(88 days)
Not Found
No
The summary describes a data acquisition and recording system for physiological signals during sleep. While it includes software for data analysis and reporting, there is no mention of AI or ML being used for this analysis or any other function of the device. The analysis is described as allowing the clinician to "display, review, edit and print analyzed data" and "validate and editing of all events," which suggests rule-based or manual analysis rather than AI/ML-driven interpretation.
No
The device is described as a "multichannel recording system designed to record and store physiologic signals" and it "acquires, records and stores" data. It is used for diagnosis and monitoring, not for providing therapy.
Yes
Explanation: The device is described as a "multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep" and its associated software "allows the clinician can display, review, edit and print analyzed data." It also explicitly states that it "utilizes the same 'engine' as Healthdyne Technologies' Alice®4 Sleep Diagnostic system," indicating its diagnostic purpose. The data recorded is intended to be "analyzed for physiological events."
No
The device description explicitly states "SmartRecorderTM is a software-controlled device" and details hardware components like transducers, a recorder, a graphic LCD display, and PCMCIA memory. It also mentions interfacing with other physical devices. While it includes associated software (Synergy S), the core medical device system is a combination of hardware and software.
Based on the provided information, the Respironics SmartRecorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to record and store physiologic signals acquired from patients during sleep. This involves measuring signals directly from the body (e.g., ECG, respiration, pressure, flow, oximetry).
- Device Description: The device acquires data via transducers attached to the patient and interfaces with other monitoring/therapeutic devices. It records and stores this data for later analysis.
- Nature of Data: The data being collected are physiological measurements, not samples taken from the body (like blood, urine, tissue) that are then analyzed in vitro (outside the body).
- Lack of In Vitro Analysis: The description focuses on the recording, storage, and analysis of in vivo (within the body) physiological signals. There is no mention of analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SmartRecorder's function is to capture and store physiological data directly from the patient, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes
DQK, MNR
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.
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 and infant patients
Intended User / Care Setting
home or hospital
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No Clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Healthdyne Technologies' Alice 4 System, K971867, Masimo SET MS-1 Pulse Oximeter and Accessories, K962603, Simon Multichannel Recording System, K983572.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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)
| Establishment
| Registration Number: | 1040777 |
|---|---|
| Submitter: | Betsy Cortelloni |
| Respironics Georgia | |
| 1255 Kennestone Circle | |
| Marietta, GA 30066 | |
| Phone: 770-429-2894 | |
| Fax: 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, 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. |
1
510(K) SUMMARY -- SMARTRECORDER™ MULTICHANNEL RECORDING SYSTEM Device Description, continued:
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.
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.
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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:
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.
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
OR
OVER - THE - COUNTER USE