SANDMAN ELITE

K153353 · Embla Systems · OLZ · Jun 23, 2016 · Neurology

Device Facts

• Record ID: K153353
• Device Name: SANDMAN ELITE
• Applicant: Embla Systems
• Product Code: OLZ · Neurology
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows: • Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; • An optional automated analysis of physiological signals that is intended for use only in adults; • An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

Device Story

Sandman Elite is a desktop/laptop-based software application for sleep laboratories. It collects/digitizes physiological signals (EEG, EOG, EMG, ECG, airflow, respiratory effort, SpO2, body position, snoring) from external proprietary amplifiers. The software provides real-time data collection, display, storage, and analysis tools. It includes computer-assisted scoring modules for respiratory events (apnea/hypopnea), limb movements, and snoring, intended for adult data. Clinicians use the software to review, score, and generate reports. The system does not control life-sustaining functions or drug delivery. By automating event detection, the device assists trained practitioners in analyzing large volumes of polysomnography data, potentially improving diagnostic efficiency and consistency in sleep disorder evaluation.

Clinical Evidence

Clinical validation study of 56 adult PSG studies (54 subjects evaluated for events). Performance of assisted-scoring modules compared to a reference standard (majority rule of 3 expert scorers). Results (Mean PPA): Central apnea 95.1%, Mixed apnea 97.6%, Obstructive apnea 92.0%, Hypopnea 85.9%, Limb movement 86.0%, Snoring 82.0%. False detection rates per hour ranged from 0.8 (Mixed apnea) to 21.6 (Snoring). Study concludes performance is clinically equivalent to expert manual scoring and predicate devices.

Technological Characteristics

Software-only device running on standard desktop/laptop hardware. Collects digitized physiological signals via external proprietary amplifiers. Signal processing includes band-pass and notch filters (e.g., 10-100 Hz band-pass, 60 Hz notch). Connectivity: local or network server storage. Software modules utilize threshold-based and signal-processing algorithms for event detection. No patient-contacting materials or energy delivery components.

Indications for Use

Indicated for pediatric and adult patients undergoing polysomnography studies to assist in the diagnosis of sleep disorders. Automated analysis features are indicated for adult patients only.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• Sandman (K934599)
• Natus SleepWorks (K090277)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2016

Embla Systems Shane Sawall Regulatory Affairs Manager 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7

Re: K153353

Trade/Device Name: Sandman Elite Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: Mav 20, 2016 Received: May 24, 2016

Dear Shane Sawall:

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K153353

Device Name Sandman Elite

#### Indications for Use (Describe)

The Sandman Elite software is intended for Polysomnography studies on pediatric and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

- •Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
- •An optional automated analysis of physiological signals that is intended for use only in adults;
- · An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) Summary

Submitted by: Embla Systems 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7

Contact Person: Shane Sawall Regulatory Affairs Manager Tel.: [phone] x8673 E-mail: [e-mail]

Date Prepared: June 22, 2016

Proprietary Name: Sandman Elite

Common Name: Polysomnograph software

Classification Name: Automatic Event Detection Software for Polysomnograph with Electroencephalograph

Product code: OLZ

Device Class: II

Requlation Number: 21 CFR 882.1400

Predicate Device: Sandman (K934599); Natus SleepWorks (K090277)

#### Description:

#### 1. Overview Sandman Elite Software

The Sandman Elite Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used at sleep labs by trained clinicians to investigate sleep disorders.

#### 2. Main Applications

The Sandman Elite application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and modules to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main applications:

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- Collection Real time collection of EEG and other physiological ● parameters.
- . Analysis - Real time analysis of data to identify events which may require special attention from qualified medical professional in attendance.
- Data Management - Allows the user to copy, move, back up, and delete collected patient files
- . Configuration - Allows the user to change configuration settings such as your site information, the media used for file storage and to create and manage user preferences.

The Sandman Elite application also includes a separate independent Report Builder module. The Report Builder is a tool developed to assist the user in creating a customized report. All data are stored either locally or on a remote hard disk (network server). Provisions exist for archiving to several appropriate types of digital media, most frequently CD ROM.

## 3. Typical work flow using the Sandman Elite Application software

During the Collection phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.

## 4. Computer-assisted scoring modules

The Sandman Elite application software contains a number of computerassisted scoring modules. All computer assisted-scoring modules are provided to assist trained medical practitioners in the review and analysis of vast amounts of polysomnography data. The computer assisted-scoring modules are for analysis of adult patient data only. Each computer-assisted scoring module runs a specific type of event scoring on the patient file. The scoring rule parameters used in the computer-assisted scoring modules depend on the montage type associated with the study.

The ten computer-assisted scoring modules are:

- · Respiratory module
- · Desaturation module
- · pH module
- · ECG module
- · Associations module
- EtC02 module
- · PLM module

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-
- Snoring module
- Bad Data module • XactTrace module
-

# 5. Diagnosis

The Sandman Elite application software is intended for use by qualified and trained medical practitioners in research and clinical environments. who evaluate the software output with their clinical experience and judgement to provide diagnostic conclusions about the patient's condition. The Sandman Elite software does not control the delivery of energy, the administration of drugs, or any form of life sustaining function to the patient.

# Indications for Use:

The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

- . Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
- An optional automated analysis of physiological signals that is intended for use only in adults:
- An optional audio/visual alert for user defined threshold on calibrated DC ● input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

# Comparison to Predicate Device:

| | Predicate | Predicate | Subject Device |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>Sandman</b> K934599 | <b>SleepWorks</b> K090277 | <b>Sandman Elite</b> |
| Device Class | Class II | Class II | Class II |
| Class Name | Electroencephalograph | Electroencephalograph | Electroencephalograph |
| Product Code | OLV = Standard<br>Polysomnograph with<br>Electroencephalograph | OLZ = Automatic Event<br>Detection Software for<br>Polysomnograph with | OLZ = Automatic Event<br>Detection Software for<br>Polysomnograph with |
| | Predicate | Predicate | Subject Device |
| | Sandman K934599 | SleepWorks K090277 | Sandman Elite |
| | | Electroencephalograph | Electroencephalograph |
| Intended User<br>Indications for<br>Use | Medical Professional<br>The SANDMAN<br>provides paperless<br>digital recording and<br>handling of<br>physiological signals<br>intended for a sleep<br>EEG laboratory. | Medical Professional<br>The Sleepworks software<br>works in conjunction with<br>Connex, Trex or Netlink<br>amplifiers intended for<br>polysomnography studies.<br>The software allows<br>recording, displaying,<br>analysis, printing and<br>storage of physiological<br>signals to assist in the<br>diagnosis of various<br>sleep disorders and sleep<br>related respiratory<br>disorders.<br>The Sleepworks allows:<br>Automated analysis of<br>physiological signals that<br>is intended for use only in<br>adults.<br>An optional Audio /<br>visual alert for user<br>defined threshold on<br>calibrated DC input.<br>These alerts are not<br>intended for use as life<br>support such as vital<br>signs monitoring<br>or continuous medical<br>surveillance in intensive<br>care units.<br>Sleep report templates<br>are provided which<br>summarize recorded and<br>scored sleep<br>data using simple<br>measures including count,<br>average, maximum and<br>minimum<br>values as well as data<br>ranges for trended values;<br>Sleep Works software<br>does not provide any<br>diagnostic conclusion | Medical Professional<br>The Sandman Elite<br>software is intended for<br>Polysomnography<br>studies on pediatric and<br>adult patients, and<br>allows recording,<br>displaying, analysis,<br>printing and storage of<br>physiological signals to<br>assist in the diagnosis<br>of various sleep<br>disorders. The<br>Sandman software also<br>allows:<br><br>Sleep report<br>templates which<br>summarize recorded<br>and scored sleep data<br>using simple measures<br>including count,<br>average, maximum and<br>minimum values as well<br>as data ranges for<br>trended values;<br><br>An optional<br>automated analysis of<br>physiological signals<br>that is intended for use<br>only in adults;<br><br>An optional<br>audio/visual alert for<br>user defined threshold<br>on calibrated DC input.<br>These alerts are not<br>intended for use as life<br>support such as vital<br>signs monitoring or<br>continuous medical<br>surveillance in intensive<br>care units. The |
| | Predicate | Predicate | Subject Device |
| | Sandman K934599 | SleepWorks K090277 | Sandman Elite |
| | | condition and is intended<br>to be used only by<br>qualified and trained<br>medical practitioners;<br>in research and clinical<br>environments. | intended for use only by<br>qualified and trained<br>medical practitioners in<br>research and clinical<br>environments, who<br>evaluate the software<br>output with their clinical<br>experience and<br>judgment to provide<br>diagnostic conclusions<br>about the patient's<br>condition. |
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard |
| Acquire,<br>display, store,<br>and archive<br>PSG data | Yes | Yes | Yes |
| Signal digitized | Amplifier included as<br>part of the system | By separate proprietary<br>amplifier | By separate proprietary<br>amplifier |
| Software<br>Modules | | | |
| Respiratory<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Sleep staging/<br>scoring | Yes. Manual | Yes. Manual/computer<br>assisted | Yes. Manual |
| Arousal Event<br>Marking | Yes (Manual) | Yes. Manual/computer<br>assisted | Yes. Manual |
| Limb<br>movements<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Snore event<br>marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Oxygen<br>Desaturation<br>event marking | Yes (Manual) | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Heart Rate data<br>trend &<br>summary | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| PH data trend<br>and summary | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| EtCO2 data<br>trend &<br>summary | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| Associate<br>related events | No | Yes (Manual & Computer<br>Assisted) | Yes (Manual &<br>Computer Assisted) |
| | Predicate | Predicate | Subject Device |
| | Sandman K934599 | SleepWorks K090277 | Sandman Elite |
| data "Bad Data" | | Assisted) | Computer Assisted)…