(62 days)
Not Found
No
The summary describes a standard vital signs monitor with wireless communication capabilities. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing for ECG and SpO2.
No
The device is intended for monitoring vital signs and does not provide therapy or treatment.
No
This device is described as a monitor for vital signs (ECG and SpO2) and provides real-time data display and transmission to a central station. While monitoring provides information vital to diagnosis, it does not explicitly state that it makes a diagnosis itself. It focuses on "monitoring" and "displaying" physiological parameters rather than interpreting them for diagnostic purposes.
No
The device description explicitly states that the Micropaq is a "patient wearable device" with a "liquid crystal display (LCD)" and is "powered by a rechargeable battery," indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Micropaq monitor is described as a device that monitors vital signs (ECG and SpO2) of patients in vivo (within the living body) using sensors attached to the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states monitoring of "ambulatory and non-ambulatory pediatric and adult patients" and "patient transport." This involves direct patient monitoring, not laboratory analysis of samples.
- Device Description: The description focuses on the wearable nature of the device, its display, and its communication capabilities for real-time monitoring. There is no mention of sample collection or analysis.
Therefore, the Micropaq monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DRT, DOA
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.
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
pediatric and adult patients
Intended User / Care Setting
clinicians; health care facilities (step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport)
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: (503) 530-7500 Fax: (503) 526-4200
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).
1
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.
3
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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
4
INDICATIONS FOR USE
Applicant:
Welch Allyn Protocol, Inc. 8500 S.W. Creekside Place Beaverton, OR 97008-7107 USA
Telephone: (503) 530-7500 Fax: (503) 526-4200
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