(71 days)
The N7000 system (with MDrive) is intended for clinical sleep applications, with recording and/or amplification capability of numerous types of physiological signals used by a physician or trained technician for the acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient connected Headbox and/or Patient Unit during sleep related studies.
The general intended environments are hospitals, institutions, sleep centers, and sleep clinics, but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably.
The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.
The N7000 system does not provide any alarms and is not intended to be a monitor.
A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the N7000 data when it is communicated and presented on a PC using a separate application software program.
The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.
The original cleared N7000 system consists of 3 separate components; a mains connected Communication Unit (CU) for signal amplification and transmission to a host PC, a Headbox that is cable connected to the CU, and a Patient unit that is cable connected to the Headbox. Patient electrodes are connected to the Headbox and the Patient Unit with several electrodes and sensors non-invasively attached to a patient during sleep.
The MDrive device is intended as an alternate upgrade for the current CU component and provides all original functionality and system connectivity that exists with the CU.
The major additions that the MDrive provides over the existing CU component in the N7000 svstem are:
- A wireless connection option to the host PC, in addition to a wired connection, . 1.
- a local keypad and display for the user to perform electrode impedance checking 2. and biocalibration locally rather that from a remote PC, and
- study recording capability using an SD card in the event of PC host 3. communication interruption. The SD card study can then be uploaded to the host PC.
The provided 510(k) summary for the Embla N7000 with MDrive describes its acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Signals received, amplified, recorded, and transmitted by the MDrive are identical to those of the predicate device's Communication Unit (CU). | "all signals received, amplified, recorded and transmitted by the MDrive were identical to signals received, amplified and transmitted by the predicate devices." |
| Compliance with IEC 60601-1/UL60601-1 (Electrical Safety) | "Safety tests... have been performed to verify compliance... with acceptable results." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Emissions) | "Electromagnetic Compatibility tests... have been performed to ensure that no intolerable electro-magnetic disturbances are introduced." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Immunity) | "Immunity tests... have been performed to ensure that the device operates satisfactorily in an electromagnetic environment." |
| Performance specifications meet acceptable results. | "The internal testing, verification in various design phases, and validation of performance specifications have been completed with acceptable results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of patient data. The "study" described is a bench test comparison of the signals generated by the new MDrive component against the signals generated by the predicate device's Communication Unit using internal testing, verification, and validation.
The data provenance is internal testing and validation conducted by Embla Systems. There is no mention of country of origin for data or whether it was retrospective or prospective, as it does not appear to involve human subject data for performance claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the testing focuses on the electrical signal equivalence between the new and predicate devices, the "ground truth" would likely be established through instrumental measurements and technical specifications rather than expert interpretation of medical images or physiological data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable in the context of electrical signal comparison. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The device is a component upgrade (MDrive) for an existing polysomnography system (N7000) that measures and transmits physiological signals. The testing focuses on the technical equivalence of the signals produced, not on how human readers interpret those signals with or without AI assistance. The device itself is not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
The study described is inherently a standalone performance assessment of the device's ability to receive, amplify, record, and transmit signals. It compares the MDrive's signal output to the predicate device's output. There is no "human-in-the-loop" aspect to this specific performance study as it pertains to the device's core function of signal processing and transmission.
7. Type of Ground Truth Used
The ground truth used was the signals produced by the predicate device's Communication Unit. The objective was to demonstrate that the MDrive produces "identical" signals, representing a technical equivalence. This isn't pathology, outcomes data, or expert consensus on clinical diagnoses, but rather engineering verification of signal integrity.
8. Sample Size for the Training Set
Not applicable. The device is a hardware component (MDrive) that processes physiological signals; it does not involve machine learning or any training set in the conventional AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K111742
ATTACHMENT 'C'
AUG 3 1 2011
510(K) SUMMARY
SUBMITTER INFORMATION
·
| A. Company Name: | Embla Systems |
|---|---|
| B. Company Address: | 9351 Grant St.., Suite 600Thornton, Colorado 80229 |
| C. Company Phone: | (303) 790-1801 |
| D. Company Facsimile: | (303) 790-1810 |
| E. Company Contact: | Robert G. SchueppertDirector, Regulatory AffairsE-mail: bob.schueppert@embla.com |
PREPARATION DATE
June 16, 2011
DEVICE IDENTIFICATION
| A. Device Trade Name: | Embla N7000 with MDrive |
|---|---|
| B. Device Common Name: | Embla N7000 |
| C. Classification Name: | Breathing Frequency Monitor |
| D. Regulation Number: | 21 CFR 868.2375 |
| E. Product Code: | MNR |
| F. Device Class: | Class II |
PREDICATE DEVICES
A. Trade Name: Embla N7000, 510(k) Number: K024322
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DEVICE DESCRIPTION
The original cleared N7000 system consists of 3 separate components; a mains connected Communication Unit (CU) for signal amplification and transmission to a host PC, a Headbox that is cable connected to the CU, and a Patient unit that is cable connected to the Headbox. Patient electrodes are connected to the Headbox and the Patient Unit with several electrodes and sensors non-invasively attached to a patient during sleep.
The MDrive device is intended as an alternate upgrade for the current CU component and provides all original functionality and system connectivity that exists with the CU.
The major additions that the MDrive provides over the existing CU component in the N7000 svstem are:
- A wireless connection option to the host PC, in addition to a wired connection, . 1.
- a local keypad and display for the user to perform electrode impedance checking 2. and biocalibration locally rather that from a remote PC, and
- study recording capability using an SD card in the event of PC host 3. communication interruption. The SD card study can then be uploaded to the host PC.
INTENDED USE
The N7000 system (with MDrive) is intended for clinical sleep applications, with recording and/or amplification capability of numerous types of physiological signals used by a physician or trained technician for the acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient connected Headbox and/or Patient Unit during sleep related studies.
The general intended environments are hospitals, institutions, sleep centers, and sleep clinics, but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably.
The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.
The N7000 system does not provide any alarms and is not intended to be a monitor.
A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the N7000 data when it is communicated and presented on a PC using a separate application software program.
{2}------------------------------------------------
INDICATIONS FOR USE
The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.
COMPARISON TO PREDICATE DEVICES
The Embla MDrive is intended as an upgrade and direct replacement for the Communications Unit in the N7000 predicate device. It is substantially equivalent to the Communications Unit in the following technological ways to the intended use and application in the N7000 system;
- Indications for Use .
- Target population ●
- Basic design and architecture
- . Where used
- Standards met .
- Signals recorded and transmitted .
TESTING AND PERFORMANCE DATA
Safety tests on the N7000 with the MDrive have been performed to verify compliance with IEC 60601-1/UL60601-1 and any applicable particular standards in this family of international safety standards to ensure that there are no potential hazards on patients, operators, or the surroundings.
Electromagnetic Compatibility tests according to IEC 60601-1-2 have been performed to ensure that no intolerable electro-magnetic disturbances are introduced.
Immunity tests to IEC 60601-1-2 have been performed to ensure that the device operates satisfactorily in an electromagnetic environment.
The internal testing, verification in various design phases, and validation of performance specifications have been completed with acceptable results.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Biocompatibility and Sterilization do not apply.
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CONCLUSION
The signals received, amplified, recorded and transmitted by the MDrive in the Embla N7000 system were compared to signals received, amplified and transmitted by the Communications Unit in the N7000 predicate system. The result of the comparison is that all signals received, amplified, recorded and transmitted by the MDrive were identical to signals received, amplified and transmitted by the predicate devices.
It is therefore the conclusion of Embla Systems that the Embla MDrive is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Robert G. Schueppert Director, Regulatory Affairs Embla Systems 9351 Grant Street, Suite 600 Thornton, Colorado 80229
AUG 3 1 2011
Re: K111742
Trade/Device Name: Embla N7000 with MDrive Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 29, 2011 Received: August 2, 2011
Dear Mr. Schueppert:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Schueppert
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S.. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Special 510(k) Notification for Embla N7000
SECTION 9
STATEMENT OF INDICATIONS OF USE
510(k) Number (if known): Unknown
Device Name: Embla N7000 with MDrive
Indications For Use:
The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.
X = Prescription Use AND/OR 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(Part
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KILTY2 510(k) Number:
§ 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).