The VSM series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

Device Description

The VSM, Vital Signs Monitor, Model 53000 Series, (VSM 300) provides real time monitoring and display of noninvasive blood pressure (NIBP), pulse rate, body temperature and nominvasive oxygen saturation of arteriolar hemoglobin (SpO2).

NIBP - Noninvasive Blood Pressure is intended to noninvasively measure systolic, diastolic and mean arterial pressures (MAP).
Temperature -- Intermittent thermometer takes patient temperature in oral, axillary or rectal mode.
SpO2 - Pulse Oximetry channel is intended to noninvasively measure oxygen saturation of arteriolar hemoglobin at a peripheral measurement site.
The subject device is a modified version of the Model 53000 Series vital signs monitor, which was cleared for marketing under 510(k) K031740. The Model 53000 Series vital signs monitor has been changed to incorporate a modified NIBP module. The modified and existing NIBP modules are similar in their basic functionality. The modified NIBP module contains an updated safety processor, which replaces a discontinued safety processor. Both safety processors belong to the same microcontroller family. The modified NIBP module also incorporates other minor software and hardware changes, including the addition of a Resistor-Capacitor network to reduce sensitivity to external vibration. The modified Vital Signs Monitor, Model 53000 Series (VSM 300) monitor communicates to the user the same basic information as the Model 53000 Series vital signs monitor, specifically:
Saturation,
Pulse rate,
Pleth waveform,
Trigger waveform for audible beep, and
Status information (e.g., sensor type, board integrity).
In addition, the user display of the above information (e.g., saturation, pulse rate, error codes) remains unchanged.

AI/ML Overview

The Welch Allyn Vital Signs Monitor, Model 53000 Series (VSM 300), underwent a modification involving its noninvasive blood pressure (NIBP) module. The K063419 submission primarily focuses on demonstrating that these changes are minor and do not alter the substantial equivalence of the device to its predicate. Therefore, the "acceptance criteria" discussed here relate to internal testing and adherence to standards rather than showing a new level of clinical performance for a novel function.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list specific acceptance criteria in terms of numerical performance thresholds for the NIBP module, nor does it provide detailed performance data against such criteria in the typical format of sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "Performance Data" section references a series of internal Welch Allyn test reports that demonstrate compliance with relevant standards and internal verification.

Feature Tested	Acceptance Standard / Test Report	Reported Performance
NIBP Performance (Adult)	ANSI/AAMI SP10:2002	VSM 300 SERIES NIBP ANSI/AAMI SP10:2002 TEST REPORT (831-1245-00) indicates compliance.
NIBP Performance (Neonate)	ANSI/AAMI SP10:2002	VSM 300 SERIES ANSI/AAMI SP10:2002 NEONATE TEST REPORT (831-1251-00) indicates compliance.
General Product Engineering	PE TEST REPORT: VSM III,NIBP/POEM II (831-1212-00)	Indicates successful engineering testing.
Safety Testing	Test Report: VSM III Safety Testing for POEM II (831-1213-00)	Indicates successful safety testing.
EMC Compliance	TEST RPT,EMC,VSM III POEM II,EN60601-1-1-2:2001 (831-0783-07)	Indicates compliance with electromagnetic compatibility standards.
Risk Analysis	Internal Welch Allyn Protocol's product development procedure	A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied.
Quality System Compliance	21 CFR 820 and ISO 13485:2003	Welch Allyn Protocol's Quality System conforms to 21 CFR 820 and is certified to ISO 13485:2003.

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

The document does not explicitly state the sample size used for the NIBP performance testing (e.g., number of patients or measurement points). The studies referenced (e.g., ANSI/AAMI SP10:2002 test reports) are inherently designed to use defined sample sizes specified by those standards, but the specific numbers are not detailed in this summary.

The data provenance is internal to Welch Allyn, as indicated by the "Welch Allyn documents" for the test reports. It is implied these were prospective tests carried out on production-equivalent units. No information is provided regarding the country of origin of the data or if it was retrospective.

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

This information is not provided. For NIBP validation, ground truth is typically established by invasive arterial pressure measurements or calibrated reference devices as per standards like ANSI/AAMI SP10. The summary does not detail the personnel or their qualifications involved in establishing this reference.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of NIBP validation, it's unlikely a human adjudication method (like 2+1, 3+1) would be directly applicable; rather, the "ground truth" would be objective measurements from a highly accurate reference method.

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 MRMC study was performed. This submission is for modifications to a vital signs monitor, not an AI-assisted diagnostic device requiring human interpretation. The device provides objective vital sign measurements.

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

The device itself is a standalone vital signs monitor. The performance studies referenced (e.g., NIBP accuracy against a standard) are inherently "algorithm only" in the sense that they assess the device's measurement capabilities independent of a human interpretation loop beyond reading the displayed values.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For NIBP measurements, the ground truth would typically be established through highly accurate, direct arterial pressure measurements or comparison against a validated reference monitor, as specified in the ANSI/AAMI SP10 standard. This is a form of objective, direct measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The VSM 300 is a hardware device with associated software/firmware for acquiring and processing vital signs. It is not an AI/ML device that requires a "training set" in the conventional sense for learning patterns. The "training" for such a device would be its engineering design, calibration, and validation against established medical device standards.

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Summary

{0}------------------------------------------------

Welch Allyn

DEC - 4 2006

P/4 Special 510(k) Premarket Notification Modification to Vital Signs Monitor

KOK3419

3. Premarket Notification [510(k)] Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness, is outlined below.

Date Prepared:	November 7, 2006
Name of Submitter:	Welch Allyn Protocol, Inc.8500 S.W. Creekside PlaceBeaverton, OR 97008-7107 USA
	Contact:Jeffrey W. Wagner, Director, Regulatory AffairsPhone: (503) 530-7909Fax: (503) 526-4901
Device Proprietary Name:	VSM, Vital Signs Monitor, Model 53000 Series (VSM 300)
Classification Name:	The Vital Signs Monitor is classified under:Monitor, Physiological, Patient, (without Arrhythmia Detection orAlarms), 21 CFR 870.2300, Product Code MWI;Noninvasive Blood Pressure Measurement System, 21 CFR870.1130, Product Code DXN;Oximeter, 21 CFR 870.2700, Product Code DQA; andThermometer, Electronic, Clinical, 21 CFR 880.2190, Product CodeFLL
Common/Usual Names:	Multi-parameter Physiological Patient Monitor,Noninvasive Blood Pressure Measurement System,Pulse Oximeter,Electronic Thermometer
Predicate Device:	The predicate device is Welch Allyn Protocol, Inc.'s VSM VitalSigns Monitor, Model 53000 Series, which was cleared formarketing under 510(k) K031740. The subject device incorporatesa modified noninvasive blood pressure (NIBP) module. Theintended use of the predicate device has not changed as a result ofthis modification.

{1}------------------------------------------------

WelchAllyn

Special 510(k) Premarket Notification Modification to Vital Signs Monitor

063419

Device Description:

. NIBP - Noninvasive Blood Pressure is intended to noninvasively measure systolic, diastolic and mean arterial pressures (MAP).
r Temperature -- Intermittent thermometer takes patient temperature in oral, axillary or rectal mode.
. SpO2 - Pulse Oximetry channel is intended to noninvasively measure oxygen saturation of arteriolar hemoglobin at a peripheral measurement site.

The subject device is a modified version of the Model 53000 Series vital signs monitor, which was cleared for marketing under 510(k) K031740. The Model 53000 Series vital signs monitor has been changed to incorporate a modified NIBP module.. The modified and existing NIBP modules are similar in their basic functionality. The modified NIBP module contains an updated safety processor, which replaces a discontinued safety processor. Both safety processors belong to the same microcontroller family. The modified NIBP module also incorporates other minor software and hardware changes, including the addition of a Resistor-Capacitor network to reduce sensitivity to external vibration. The modified Vital Signs Monitor, Model 53000 Series (VSM 300) monitor communicates to the user the same basic information as the Model 53000 Series vital signs monitor, specifically:

. Saturation,
Pulse rate, .
. Pleth waveform,
Trigger waveform for audible beep, and .
◆ Status information (e.g., sensor type, board integrity).

In addition, the user display of the above information (e.g., saturation, pulse rate, error codes) remains unchanged.

Intended Use: The VSM series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and

{2}------------------------------------------------

WelchAllyn

KO63419 p 3/4

adult patients. The most likely locations for patients to be monitoredare general medical and surgical floors, general hospital andalternate care environments. This device is available for sale onlyupon the order of a physician or licensed health care professional.
TechnologicalCharacteristics:	The modified Model 53000 Series (VSM 300) vital signs monitor(i.e., the subject device) has the same technological characteristicsas originally cleared with the predicate device.
	•	It has the same basic design;
	•	It uses the same energy source;
	•	It uses the same operating principle;
	•	It incorporates the same basic materials; and
	•	It is packaged using the same materials and processes.Based on these similarities, Welch Allyn believes that the subjectdevice is substantially equivalent to the VSM Model 53000 Seriesthat was cleared for marketing under K031740.
Performance Data:	The subject device has been tested in accordance with the followingWelch Allyn documents using production equivalent units prior tomarket release.
	831-1212-00	PE TEST REPORT: VSM III,NIBP/POEM II
	831-1213-00	Test Report: VSM III Safety Testing for POEM II
	831-0783-07	TEST RPT,EMC,VSM III POEM II,EN60601-1-1-2:2001
	831-1245-00	VSM 300 SERIES NIBP ANSI/AAMI SP10:2002TEST REPORT
	831-1251-00	VSM 300 SERIES ANSI/AAMI SP10:2002NEONATE TEST REPORT
	A risk analysis identifying potential hazards and documentingmitigation of the hazards has been developed and applied as part ofWelch Allyn Protocol's product development procedure. WelchAllyn Protocol's Quality System conforms to 21 CFR 820 and is

certified to ISO 13485:2003.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is black and the background is white.

Conclusions: Based on the information contained herein, we conclude that the changes are minor and that the subject device is substantially equivalent to the predicate device. The intended use of the Vital Signs Monitor, Model 53000 Series, as described in its labeling, has not changed as a result of this modification.

{4}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2006

Welch Allyn Protocol. Inc., c/o Mr. Jeffrey W. Wagner Director, Regulatory Affairs 8500 SW Creekside Place Beaverton, OR 97008-7107

Re: K063419

Trade Name: VSM-Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II Product Code: MWI Dated: November 7, 2006 Received: November 13, 2006

Dear Mr. Wagner:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

{5}------------------------------------------------

Page 2 -- Mr. Wagner

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labcling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

{6}------------------------------------------------

Welch Allyn

Special 510(k) Premarket Notification Modification to Vital Signs Monitor

Statement of Indications for Use 4.

Applicant:

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

510(k) Number:

Device Name: VSM, Vital Signs Monitor, Model 53000 Series (VSM 300)

Indications for Use:

Prescription Use

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

(Part 21 CFR 801 Subpart D)	(Part 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 Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K063419

AND/OR

Over-The-Counter Use

Section 4 - 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).