The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

Device Description

The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal events, SmartMonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review.

SmartMonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via softwarebased algorithms, which analyze the ECG and respiration signals. When beats or breaths are detected, SmartMonitor 2 provides feedback by blinking the Heart and Respiration LED's and calculates apnea intervals, average heart rates, and average breath rates for the purpose for identifying ECG and respiration rates that violate preset threshold values. In addition to the alarms, when abnormal ECG and respiration rates are detected, both tabular data and associated waveforms are logged in nonvolatile memory for subsequent review by a Health Care Professional.

AI/ML Overview

Here's an analysis of the provided text regarding the Respironics SmartMonitor 2, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for both Respiration and ECG monitoring. These specifications serve as the acceptance criteria. The document states that the SmartMonitor 2 "meets the requirements specified in the Product Specification and that it conforms to the required standards," indicating it achieved these criteria.

Feature	Acceptance Criteria (SmartMonitor and SmartMonitor 2)	Reported Device Performance (SmartMonitor 2)
Respiration Monitoring
Resp. Detection Rate	1 to 120 BrPM @ 1 Ohm, peak to peak	Meets requirements
Sensitivity	0.1 to 5 Ohms, peak to peak	Meets requirements
Output Amplitude Accuracy	+/- 5%	Meets requirements
CMRR	> 75 dB at 60 Hz	Meets requirements
Input Impedance	> 75 KOhms	Meets requirements
Detection Amplitude Range	0.2 to 5 Ohms, peak to peak	Meets requirements
ECG Monitoring
ECG Detection Rate	25 to 300 BPM @ 1mV, baseline to peak	Meets requirements
Sensitivity	+/- 0.1 to +/- 5.0 mV	Meets requirements
Output Amplitude Accuracy	+/- 2%	Meets requirements
ECG CMRR	> 75 dB at 60 Hz	Meets requirements
Input Impedance	> 75 KOhms	Meets requirements
Detection Amplitude Range	0.2 mV to 5 mV, baseline to peak	Meets requirements

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

The document states: "Data were compiled from multiple sites on at least 25 patients."

Sample size for test set: At least 25 patients.
Data Provenance: Not explicitly stated (e.g., country of origin, specific demographics). The study was a comparison of the SmartMonitor 2 to a predicate, and the data was "compiled from multiple sites," implying it was real-world clinical data. It's likely retrospective as it involves comparing to "predicate devices" and using "hand scoring" of data, suggesting analysis of pre-existing records rather than a forward-looking, interventional study. However, the document doesn't explicitly state retrospective or prospective.

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

The document indicates that the "gold standard" for ground truth was "hand scoring."

Number of experts: Not specified.
Qualifications of experts: Not specified (e.g., radiologist with 10 years of experience). It simply refers to "hand scoring," implying trained personnel who interpret the raw physiological signals.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1 or 3+1). It only mentions "hand scoring" as the "gold standard," which could imply a single scorer or an internal process not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study is mentioned. The clinical study described compares the device (SmartMonitor 2) against a "gold standard" (hand scoring) and aims to show substantial equivalence to a predicate device, not to evaluate human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was done. The clinical protocol compared the SmartMonitor 2's performance (its algorithms for detecting apnea) "to the gold standard of hand scoring." This directly assesses the algorithm's performance without a human in the loop for the detection task itself, though a healthcare professional reviews the logged data. The device's primary function is automated detection and alarm.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical study was expert consensus (implied via "hand scoring") on the physiological signals (respiration and heart rate) to identify central apnea events.

8. The Sample Size for the Training Set

The document does not specify a separate training set. The descriptions of "system qualification testing" and "software testing" refer to verification and validation activities. The clinical study described is for validation of the final device, not for training a model. Given the time period (2002) and the nature of apnea monitors, it's highly likely it was based on deterministic algorithms rather than machine learning models requiring extensive training data.

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

As no specific training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable or provided. The device's performance is validated against clinical data after its algorithms are developed, implying ground truth for algorithm development would be based on physiological principles and expert-defined thresholds, not a machine learning training set in the modern sense.

Summary

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![Image of Respironics logo]

RESPIRONICS™

www.respironics.com

JAN 1 1 2002

510(k) SUMMARY OF SAFETY & EFFECTIVENESS SMARTMONITOR 2 INFANT APNEA MONITOR / SYNERGY-E SOFTWARE

Establishment
	Registration Number:

Official Contact:

1040777

Betsy Cortelloni Respironics Georgia, Inc. 175 Chastain Meadows Court Kennesaw, GA 30144 Phone: 770-429-2894 Fax: 770-423-2309

Name of Contact:

Device Model Number:

Classification Name:

Device Classification:

Predicate Devices:

Device Description:

Device Name:

SmartMonitor 2 / Synergy-E

4000 Series

Apnea Monitor, 21 CFR 868.2377

Betsy Cortelloni, Regulatory Affairs Manager

Class II (Special Controls)

Healthdyne Technologies SmartMonitor. Originally cleared under K892006 (5/23/89).

KO11597

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Image /page/1/Picture/0 description: The image shows the logo for Respironics. The logo consists of a stylized human figure inside a triangle, with the word "RESPIRONICS" written below it in a sans-serif font. Below the company name is the website address, "www.respironics.com", also in a sans-serif font. The logo is white against a black background.

510(k) Summary, continued:

The SmartMonitor 2 Infant Apnea Monitor is intended for use in the Intended Use: continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

Comparison of Technological

Characteristics:

The SmartMonitor 2 is functionally equivalent to the original SmartMonitor. Many of the differences that exist are not readily visible to the user. Primary differences are:

SmartMonitor 2 is available with an internal modem and/or a removable . PCMCIA memory card;
. Enhanced menu options;
SmartMonitor 2 powers down in less than 1 second; and .
SmartMonitor 2 can download memory (2 Mbytes) in approximately three . minutes.

The performance specifications of SmartMonitor and SmartMonitor 2 for Respiration monitoring are:

Resp. Detection Rate .
. Sensitivity

1 to 120 BrPM @ 1Ohm, peak to peak

0.1 to 5 Ohms, peak to peak

Output Amplitude Accuracy .
CMRR .

Input Impedance .
75 dB at 60 Hz > 75 KOhms
0.2 to 5 Ohms, peak to peak Detection amplitude range

The performance specifications of SmartMonitor and SmartMonitor 2 for ECG monitoring are:

+1-5%

. ECG Detection Rate
Sensitivity .
Output Amplitude Accuracy .
.
75 dB at 60 Hz > 75 KOhms
Input Impedance Detection Amplitude Range

0.2 mV to 5 mV, baseline to peak

@ 2000 Respironics, Inc.
25 to 300 BPM @ 1mV, baseline to peak +/- 0.1 to +/- 5.0 mV
+1-2%
ECG CMRR

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510(k) Summary, continued:

Testing:

Performance

System qualification testing of the SmartMonitor 2 was conducted in accordance System qualification tooting of the en as well as applicable standards and with internal Rooplionies pro timited to, the draft apnea monitor performance guidances including, but not linked to the Part 896, ANSI/AAMI EC13, and IEC 601-1.

The results of these tests support that the SmartMonitor 2 meets the requirements specified in the Product Specification and that it conforms to the required standards.

Software

Testing for the firmware and host software consisted of system level testing, resting for the firmware and module/integration level testing. Test results confirmed that all requirements were met.

Clinical

The clinical protocol was designed to compare the performance of SmartMonitor The cillinoarprotoon was accigned Data were compiled from multiple sites on at 2 to the prodiouts orified via the "gold standard" of hand scoring.

Data were analyzed as specified in the Guidance for Apnea Monitor 510(K) Data were analyzou do opeomou ille substantial equivalence Oubmissions, folouos to the predicate SmartMonitor in detection of central apnea.

Conclusion:

The results of the performance and clinical testing demonstrated the functionality, rne results of the portent the SmartMonitor 2 Infant Apnea Monitor, as well as its substantial equivalence to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

Ms. Betsy Cortelloni Regulatory Affairs Manager Respironics Georgia, Inc. 175 Chastain Meadows Court Kennesaw, GA 30144

Re: K011597

SmartMonitor® 2, Model 4000 Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II (two) Product Code: FLS Dated: October 12, 2001 Received: October 15, 2001

Dear Ms. Cortelloni:

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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to cash was a 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 - Ms. Betsy Cortelloni

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of adrisou that I Dr. over device complies with other requirements of the Act that I Dr has intaintes and regulations administered by other Federal agencies. You must or any I edital statutes and registents, including, but not limited to: registration and listing (21 Comply with an the 110- 370quirements) 01); good manufacturing practice requirements as set CI K Part 607); facomig (21 OS) 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) I mis lotter will and in your le FDA finding of substantial equivalence of your device to a legally premated notineted wice 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 1 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Center of Devices and Radiological Health

510(k) Number (if known):__________K011597

Page 1 of 1

Device Name: SMARTMONITOR 2

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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\Prescription Use

Regulation Number and Section

§ 868.2377 Apnea monitor.

(a)
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”