The Respironics SmartRecorder is a multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep. SmartRecorder is designed for use in the home or hospital.

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder.

Use of the associated Synergy S (host) software facilitates retrieval of data recorded by SmartRecorder via direct PC connection; remotely via internal modem; or by transferring data directly from the removable PCMCIA memory card to a PC. Once downloaded, the recorded data can be analyzed for physiological events.

Synergy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.

Device Description

SmartRecorderTM is a software-controlled device, which utilizes the same "engine" as Healthdyne Technologies' Alice®4 Sleep Diagnostic system. SmartRecorder is a scaled down version of Alice 4, having fewer channels and weighing less than three pounds. SmartRecorder acquires, records and stores up to seven dedicated channels of sensor-input physiologic data, and provides the capability to interface with Respironics infant monitoring devices and sleep therapy devices to record ECG and respiration signals, or pressure and flow signals, respectively. Additionally, SmartRecorder acquires analog data through four auxiliary channels. SmartRecorder includes built-in Masimo SET® oximetry technology.

The acquired data is recorded and stored in non-volatile removable PCMCIA flash memory, and can be retrieved by direct PC connection: remotely via internal modem; or by transferring the data directly from the memory card to a PC.

A graphic LCD display provides feedback and instruction to the clinician to assist in setup of a patient.

The associated Host software, Synergy S™, allows the HealthCare Professional (user) to access the stored data for subsequent validation and editing of all events, and provides reporting capabilities that are fully user-configurable. Synergy S is a Windows-based application, which also facilitates remote titration of CPAP / BiPAP settings via modem.

AI/ML Overview

The SmartRecorder™ MULTICHANNEL RECORDING SYSTEM is a software-controlled device for acquiring, recording, and storing up to seven dedicated channels of sensor-input physiologic data, and interfacing with other Respironics devices. It also acquires analog data through four auxiliary channels, includes built-in Masimo SET® oximetry technology, and utilizes a graphic LCD display for patient setup. The associated Host software, Synergy S™, allows healthcare professionals to access stored data for validation, editing, and reporting, and facilitates remote titration of CPAP/BiPAP settings.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Operational and Performance Testing	System level and module/integration level tests verified all defined hardware and software requirements.
Environmental Testing	Testing confirmed functionality under various environmental conditions.
EMC Testing	Testing confirmed electromagnetic compatibility.
Functionality, Safety, and Effectiveness	Cumulative test results demonstrated functionality, safety, and effectiveness.
Substantial Equivalence to Predicate Device	Demonstrated substantial equivalence to the predicate device (Healthdyne Technologies' Alice 4 System).

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

Sample Size: Not explicitly stated, though the document refers to "bench testing utilized simulated data" (Page 3). This implies that a controlled set of simulated data was used for testing, rather than a clinical patient sample.
Data Provenance: The data used for testing was "simulated data," implying it was artificially generated or controlled in a lab setting, not derived from human subjects. The country of origin is not directly relevant for simulated data in this context. The study was a retrospective bench test, not a prospective clinical trial.

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

Not applicable. Since the study used "simulated data" for bench testing, there was no need for experts to establish ground truth in the traditional sense of clinical interpretation. The ground truth would have been based on the predefined parameters of the simulated data itself, which was designed to test specific hardware and software functionalities.

4. Adjudication Method for the Test Set

Not applicable. As no human interpretation of results against a "true" condition was involved (due to simulated data), there was no adjudication method needed. The testing would have involved comparing the device's output against the expected output of the simulated data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No Clinical testing was performed." The study was focused on engineering and performance verification using simulated data.

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

Yes, a standalone performance assessment was effectively done. The "System Qualification Test Plan," which included Operational, Performance, Environmental, and EMC testing, along with Hardware and Software Test Plans, evaluated the device and its associated software primarily in a standalone capacity using simulated data. There was no human-in-the-loop performance evaluation reported.

7. The Type of Ground Truth Used

The ground truth used was based on simulated data. This means the "true" signals, parameters, and expected outputs were defined programmatically or by design specifications for the purpose of testing the device's hardware and software functionalities.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or AI models that would require a distinct "training set." The SmartRecorder™ seems to be a deterministic system based on predefined algorithms and hardware, rather than a system that "learns" from data.

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

Not applicable, as no training set was used.

Summary

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

K990199

Image /page/0/Picture/1 description: The image shows the logo for Respironics. The logo consists of a stylized figure inside a triangle, with the word "RESPIRONICS" written below it in a bold, sans-serif font. There is a registered trademark symbol next to the figure and the word "RESPIRONICS".

1255 Kennestone Circle Marietta, Georgia 30066-6029 USA

SmartRecorder™ MULTICHANNEL RECORDING SYSTEM

510(k) SUMMARY

(As required by 21 CFR 807.93)

EstablishmentRegistration Number:	1040777
Submitter:	Betsy CortelloniRespironics Georgia1255 Kennestone CircleMarietta, GA 30066Phone: 770-429-2894Fax: 770-499-1418
Name of Contact:	Betsy Cortelloni, Regulatory Affairs Manager
Device Name:	SmartRecorder Multichannel Recording System
Device Model Number:	2500
Classification Name:	Programmable Diagnostic Computer, 21 CFR 870.1425
Device Classification:	DQK
Predicate Devices:	Healthdyne Technologies' Alice 4 System, K971867.Masimo SET MS-1 Pulse Oximeter and Accessories,K962603. Simon Multichannel Recording System, K983572.
Device Description:	SmartRecorderTM is a software-controlled device, whichutilizes the same "engine" as Healthdyne Technologies'Alice®4 Sleep Diagnostic system. SmartRecorder is a scaleddown version of Alice 4, having fewer channels and weighingless than three pounds. SmartRecorder acquires, recordsand stores up to seven dedicated channels of sensor-inputphysiologic data, and provides the capability to interface withRespironics infant monitoring devices and sleep therapydevices to record ECG and respiration signals, or pressureand flow signals, respectively. Additionally, SmartRecorderacquires analog data through four auxiliary channels.SmartRecorder includes built-in Masimo SET® oximetrytechnology.

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

510(K) SUMMARY -- SMARTRECORDER™ MULTICHANNEL RECORDING SYSTEM Device Description, continued:

A graphic LCD display provides feedback and instruction to the clinician to assist in setup of a patient.

Intended Use: The Respironics SmartRecorder is a multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep. SmartRecorder is designed for use in the home or hospital.

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder.

Use of the associated Synergy S (host) software facilitates retrieval of data recorded by SmartRecorder via direct PC connection: remotely via internal modem; or by transferring data directly from the removable PCMCIA memory card to a PC. Once downloaded. the recorded data can be analyzed for physiological events.

Synerqy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.

Comparison of Technological Characteristics:

SmartRecorder is essentially a line extension of the Healthdyne Technologies Alice 4 System and utilizes the same software "engine" to control device functions. SmartRecorder records seven sensor-input channels and four auxiliary channels, as compared to 20 channels on Alice 4. Signals are recorded in a similar manner.

SmartRecorder is small and lightweight, and is designed for home or hospital use. It is operated using a wall mounted power supply.

The Synerqy Software facilitates download of recorded data to a PC via internal modem or direct connection to the device.

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

510(K) SUMMARY – SmartRecorder™ MULTICHANNEL RECORDING SYSTEM Continued:

The System Qualification Test Plan for SmartRecorder included Testing: Operational and Performance testing, Environmental testing and EMC testing. The Hardware Test Plan and Software Test Plan consisted of system level and module / integration level testing to verify all the defined hardware and software requirements, respectively. Bench testing utilized simulated data. No Clinical testing was performed.
The cumulative test results demonstrated the functionality, safety Conclusion: and effectiveness of the SmartRecorder Multichannel Recording System and the associated Synergy Software, as well as their substantial equivalence to the predicate device.

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

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 1999

Ms. Betsy Cortelloni Respironics, Inc. 1255 Kennestone Circle Marietta, GA 30066

K990199 Re: Smartrecorder, Model 2500 Requlatory Class: II (two) 73 MNR Product Code: January 19, 1999 Dated: Received: January 21, 1999

Dear Ms. Cortelloni:

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 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 (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your 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.

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

Page 2 - Ms. Betsy Cortelloni

This letter will allow you to beqin 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) 594-4648. 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"(21 CFR 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,

Thomas J. Callahan

Thomas J. Cal ahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Devices and Radiological Health

Page of of

510(k) Number (if known):	K990199
---------------------------	---------

Device Name: SMARTRECORDER MULTICHANNEL RECORDING SYSTEM

Indications for Use:

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder.

Synergy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.

A.A. Calla.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number

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

Concurence of CDRH, Office of Device Evaulation (ODE)

PRESCRIPTION પર્ટદ

OVER - THE - COUNTER USE

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).