MICROPAQ, MODELS 402, 404

K021681 · Welch Allyn Protocol, Inc. · DRT · Jul 23, 2002 · Cardiovascular

Device Facts

• Record ID: K021681
• Device Name: MICROPAQ, MODELS 402, 404
• Applicant: Welch Allyn Protocol, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Jul 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs monitoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn Protocol's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages. The ECG channel is intended for five-lead ECG monitoring. The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Device Story

Micropaq is a wearable patient monitor for ECG and SpO2; provides real-time waveform and numeric display via integrated LCD. Device operates on rechargeable battery; communicates bi-directionally with Acuity central station via 2.4 GHz WLAN (FlexNet network). Used in step-down units, telemetry, med/surg floors, emergency departments, and during in-hospital transport. Clinicians use device to monitor patient status; remote control available from central station. If wireless connection lost, device continues local monitoring, display, and alarm generation. Output assists clinicians in patient assessment and clinical decision-making; benefits include continuous monitoring during patient movement.

Clinical Evidence

Bench testing only. Device complied with recognized national and international performance, safety, and electromagnetic compatibility standards. Risk analysis performed and validated per ISO 9001 and EN46001 standards.

Technological Characteristics

Wearable patient monitor; 5-lead ECG and SpO2 sensing; rechargeable battery power; LCD display; 2.4 GHz WLAN connectivity (FlexNet); bi-directional communication with Acuity central station. Complies with 21CFR820, ISO 9001, and EN46001.

Indications for Use

Indicated for single or multiparameter vital signs monitoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities, including patient transport. Contraindications not specified.

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

• Micropaq 400 series (K002725)
• Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter (K019821)
• Criticare System, Inc. MPT® 2.4 Multiple Parameter Telemetry (K002725)

Submission Summary (Full Text)

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Ko2168

# 510(k) Summary of Safety and Effectiveness

June 28, 2002

# Submitter

Welch Allyn Protocol, Inc. 8500 S.W. Creekside Place Beaverton, OR 97008-7107 USA

Telephone: [phone] Fax: [phone]

Contact: Mr. Don M. Abbey, Vice President, Quality Systems

#### Device Name

Trade Name: Micropaq™ vital signs monitor, models 402 and 404 Common Name: Cardiac Monitor Classification Name: Cardiac Monitor (Reference, 21CFR870.2300, April 1, 2001). The Micropag model 404 also contains a Pulse Oximetry (SpO2) channel (Reference, 21CFR870.2700, April 1, 2001). Classification: Class II

Predicate Device

#### Device Description

The Micropaq is a patient wearable device that provides real time monitoring and display of ECG and SpO2. The Micropaq is powered by a rechargeable battery and has a liquid crystal display (LCD) that displays both waveforms and numerics. The Micropag communicates with Welch Allyn Protocol's Acuity® central station through a wireless local area network (WLAN) operating in the ISM 2.4 GHz band. The communication link is bi-directional, providing monitoring at the Acuity central station and remote control of the Micropaq from the Acuity central station.

### Indications for Use

The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs monitoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages.

- . The ECG channel is intended for five-lead ECG monitoring.
- . The Pulse Oximetry channel is intended for continuous nonitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

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The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

# Technological Comparison to the Predicate Device

The Micropaq 400 series monitors are substantially equivalent to the Micropaq 400 series monitors cleared for market under 510(k) submission number K002725. The SpO2 channel in the model 404 is substantially equivalent to the SpO2 channel in the Nellcor Puritan Bennett, Inc.N-595 Pulse Oximeter cleared for market under 510(k) number K019821

# Summary of Performance Testing

The Micropag and associated accessories have been tested and found to comply with the recognized, national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Micropaq labeling.

A risk analysis, identifying potential hazards and documenting mitigation of the hazards, has been developed and verified/validated as part of Welch Allyn Protocol's product development procedures. Welch Allyn Protocol's Quality System conforms to 21CFR820 and certified by TÜV Product Service to ISO 9001 and EN460011.

# Conclusions

As stated above and in the previous 510(k) submission number K002725, Welch Allyn Protocol's conclusion is that the Micropaq vital signs monitor and WLAN connection to the Acuity central station is safe, effective, complies with the appropriate medical device standards; and is substantially equivalent to the Criticare System, Inc. MPT® 2.4 Multiple Parameter Telemetry and RF link to their Vital View™ 2.4 Central Station, and the SpO2 channel in the Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter cleared for market under 510(k) submission number K019821.

This 510(k) Summary of Safety and Effectiveness may be copied and submitted to interested parties as required by 21CFR807.92.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 3 2002

Mr. Donald M. Abbey Vice President, Quality Systems Welch Allyn Protocol, Incorporated 8500 SW Creekside Place Beaverton, Oregon 97008-7107

Re: K021681

Trade/Device Name: Micropaq, Models 402 and 404 Regulation Number: 870.2300 and 870.2700 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) and Oximeter Regulatory Class: II Product Code: DRT and DOA Dated: June 28, 2002 Received: July 1, 2002

Dear Mr. Abbey:

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.

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.

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Page 2 - Mr. Abbey

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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

# Applicant:

Welch Allyn Protocol, Inc. 8500 S.W. Creekside Place Beaverton, OR 97008-7107 USA

Telephone: [phone] Fax: [phone]

510(k) Number: K021681

Device Name: Micropaq™ vital signs monitor, models 402 and 404

# Indications for Use:

The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs montoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn Protocol's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages.

- The ECG channel is intended for five-lead ECG monitoring. .
- The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional . oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter

30

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K027681