(184 days)
K862527A
Unknown
The description mentions "automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas," which could potentially involve AI/ML, but the document does not explicitly state the use of these technologies. The lack of mention of training or test sets for AI/ML models further contributes to the uncertainty.
No
The device is described as a system for the acquisition, display, storage, and analysis of polysomnography data, intended to assist in the diagnosis of sleep disorders. It does not provide treatment.
Yes
The intended use explicitly states, "It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders."
No
The device description explicitly states that the hardware consists of a personal computer with an enclosed analog-to-digital converter and a connector block, indicating it includes hardware components beyond just software.
Based on the provided information, this 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.
- Device Function: This device acquires, displays, stores, and analyzes polysomnography data. This data is obtained from a polygraph which measures physiological signals directly from the patient's body (EEG, eye movements, muscle activity, airflow, respiratory effort, oxygen saturation). It is not analyzing samples taken from the body.
- Intended Use: The intended use is to assist in the diagnosis of sleep disorders by analyzing physiological signals, not by analyzing biological samples.
Therefore, this device falls under the category of a medical device used for physiological monitoring and analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use in a sleep laboratory for the acquisition, display, storage, and analysis of polysomnography data from a polygraph with IRIG compatible outputs. The analysis features of the system are designed for subjects 13 years of age and older.
This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 1.3 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.
Product codes
73 MNR
Device Description
POLYSMITH is a polysomnography data acquisition, analysis, display, and storage system, which accepts polysomnography data and allows the operator to view the data on the computer monitor. The device also automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas. The hardware consists of a personal computer with an enclosed analog-to-digital converter and a connector block for conveniently connecting the input data leads. The device is designed to input data from a polygraph that has IRIG-compatible outputs. To use all analysis capabilities, there should be at least two EEG channels, two rapid eye movement channels (electro-occulograms), a chin EMG (electromyogram), a leg EMG, an ECG, airflow, two respiratory effort channels and an oxygen saturation channel. The software, which is running under the NT operating system, will display all of the acquired data on the computer screen for reviewing and operator editing. The automated analysis feature, designed tor subjects 13 years of age and older, generates multiple reports, including a sleep stage summary, describing the sleep data.
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
13 years of age and older.
1.3 years of age and older.
Intended User / Care Setting
sleep laboratory, qualified sleep practitioner, physician or qualified sleep technician
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 performance was evaluated by analyzing six all-night sleep records recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan and comparing the results obtained with the predicate device. In addition, the device performance was compared to human scoring, using two all night sleep recordings, from the HFSDC, of patients with severe sleep apnea. Each recording contains two EEG channels (central and occipital), two eye channels, a chin EMG channel, a leg EMG channel, an airflow channel, and one respiratory effort channel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device performance was compared with that of a predicate device, the Oxford SAC system. The system performance was evaluated by analyzing six all-night sleep records recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan and comparing the results obtained with the predicate device. In addition, the device performance was compared to human scoring, using two all night sleep recordings, from the HFSDC, of patients with severe sleep apnea. Each recording contains two EEG channels (central and occipital), two eye channels, a chin EMG channel, a leg EMG channel, an airflow channel, and one respiratory effort channel.
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.
K862527A
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.
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
411005
Nov 1 2 1997
2. 510 (K) Summary
Applicant: Neurotronics Incorporated 20825 NE 132nd Ave. Route 1 Box 543 Waldo, FL 32694
Contact person: Jack R. Smith, Ph.D. 352-468-1006 Fax: 352-468-1006 e-mail: smith@neurotronics.com
Device Name: POLYSMITH
SUBSTANTIAL EQUIVALENCE
This new system, the POLYSMITH, is essentially equivalent, with the same intended use, to the Microtronics SAC system. same individual (Dr. Jack R. Smith) designed both The On October 6, 1986, the FDA notified Microtronics systems. K862527A) that their sleep-analyzing computer was (Re: determined to be substantially equivalent to devices in interstate commerce prior to May 28, 1976. Software for the processing of heart rate and respiration signals was subsequently added (FDA Ref. K863124). Microtronics was subsequently sold to Oxford Medical Instruments, and the Microtronics system is now known as the Oxford SAC system.
Device Description
Staturarian the land
POLYSMITH is a polysomnography data acquisition, analysis, display, and storage system, which accepts polysomnography data and allows the operator to view the data on the computer monitor. The device also automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas. The hardware consists of a personal computer with an enclosed analog-todigital converter and a connector block for conveniently connecting the input data leads. The device is designed to input data from a polygraph that has IRIG-compatible outputs. To use all analysis capabilities, there should be at least two EEG channels, two rapid eye movement channels (electro-occulograms), a chin EMG (electromyogram), a leg EMG, an ECG, airflow, two respiratory effort channels and an oxygen saturation channel. The software, which is running under the NT operating system, will display all of the acquired data on the computer screen for reviewing and operator editing. The automated analysis feature, designed tor subjects 13 years of age and older, generates multiple reports, including a sleep stage summary, describing the sleep data.
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Intended Use
The device is intended for use in a sleep laboratory for the acquisition, display, storage, and analysis of polysomnography data from a polygraph with IRIG compatible outputs. The analysis features of the system are designed for subjects 13 years of age and older.
Warning:
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The POLYSMITH software derives a description of a night's sleep from raw polysomnography data presented to the system. It is possible for the summary data to be incorrect for reasons including bad or missing polysomnography data, power failure, inaccurate calibration, and clinical data, to which the system has not been exposed. The POLYSMITH maintains all of the raw data. All summary data should be verified by examining the raw data on the computer monitor. The data can be viewed with the same resolution as a 10mm/sec. polygraph recording by viewing the data in the 10-second screen display mode. Since some of the sleep-staging criteria are based on specified amplitude levels, the EEG and EOG signals must be calibrated for accurate sleep It is recommended that a signal with known staging. waveform characteristics, such as a calibration signal, be included at the beginning or end of the recording as verification that the calibration was done.
Assessment of Performance Data
The device performance was compared with that of a predicate device, the Oxford SAC system. The system performance was evaluated by analyzing six all-night sleep records recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan and comparing the results obtained with the predicate device. In addition, the device performance was compared to human scoring, using two allnight sleep recordings, from the HFSDC, of patients with severe sleep apnea. Each recording contains two EEG channels (central and occipital), two eye channels, a chin EMG channel, a leg EMG channel, an airflow channel, and one respiratory effort channel.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three overlapping profiles, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1997
Jack R. Smith, Ph.D. Neurotronics Incorporated 4609 NW 6th Street, B-5 Gainesville, Florida 32609
Re : K971803 Polysmith Regulatory Class: II (two) Product Code: 73 MNR Dated: August 18, 1997 Received: August 20, 1997
Dear Dr. Smith:
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 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, Druq, 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 requlation (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 - Jack R. Smith, Ph.D.
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/dsmamain.html".
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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Page 1_of_ 1
510(k) Number (if known): K971803
Device Name: Polysmith
Indications For Use:
This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 1.3 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adol A. Ciark.
(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory, Division ological Devices
510(k) Number _
Prescription Use_V (Par 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)