(157 days)
No
The summary describes a system for recording and scoring physiological signals based on user-defined parameters, with no mention of AI or ML technologies.
No.
The device is a multichannel recording system designed to acquire and store physiological signals during sleep for diagnostic purposes, and it does not directly provide therapy.
Yes
Explanation: The device is described as a multichannel recording system that records and stores physiological signals to be scored for physiological events, which clinicians can review, validate, and print. This process of acquiring and analyzing physiological data to identify events is characteristic of a diagnostic device, particularly for sleep disorders.
No
The device description explicitly states that the system is comprised of both hardware (Simon Recorder, computer equipment, accessories) and software (Simon™ Host Software). The software processes data acquired by the hardware components.
Based on the provided information, the Simon™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Simon™ Function: The Simon™ system records physiological signals directly from the patient's body using transducers and sensors attached externally. It does not analyze samples taken from the body.
- Intended Use: The intended use is to record and store physiological signals during sleep for the purpose of scoring physiological events. This is a diagnostic tool, but it's based on in vivo (within the living body) measurements, not in vitro (in glass/outside the body) analysis of samples.
Therefore, the Simon™ device falls under the category of a medical device used for physiological monitoring and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MNR
Device Description
Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings. The system is comprised of the Simon Recorder, Host Software, auxiliary CPAP / BiPAP devices (as applicable), computer equipment (CPU and monitor) and various accessories (modem, etc.). The recorder is small, lightweight and may be worn while the patient sleeps. The recorder collects physiologic signals from sensors attached to the patient. This eight- channel system records Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, Pressure and Flow from auxiliary Respironics CPAP / BiPAP devices. The Simon™ Host Software is a Windows-based application, which facilitates remote titration of CPAP / BiPAP settings via modem, as well as download of recorded data onto a personal computer. Once downloaded, the Host software scores the recorded data for physiological events per user-defined parameters. The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
any clinical setting or in the home environment. The clinician can review, validate, edit and print scored data.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing utilized simulated data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The System Qualification Test Plan for Simon™ included 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 and effectiveness of the Simon™ Multichannel Recording System, as well as its substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
| 3/19/99 | K983572 |
|---|---|
| 1. | 510(k) SUMMARY |
| (As required by 21 CFR 807.93) | |
| Establishment | |
| Registration Number: | 1040777 |
| Submitter: | Betsy Cortelloni |
| Respironics, Inc. | |
| 1255 Kennestone Circle | |
| Marietta, GA 30066 | |
| Phone: 770-429-2894 | |
| Fax: 770-499-1139 | |
| 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 |
| cleared under K971867 (8/13/97). | |
| Device Description: | Simon™ is a multichannel recording system, which may |
| be used for adult or pediatric patients in a variety of | |
| settings. The system is comprised of the Simon | |
| Recorder, Host Software, auxiliary CPAP / BiPAP | |
| devices (as applicable), computer equipment (CPU and | |
| monitor) and various accessories (modem, etc.). The | |
| recorder is small, lightweight and may be worn while the | |
| patient sleeps. The recorder collects physiologic | |
| signals from sensors attached to the patient. This eight- | |
| channel system records Nasal Flow or Pressure, Body | |
| Position, Snoring Sounds, Oximetry, Respiration via | |
| Chest Effort, Respiration via Abdominal Effort, | |
| Actigraphy, Pressure and Flow from auxiliary | |
| Respironics CPAP / BiPAP devices. |
The Simon™ Host Software is a Windows-based
application, which facilitates remote titration of CPAP /
BiPAP settings via modem, as well as download of
recorded data onto a personal computer. Once
downloaded, the Host software scores the recorded data
for physiological events per user-defined parameters.
- continued - |
| | FILENAME: HORISEC2.DOC |
| Intended Use: | The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.
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. |
| Comparison of
Technological
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.
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.
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
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, 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 (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,
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
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