(85 days)
Not Found
No
The summary describes a computer-based interface for providing instructions, summarized information, and remote access, with no mention of AI, ML, or related concepts.
No
The device is an interface accessory that provides instructions, summarized information, and remote viewing of treatment information, rather than directly treating a condition.
No
The device provides online instructions, summarized system information, and remote access/viewing of treatment information; it is not for monitoring and does not provide diagnostic insights. Its primary function is an interface accessory.
No
The device description explicitly states that OneView consists of software, a flat panel touch screen display, and a central processing unit (CPU), indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that OneView is an interface for the NxStage System One to provide instructions, summarized system information, and remote access. It is used with a medical device (the NxStage System One), but it does not perform any diagnostic testing on biological samples.
- Device Description: The description confirms it's a computer-based interface with software, a display, and a CPU. This aligns with a user interface or monitoring accessory, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. OneView's function is to provide information and control related to the operation of the NxStage System One, which is likely a therapeutic or life-support device (given the context of "treatment").
N/A
Intended Use / 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.
Product codes
78FKP
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 501 |
| Lawrence, MA 01843 | |
| Phone: | (978) 687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Norma LeMay |
| Manager, 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:
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).
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NxStage Medical, Inc. NxStage OneView Interface 510(k) Premarket Notification
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.
3
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
4
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
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