INTEGRITI PATIENT MONITOR

K980688 · Alliance Instruments · MWI · Mar 16, 1999 · Cardiovascular

Device Facts

• Record ID: K980688
• Device Name: INTEGRITI PATIENT MONITOR
• Applicant: Alliance Instruments
• Product Code: MWI · Cardiovascular
• Decision Date: Mar 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.

Device Story

Integriti Patient Monitor collects vital signs data including ECG, SpO2, invasive/noninvasive blood pressure, and temperature. Device provides real-time monitoring, alarm functionality for preset threshold violations, and acts as a terminal for hospital patient information systems. Operated by licensed practitioners in various hospital departments and during patient transport. Powered by standard electrical sources or 12-28V external power. Output allows clinicians to track patient status and manage clinical interventions based on vital sign trends and alarms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter patient monitor; inputs include ECG, SpO2, invasive/noninvasive blood pressure, and temperature sensors. Connectivity includes integration with hospital patient information systems. Power source: standard AC or 12-28V DC external power. Form factor: portable monitor for bedside and transport use.

Indications for Use

Indicated for adult and pediatric patients requiring vital signs monitoring (ECG, SpO2, noninvasive/invasive blood pressure, temperature) in hospital environments, including transport. Contraindicated for use in proximity to magnetic resonance imaging.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1999

Mr. Jim Rooks Senior Product Manager Alliance Instruments 3112 NE 112th Avenue, Suite C 98682 Vancouver, WA

Re : K980688 Integrity Patient II (two) Requlatory Class: Product Code: MWI Dated: March 5, 1999 Received: March 8, 1999

Dear Mr. Rooks:

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 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). 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 regulatory 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

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Page 2 - Mr. Jim Rooks

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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification² (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan
Thomas J. Callahan, Ph.D.

Thomas J. J Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K980688

## Device Name: Integriti Patient Monitor

## Indications for Use

The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.

K. Carlile

(Division Sign-Off) Division of Cardiovascular, Respiratory. and Neurological D 510(k) Number

**Prescription Use**
**(Per 21 CFR 801.109)**