(168 days)
No
The summary focuses on the addition of wireless networking capabilities to an existing patient monitor and does not mention any AI or ML functionalities.
No
The device is described as a patient monitor intended for observation and communication within a hospital network, not for treating conditions or diseases.
No
The document describes the device as a "multi-parameter patient monitoring system" and focuses on its networking capabilities. It is intended for monitoring, not for diagnosing conditions.
No
The device is described as a "multi-parameter patient monitoring system," which inherently implies hardware components for acquiring physiological data. The 510(k) is for adding wireless LAN capability to an existing hardware device, not for a standalone software product.
Based on the provided text, the Marquette Eagle 4000 Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes a multi-parameter patient monitoring system used for monitoring patients within a hospital/facility environment. It focuses on communication and networking capabilities for patient data.
- Device Description: The description reinforces that it's a patient monitoring system with a focus on its networking capabilities (wired and wireless).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or at the point of care for analyzing biological samples.
The device described is a patient monitor, which is a type of medical device used for directly monitoring physiological parameters of a patient. This falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet;
~permits integration to the network without physical connection to the Ethernet wall plate.
This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with.
This device is intended to be used within the hospital / facility environment.
Product codes (comma separated list FDA assigned to the subject device)
74 MSX
Device Description
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate.
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
The intended patient population is limited to the same population as the device that the technology is being used with.
Intended User / Care Setting
This device should be used by people who are trained in the use of the equipment.
This device is intended to be used within the hospital / facility environment.
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)
The Wireless LAN device when used in conjunction with the patient monitor meets the safety requirements of IEC 601-1-1. It also meets the requirements of IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz (IEEE C95.1-1991) and has the appropriate FCC certification. Electromagnetic compatibility testing demonstrates that the device meets the reauirements of CISPR 1 1 Class A for both radiated and conducted emissions. Immunity testing demonstrates that the device meets the requirements of the IEC 1000-4 series and MIL-STD 462D.
Verification and validation testing was done on the wireless LAN in use with the Eagle 4000 Patient Monitor. Test results indicate that the Eagle 4000 Patient Monitor with wireless LAN provides an equivalent level in performance, when compared to the Eagle 4000 Patient Monitor with wired LAN, when tested to the accuracy requirements as specified in the contents of the premarket notification submission.
Marquette Medical Systems has demonstrated that use of the wireless LAN capability in its devices is as safe and effective, and performs substantially equivalent to use of the wired LAN in its devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
Manufacturer / Submitter 1.
OCT 2 2 1997
Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA
Establishment Registration Number 2124823
Contact Name / Telephone Number Dianne Schmitz Corporate Regulatory Affairs Marquette Medical Systems
Phone: (414) 362-3230
Date: 21 April 97
2. General Information
Trade/Proprietary Name
There is no trade/ proprietary name that will be associated with this technology change. Marquette will refer to it as wireless LAN (Local Area Network) - wireless Ethernet.
Common/Usual Name
This device is commonly known as wireless networking.
Device Classification
The wireless LAN technology change may be used with devices which are Class III, therefore, it will remain in Class III. The modified device that is the subject of this 510(k) submission is a Class III device.
Performance Standards
Peformance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.
Legally Marketed Predicate Device(s) 3.
The device chosen to be used to demonstrate SE for the wireless LAN capability was the Eagle 4000 Patient Monitor. Support testing compared the Eagle 4000 using wired LAN to the Eagle 4000 using wireless LAN. Its 510(k) equivalency references include the following:
| K912799 | Eagle System |
|---|---|
| K920790 | Eagle Monitor |
| K964750 | Eagle 4000 Patient Monitor |
1
4. Device Description
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate.
5. Intended Use
This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with.
This device is intended to be used within the hospital / facility environment.
6. Brief Description of Testing & Conclusion
The Wireless LAN device when used in conjunction with the patient monitor meets the safety requirements of IEC 601-1-1. It also meets the requirements of IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz (IEEE C95.1-1991) and has the appropriate FCC certification. Electromagnetic compatibility testing demonstrates that the device meets the reauirements of CISPR 1 1 Class A for both radiated and conducted emissions. Immunity testing demonstrates that the device meets the requirements of the IEC 1000-4 series and MIL-STD 462D.
Verification and validation testing was done on the wireless LAN in use with the Eagle 4000 Patient Monitor. Test results indicate that the Eagle 4000 Patient Monitor with wireless LAN provides an equivalent level in performance, when compared to the Eagle 4000 Patient Monitor with wired LAN, when tested to the accuracy requirements as specified in the contents of the premarket notification submission.
Marquette Medical Systems has demonstrated that use of the wireless LAN capability in its devices is as safe and effective, and performs substantially equivalent to use of the wired LAN in its devices.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 1997
Ms. Dianne Schmitz Marquette Medical Systems 8200 West Tower Avenue Milwaukee, Wisconsin 53223
K971683 Re : Marquette Wireless LAN (Local Area Network) Wireless Ethernet III (three) Requlatory Class: Product Code: 74 MSX Dated: August 26, 1997 Received: August 27, 1997
Dear Ms. Schmitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to,895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Dianne Schmitz
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K971683
Device Name: Marquette Wireless LAN (Local Area Network) Wireless Ethernet
Indications For Use:
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet;
~permits integration to the network without physical connection to the Ethernet wall plate.
This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with.
This device should be used by people who are trained in the use of the equipment.
This device is intended to be used within the hospital / facility environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.A. Ciarkowski
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardios) Devices Division of Caralo.
and Neurological Devices
OR 510(k) Number _
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)
(W