(157 days)
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.
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.
This 510(k) summary describes the Simon™ Multichannel Recording System (Model 5500), manufactured by Respironics, Inc. The device is a portable system designed to record and store physiological signals from adult and pediatric patients during sleep, for use in clinical or home settings. It collects data from eight channels, including Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, and Pressure/Flow from auxiliary CPAP/BiPAP devices. The associated Host Software facilitates data download, scoring of physiological events, and allows clinicians to review, validate, edit, and print scored data.
Acceptance Criteria and Study for Simon™ Multichannel Recording System
Based on the provided 510(k) summary, the acceptance criteria and study that prove the device meets these criteria are detailed below. It's important to note that this submission did not include clinical testing. The evaluation was based on non-clinical testing to demonstrate functionality, safety, and effectiveness, and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| System Functionality | - Operational Testing (System level) | The cumulative test results demonstrated the functionality of the Simon™ Multichannel Recording System. |
| Device Performance | - Performance Testing (System level) | The cumulative test results demonstrated the effectiveness of the Simon™ Multichannel Recording System. |
| Safety | - Environmental Testing | The cumulative test results demonstrated the safety of the Simon™ Multichannel Recording System. |
| Electromagnetic Compatibility (EMC) | - EMC Testing | The cumulative test results demonstrated compliance with EMC requirements. |
| Hardware Requirements | - Hardware Test Plan (System level, module/integration level) | The Hardware Test Plan verified all defined hardware requirements. |
| Software Requirements | - Software Test Plan (System level, module/integration level) | The Software Test Plan verified all defined software requirements. |
| Substantial Equivalence | - Comparison to predicate device: Healthdyne Technologies' Alice 4 System (K971867) regarding technology (software engine, signal recording manner), intended use (recording physiological signals during sleep), settings (clinical/home), and features (data download, scoring, review, editing, printing). | The cumulative test results demonstrated the substantial equivalence of the Simon™ Multichannel Recording System to the predicate device. Simon™ utilizes the same software "engine" and records signals in a similar manner to the Alice 4 System. Differences noted (e.g., number of channels) were not deemed to alter the fundamental equivalence for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: "Bench testing utilized simulated data." No specific number of simulated cases or data points is mentioned.
- Data Provenance: The data used for testing was entirely simulated data. There is no mention of data provenance in terms of country of origin or whether it was retrospective or prospective, as it was not real patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The testing utilized simulated data and no clinical experts were involved in establishing ground truth for a test set based on real patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As no clinical testing was performed and simulated data was used, there was no adjudication method involving human interpretation of real patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document explicitly states, "No Clinical testing was performed." Therefore, no MRMC study, with or without AI assistance, was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: The testing described ("Operational and Performance testing," "Hardware Test Plan," "Software Test Plan") would largely constitute standalone performance assessment of the device's components and system functionality against its defined requirements using simulated data. However, it is not presented as a formal "standalone performance study" in terms of diagnostic accuracy with real patient data compared to a clinical ground truth. The device includes software that scores physiological events, but the validation of this scoring against clinical outcomes or expert consensus on real data was not part of this 510(k) submission. The intended use states the clinician reviews, validates, and edits scored data, indicating a human-in-the-loop workflow.
7. The Type of Ground Truth Used:
- Ground Truth Type: For the non-clinical testing performed, the "ground truth" was based on defined hardware and software requirements and expected outputs from simulated data. There was no clinical ground truth (e.g., expert consensus, pathology, or outcomes data) established from real patient cases.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document describes a medical device, not an AI/ML algorithm that undergoes a training phase using a specific training dataset in the typical sense. The "software engine" is mentioned as being the same as the predicate device, suggesting a previously developed and established system, rather than a newly trained model requiring a distinct training set for this specific submission.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As it is not an AI/ML algorithm requiring a training set with established ground truth, this information is not relevant to this submission. The software's event scoring parameters are described as "user-defined parameters," implying configurability rather than a fixed algorithm established through a training process with ground truth data.
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| 3/19/99 | K983572 |
|---|---|
| 1. | 510(k) SUMMARY(As required by 21 CFR 807.93) |
| EstablishmentRegistration Number: | 1040777 |
| Submitter: | Betsy CortelloniRespironics, Inc.1255 Kennestone CircleMarietta, GA 30066Phone: 770-429-2894Fax: 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. Originallycleared under K971867 (8/13/97). |
| Device Description: | Simon™ is a multichannel recording system, which maybe used for adult or pediatric patients in a variety ofsettings. The system is comprised of the SimonRecorder, Host Software, auxiliary CPAP / BiPAPdevices (as applicable), computer equipment (CPU andmonitor) and various accessories (modem, etc.). Therecorder is small, lightweight and may be worn while thepatient sleeps. The recorder collects physiologicsignals from sensors attached to the patient. This eight-channel system records Nasal Flow or Pressure, BodyPosition, Snoring Sounds, Oximetry, Respiration viaChest Effort, Respiration via Abdominal Effort,Actigraphy, Pressure and Flow from auxiliaryRespironics CPAP / BiPAP devices.The Simon™ Host Software is a Windows-basedapplication, which facilitates remote titration of CPAP /BiPAP settings via modem, as well as download ofrecorded data onto a personal computer. Oncedownloaded, the Host software scores the recorded datafor 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 ofTechnologicalCharacteristics: | 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 - |
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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
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510(K) SUMMARY - SIMON™ MULTICHANNEL RECORDING SYSTEM
| Testing: | The System Qualification Test Plan for Simon™ includedOperational and Performance testing, Environmental testingand EMC testing. The Hardware Test Plan and Software TestPlan consisted of system level and module / integration leveltesting to verify all the defined hardware and softwarerequirements, respectively. Bench testing utilized simulateddata. 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
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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 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.
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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
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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
§ 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).