SANDMAN POCKET
Device Facts
| Record ID | K061996 |
|---|---|
| Device Name | SANDMAN POCKET |
| Applicant | Eb Neuro S.P.A. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Oct 3, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The Sandman Pocket is intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments. The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor. The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.
Device Story
Sandman Pocket is a portable, battery-powered physiological data recorder for polysomnography. System comprises a Headbox Unit (sensor/electrode interface) and a Recorder Unit (data storage/processing). Inputs include EEG, EOG, EMG, ECG, respiratory effort, airflow, body position, and SpO2 (via external Nellcor Puritan Bennett oximetry probe). Headbox performs signal isolation (CF type) and A/D conversion; Recorder amplifies, filters, and stores data on internal NAND flash memory. Device features built-in impedance meter for electrode contact verification. During attended studies, data transmits in real-time to a host PC via USB; for unattended studies, data is downloaded post-study. Device acts as a passive bridge for third-party CPAP data. Clinicians review data on host PC using third-party sleep analysis software. Output provides raw physiological waveforms and derived metrics like Pulse Transit Time (PTT) and heart rate. Used in home or hospital settings by clinicians to aid in sleep disorder diagnosis.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), mechanical safety, and electromagnetic compatibility (EMC) testing.
Technological Characteristics
Portable physiological recorder; 16-bit A/D resolution; internal NAND flash storage; USB connectivity. Headbox includes CF-type isolated inputs for EEG, EOG, EMG, ECG, respiratory, airflow, and body position sensors. Powered by 3x 1.5V alkaline batteries or USB. Microprocessors: TI TMS320UC5402 (recorder) and TI MSP430F169 (headbox). Complies with IEC 60601-1, IEC 60601-1-2, and related EMC standards (CISPR 11, IEC 61000 series).
Indications for Use
Indicated for pediatric through adult patients requiring polysomnography or sleep disorder studies. Not for use as life-support, intensive care vital sign monitoring, or automated apnea monitoring. Must be used under physician, technologist, or clinician supervision.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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K061996
### 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
#### Submitter Information
Carri Graham Official Correspondent The Anson Group 11460 N. Meridian St. Suite 150 Carmel, IN 46032 Phone: (317) 569-9500 x 103 Facsimile: (317) 569-9520 Contact Person: Carri Graham Date: June 12, 2006 807.92(a)(2) Trade Name: Sandman Pocket Common Name: Ventilatory Effort Recorder Classification Name(s): Ventilatory Effort Recorder Classification Number: MNR 807.92(a)(3) Predicate Device(s) Nellcor Puritan Bennett Inc. SUZANNE K990565 Respironics, IN Alice S K040595
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
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807.92 (a)(4)
#### Device Description
The Sandman Pocket is a physiological data recorder that is part of a polysomnography system. It consists of two units: the Recorder Unit, which stores the data and sends it to a USB port, and Headbox Unit, which is the connection point for all patient sensors with the exception of the Nellcor Puritan Bennett oximetry probe.
The role of the Sandman Pocket is only to capture the data and pass it to the host with the necessary accuracy and reliability according to the product and communication control specifications.
A fundamental characteristic of the Sandman Pocket is the ability to be an ambulatory/portable physiological data recorder. Because of its small size and light weight (about 210 grams including the battery), the system is compact and durable.
The Headbox Unit is used for connecting patient electrodes and sensors. It includes Bipolar channels, pressure sensors, power supply for a dedicated body position sensor, an abdomen sensor, a chest sensor, a snore sensor and a thermistor. The patient inputs are isolated with a CF type isolation level. The Sandman Pocket device is provided without standard sensors. The system builder should integrate the device with FDA cleared Nellcor Puritan Bennett sensors only and specified for the usage with NELL-1 module.
The Headbox Unit captures the biological signals from the human body surface through specialized sensors and electrodes, while the Recorder Unit amplifies the very low electrical signal and filters the signals to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are sent to a host computer for review and analysis. The host can "program" the amplifier behavior by setting the sampling frequency and the dynamic range allowed and so on.
The host computer reads the acquired data through a dedicated interchange protocol, and allows a clinician to analyze the data using sleep review analysis software, provided by the end user or system builder. The clinician must use an electrically isolated computer (with a medical grade isolation transformer or medical grade power supply) or batterysupplied laptop when the Sandman Pocket device is connected to the host PC and the patient is connected to the Sandman Pocket Headbox.
The Sandman Pocket system is not in any way involved in the data management performed by the host. The host computer must operate using one of the following Operating System:
Microsoft Windows 98 / ME / NT / 2K / XP.
The device has a built-in impedance meter. This function allows the clinician to check the electrode contact impedance and display the results of the check on the display. The
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display is located in the Recorder Unit, while the circuitry controlling the impedance meter is located in the Headbox Unit.
The Sandman Pocket can be powered through 3 Alkaline 1.5V standard non rechargeable batteries or via the USB cable. The user is recommended to use a medical grade type PC.
The Sandman Pocket system consists of two interconnected units: the Headbox Unit and the Recorder Unit.
Image /page/2/Figure/4 description: The image shows a diagram of a recorder unit and a headbox unit. The recorder unit has a USB port and a serial port for CPAP. The headbox unit has inputs for abdomen, chest, body position, snore, thermistor, and cannula. An oximeter cable is also shown.
SANDMAN POCKET System Connection Diagram
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The Headbox Unit has the following functions:
- Physically connects the source of signals (the patient) to the amplifier. ●
- Provide impedance testing capabilities ●
- Provide Analog to Digital (A/D) conversion .
The Recorder Unit has the following functions:
- Amplify and isolate signals coming from the electrodes .
- Reference input channels ●
- Generate calibration pulse .
- Provide dynamic range (gain), sampling rate and active channels selection .
- Performs antialiasing filtering for optimal Analog to Digital conversion .
- Provide, when requested, the Pulse Transition Time (PTT) calculation. .
- Send the digital data through the USB interface to the host ●
- Provide the Oximeter option .
- . Manage the display
- Manage the Time .
- Manage the batteries power supply .
#### 807.92(a)(5)
#### Intended Use(s)
The Sandman Pocket is intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments.
The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor.
The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.
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### Technological Characteristics Substantial Equivalence Comparison Table
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet<br>K990565 | Alice 5<br>(Predicate Device)<br>Respironics<br>K040595 | Sandman Pocket<br>(submission device)<br>EB Neuro<br>Via this Submission |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device class | Class II | Class II | Class II |
| Product code | MNR | GWQ | MNR |
| Device type | Ventilator Effort<br>Recorder | Electroencephalograph | Ventilator Effort<br>Recorder |
| Regulation Number | 868.2375 | 882.1400 | 868.2375 |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet<br>K990565 | Alice 5<br>(Predicate Device)<br>Respironics<br>K040595 | Sandman Pocket<br>(submission device)<br>EB Neuro<br>Via this Submission |
| Labelling | | | |
| Intended use | Intended for use in<br>collecting and recording<br>physiological data to be<br>used in diagnosing sleep<br>disorders | Intended to record,<br>display and print<br>physiological<br>information to<br>clinicians/physicians.<br>These parameters are<br>presented graphically<br>on a computer screen<br>for diagnostic review,<br>similar in application<br>to the use of a<br>traditional paper based<br>polygraph recorder.<br>The device will be<br>used in hospitals,<br>institutions, sleep<br>centers or clinics, or<br>other test<br>environments where<br>adult or infant patients<br>require the<br>documentation of<br>various sleep or other<br>physiological<br>disorders.<br>This device does not<br>provide alarms and is<br>not intended for use as<br>an automated apnea<br>monitor. | Intended for use in<br>collecting and<br>recording<br>physiological data to<br>be used in<br>polysomnography and<br>sleep disorder studies.<br>For use in either home<br>or hospital<br>environments with a<br>pediatric through adult<br>patient population.<br>This device does not<br>provide alarms and is<br>not intended for use as<br>an automated apnea<br>monitor |
| Target population | Pediatric through adult<br>(excluding neonates and<br>infants) | Pediatric through adult<br>(including all pediatric<br>subpopulations) | Pediatric through adult<br>(including all pediatric<br>subpopulations) |
| Environment of use | Hospital and home | Hospitals, institutions,<br>sleep centers, or other<br>test environments. | Hospital and home |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet | Alice 5<br>(Predicate Device)<br>Respironics | Sandman Pocket<br>(submission device)<br>EB Neuro<br>Via this Submission |
| Warnings | Items related to sensor<br>irritation, strangulation<br>avoidance and off-label<br>use. | Items related to sensor<br>irritation, strangulation<br>avoidance, and off-<br>label use. | Items related to sensor<br>irritation,<br>strangulation<br>avoidance and off-<br>label use. |
| Contraindications | Items related to design<br>and indicated use<br>limitations, such as not<br>for use in the presence<br>of flammable<br>anesthetics or in<br>conjunction with<br>defibrillation<br>equipment. | Items related to design<br>and indicated use<br>limitations, such as not<br>for use in the<br>presence of<br>flammable substances<br>or anesthetic mixtures<br>with air oxygen or<br>nitrous oxide,<br>defibrillation, and<br>MRI equipment, and<br>not for use as<br>automated apnea<br>monitor or a<br>continuous monitor. | Items related to design<br>and indicated use<br>limitations, such as<br>not for use in the<br>presence of flammable<br>anesthetics or in<br>conjunction with<br>defibrillation<br>equipment.<br>The Sandman Pocket is<br>not intended for use as<br>life support equipment<br>such as a vital sign<br>monitoring in intensive<br>care unit. The device<br>does not produce<br>alarms and is not<br>intended as an<br>automated apnea<br>monitor.<br>The Sandman Pocket<br>is only to be used<br>under the direction or<br>supervision of a<br>physician,<br>technologist or<br>clinician. It will not<br>prevent or restore the<br>interruption or loss of<br>any physiological<br>system. |
| Prescription status | Available only on the<br>order of a physician. | Available only on the<br>order of a physician. | Available only on the<br>order of a physician. |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet<br>K990565 | Alice 5<br>(Predicate Device)<br>Respironics<br>K040595 | Sandman Pocket<br>(submission device)<br>EB Neuro<br>Via this Submission |
| Service instructions | No field service<br>allowed. | No field service<br>allowed. | No field service<br>allowed. |
| Design | | | |
| Communication<br>Interfaces | Physiological signals<br>are sent to the Slow<br>Wave and Fast Wave<br>headbox through the<br>sensor cables.<br>The Slow Wave and<br>Fast Wave headboxes<br>sends the data to the<br>Recorder Plus module<br>where the data is stored<br>either to a flash memory<br>card or to a PC via a<br>fiber optic interface. | Physiological signals<br>are sent from the<br>patient sensors to the<br>headbox through the<br>sensor cables.<br>The data is sampled<br>and sent to the base<br>station where it is<br>stored on a disk until it<br>is sent through an<br>Ethernet connection to<br>a Host PC. | Physiological signals<br>are sent from the<br>patient sensors to the<br>amplifier box through<br>the sensor cables.<br>The amplifier box<br>sends the data to the<br>recorder where the<br>data is stored in flash<br>memory in both<br>attended and<br>unattended studies.<br>During attended<br>studies, the data is<br>also transmitted to a<br>computer in real-time<br>via a USB cable. After<br>unattended studies,<br>data can be<br>downloaded from the<br>recorder using a USB<br>cable. |
| Microprocessor | Siemens 80C537<br>12 MHz | Unknown | Texas Instruments<br>TMS320UC5402 on<br>recorder<br>Texas Instruments<br>MSP430F169 on<br>headbox |
| A/D Resolution | 12 bit | 16 bit | 16 bit |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet | Alice 5<br>(Predicate Device)<br>Respironics | Sandman Pocket<br>(submission device)<br>EB Neuro |
| | K990565 | K040595 | Via this Submission |
| Data recording | On PCMCIA card,<br>magnetic disk or optical<br>disk (via a personal<br>computer). | Computer hard drive,<br>compact disc, or<br>transferred via<br>Ethernet connection to<br>a Host PC. | On internal NAND<br>flash chip |
| Configuration | Desktop and wearable | Desktop only | Wearable |
| Amount of memory<br>required for a typical<br>8 hour study. | 20 MB | 600 MB without<br>audio/ video<br>6 GB with audio/video | 28 MB |
| | | NOTE: Alice 5 can<br>collect up to 21<br>neurological channels.<br>These channels are<br>recorded at very high<br>sampling rates. In<br>addition, Alice 5<br>records video at very<br>high frame rates with<br>no compression. These<br>two factors contribute<br>to the large study size.<br>All data are stored to<br>computer hard disk. | |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet<br>K990565 | Alice 5<br>(Predicate Device)<br>Respironics<br>K040595 | Sandman Pocket<br>(submission device)<br>EB Neuro<br>Via this Submission |
| Sampling rate | Slow waves :<br>12 samples/s<br>Fast waves :<br>120 samples/s | Neurological channels<br>2000 samples/s | Fast waves:<br>For example, ECG<br>programmable up to<br>2048 sample/s<br>Medium waves:<br>For example, EMG,<br>EOG, Snore<br>programmable up to<br>1024 sample/s<br>Slow waves: For<br>example, airflow,<br>respiratory effort,<br>body position<br>programmable up to<br>256 sample/s |
| Power | Battery powered<br>(internal) or Medical<br>Grade AC-DC Power<br>Supply | Medical grade AC<br>Power Supply | Battery powered or<br>USB powered |
| Sensors | Commercially available<br>sensors only | Commercially<br>available sensors only | FDA Cleared sensors<br>only |
| Product<br>Characteristic | Suzanne<br>(Predicate Device)<br>Nellcor Puritan Bennet<br>K990565 | Alice 5<br>(Predicate Device)<br>Respironics<br>K040595…
