506 PATIENT MONITOR

K051038 · Ciriticare Systems, Inc. · DRT · Aug 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051038
• Device Name: 506 PATIENT MONITOR
• Applicant: Ciriticare Systems, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

Device Story

506 Patient Monitor measures/displays real-time physiological data: NIBP, SpO2, and temperature. Inputs: NIBP cuffs, SpO2 sensors (Nellcor module), and temperature probes (Kendall Filac FasTemp module). Device processes signals to provide numerical data, pulse bar plethysmogram, limit alarms, and trend storage. Used in healthcare facilities by professional healthcare providers; stationary or portable during patient translocation. Output displayed on alphanumeric/LED screen; provides strip chart recordings. Enables clinicians to monitor patient status, assess vital signs, and make clinical decisions based on real-time data and trends. Benefits include continuous or predictive temperature monitoring and motion-resistant SpO2 tracking.

Clinical Evidence

Bench testing only. Compliance with national and international standards including UL 60601-1 (electrical safety), EN 60601-1-2 (EMC), IEC 60601-2-49 (multiparameter monitor safety), ISO 10993-5.10-11 (biocompatibility), IEC 60601-2-30/EN 1060-1/EN 1060-3/AAMI SP-10 (NIBP performance), and EN 865 (oximetry performance).

Technological Characteristics

Molded plastic housing; alphanumeric and LED numeric displays; membrane key panel interface. Parameters: NIBP, SpO2 (Nellcor module), Temperature (Kendall Filac FasTemp module). Standards: UL 60601-1, EN 60601-1-2, IEC 60601-2-49, ISO 10993, IEC 60601-2-30, EN 1060-1/3, AAMI SP-10, EN 865/ASTM F 1415. Connectivity: Strip chart printer output. Power: Medical electrical.

Indications for Use

Indicated for monitoring NIBP, SpO2, and temperature in adult or pediatric patients in any healthcare environment. Temperature measurement via oral, axillar, or rectal placement. No specific contraindications listed.

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.

Predicate Devices

• 507EL Vital Signs Monitoring System (K022435)

Submission Summary (Full Text)

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

K051038

Image /page/0/Picture/1 description: The image shows a symbol that appears to be a combination of a circle, a line, and two short horizontal dashes. A diagonal line intersects the circle, extending beyond it at both ends. The circle is positioned around the middle of the line. Two short, horizontal dashes are placed on either side of the circle and line, roughly aligned with the horizontal center of the symbol.

15 March 2005

# AUG 1 2 2005

510K Summary

## Model 506 Patient Monitor

Alex Kaplan Contact: Director of QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX

Trade Name: 506 Patient Monitor

Common Name: Vital Signs Monitor

Classification Name: Monitor, Physiological, Patient (74 MWI)

Substantial Equivalence is claimed to : 507EL Vital Signs Monitoring System (K022435).

## Device Description:

The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar plethysmogram and numerical data. The 506 can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP), SpO2, and Temperature. For all these vital parameters, the 506 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

#### Intended Use:

This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

#### Comparison with predicate device:

Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 506 monitor utilizes existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO2,

> @2005 Criticare Systems, Inc All Rights Reserved

Yz

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

Image /page/1/Picture/0 description: The image shows a handwritten symbol. The symbol consists of a circle with a line going through it. There are two short horizontal lines on either side of the symbol.

and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. This SpO2 technology has been listed with the capability to be used in an environment where resistance to clinical motion is required. The patient data collected by the 506 monitor is displayed for the user on an alphanumeric display and LEDs equivalent to the predicate device. The 506 monitor utilizes alphanumeric display technology in combination with LED numeric displays. Membrane key panels provide a user interface equivalent to the predicate device. The packaging design of the 506 monitor is molded plastic and allows for it to be either a stationary monitor or to be used during patient translocation within the healthcare facility, as did the predicate 506EL.

## Determination of Substantial Equivalence:

The 506 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 506 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 506 monitor have been in clinical use for at least six years in the 507EL monitor and it's predicates. CSI's field experience with these modalities in the predicate devices has been satisfactory. This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 506 monitor.

Therefore, the 506 monitor is substantially equivalent to the predicate devices.

#### Compliance to standards and regulations:

The 506 Vital Signs Monitor complies with the following national and international standards:

#### Safety

UL 60601-1 Medical Electrical Safety EN 60601-1-2 EMC Compliance IEC 60601-2-49 Multiparameter Monitor Safety ISO 10993-5.10-11 Biocompatibility

#### Performance

IEC 60601-2-30 NIBP Safety EN1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415)

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Criticare Systems, Inc. c/o Mr. Alex Kaplan Director of QA and RA 20925 Crossroads Circle Waukesha, WI 53186

K051038 Re: Trade Name: 506 Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: August 5, 2005 Received: August 9, 2005

Dear Mr. Kaplan:

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 such 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.

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

## Page 2- Mr. Alex Kaplan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Freast oc advised that I DTT 3155aanse or our device complies with other requirements of the Act that I DA has made a acterinaulations administered by other Federal agencies. You must of any I cochar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product tadiation only to begin marketing your device as described in your Section 510(k) I his iciter will anow you to cogm mains of substantial equivalence of your device to a legally premarket notification " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " 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 spocific at noliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrimational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B.Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications For Use

510(k) Number (if known): K051038

Device Name: 506 Patient Monitor

---

Indications for Use:

The 506 Patient monitor interprets and displays real time physiological data of the patient I he 300 I attent inomitor interpred and safigured to monitor Noninvasive BP (NIBP), S.O., and Temperature. For each patient vital parameter, the 506 will be capable of providing limit Temperature. Tor each patient that pat recordings and storing data trends for retrospective alarins and arets, primatig of carpexisting core technologies from the predicate 507EL monitor for patient monitor unfized embining of Niemperature. Temperature measurement is provided 101 patient momtoring of Nibly Op on thich has been integrated into the 506 monitor. This of Rendan's I has Fear enterest and one predictive or continuous temperature measurement temperature measurements in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module.

provided by Nentor of DPOD model.
This system is intended to monitor physiological parameters of patients within any healthcare I mis system is intended to interpret the monitored data made available, will be a environinent. The user, respendere w sistem alarms and patient data analysis will be available to the care provider from the monitor.

Prescription Use (Part 21 CFR 801.109)

AND/OR

Over-The-Counter Use

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

B.B. Summer

Division Slan-Om Division of Cardiovascular Devices 510(k) Number Korloßo