(250 days)
Not Found
No
The document describes a system for recording and analyzing physiological parameters related to sleep disorders, but it does not mention the use of AI or ML for analysis or interpretation. The analysis is described as an "aid in the diagnosis" by qualified physicians, implying traditional signal processing and physician interpretation.
No
The device is used for diagnosis and monitoring, and does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is used "to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders." The "Device Description" also mentions that the parameters collected are "used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians." These statements clearly indicate its diagnostic purpose.
No
The device description explicitly states that the Somté PSG System comprises both hardware and software, and details hardware components like the Patient Input Box and Recorder.
Based on the provided information, the Somté PSG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Somté PSG Function: The Somté PSG records physiological parameters directly from the human body (heart and muscle activity, eye movement, breathing, body movements) using sensors attached to the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it records, displays, analyzes, prints, and stores human biological parameters to assist in the diagnosis of sleep disorders. This is a direct measurement of physiological signals, not an analysis of a biological specimen.
Therefore, the Somté PSG falls under the category of a physiological monitoring device used for diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.
The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a physician.
Product codes (comma separated list FDA assigned to the subject device)
MINR
Device Description
The Somté PSG System comprises hardware and software which provides up to 27 separate parameters for recording, review and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.
The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.
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
Not Found
Intended User / Care Setting
The Somté PSG is intended for use by or under the direction of physicians in private practices or hospital environments to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An extensive collection of tests has been conducted and successfully completed, including:
- Safety Tests to conform to IEC 60601-1, to ensure that there is no A potential for detrimental effects on patients, other persons, animals or the surroundings. (refer to IEC60601-1 rpt-46275.1-6Dec06-SomtePSG-IEC60601-1 rpt). - refer to Attachment F.
- A Electromagnetic Compatability Tests to IEC 60601-1-2 to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment. (refer to IEC60601-1-2 rpt-M060825-21Sep06-SomtePSG-IEC60601-1-2 rpt). - refer to Attachment F.
- Performance Validation was conducted, results were recorded and an A internal and external Sleep authority generated a Somté PSG Performance Validation Report (refer to AC550-01 Woody Clinical Validation Report, AD052-01 Vampire Heart Rate Verification Report and AC551-01 Report to EN60601-1-4 for Woody-Somte PSG). ). refer to Attachment D.
- Compliance tested to hardware, software and firmware test specifications to ensure conformance to all design requirements. ). refer to Attachments C & D.
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.
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
K072201
page 1 of 5
4 510(k) SUMMARY
APR 1 4 2008
In accordance with 21 CFR 807.92, the following information constitutes the Compumedics Pty Ltd summary for the SOMTÉ PSG SYSTEM.
| SUBMITTER'S NAME: | Compumedics Pty Ltd |
|---|---|
| ADDRESS: | 30-40 Flockhart Street, |
| Abbotsford, Victoria, 3067 | |
| Australia | |
| CONTACT PERSON: | Gordon Ferguson |
| TELEPHONE NUMBER: | +61 3 8420 7300 |
| FAX NUMBER: | +61 3 8420 7399 |
| DATE OF SUBMISSION: | 3May07 |
1. Identification of device
| Proprietary Name: |
|---|
| Common Name: |
| Classification Status: |
| Product Codes: |
Compumedics Somté PSG System SOMTE PSG SYSTEM Class II per regulations 868.2375 MINR
2. Predicate devices
Compumedics Limited believes the SOMTÉ PSG SYSTEM is substantially equivalent to:
| Device name: | Compumedics Sleep Monitoring System |
|---|---|
| Supplier: | Compumedics Limited |
| 510(k) number: | K955841. |
| Device name: | Compumedics Somté Recording System |
| Supplier: | Compumedics Limited |
| 510(k) number: | K021176. |
Description of the Device 3.
The Somté PSG System comprises hardware and software which provides up to 27 separate parameters for recording, review and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.
The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.
1
4. Intended use
The Somté PSG is intended for use by or under the direction of physicians in private practices or hospital environments to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.
: :
Technological characteristics, comparison to predicate device. 5.
COMPARATIVE TABLE
| Characteristic | Compumedics
Somté PSG
Recording System | Compumedics
P-Series
Sleep Monitoring
System
(predicate device) | Compumedics
Somté Recording
System
(predicate device) |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | Sleep/Respiratory
recording and
analysis,
Ambulatory ECG
recording and
analysis | Sleep/Respiratory
recording and
analysis | Sleep/Respiratory
recording and
analysis,
Ambulatory ECG
recording and
analysis |
| 510(k) number | | K955841 | K021176 |
| Environmental | 5 to 45 deg C
20 to 90 % relative
humidity
less than 3000m
altitude | 0 to 45 deg C
30 to 95% relative
humidity
less than 3000m
altitude | 0 to 45 deg C
30 to 95% relative
humidity
less than 3000m
altitude |
| Local User Interface | Monochrome graphic
LCD, 3 push buttons | Monochrome graphic
LCD, 3 push buttons | Monochrome graphic
LCD, 3 push buttons |
| Physical
dimensions | Recorder:113x65x30
mm
PIB: 53 x 133 x 25
mm | Recorder:
240x120x58mm
PIB: 127x66x27mm | Recorder:116x65x30
mm
PIB: 78 x 45 x 22
mm |
| Weight | 270 grams (including
batteries) | 1570 grams
(including battery) | 250 grams (including
batteries) |
| Number of Patients
Can Record
Simultaneously | 1 per Unit
2 Units per PC | 1 per Unit
2 Units per PC | 1 per Unit |
| Portable Design | Yes | Yes | Yes |
| Patient worn device | Yes | Yes | Yes |
| Main Recording unit | Yes | Yes | Yes |
| Patient Interface
Box | Yes | Yes | Yes |
| Use for in-lab
monitored studies | Yes | Yes | No |
| Use for ambulatory
studies at home | Yes | Yes | Yes |
| General
Functionalities: | | | |
| Data Collection | Yes | Yes | |
| Displays Raw Data
during Recording | Yes, PC during in-lab
use, or LCD on unit | Yes, PC during in-lab
use, or LCD on unit | Yes, on LCD on unit |
| Built in Display for
waveform preview | Yes - Integrated LCD
including full
disclosure waveform
preview | Yes - Integrated
LCD including full
disclosure waveform
preview | Yes - LCD |
| Characteristic | Compumedics
Somté PSG
Recording System | Compumedics
P-Series
Sleep Monitoring
System
(predicate device) | Compumedics
Somté Recording
System
(predicate device) |
| Data display on PC
for interpretation | Yes, during or after
recording | Yes, during or after
recording | Yes, after recording
only |
| Data Analysis | Optional | Optional | Optional |
| Report Generation | Optional | Optional | Optional |
| Capable of Data
Transfer for
Analysis and Report
Generation | Yes | Yes | Yes |
| Data Inputs | Generic and custom
sensors. Data inputs
as listed below | Generic and custom
sensors. Data inputs
as listed below | Generic and custom
sensors. Data inputs
as listed below |
| Signal Conditioning | Yes | Yes | Yes |
| Data Analysis
(Computer,
Computer-Assisted
or manual). | Optional | Optional | Optional |
| Comprehensive
Report Generation | Optional | Optional | Optional |
| Remote Sleep
Surveillance | Yes, via broadband | Yes, via dial-up | No |
| Remote Capability
to Monitor Lead
Quality | Yes | Yes | No |
| Remote Capability
to Monitor
Recording
Parameters | Yes | Yes | No |
| Look
Forward/Watch
Back Display | Yes | Yes | No |
| Data Recorded: | | | |
| # Channels of Data
Recorded | Up to 19 | Up to 18 | Up to 13 |
| Respiratory Effort
Channels | 2 Inductive
plethysmography | 2 Inductive
plethysmography | 2 Inductive
plethysmography |
| Airflow | 1 Nasal Cannula | 1 Nasal Cannula | 1 Nasal Cannula |
| Pressure | 1 Nasal Cannula | 1 Nasal Cannula | 1 Nasal Cannula |
| Snore
Body Position | From Cannula
1 built in | From Microphone
1 | From Cannula
1 |
| SaO2 | Yes | Yes | Yes |
| Heart Rate | Yes | Yes | Yes |
| Pulse Wave | Yes | No | Yes |
| Oximeter status
(signal quality) | Yes | Yes | Yes |
| ECG Channels | Up to 2 | 1 | Up to 2 |
| EEG Channels | 2 or 3 | Up to 2 | Up to 2 |
| Chin EMG | Up to 2 | 1 | Up to 2 |
| Diaphragmatic EMG | Up to 1 | optional | Up to 2 |
| EOG | 2 | 2 | Up to 2 |
| Leg Movement | Yes 2 Piezo Electric | Yes 2 Piezo Electric | Yes 2 Piezo Electric |
| Characteristic | Compumedics
Somté PSG
Recording System | Compumedics
P-Series
Sleep Monitoring
System
(predicate device) | Compumedics
Somté Recording
System
(predicate device) |
| Aux AC | 1 (or DC) | 1 | No |
| Aux DC | 1 (or AC) | option | No |
| Impedance Check | Yes | Yes | No |
| Power Source | 2 AA Batteries –
Alkaline or NiMh | 7.2V NiMh | 2 AA Batteries –
Alkaline or NiMh |
| Maximum recording
duration | 30 hours | 15 hours | 30 hours |
| Storage Media | CF Card up to 2Gb | CF Card up to
128Mb | CF Card up to 2Gb |
| Channel Sampling
Rates | 1-1024 Hz channel
dependent | 1-256 Hz channel
dependent | 1-1024 Hz channel
dependent |
| Channel Storage
Rates | 1-256 Hz channel
dependent | 1-256 Hz channel
dependent | 1-256 Hz channel
dependent |
| A/D Vertical
Resolution (in Bits) | 16 | 8 or 12 | 16 |
| Average study size
per 8 hour study | 100Mb | 30Mb | 42Mb |
| Ability to calibrate
DC channels | Yes | Yes | Yes |
| Communications to
PC | IrDA & Bluetooth | Comms port | Not applicable |
| When used for
ECG: | | | |
| Number of ECG
channels | 1 or 2 | Not applicable | 1 or 2 |
| Sensors | Standard ECG
electrodes | Not applicable | Standard ECG
electrodes |
| Sample rate | 1024 | Not applicable | 1024 |
| Recording rate | 256 | Not applicable | 256 |
| Frequency
response | 0.048Hz to 102Hz
(-3dB) | Not applicable | 0.05Hz to 100Hz
(-3dB) |
| Full scale range | 10mV p-p | Not applicable | 10mV p-p |
| ECG analysis
software | Somté ECG Analysis
V1.02 | Not applicable | Somté ECG Analysis
V1.02 |
2
:
.
.
3
:
.
・
4
6. Discussion of performance testing.
An extensive collection of tests has been conducted and successfully completed, including:
- Safety Tests to conform to IEC 60601-1, to ensure that there is no A potential for detrimental effects on patients, other persons, animals or the surroundings. (refer to IEC60601-1 rpt-46275.1-6Dec06-SomtePSG-IEC60601-1 rpt). - refer to Attachment F.
- A Electromagnetic Compatability Tests to IEC 60601-1-2 to ensure no intolerable magnetic disturbances are introduced into its electromagnetic environment. (refer to IEC60601-1-2 rpt-M060825-21Sep06-SomtePSG-IEC60601-1-2 rpt). - refer to Attachment F.
- Performance Validation was conducted, results were recorded and an A internal and external Sleep authority generated a Somté PSG Performance Validation Report (refer to AC550-01 Woody Clinical Validation Report, AD052-01 Vampire Heart Rate Verification Report and AC551-01 Report to EN60601-1-4 for Woody-Somte PSG). ). refer to Attachment D.
- ﺮ ﺍﻟﻤﺮﺍﺟﻊ Compliance tested to hardware, software and firmware test specifications to ensure conformance to all design requirements. ). refer to Attachments C & D.
7. Conclusion
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Compumedics Limited that the SOMTE PSG SYSTEM is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gordon Ferguson Compumedics Pty Limited 30-40 Flockhart Street Abbotsford, Victoria 3067 AUSTRALIA
APR 1 4 2008
Rc: K072201
Trade/Device Name: Somté PSG System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 10, 2008 Received: April 11, 2008
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Ferguson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte Y. Michael Davis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
3 STATEMENT OF INDICATIONS FOR USE
510(k) Number: K072201
Device Name: SOMTÉ PSG SYSTEM
Indications for Use:
The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders.
The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a
Prescription Use
(Per 21 CFR 801 Subpart D)
physician.
AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. N.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: