2004 Received: July 30, 2004

Dear Ms. LeMay:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o forrowed your and have determined the device is substantially equivalent (for the indications forchenood above and harsure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, de Hoos that have been 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 r ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision 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 your device is easonivals. 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 round in 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 that I Drines interves and regulations administered by other Federal agencies. You must or any Federal statuter and and ing, 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)
The same and the same of the first of Substantial equivalence of your device to This letter will allow you to begin marketing your actives of your device of your device to a legally
premarket notification The FDA indines of substantial equivalence of y premarket notification - The FDA linding of substantial or 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
s and the many of the many of the fellouing numbers, hased on the regulat If you desire specific advice for your device on our laboling toge.
contact the Office of Compliance at one of the following numbers, based on the regulation in number at the top of the letter:

8xx. Ixxx	(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 advectising of your device, please contact the Additionally, for questions on the production and the regulation entitled, "Maintanding
Office of Compliance at (301) 594-4639 - Association may obtain - Other oceecal Office of Compliance at (301) 394-4057. Also, posts and obtain. Other general by reference to premarket notification (210, 10, 10, 10, 10, 2011, 10:11 the Division of Small
information on your responsibilities under the Act may be obtained from the Div information on your responsibilities and its its tall-free number (800) -638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free maman huml Manufacturers, International and Collisumer Assistantoo at le 18.1.2017
(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

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Indications for Use

510(k) Number (if known):

NxStage PureFlow-B Solution Device Name:

Indications for Use:

NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

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)

Daniel R. Larson

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 51()(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.