SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500

K983572 · Healthdyne Technologies, Inc. · MNR · Mar 19, 1999 · Anesthesiology

Device Facts

• Record ID: K983572
• Device Name: SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
• Applicant: Healthdyne Technologies, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment. Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software. The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.

Device Story

Simon™ is a portable, 8-channel multichannel recording system for sleep studies. It collects physiological signals via patient-attached sensors, including nasal flow/pressure, body position, snoring sounds, oximetry, respiration (chest/abdominal effort), actigraphy, and auxiliary CPAP/BiPAP data. The device is worn by the patient during sleep in clinical or home environments. Data is downloaded to a PC running Simon™ Host Software via modem or direct connection. The software automatically scores physiological events based on user-defined parameters; clinicians review, validate, and edit these events. The system supports remote titration of CPAP/BiPAP settings via modem. The output allows clinicians to generate customized reports to assist in sleep disorder diagnosis and therapy management, potentially improving patient outcomes through optimized titration and monitoring.

Clinical Evidence

Bench testing only. No clinical data was performed. Testing included operational, performance, environmental, and EMC testing, alongside system and module-level hardware and software verification using simulated data.

Technological Characteristics

8-channel recording system; portable form factor; powered by wall supply or rechargeable battery. Software-based analysis using the same engine as the Alice 4 predicate. Connectivity via modem or direct PC link. No specific materials or sterilization standards cited.

Indications for Use

Indicated for adult and pediatric patients requiring recording and storage of physiological signals during sleep in clinical or home settings.

Regulatory Classification

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.

Predicate Devices

• Healthdyne Technologies' Alice 4 System (K971867)

Submission Summary (Full Text)

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

| 3/19/99 | K983572 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | 510(k) SUMMARY<br>(As required by 21 CFR 807.93) |
| | |
| Establishment<br>Registration Number: | 1040777 |
| Submitter: | Betsy Cortelloni<br>Respironics, Inc.<br>1255 Kennestone Circle<br>Marietta, GA 30066<br>Phone: [phone]<br>Fax: [phone] |
| Name of Contact: | Betsy Cortelloni, Regulatory Affairs Process Leader |
| Device Name: | Simon™ Multichannel Recording System |
| Device Model Number: | 5500 |
| Classification Name: | Programmable Diagnostic Computer, 21 CFR 870.1425 |
| Device Classification: | DQK |
| Predicate Devices: | Healthdyne Technologies' Alice 4 System. Originally<br>cleared under K971867 (8/13/97). |
| Device Description: | Simon™ is a multichannel recording system, which may<br>be used for adult or pediatric patients in a variety of<br>settings. The system is comprised of the Simon<br>Recorder, Host Software, auxiliary CPAP / BiPAP<br>devices (as applicable), computer equipment (CPU and<br>monitor) and various accessories (modem, etc.). The<br>recorder is small, lightweight and may be worn while the<br>patient sleeps. The recorder collects physiologic<br>signals from sensors attached to the patient. This eight-<br>channel system records Nasal Flow or Pressure, Body<br>Position, Snoring Sounds, Oximetry, Respiration via<br>Chest Effort, Respiration via Abdominal Effort,<br>Actigraphy, Pressure and Flow from auxiliary<br>Respironics CPAP / BiPAP devices.<br><br>The Simon™ Host Software is a Windows-based<br>application, which facilitates remote titration of CPAP /<br>BiPAP settings via modem, as well as download of<br>recorded data onto a personal computer. Once<br>downloaded, the Host software scores the recorded data<br>for physiological events per user-defined parameters.<br><br>- continued - |
| | FILENAME: HORISEC2.DOC |
| Intended Use: | The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.<br>Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment.<br>Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software.<br>The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs. |
| Comparison of<br>Technological<br>Characteristics: | Simon™ is essentially a line extension of the Healthdyne Technologies Alice 4 System and utilizes the same software "engine" to control device functions. Simon records eight input channels and will display ten, as compared to 20 channels on Alice 4. Signals are recorded in a similar manner.<br>Simon™ is designed to facilitate home use although it may also be used in clinical settings. It is small and lightweight enough to be worn by the patient as s/he sleeps. It is operated using a wall mounted power supply or a rechargeable battery back.<br>The Simon™ Host Software facilitates download of recorded data to a PC via external modem or direct connection to the device. |
| - continued - | |

1

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

## 510(K) SUMMARY – SIMON™ MULTICHANNEL RECORDING SYSTEM Device Description, continued:

Image /page/1/Picture/2 description: The image shows the logo for Respironics. The logo consists of a stylized human figure inside of a triangle shape, which is positioned above the word "RESPIRONICS". The logo is black and white. The human figure appears to be abstract, with a circular head and geometric shapes forming the body and limbs.

MARIETTA, GA. 30066

FILENAME: HORISEC2.DOC

PAGE 3 of 4

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

## 510(K) SUMMARY - SIMON™ MULTICHANNEL RECORDING SYSTEM

| Testing: | The System Qualification Test Plan for Simon™ included<br>Operational and Performance testing, Environmental testing<br>and EMC testing. The Hardware Test Plan and Software Test<br>Plan consisted of system level and module / integration level<br>testing to verify all the defined hardware and software<br>requirements, respectively. Bench testing utilized simulated<br>data. No Clinical testing was performed. |
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

- The cumulative test results demonstrated the functionality, Conclusion: safety and effectiveness of the Simon™ Multichannel Recording System, as well as its substantial equivalence to the predicate device.
Image /page/2/Picture/3 description: The image shows the logo for Respironics. The logo features a stylized triangle with a human-like figure inside. The word "RESPIRONICS" is written in bold, sans-serif font below the triangle. There is a trademark symbol to the right of the word.

MARIETTA, GA. 30066

FILENAME: HORISEC2.DOC

PAGE 4 of 4

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

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Ms. Betsy Cortelloni Healthdyne Technologies 1255 Kennestone Circle Marietta, GA 30066-6029

Re: K983572 Simon Multichannel Recording System Requlatory Class: II (two) Product Code: 73 MNR Dated: February 8, 1999 February 9, 1999 Received:

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 assumptions. Failure to comply with the GMP regulation may result in requlatory 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Thomas J. Callahan

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

Enclosure

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

Center for Devices and Radiological Health

Page l of

| 510(k) Number (if known): | 12983572 |
|---------------------------|-------------------------------------|
| Device Name: | SIMON MULTICHANNEL RECORDING SYSTEM |

Indications for Use:Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment.

Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software.

The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Ath A. Ciarkush.

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

510(k) Number

પરા