(131 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard vital signs monitoring without mentioning any advanced analytical capabilities.
No
Explanation: This device is for vital signs monitoring and is not intended to treat or cure any conditions, which is the definition of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "single or multi-parameter vital signs monitoring." Monitoring vital signs (ECG, NIBP, respiration, SpO2) provides data used by clinicians to assess a patient's health status and potentially diagnose conditions, aligning with the definition of a diagnostic device.
No
The device description explicitly states it is a "small, lightweight patient monitoring device" and mentions monitoring parameters like ECG, NIBP, respiration, and SpO2, which require hardware sensors and components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "single or multi-parameter vital signs monitoring" of patients. This involves measuring physiological parameters directly from the patient (ECG, NIBP, respiration, SpO2).
- Device Description: The description reinforces that it's a "patient monitoring device" for measuring "noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2)". These are all measurements taken from the patient's body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention the analysis of any such specimens.
Therefore, the Propaq LT 802 series monitors are patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes
MWI
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
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
neonate, pediatric and adult patients
Intended User / Care Setting
clinicians and medically qualified personnel, hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951246, K012451, K021681, K031740 I, K002725, K021090
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
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: (503) 530-7500 Fax: (503) 526-4901
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
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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) |
|---|
| -------------------------------------- |
| 510(k) Number | K033378 |
|---|---|
| --------------- | --------- |
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