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 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

AI/ML Overview

This document is a 510(k) summary for the Welch Allyn Propaq LT 802 Series vital signs monitor. It describes the device, its intended use, and provides a statement of its substantial equivalence to predicate devices. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typical for an AI/ML device submission.

Therefore, I cannot fully complete the requested table and sections based on the provided text.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states that the device "will be tested in accordance with the [test methods mentioned elsewhere in the submission]" but does not detail the specific acceptance criteria for parameters like NIBP accuracy, ECG performance, or SpO2 accuracy.	Not explicitly reported in this document. The document generally concludes that the device is "safe and effective and comply with the appropriate medical device standards" and "substantially equivalent to the earlier identified predicate devices," but it does not provide quantitative performance metrics against specific acceptance criteria.

Missing Information:

Specific numerical acceptance criteria for each vital sign parameter (ECG, NIBP, Respiration, SpO2).
Quantified performance results (e.g., mean absolute difference for NIBP, accuracy percentages for heart rate, SpO2 accuracy over specific ranges).

Study Related Information (Based on what can be inferred/is missing):

Study That Proves the Device Meets Acceptance Criteria: The document mentions that the device "will be tested in accordance with the [test methods mentioned elsewhere in the submission] using production equivalent units prior to release to market." This indicates that verification and validation testing was planned or executed, but the details of these studies are not present in this summary. The summary focuses on regulatory compliance and substantial equivalence rather than detailed performance study reports.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified in the document. The document does not provide details on specific test sets, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. For a vital signs monitor, ground truth is typically established by reference devices (e.g., a highly accurate NIBP simulator, a SpO2 simulator, or a known ECG waveform generator) rather than expert consensus on medical images or diagnoses. The document does not mention experts for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading). For vital sign measurements, accuracy is usually determined against a validated reference.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a vital signs monitor, not an AI-powered diagnostic device. MRMC studies are not relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone vital signs monitor. Its performance would be evaluated as an algorithm/device-only performance against reference standards. This is the primary mode of evaluation for such devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Likely a combination of physical simulators and clinical studies against reference devices. While not explicitly stated, for vital signs monitors, ground truth typically comes from:
  - For NIBP: Cuff inflation measurements against a reference manometer or invasive arterial pressure measurements.
  - For ECG: Standardized ECG waveforms, or simultaneous recordings with a highly accurate reference ECG device.
  - For SpO2: Controlled hypoxia studies against a CO-oximeter, or testing with calibrated SpO2 simulators.
- The document mentions "production equivalent units," implying testing against established standards.
8. The sample size for the training set:
- Not applicable/Not specified. This is not an AI/ML device that requires a "training set" in the conventional sense. The device's algorithms for processing vital signs are likely based on established physiological principles and signal processing, not statistical learning from a large training dataset.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. As it's not an AI/ML device relying on a training set, this question is not relevant.

Summary of Device and Regulatory Context:

This 510(k) summary is for a traditional medical device (vital signs monitor). The regulatory pathway focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate. The performance data, while crucial for the submission, is usually summarized or referenced rather than detailed in the public 510(k) summary.

Summary

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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: (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

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 (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

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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:

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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Page 1 of 1

Regulation Number and Section

§ 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).