The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.

Device Description

The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system.

The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2 and pulse rate) acquired from infant patients during sleep. Its primary function is to analyze the physiologic signals and generate visual and audible alarm indications upon detection of physiologic events such as central apnea, bradycardia, and high or low SpO2. The portable design of the device facilitates its use in a hospital or in a home environment.

ECG and respiration signals are acquired via a single transducer set attached to the patient and directly connected to the monitor. The measurement method used to derive the respiration signal is Transthoracic Impedance. SpO2 and plethysmographic pulse rate acquired via an oximeter finger sensor. The acquired physiologic signals are classified and stored for use at a later time.

A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data.

The SmartMonitor 2PS is a compact, lightweight unit. Two front panel connectors are provided for the patient sensor input. The sensor connectors and associated sensor plugs are individually keyed to prevent improper insertion.

The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds.

The enclosure for the monitor is constructed of plastic injection molded materials. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.

AI/ML Overview

The provided text describes the SmartMonitor 2 Professional Series (SmartMonitor 2PS), an infant apnea monitor with an internal oximeter. It is a 510(k) submission seeking to extend the existing claims of the monitor to include an internal pulse oximeter.

However, the provided text does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, it lacks:

A table of acceptance criteria and reported device performance.
Details about sample size, data provenance, number or qualifications of experts for ground truth, adjudication methods, or specific study designs (MRMC or standalone).
Information on the training set or how its ground truth was established.

The text primarily focuses on:

The product's proprietary and common name, classification, and predicate devices.
The reason for submission (additional or expanded indications).
Device description and its intended use (Indications for Use).
General statements about design verification testing, IEC 60601-1 and 60601-2 testing, and a Risk Traceability Matrix to assure safety and mitigate hazards.

Based on the information available, here's what can be provided:

Acceptance Criteria and Device Performance Study Information

The document mentions that the functionality of the design was verified through "design verification testing" and safety was assured by "IEC 60601-1 and 60601-2 testing" and a "Risk Traceability Matrix." However, it does not provide specific acceptance criteria or the reported device performance from these tests. It focuses on demonstrating substantial equivalence to predicate devices (Respironics SmartMonitor 2 and Masimo SET Pulse Oximeter) rather than a detailed performance study proving specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not provided in the text. The document states that "functionality of the design of the monitor was verified through the use of design verification testing" and "safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing." However, specific numerical or qualitative acceptance criteria and the corresponding reported performance measurements are not detailed.	Not provided in the text. The document does not offer specific results or metrics from performance testing against predefined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text broadly mentions "design verification testing" but does not specify the sample size of patients or data used, nor its provenance (country, retrospective/prospective).

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)

This information is not provided in the document. The submission focuses on device functionality and safety standards compliance, not on expert-adjudicated ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The SmartMonitor 2PS is an apnea monitor with an internal oximeter, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description.

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

The context suggests the device operates as a standalone monitor, analyzing physiological signals and generating alarms. The entire device essentially represents the "standalone" performance, as it directly monitors and alarms without "human-in-the-loop" performance for its primary function of detecting and alarming. However, the text does not detail specific algorithm-only performance studies with metrics; it broadly states "design verification testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly provided in the document. For an apnea monitor, ground truth would typically involve independently confirmed physiological events (e.g., using polysomnography or other gold-standard monitoring) against which the device's detections are compared. The text only mentions "analyzing physiologic signals and generating visual and audible alarm indications upon detection of physiologic events."

8. The sample size for the training set

This information is not provided in the document. The device is microprocessor-based and software-controlled; while software likely involves development and testing, typical "training sets" as seen in machine learning contexts are not mentioned.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary

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Abbreviated 510(k) Tab 10 - 510(K) Summary

TAB 10

510(K) SUMMARY

Official Contact / Addressof Manufacturing facility	Zita A. YurkoManager, Regulatory AffairsRespironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668Phone: 724-387-4120Fax: 724-387-4216
Proprietary Name	SmartMonitor 2 Professional Series
Common/Usual Name	Apnea Monitor w/ Internal Oximeter
Classification Reference	21 CFR 868.2377 and 21 CFR 870.2700.
Classification	Class II
Appropriate Classification Panel	Anesthesiology and Cardiovascular Devices
Product Code	NPF - Apnea Monitor
	DQA -Oximeter
Predicate Devices	Respironics SmartMonitor 2 (K011597)
	Masimo SET Oximeter (K990966)
Reason for submission	Additional or expanded indications

Substantial Equivalence

This premarket notification submission demonstrates that the SmartMonitor 2 PS is substantially equivalent to a combination of the Respironics SmartMonitor 2 (K011597) and the Masimo SET Pulse Oximeter (K990966).

The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing. The Risk Traceability Matrix provided in Appendix B of the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.

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This submission is seeking to extend the existing claims of the monitor to include an internal pulse oximeter.

Indications for Use

Device Description

The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system.

A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data.

The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds.

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Locations for serial number plate, and necessary user notes are provided at the bottom of the unit. Refer to Tab 6 of this 510(k) for labels.

Accessories for the SmartMonitor 2PS include a patient cable, lead wires, and reusable ECG electrodes; a sensor belt to secure the sensors; a reusable oximeter finger sensor.

The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing. The Risk Traceability Matrix provided the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.

(End of Tab)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2003

Ms. Zita Yurko Manager, Regulatory Affairs Respironics, Inc. Homecare Division 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550

Re: K032403

Trade/Device Name: SmartMonitor 2PS Regulation Number: 868.2377 Regulation Name: Apnea Monitor Regulatory Class: II Product Code: NPF, DQA Dated: August 1, 2003 Received: August 4. 2003

Dear Ms. Yurko:

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 - Ms. Zita Yurko

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 or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

or, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Center of Devices and Radiological Health

510(k) Number (if known): KO32463

Page 1 of 1

SMARTMONITOR 2PS Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription use √

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
033403

510(k) Number:

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.”