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
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.
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, Micropaq Model 402/404 (K002725)
Nellcor Puritan Bennett Pulse Oximeter Model N-550 (K021090)
Submission Summary (Full Text)
{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 |
|---------------|---------|
|---------------|---------|
Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
