VITAL SIGNS MONITOR, PROPAQ LT

K033378 · Welch Allyn Protocol, Inc. · MWI · Mar 1, 2004 · Cardiovascular

Device Facts

• Record ID: K033378
• Device Name: VITAL SIGNS MONITOR, PROPAQ LT
• Applicant: Welch Allyn Protocol, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity central station through wireless communication over Welch Allyn's FlexNet network. This device is available for sale only upon the order of a physician or licensed health care professional.

Device Story

Propaq LT 802 Series is a portable, lightweight vital signs monitor for neonate, pediatric, and adult patients. It captures ECG, NIBP, respiration, and SpO2 signals. Used by clinicians in hospital settings (general medical, telemetry, intermediate care, emergency departments) and transport/EMS environments. Operates as a standalone unit or networked via Welch Allyn FlexNet to an Acuity central station. Provides real-time vital sign data to clinicians to support patient assessment and clinical decision-making in ambulatory and non-ambulatory contexts.

Clinical Evidence

Bench testing only. Performance verified using production-equivalent units. Risk analysis (PN 831-0692-XX) conducted per ISO 9001, EN 46001, and ISO 13485 standards to identify and mitigate potential hazards.

Technological Characteristics

Portable, lightweight vital signs monitor. Parameters: ECG, NIBP, respiration, SpO2. Connectivity: Standalone or networked via FlexNet wireless communication. Quality standards: ISO 9001, EN 46001, ISO 13485.

Indications for Use

Indicated for single or multi-parameter vital signs monitoring (ECG, NIBP, respiration, SpO2) of neonate, pediatric, and adult patients in ambulatory, non-ambulatory, and transport settings, including hospital floors, emergency departments, and EMS.

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

• Welch Allyn Protocol, Propaq Encore Model 2XX Series (K951246, K012451)
• Welch Allyn Protocol, VSM Model 5300 (K021681, K031740)
• Welch Allyn Protocol, Micropaq Model 402/404 (K002725)
• Nellcor Puritan Bennett Pulse Oximeter Model N-550 (K021090)

Submission Summary (Full Text)

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MAR - 1 2004

# 510(k) Summary of Safety and Effectiveness

September 20, 2003

#### Submitter

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

Telephone: [phone] Fax: [phone]

Contact: Dave Klementowski, Senior Manager, Regulatory Affairs at 315-685-4133 or if he is not available, Chris Letscher at 503-530-7389.

#### Device Name:

Trade Name: VSM (vital signs monitor), Propaq LT Common Name: Cardiac Monitor Obmilion Name: Cardiac Monitor (Reference, 21CFR870.2300), NIBP measurement system (Reference 21CFR870.1130, April 1, 2003). The VSM model Propaq LT 802 System (Horononou 2101se Oximetry (SpO2) channel (Reference, 21CFR870.2700, April 1 2003) April 1, 2003), and radio frequency physiologic signal transmitter (Reference, 870.2910, April 2003)

Classification: Class II

# Predicate Devices

The predicate devices for the Propaq LT 802 Series monitors are:

- Welch Allyn Protocol, Propag Encore Model 2XX Series, K951246, K012451, .
- Welch Allyn Protocol, VSM Model 5300, KO21681, K031740 I
- Welch Allyn Protocol, Micropaq Model 402/404, K002725 트
- Nellcor Puritan Bennett Pulse Oximeter Model N-550, K021090 트

# Device Description

The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) in ambulatory, non-ambulatory and transport environments

# Indications for Use

The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs

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monitoring of ambulatory and non-ambulatory neonate, pediativ and adult patiention monioning of ambulatory and from ambulatery nee blood pressure (NIBP), respiration These fromlers are indicated for EOG, nonitored by this device are floors, hearite and SpO2 The most likely locations for pations for pations and other hospital nospital general Theatoar Surgiour, toremany .
emergency departments, transport, emergency medical services natus neatus neatus con emergency departments, transport, omorgency withing devices or as devices networked applications. The monitors may be docu as communication over Welch Allyn's FlexNet™ network.

This device is available for sale only upon the order of a physician or licensed health care professional.

# Summary of Performance Testing

The Welch Allyn Propaq LT 802 Series vital signs monitor will be tested in accordance with the The Welch Allyn Fropaq ET 002 Genoo Kiar Signe Remover in the submission using production equivalent units prior to release to market.

A risk analysis PN 831-0692-XX identifying potential hazards and documenting mitigation of the A TISK analysis FTV 051-0092-70 Normily in Protocol's product product development
hazards has been developed and applied as part of Welch Allyn PREDSCO and institution by TV nazards has been developed and applied & parterns to 21CFR820 and is certified by TÜV Product Service to ISO 9001, EN 46001 and ISO 13485.

#### Conclusions

As documented and stated above, Welch Allyn Protocol's conclusion is that the welch Allyn As documented and stated and effective and comply with the appropriate medical I Topaq ET '002 Ochoo monitore are "seguivalent to the earlier identified predicate devices.

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 logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Welch Allyn, Inc. c/o Mr. David Klementowski Corporate Regulatory Affairs Manager 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K033378

Trade Name: Propaq LT Vital Signs Monitor, Model 802 Series Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: January 27, 2004 Received: January 28, 2004

Dear Mr. Allyn:

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.

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Page 2 -- Mr. David Klementowski

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), please If you desire specific acrite 101 your 301) 594-4648. 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 international 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,

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

Enclosure

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# Indications for Use

510(k) Number (if known): K033378

Device Name: Propaq LT vital signs monitor, model 802 series

Indications For Use:

The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity " central station through wireless communication over Welch Allyn's FlexNet™ network.

This device is available for sale only upon the order of a physician or licensed health care professional.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division of Cardiovascular Devices) |
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| 510(k) Number | K033378 |
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