NxStage Dialysate Concentrate is a clear, sterile, non-pyrogenic concentrate, provided in 150 ml unit-dose vials, which, when diluted with sterile water in the required proportions, creates a dialysate for use in renal replacement therapy. When diluted, NxStage Dialysate Concentrate yields a dialysate with the following composition:

Sodium 140.0 mEq/L;
Calcium 3.0 mEq/L;
Potassium 2.0 mEq/L ;
Magnesium 1,0 mEq/L;
Chloride 111.0 mEq/L;
L-Lactate 35.0 mEq/L.

AI/ML Overview

This document describes the 510(k) Premarket Notification for the NxStage Dialysate Concentrate. It's important to note that this is a submission for a dialysate concentrate, which is a medical device (a substance used for dialysis), not a diagnostic algorithm or AI software, therefore many of the standard questions regarding AI/ML studies are not applicable.

Here's an analysis of the provided information in the context of the requested categories, highlighting where information is not applicable due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are primarily based on achieving substantial equivalence to existing predicate devices in terms of intended use and technological characteristics, particularly its chemical composition and method of preparation. The performance discussed is about meeting these equivalence criteria rather than quantified performance metrics typically seen in AI/ML studies (like accuracy, sensitivity, specificity).

Acceptance Criteria (from 510(k) Substantial Equivalence Decision Making Process)	Reported Device Performance (as claimed by NxStage Medical, Inc.)
Is the product a device? (Per 21 CFR §201 [321] (h))	YES - NxStage Dialysate Concentrate is a device.
Does the new device have the same intended use as the predicate devices?	YES - The intended use for the NxStage Dialysate Concentrate ("after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate") is considered equivalent to those for the predicate devices (NormoCarb Sterile Bicarbonate Concentrate and Baxter Premixed Dialysate for Hemodiafiltration), despite slight variations in wording.
Does the device have technological characteristics that raise new types of safety or effectiveness questions?	NO - "The composition of the NxStage Dialysate Concentrate is equivalent to that of other commercially available hemodialysis concentrates and raises no new types of safety or effectiveness questions. In addition, the packaging, sterility status and method of preparation are equivalent to those of the NormoCarb Sterile Bicarbonate Concentrate." Specifically, the composition is: Sodium 140.0 mEq/L, Calcium 3.0 mEq/L, Potassium 2.0 mEq/L, Magnesium 1.0 mEq/L, Chloride 111.0 mEq/L, L-Lactate 35.0 mEq/L.
Does descriptive or performance information demonstrate equivalence?	YES - NxStage Medical, Inc. "believes that the information provided in this submission clearly describes the NxStage Dialysate Concentrate and demonstrates that it is substantially equivalent to other commercially available hemodialysis concentrates." (Specific performance data beyond composition is not detailed in this summary for comparison, but is implied to be part of the full submission).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this describes a chemical concentrate, not a data-driven AI/ML device. No test set of data (e.g., medical images, patient records) was used in the manner of an AI/ML study. The "testing" involved chemical analysis and manufacturing process validation to demonstrate composition and sterility, which are not typically described with sample sizes or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. There was no "ground truth" to establish through expert consensus as this is a chemical product. The ground truth for a chemical concentrate would be its verified chemical composition, purity, and sterility according to established analytical methods and quality control standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. No adjudication method was used for a "test set" in the context of expert review, as this is a chemical product rather than a diagnostic interpretation.

5. 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

This is not applicable. This is not an AI-assisted device, so no MRMC study involving human readers and AI was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithm; it's a dialysate concentrate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device, if one were to loosely apply the term, would be the established chemical composition standards, sterility requirements, and manufacturing specifications for dialysate concentrates. Equivalence was demonstrated by showing the NxStage product meets these standards and is comparable to existing legally marketed devices.

8. The sample size for the training set

This is not applicable. There is no software algorithm or AI model that requires a training set for this device.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth for a training set to be established.

In summary, the provided document describes a 510(k) Premarket Notification for a Dialysate Concentrate, a chemical medical device. The "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices, primarily through matching chemical composition, intended use, and manufacturing processes, rather than performance metrics typically associated with AI/ML systems. Therefore, most of the questions relating to AI/ML study designs are not relevant to this specific submission.

Summary

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K013655 pgΣ 1 of 3

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

FEB 0 4 2002

Section VI: Summary of Safety and 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 501Lawrence, MA 01843
Phone:	1-978-687-4700
Fax:	(978) 687-4800
Contact Person:	Karen St. Onge,Director, Quality Assurance/Regulatory Affairs
Date of Preparation:	1 February 2002

B. Device Name:

Trade Name:	NxStage Dialysate Concentrate
Common/Usual Name:	Dialysate Concentrate for Hemodialysis(Liquid or Powder)
Classification Name:	Dialysate Concentrate for Hemodialysis(Liquid or Powder)

C. Predicate Device Name:

The predicate devices for the NxStage Dialysate Concentrate are:

NormoCarb Sterile Bicarbonate Concentrate (#K001059, 6/30/2000); ●
Baxter Premixed Dialysate for Hemodiafiltration (#K910270, 4/18/1991). .

D. Device Description/Indications for Use:

Sodium 140.0 mEq/L; �
Calcium 3.0 mEq/L; .
Potassium 2.0 mEq/L ; ●
Magnesium 1,0 mEq/L; .
Chloride 111.0 mEq/L; .
L-Lactate 35.0 mEq/L.

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KO19655

NxStage Medical. Inc. Dialysate Concentrate 510/k) Premarket Notification

Section VI: Summary of Safety and Effectiveness

Intended Use

NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

E. Substantial Equivalence:

510(k) Substantial Equivalence Decision Making Process

1. Is the product a device?

YES - NxStage Dialysate Concentrate is a device pursuant to 21 CFR §201 [321] (h).

2. Does the new device have the same intended use?

YES - The intended use for the NxStage Dialysate Concentrate is equivalent to those for the predicate dialysis concentrates.

NxStage Dialysate Concentrate

NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

NormoCarb Sterile Bicarbonate Concentrate (#K001059)

Normocarb, after dilution, is indicated for use in Continuous Renal Replacement Therapy (CRRT).

Baxter Premixed Dialysate for Hemodiafiltration (#K910270)

Baxter Premixed Dialysate is indicated for acute dialysis modalities such as continuous arteriovenous hemodiafiltration (CAVHD), and continuous venousvenous hemodiafiltration (CVVHD), when treating acute renal failure patients with hypervolemia and uremia that requires high solute clearance.

3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?

NO - The composition of the NxStage Dialysate Concentrate is equivalent to that of other commercially available hemodialysis concentrates and raises no new types of safety or effectiveness questions. In addition, the packaging, isterility status and method of preparation are equivalent to those of the NormoCarb Sterile Bicarbonate Concentrate.

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K013655 page 3 of 3

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

Section VI: Summary of Safety and Effectiveness

4. Does descriptive or performance information demonstrate equivalence?

YES - NxStage Medical, Inc. believes that the information provided in this submission clearly describes the NxStage Dialysate Concentrate and demonstrates that it is substantially equivalent to other commercially available hemodialysis concentrates.

F. Satety Summary

Both the vial label and Instructions for Use include indications for uso, cautions and both the vial labor and motions instructions required for proper use of NxStage Dialysate Concentrate. In addition, "Medication Added" labels are provided for customer use. This information promotes safe and effective use of the device.

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Image /page/3/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the circle is a symbol that resembles three curved lines, possibly representing a stylized wing or a similar design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2002

Ms. Karen St. Onge Director, Quality Assurance NxSTAGE Medical, Inc. 439 S. Union St., 5th Floor LAWRENCE MA 01843

Re: K013655

Trade/Device Name: NxStage Dialysate Concentrate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: November 2, 2001 Received: November 6, 2001

Dear Ms. St. Onge:

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. Iisting 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 (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); 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 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:

8xx.1xxx	(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 advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/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 Statement

Page 1 of 1

510(k) Number (if known): K013655

NxStage Dialysate Concentrate Device Name:

Indications for Use:

NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 CFR 801.109)

Over-The-Counter

David G. Ferguson

(Division Sign-Off

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

K013655

004

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.