The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

Device Description

The NxStage Therapy System, consisting of hardware, software and a sterile disposable cartridge, is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

AI/ML Overview

This document is a 510(k) summary for the NxStage™ Therapy System, a hemofiltration system, submitted to the FDA. It declares the device's substantial equivalence to a previously cleared device (K012510) and does not provide specific acceptance criteria or an explicit study detailing performance metrics in the way a clinical trial report would.

Therefore, many of the requested elements about acceptance criteria, device performance, sample sizes, and ground truth cannot be directly extracted from this document as it focuses on demonstrating substantial equivalence through design control and comparison to a predicate device, rather than presenting a performance study with detailed metrics.

Here's an attempt to answer the questions based solely on the provided text, indicating when information is not available:

A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or specific performance metrics. It states: "Design validation testing has been performed to ensure that the modified device meets design specifications." and "Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage Therapy System has been shown to meet the minimum requirements that are considered acceptable for its intended use." However, the specific "design specifications" or "minimum requirements" are not detailed, nor are the quantitative results of the "design validation testing."
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The document mentions "Design validation testing" but does not detail sample sizes, data provenance, or whether the study was retrospective or prospective.
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)

Not applicable/Not provided. This submission is for a medical device (hemofiltration system), not an AI/diagnostic imaging device where expert ground truth is typically established in this manner. The validation described is related to engineering design specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. This concept is not relevant to the type of device validation presented in this 510(k) summary.
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. The device is a "Hemofiltration System" and does not involve human readers or AI assistance in the context of diagnostic interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a hemofiltration system, not an algorithm, and its performance evaluation would focus on its mechanical, fluid dynamics, and safety aspects, not "algorithm only" performance. The device is explicitly stated to require administration "by a health care provider, under physician prescription."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided, but likely related to established engineering and medical device performance standards for hemofiltration. The "ground truth" for this type of device would typically be defined by its ability to perform hemofiltration and ultrafiltration effectively and safely according to pre-defined engineering and clinical specifications (e.g., fluid removal rates, clearance rates, structural integrity, biocompatibility, safety features).
The sample size for the training set

Not applicable/Not provided. This device is not an AI/machine learning model that requires a training set in the conventional sense.
How the ground truth for the training set was established

Not applicable. As described above, this device does not involve a "training set" for an AI model.

In summary, this 510(k) submission is a special 510(k) for a device modification, relying on design control certification and comparison to a predicate device to demonstrate substantial equivalence, rather than a de novo performance study with detailed acceptance criteria, sample sizes, and ground truth definitions typically found for diagnostic or AI-driven medical devices.

Summary

{0}------------------------------------------------

Section 7 510(k) Summary

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:	March 15, 2002
Common/Usual Name:	Hemofiltration System
Trade/Proprietary Name:	NxStage™ Therapy System
Classification Name &Device Classification:	Dialyzer, High Permeability with or withoutDialysate System; Class II
Product Code:	KDI
21 CFR Ref.:	876.5860
Device Panel:	Gastroenterology-Urology (GU)/Gastro-Renal(GRDB)
510(k) Sponsor &Owner/Operator:	NxStage Medical, Inc439 South Union St, Suite 501South Lawrence, MA 01843Owner/Operator No. 9045797
Contact Person:	Norma LeMaySr. Regulatory Specialist

Device Description:

Confidential

)

075

{1}------------------------------------------------

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 Medical 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 Therapy System has been compared to the NxStage Therapy System as cleared in K012510 and found to be substantial equivalent.

Conclusion:

Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage Therapy System has been shown to meet the minimum requirements that are considered acceptable for its intended use.

Image /page/1/Picture/6 description: The image shows the number 076. The numbers are in a bold, sans-serif font. The background is white. There is some other text to the left of the numbers, but it is not clear.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

Ms. Norma LeMay Sr. Regulatory Specialist NxStage Medical, Inc. 439 S. Union St., Suite 501 LAWRENCE MA 01843

Re: K020858

Trade/Device Name: NxStage™ Therapy System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system

Regulatory Class: II Product Code: 78 KDI Dated: March 15, 2002 Received: March 18, 2002

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 (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.

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

{3}------------------------------------------------

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 noutication. The PDF 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 If you desire specific daving 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 of received to premiument 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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K020858

Device Name:

NxStage Therapy System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K020858

Prescription Use (Per 21 CFR 801.109)	OR	Over-the-Counter Use
---------------------------------------	----	----------------------

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”