The NxStage Premixed Dialysate Solutions are a family of premixed dialysate solutions which are sterile, non-pvrogenic solutions to be provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The premixed dialysate solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. A family of dialysate solutions will allow the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (NxStage Premixed Dialysate) and does not contain the level of detail typically found in a clinical study report that would include acceptance criteria and specific performance metrics in the format requested.

This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparing indications for use and technological (chemical) characteristics, and confirming the ability to manufacture a solution meeting end-product specifications. It is not an AI/software device, so many of the requested fields are not applicable.

Here's an analysis of what can be extracted or inferred from the document regarding the "study" that proves the device meets the "acceptance criteria":

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of quantitative acceptance criteria and corresponding reported device performance values in the way one would expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful production of a validation batch meeting "end-product specifications."

Acceptance Criteria (Implied)	Reported Device Performance
For Substantial Equivalence:	Demonstrated:
Same Indication Statement as predicate devices	YES - "The indication for use for the NxStage Premixed Dialysate Solutions is equivalent to that of the predicate devices." (NxStage Dialysate Concentrate (K013655), Baxter Premixed Dialysate for Hemodiafiltration (K910270), PrismaSate Dialysis Solutions (K013448))
Same technological characteristics (design, materials, etc.)	YES - "The chemical composition ranges, for the common constituents, of the NxStage Premixed Dialysate are identical to that of the PrismaSate Dialysis Solutions, K013448 and therefore raise no new types of safety or effectiveness issues."
Descriptive characteristics precise enough to ensure equivalence	NO (but not a failure) - "However, variations in product formulations and sterilization methods may impact final characteristics of the product." (This indicates the need for performance data).
Performance data available to assess equivalence	YES - "NxStage Medical, Inc. has provided data for a validation batch of the NxStage Premixed Dialysate Solutions produced under controlled manufacturing conditions..."
Performance data demonstrates equivalence	YES - "Results of the batch validation assays have demonstrated that the dialysate manufacturer is capable of producing a solution meeting all endproduct specifications."
For Manufacturing Quality:	Demonstrated:
Meets "all end-product specifications"	A validation batch was produced under controlled manufacturing conditions, and its results "demonstrated that the dialysate manufacturer is capable of producing a solution meeting all end-product specifications."

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

Sample Size for Test Set: The document refers to "data for a validation batch." The exact number of units or measurements within this batch is not specified. It is likely a single manufacturing batch was tested for chemical and physical properties.
Data Provenance: The manufacturing location is "Glandorf, Germany." The study itself is an internal validation of a manufacturing batch, not a clinical trial with patient data. It is a prospective test of a newly manufactured batch.

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

Experts: Not applicable. This is not a study requiring expert consensus for ground truth as it relates to chemical and manufacturing specifications, not diagnostic interpretation. The "ground truth" would be established by validated analytical methods against pre-defined specifications.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This is a chemical/manufacturing validation, not a study requiring human adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, this type of study was not done. This device is a premixed dialysate, not an imaging or diagnostic device requiring human interpretation assistance.

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

Standalone Performance: Not applicable. This device is a medical solution, not an algorithm. The "performance" refers to its chemical composition and sterility.

7. The Type of Ground Truth Used:

Ground Truth: The ground truth for this validation would be the pre-defined chemical and physical "end-product specifications" for the dialysate solution (e.g., specific concentrations of electrolytes, pH, sterility, endotoxin levels). These specifications would be derived from medical literature, regulatory guidelines, and the composition of the predicate devices.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is a manufactured product validation, not a machine learning model, so there is no "training set."

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

Ground Truth for Training Set: Not applicable. As mentioned, there is no training set in this context.

In summary:

This 510(k) submission details the substantial equivalence of a premixed dialysate to existing predicate devices. The "study" mentioned refers to internal manufacturing validation of "a validation batch" to ensure it meets pre-defined "end-product specifications." The nature of the device (a chemical solution) means most of the questions pertaining to AI/diagnostic device studies are not applicable.

Summary

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K022913
Page 1 of 3

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

OCT 21 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:	(978) 687-4700
Fax:	(978) 687-4800
Contact Person:	Norma LeMaySenior Regulatory Affairs Specialist
Date of Preparation:	August 23, 2002

B. Device Name:

Trade Name:	NxStage Premixed Dialysate
Common/Usual Name:	Premixed Dialysate
Classification Name:	Hemodialysis system and accessories(21CFR 876.5820)
Product Code:	78 KP0 - Dialysate Concentrate for Hemodialysis(Liquid or Powder)

C. Predicate Device Name:

The predicate devices for the NxStage Premixed Dialysate are:

NxStage Dialysate Concentrate (K013655, 02/04/02) .
Baxter Premixed Dialysate for Hemodiafiltration (K910270, 4/18/1991) .
. PrismaSate Dialysis Solutions (K013448, 01/15/02)

D. Device Description/Indications for Use:

The NxStage Premixed Dialysate Solutions are manufactured by B. Braun Schiwa located in Glandorf, Germany.

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K022913
Page 2 of 3

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

Section VI: Summary of Safety and Effectiveness

Indications for Use

NxStage Premixed Dialysate 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. Does the new device have the same Indication Statement?

YES - The indication for use for the NxStage Premixed Dialysate Solutions is equivalent to that of the predicate devices.

Proposed NxStage Premixed Dialysate

NxStage Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

NxStage Dialysate Concentrate (K013655)

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

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.

PrismaSate Dialysis Solution (K013448)

Gambro PrismaSate Solutions are indicated for use as a dialysate in continuous renal replacement therapy.

2. Does the new device have the same technological characteristics (e.g., design, materials, etc.)

Yes - The chemical composition ranges, for the common constituents, of the NxStage Premixed Dialysate are identical to that of the PrismaSate Dialysis Solutions, K013448 and therefore raise no new types of safety or effectiveness issues. As described in this submission, there are no major differences in the technology characteristics as compared to the predicate devices.

3. Are the descriptive characteristics precise enough to ensure equivalence?

No - The chemical composition ranges, for the common constituents, of the NxStage Premixed Dialysate are identical to that of the PrismaSate Dialysis Solutions, K013448 and similar to the Baxter Premixed Dialysate, K910270 and the NxStage Concentrate, K013655. However, variations in product formulations and sterilization methods may impact final characteristics of the product.

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

Section VI: Summary of Safety and Effectiveness

4. Are performance data available to assess equivalence?

YES - NxStage Medical, Inc. has provided data for a validation batch of the NxStage Premixed Dialysate Solutions produced under controlled manufacturing conditions representative of those to be used to produce the dialysate for commercial distribution. Results of the batch validation assays have demonstrated that the dialysate manufacturer is capable of producing a solution meeting all endproduct specifications.

5. Does performance data demonstrate equivalence?

YES - NxStage Medical, Inc. believes that the information and data provided in this submission clearly describes the NxStage Premixed Dialysate Solutions and demonstrates that the solutions are substantially equivalent to the predicate devices.

F. Safety Summary

Both the bag label and Instructions for Use include indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the NxStage Premixed Dialysate Solutions. This information promotes safe and effective use of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces left and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

OCT 21 2002

NxStage Medical, Inc. c/o Mr. Donald James Sherratt Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K022913

Trade/Device Name: NxStage Premixed Dialysate Regulation Number: 21 CFR 8876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: October 4, 2002 Received: October 7, 2002

Dear Mr. Sherratt:

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 (OS) 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 Chrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2 .

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Page 1 of 1

Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

Device Name:

. . . . . . . .

): KOZZ913

NxStage Premixed Dialysate

Indications for Use:

NxStage Premixed Dialysate 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	✓	OR	Over-The-Counter
Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022913

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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.