OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.

OneView is contraindicated as the sole method of monitoring a patient during treatment.

Device Description

OneView is an optional computer-based interface accessory to the NxStage System One to provide on-line instructions for use, summarized system information, and remote viewing of treatment information. OneView consists of software, a flat panel touch screen display, and a central processing unit (CPU).

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the NxStage OneView Interface, a hemodialysis accessory. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, nor does it provide information on reader studies, sample sizes, ground truth establishment, or expert qualifications.

The content focuses on regulatory submission details and general statements about performance testing. Therefore, based on the provided text, I cannot complete the table or answer most of the questions as the information is not present.

Here's what can be extracted from the given input:

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

The document states: "Performance testing was conducted to characterize performance of the proposed NxStage OneView Interface to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the proposed NxStage OneView Interface is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."

However, no specific acceptance criteria or quantitative performance metrics are provided in the document. Therefore, this table cannot be filled out.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

This information is not provided in the document.

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 information is not provided in the document.

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

This information is not provided in the document.

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 information is not provided in the document. The device is an interface accessory, not an AI for interpretation.

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

The device is an interface accessory and not an algorithm for standalone diagnostic performance. The document explicitly states: "OneView is contraindicated as the sole method of monitoring a patient during treatment." This implies it's designed to assist, not replace, human monitoring.

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

This information is not provided in the document. The device is for displaying information and instructions, not making diagnostic or therapeutic decisions independently.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary

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NxStage Medical, Inc. NxStage OneView Interface 510(k) Premarket Notification

K040074
Page 1 of 2

Section VIII: 510(k) Summary of Safety & 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 LeMayManager, Regulatory Affairs
Date of Preparation:	January 12, 2004
B. Device Name:Trade Name:	NxStage OneView Interface
Common/Usual Name:	Hemodialysis Accessory
Classification Name:	Hemodialysis system and accessories (876.5820)Product Code: 78FKP

C. Substantial Equivalence/Predicate Devices:

The proposed NxStage OneView Interface is substantially equivalent to the Fresenius Documentation System (FDS-08), K921456, cleared on 04/20/94 and the Fresenius iCare Monitoring System, K021060 cleared on 11/13/02.

D. Device Description/Indications for Use:

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NxStage Medical, Inc. NxStage OneView Interface 510(k) Premarket Notification

K040074

Page 2 of 2

Section VIII: 510(k) Summary of Safety & Effectiveness

Indications for use:

OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.

OneView is contraindicated as the sole method of monitoring a patient during treatment.

E. Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The proposed device is designed with similar software, components and features commonly found in the predicate devices.

F. Summary of Non-Clinical Test/Performance Testing

NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance testing was conducted to characterize performance of the proposed NxStage OneView Interface to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the proposed NxStage OneView Interface is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

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

Re: K040074

Trade/Devicc Name: NxStage OneView Interface Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FKP Dated: January 12, 2004 Received: January 14, 2004

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 cither 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 Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nothcation. The PDA miams sification 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 advice for your dones to the following numbers, based on the regulation number at the top of the 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 Additionally, 10r questions on the promotion Also, please note the regulation entitled, "Misbranding Onice of Comphanes at (2017 ->>>>>>>>>> (21CFR Part 807.97) you may obtain. Other general by relevence to prematics notification (er the Act may be obtained from the Division of Small information on your responsionalites and its toll-free number (800) 638-2041 or Manufacturers, International and Octiess 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

Page 2

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INDICATIONS FOR USE

510(k) Number (if known): K040074

NxStage OneView Interface Device Name:

Indication for Use:

OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.

OneView is contraindicated as the sole method of monitoring a patient during freatment.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (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. Brogdon
Division Sign Off

and Radiological Device 510(k) Number

Page 1 of 1

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.