The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.

Device Description

The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped with either a monochrome or color display. The monitors provide real time monitoring and display of ECG, respiration, invasive blood pressure, noninvasive blood pressure, temperature, CO2 and SpO22. Rechargeable batteries power the monitors. The Propaq 200 Series monitors can communicate with Welch Allyn Protocol's Acuity® central station through a local area network. The communication link is bi-directional, ventral station and one a louity central station and remote control of the Propaq from the Acuity central station.

AI/ML Overview

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here’s a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantifiable acceptance criteria for the Propaq 200 Series Monitors' overall performance or for the improved SpO2 channel in a clear table format. The performance section states:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics.	The Propaq 200 Series monitors 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 Propaq labeling."

For the improved SpO2 channel, the device is considered "substantially equivalent to the SpO2 channel in the Nellcor model N-395 Pulse Oximeter," which was previously cleared. This implies that the performance of the improved SpO2 channel is expected to meet the same standards demonstrated by the predicate Nellcor N-395.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The type of testing mentioned relates to compliance with standards, not performance against expert-established ground truth for diagnostic accuracy in a clinical setting.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC comparative effectiveness study is mentioned. This 510(k) relies on substantial equivalence to predicate devices and compliance with recognized standards, not a comparative study demonstrating improvement with AI assistance (as AI is not explicitly mentioned as a component here).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Propaq 200 Series monitors are patient monitors intended for use by "skilled clinicians." The document does not describe standalone algorithm performance without human intervention. The testing described appears to be for the device's adherence to engineering and safety standards.

7. The Type of Ground Truth Used

For the overall device, the "ground truth" seems to be compliance with "recognized national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Propaq labeling."

For the improved SpO2 channel, the "ground truth" for substantial equivalence is implied to be the performance characteristics of the predicate Nellcor N-395 Pulse Oximeter, which presumably met its own set of performance standards at the time of its clearance. No specific clinical ground truth data (e.g., pathology, outcomes data, or expert consensus on clinical readings) is mentioned as being used for the Propaq 200 Series in this summary.

8. The Sample Size for the Training Set

This information is not provided. The development of the Propaq 200 Series monitors and its SpO2 channel would have involved development and verification processes, but specific "training set" sample sizes, as might be relevant for machine learning algorithms, are not discussed.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Given the nature of medical device standards compliance and substantial equivalence claims for patient monitors, the concept of a "training set" and "ground truth establishment" in the context of diagnostic accuracy (as would be typical for AI/CAD devices) is not explicitly applicable or discussed in this document. The "ground truth" for development and verification would be derived from engineering specifications, established physiological principles, and compliance with recognized standards.

Summary

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AUG 2 0 2001

Koi 2451 p.1/2

510(k) Summary of Safety and Effectiveness

July 31, 2001

Submitter

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

Telephone: (503) 526-8500 Fax: (503) 526-4200

Contact: Mr. Donald M. Abbey, Vice President, Quality Systems

Device Name

Trade Name: Propaq 200 Series Monitors Common Name: Cardiac Monitor Common Name: Cardiac Monitor (Reference, 21CFR870.2300, April 1, 1999). The Propaq Monitors also contains a Pulse Oximetry (SpO2) channel (Reference, 21CFR870.2700, April 1, 1999).

Classification: Class II

Predicate Device

The predicate device for the Propaq 200 Series Monitors is the Propaq 200 Series cleared for market under 510(k) submissions K945071 and K951246, except for the improved SpO2 Channel. The predicate device for the improved SpO2 Channel in the Propaq 200 Series is the Nellcor model N-395 Pulse Oximeter cleared for market under 510(k) submissions K951246 and K993637.

Device Description

Indications for Use

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K012451 p. 2/2

Technological Comparison to the Predicate Device

The Protocol 200 Series monitor is the same as the Propaq 200 Series Monitors cleared for market under 510(k) submission numbers K945071 and K951246. The improved SpO2 channel in the Propaq 200 Series is a replacement for the SpO2 channel currently in the Propaq 200 Series monitors. Nellcor Puritan Bennett manufactures the SpO2 Channel currently in the Propaq 200 series. The improved SpO2 channel is also manufactured Nellcor Puritan Bennett. The improved SpO2 channel is substantially equivalent to the SpO2 channel in the Nellcor model N-395 Pulse Oximeter. The Nellcor model N-395 was cleared for market under 510(k) submissions K991823 and K993637.

Summary of Performance Testing

The Propaq 200 Series monitors 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 Propaq 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 is certified by TUV Product Service to ISO 9001 and EN46001.

Conclusions

As stated above, Protocol's conclusion is that the Propaq 200 Series monitors are safe, effective, comply with the appropriate medical device standards, and equivalent to the Propaq 200 series currently on the market.

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 contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line. The words are in black and the background is white.

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

AUG 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald M. Abbey Vice President, Quality System Welch Allyn Protocol, Inc. 8500 S.W. Creekside Place Beaverton, OR 97008-7107

Re: K012451

Trade Name: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 DRT Dated: July 31, 2001 Received: August 1, 2001

Dear Mr. Abbey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning vour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Donald M. Abbey

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Dale Millh

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant: Welch Allyn Protocol. Inc. Beaverton, OR 97008-7107 USA

Telephone: (503) 526-8500 Fax: (503) 526-4245

Kol2451 510(k) Number: _

Device Name: Propaq 200 Series Monitors

Indications for Use:

Indications for USE.
The Propaq 200 Series monitors are intended to be used by skilled continutions and wall as THE Fropaq 200 Scries moliners are meensed in health care facility bedside applications; as well as for intrafacility and interfacility transport.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The Counter __

Ram W
on of Cardiovascular & Respiratory De
Number: K045

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).