(41 days)
The SOMNOscreen EEG10-20 is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.
The SOMNOscreen EEG10-20 is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.
The SOMNOscreen EEG10-20, a portable physiological signal recording system, did not undergo a study with acceptance criteria in the provided documentation. Instead, its substantial equivalence to a predicate device, the Somnomedics SOMNOscreen (K060708), was established through performance testing and a comparison of technological characteristics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compliance to Device Specifications | All functions operate as designed; measured parameters meet required ranges and accuracies. | Confirmed, all functions verified to operate as designed. Measured parameters met required ranges and accuracies. |
| Electrical Safety | Compliance with international standards for electrical safety. | Found to be compliant with the requirements of these standards. |
| Electromagnetic Compatibility (EMC) | Compliance with international standards for electromagnetic compatibility. | Found to be compliant with the requirements of these standards. |
| Consistency with Predicate Device (K060708) | Only difference is the number of AC-Channels; no new concerns about safety and effectiveness; identical indications for use; consistent labeling; same principles of operation and technological characteristics. | SOMNOscreen EEG10-20 provides up to 40 channels (22 AC Channels, 20 Referential, 11 Respiratory and AUX, 7 Internal). Predicate Device (K060708) provides up to 28 channels (10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX, 7 Internal). This difference in channel count was deemed not to raise new safety or effectiveness concerns, maintaining substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission describes performance testing for device specifications and compliance with standards, not a clinical study with a patient test set.
- Data Provenance: Not applicable. The testing was described as "performance testing" and "testing to the international standards," which implies internal device validation rather than clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This information is not provided because no clinical (human subject) test set requiring expert adjudication was conducted for this 510(k) submission.
4. Adjudication Method
- Not applicable. No clinical test set requiring ground truth establishment through expert adjudication was mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not described in the provided text. The device is a physiological signal recording system, and the submission focuses on its technical performance and equivalence to a predicate, not on human reader interpretation or AI assistance.
6. Standalone Performance Study
- Yes, effectively. The performance testing described ("Performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed. Measured parameters met required ranges and accuracies.") can be considered a standalone assessment of the device's functional performance, albeit at a technical level rather than a clinical performance (e.g., diagnostic accuracy) level. The submission is for a recording device, not an analytical algorithm.
7. Type of Ground Truth Used
- Technical specifications/Compliance Standards. The "ground truth" for the performance testing was derived from the device's technical specifications and the requirements of international standards for electrical safety and electromagnetic compatibility. This is not clinical ground truth like pathology or expert consensus.
8. Sample Size for the Training Set
- Not applicable. This device is a physiological signal recording system, not an AI/ML algorithm that requires a training set of data for development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML algorithm, it does not have a training set.
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Ko71556
Section 6: 510(k) Summary
510(k) Summary
JUL 1 8 2007
| Applicant: | SOMNOmedics GmbHAm Sonnenstuhl 63Randersacker, Germany D-97236Phone: +49-931-359094-0Facsimile: +49-931-359094-49 |
|---|---|
| US Contact: | M Squared Associates, Inc.Cherita James719 A Street, NEWashington DC 20002Phone: 202-546-1262 ext. 257Facsimile: 202-546-3848E-mail: CJames@msquaredassociates.com |
| Manufacturing/Distribution Address: | SOMNOmedics GmbHAm Sonnenstuhl 63Randersacker, Germany D-97236 |
Establishment Registration Number: Active, awaiting assignment of registration number
| Date submitted: | June 6, 2007 |
|---|---|
| Proprietary Name: | Somnomedics SOMNOscreen EEG10-20 |
| Common Name: | Ventilatory Effort Recorder |
| Classification Status: | Class II per regulations §868.2375 Breathing frequencymonitor |
| Product Codes: | MNR |
| Predicate Device: | Somnomedics SOMNOscreen (K060708) cleared January 24, 2007 |
Device Description: The SOMNOscreen EEG10-20 is a portable physiological signal recording
system intended to be used to record, display, monitor, print and store biophysical events to
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aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.
This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers.
Indication for Use: The SOMNOscreen EEG10-20 is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.
Summary of Technological Characteristics: The system provides up to 40 channels for data acquisition: 22 AC Channels, 20 Referential, 11 Respiratory and AUX Channels, 7 Internal Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort).
The SOMNOscreen EEGI0-20 includes a Compact Flash Card and Reader, Li ION Batteries, (2350mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen ERGIO-20 and Sensors, Instruction Manuals and the DOMINO software for Initialization, Data Transfer and Analysis.
Summary of Nonclinical Testing: The SOMNOscreen EEGIO-20 was subject to the same preclinical requirements as the previously cleared predicate device the Somnomedics SOMNOscreen (K060708).
Performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed. Measured parameters met required ranges and accuracies. Testing to the international standards for electrical safety and electromagnetic compatibility were performed. SOMNOscreen EEGI0-200 was found to be compliant with the requirements of these standards.
Substantial Equivalence Discussion:
The SOMNOscreen (K060708) and the SOMNOscreen EEGI0-20 differ only in the number of AC-Channels. The predicate device provides up to 28 channels for data acquisition; 10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal
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Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort) as compared to the SOMNOscreen EEGI0-20 providing an additional 12 data acquisition Channels, 12 AC Channels, and 12 Referential Channels (40 channels for data acquisition; 22 AC Channels, 20 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal Channels).
Conclusion:
SOMNOMEDICS Somnoscreen EEGI0-20 is substantially equivalent to Somnomedics SOMNOscreen (K060708) already on the market and presents no new concerns about safety and effectiveness. Additionally, the device has identical indications to the predicate device and the labeling of the device is consistent both with FDA's guidance as well as current medical practice. SOMNOMEDICS Somnoscreen EEGIO has the same principles of operation and technological characteristics as the previously 510k cleared predicate.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2007
SOMNOmedics GmbH C/O Ms. Cherita James Regulatory Consultant M. Squared Associates, Incorporated 719 A Street North East Washington, DC 20002
Re: K071556
Trade/Device Name: SOMNOscreen EEG10-20 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 9, 2007 Received: July 10, 2007
Dear Ms. James:
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.
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Page 2 -Ms. James
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) 276-0120. 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,
Chiu Lin, Ph.D.
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
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Indications for Use
510(k) Number (if known): K071556
Device Name: SOMNOscreen eeg10-20
Indications For Use: The SOMNOscreen secuen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleeprelated breathing disorders.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel J. Rebol
(Division Sign-Ott) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K071556
§ 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).