(81 days)
Not Found
No
The device description explicitly states its role is solely to capture and pass data. The analysis and interpretation are performed by the host computer and clinician using separate software. There is no mention of AI or ML in the device's function or the provided text.
No
The device is described as a physiological data recorder used for collecting and recording data for polysomnography and sleep disorder studies. It is not intended for treatment or therapeutic purposes.
Yes
Explanation: The device is intended for "collecting and recording physiological data to be used in polysomnography and sleep disorder studies," and the data is then sent "to a host computer for review and analysis" by a clinician using "sleep review analysis software." This process of collecting and analyzing physiological data to study sleep disorders is a diagnostic function.
No
The device description clearly outlines two hardware units: the Recorder Unit and the Headbox Unit, which include physical components like sensors, connectors, and circuitry for signal amplification and conversion.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Sandman Pocket collects physiological data from the body surface (in vivo) through sensors and electrodes.
- The intended use and device description clearly state it's for collecting and recording physiological data for polysomnography and sleep disorder studies. This involves measuring electrical signals, pressure, and other physical parameters directly from the patient.
- There is no mention of analyzing biological samples.
Therefore, the Sandman Pocket is a physiological data recorder, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
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 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.
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.
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
Pediatric through adult patient populations.
Intended User / Care Setting
Used under the direction or supervision of a physician, technologist or clinician. Can be used in either home or hospital environments.
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)
Not Found
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
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.
1
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
2
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
3
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.
4
.
Technological Characteristics Substantial Equivalence Comparison Table
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device class | Class II | Class II | Class II |
| Product code | MNR | GWQ | MNR |
| Device type | Ventilator Effort
Recorder | Electroencephalograph | Ventilator Effort
Recorder |
| Regulation Number | 868.2375 | 882.1400 | 868.2375 |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Labelling | | | |
| Intended use | Intended for use in
collecting and recording
physiological data to be
used in diagnosing sleep
disorders | Intended to record,
display and print
physiological
information to
clinicians/physicians.
These parameters are
presented graphically
on a computer screen
for diagnostic review,
similar in application
to the use of a
traditional paper based
polygraph recorder.
The device will be
used in hospitals,
institutions, sleep
centers or clinics, or
other test
environments where
adult or infant patients
require the
documentation of
various sleep or other
physiological
disorders.
This device does not
provide alarms and is
not intended for use as
an automated apnea
monitor. | Intended for use in
collecting and
recording
physiological data to
be used in
polysomnography and
sleep disorder studies.
For use in either home
or hospital
environments with a
pediatric through adult
patient population.
This device does not
provide alarms and is
not intended for use as
an automated apnea
monitor |
| Target population | Pediatric through adult
(excluding neonates and
infants) | Pediatric through adult
(including all pediatric
subpopulations) | Pediatric through adult
(including all pediatric
subpopulations) |
| Environment of use | Hospital and home | Hospitals, institutions,
sleep centers, or other
test environments. | Hospital and home |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet | Alice 5
(Predicate Device)
Respironics | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Warnings | Items related to sensor
irritation, strangulation
avoidance and off-label
use. | Items related to sensor
irritation, strangulation
avoidance, and off-
label use. | Items related to sensor
irritation,
strangulation
avoidance and off-
label use. |
| Contraindications | Items related to design
and indicated use
limitations, such as not
for use in the presence
of flammable
anesthetics or in
conjunction with
defibrillation
equipment. | Items related to design
and indicated use
limitations, such as not
for use in the
presence of
flammable substances
or anesthetic mixtures
with air oxygen or
nitrous oxide,
defibrillation, and
MRI equipment, and
not for use as
automated apnea
monitor or a
continuous monitor. | Items related to design
and indicated use
limitations, such as
not for use in the
presence of flammable
anesthetics or in
conjunction with
defibrillation
equipment.
The Sandman Pocket is
not intended for use as
life support equipment
such as a vital sign
monitoring in 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. It will not
prevent or restore the
interruption or loss of
any physiological
system. |
| Prescription status | Available only on the
order of a physician. | Available only on the
order of a physician. | Available only on the
order of a physician. |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Service instructions | No field service
allowed. | No field service
allowed. | No field service
allowed. |
| Design | | | |
| Communication
Interfaces | Physiological signals
are sent to the Slow
Wave and Fast Wave
headbox through the
sensor cables.
The Slow Wave and
Fast Wave headboxes
sends the data to the
Recorder Plus module
where the data is stored
either to a flash memory
card or to a PC via a
fiber optic interface. | Physiological signals
are sent from the
patient sensors to the
headbox through the
sensor cables.
The data is sampled
and sent to the base
station where it is
stored on a disk until it
is sent through an
Ethernet connection to
a Host PC. | Physiological signals
are sent from the
patient sensors to the
amplifier box through
the sensor cables.
The amplifier box
sends the data to the
recorder where the
data is stored in flash
memory in both
attended and
unattended studies.
During attended
studies, the data is
also transmitted to a
computer in real-time
via a USB cable. After
unattended studies,
data can be
downloaded from the
recorder using a USB
cable. |
| Microprocessor | Siemens 80C537
12 MHz | Unknown | Texas Instruments
TMS320UC5402 on
recorder
Texas Instruments
MSP430F169 on
headbox |
| A/D Resolution | 12 bit | 16 bit | 16 bit |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet | Alice 5
(Predicate Device)
Respironics | Sandman Pocket
(submission device)
EB Neuro |
| | K990565 | K040595 | Via this Submission |
| Data recording | On PCMCIA card,
magnetic disk or optical
disk (via a personal
computer). | Computer hard drive,
compact disc, or
transferred via
Ethernet connection to
a Host PC. | On internal NAND
flash chip |
| Configuration | Desktop and wearable | Desktop only | Wearable |
| Amount of memory
required for a typical
8 hour study. | 20 MB | 600 MB without
audio/ video
6 GB with audio/video | 28 MB |
| | | NOTE: Alice 5 can
collect up to 21
neurological channels.
These channels are
recorded at very high
sampling rates. In
addition, Alice 5
records video at very
high frame rates with
no compression. These
two factors contribute
to the large study size.
All data are stored to
computer hard disk. | |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Sampling rate | Slow waves :
12 samples/s
Fast waves :
120 samples/s | Neurological channels
2000 samples/s | Fast waves:
For example, ECG
programmable up to
2048 sample/s
Medium waves:
For example, EMG,
EOG, Snore
programmable up to
1024 sample/s
Slow waves: For
example, airflow,
respiratory effort,
body position
programmable up to
256 sample/s |
| Power | Battery powered
(internal) or Medical
Grade AC-DC Power
Supply | Medical grade AC
Power Supply | Battery powered or
USB powered |
| Sensors | Commercially available
sensors only | Commercially
available sensors only | FDA Cleared sensors
only |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Performances | | | |
| Maximum number of
channels | 35 | 55 | 22 |
| Recording channels
EEG
EOG
EMG
ECG
Respiratory efforts
Airflow
Ambient sounds
Body position
Ambient light
SpO2
Pulse rate
Plethysmograph
Differential pressure
Actimeter
Derived channel | Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes - internal
Yes - internal
Yes - internal
Yes - internal
No
Yes - internal
No
N/A | Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes - external
No
Yes - internal
Yes - internal
Yes
Yes - external
Yes
Pulse Transit Time
(PTT) - A calculation
of the time between
the occurrence of the
R wave on the EKG
and the peak flow on
the plethysmogram.
RR Interval -
Measurement of the
period of time
between two
consecutive R waves
on the EKG. Displays
as a real-time beat-to-beat heart rate | Yes
Yes
Yes
Yes
Yes
Yes
No
Yes - external
No
Yes - internal
Yes - internal
Yes
Yes - internal
No
Pulse Transit Time
(PTT) - A calculation
of the time between
the occurrence of the
R-wave on the EKG
and 50% ascending
slope on the
plethysmogram.
Heart rate - Derived
from the ECG channel |
| | | calculation. | |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet
K990565 | Alice 5
(Predicate Device)
Respironics
K040595 | Sandman Pocket
(submission device)
EB Neuro
Via this Submission |
| Passbands | | | |
| EEG | 0.625 to 18 Hz | Neurological Channels | 0.1 to 135 Hz |
| EOG | 0.625 to 18 Hz | 0.32 to 106 Hz | 0.1 to 135 Hz |
| EMG | 0.625 to 18 Hz | | 0.1 to 135 Hz |
| ECG | 0.625 to 18 Hz | | 0.1 to 135 Hz |
| Respiratory efforts | 0.055 to 1.25 Hz | | 0.1 to 45 Hz |
| Airflow | 0.1 to 1.3 Hz | | 0.015 to 10 Hz |
| Ambient sounds | None | | None |
| Pressure sensor | 0 to 175 Hz | | DC to 15 Hz |
| SpO2 | NPB proprietary | | NPB proprietary |
| Pulse rate | NPB proprietary | | NPB proprietary |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet | Alice 5
(Predicate Device)
Respironics | Sandman Pocket
(submission device)
EB Neuro |
| CPAP (Continuous
Positive Airway
Pressure) | K990565
Suzanne supports all
models of CPAP
devices because the
CPAP device
connections were air-
based rather than
electrically based.
Using a
pneumotachograph kit,
users could connect
hoses and adapters to
the CPAP device and
the flow and pressure
nipples on the Suzanne
slow wave headbox to
measure CPAP airflow
and/or air pressure at the
mask out-take during
nasal CPAP/Bi-level
titration. | K040595
Alice 5 supports the
use of all Respironics
lab therapy devices:
Aria LX
BiPAP Pro
Duet LX
Harmony
HeartPAP
REMStar Auto
REMStar Pro
REMStar Pro with C-
Flex
Synchrony
Virtuoso LX | Via this Submission
Sandman Pocket stores
data from Nellcor
Puritan Bennett
GK420E, GK425, and
GK425ST CPAP
devices. When the
recorder is also
connected to the host
computer, the Sandman
Pocket not only stores
data in the on-board
memory, but also acts as
a passive bridge between
the aforementioned GK
CPAP and the host
computer by receiving
data streams from the
CPAP and transmitting
the data streams to the
host computer and vice
versa.
When the Sandman
Pocket is connected to a
third party CPAP device
and a host computer,
Sandman Pocket acts as
a passive bridge between
the third party CPAP
device and the computer
by receiving data
streams from the CPAP
and transmitting the data
streams to the host
computer and vice versa.
Alternatively, Sandman
Pocket may also handle
CPAP device
connections in the same |
| Product
Characteristic | Suzanne
(Predicate Device)
Nellcor Puritan Bennet | Alice 5
(Predicate Device)
Respironics | Sandman Pocket
(submission device)
EB Neuro |
| | K990565 | K040595 | Via this Submission |
| Mechanical safety | Device complies with
the requirements of
Nov' 93 Draft
Reviewer's Guidance | Device complies with
the International
Standard
IEC 60601-1
CSA C22.2 No. 601.1
EN 60601-1
UL 60601-1
AS 3200.1.0*
- Australian Deviation
to IEC 60601-1 | Device complies with
the International
Standard
IEC 60601-1
CSA C22.2 No 601-1-
M90
UL 2601 |
| Electrical safety | Device complies with
the International
Standard
CSA C22.2 No. 601-1-
M90
UL 2601
Device complies with
the requirements of
Nov' 93 Draft
Reviewer's Guidance | Device complies with
the International
Standard
IEC 60601-1
Guidance, when
applicable, has been
adopted from the
following standards:
IEC 60601-2-25
IEC 60601-1-26
IEC 60601-2-40
IEC 60601-2-49 | Device complies with
the International
Standard
IEC 60601-1
IEC 60601-1-4
IEC 60601-1-26
CSA C22.2 No 601-1-
M90
UL 2601 |
5
6
7
:
8
:
9
10
.
11
:
.
:
:
:
:
12
13
.
14
510(k) Summary
EB Neuro, S.p.A.
Sandman Pocket
.
| Product
Characteristic | Suzanne
(Predicate Device) | Alice 5
(Predicate Device) | Sandman Pocket
(submission device) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nellcor Puritan Bennet | Respironics | EB Neuro |
| | K990565 | K040595 | Via this Submission |
| Electromagnetic
Compatibility (EMC) | Device complies with
the following EMC
standards
IEC 60601-1
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-6
Mil Std 462D
IEC 61000-4-4
IEC 61000-4-5
EN55011 Class B
Device complies with
the requirements of
Nov' 93 Draft
Reviewer's Guidance | Device complies with
the International
Standard
IEC 60601-1-2,
including the
following standards:
CISPR 11
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2,
IEC 61000-4-3
IEC 61000-4-4,
IEC 61000-4-5,
IEC 61000-4-6,
IEC 61000-4-8
IEC 61000-4-11 | Device complies with
the International
Standard
IEC 60601-1- 2,
including the
following standards:
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3,
IEC 61000-4-4,
IEC 61000-4-5,
IEC 61000-4-6,
IEC 61000-4-8
IEC 61000-4-11
EN55011 class B
EN55014-1 |
15
Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regulatory Technology Services LLC C/O Mr. Mark Job Responsible Third Party Official EB NEURO, S.P.A. 1394 25th Street NW Buffalo, Minnesota 55313
Re: K061996
Trade/Device Name: Sandman Pocket Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 22, 2006 Received: September 25, 2006
Dear Mr. Job:
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.
OCT - 3 2006
If your device is classified (see above) into cither 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 - Mr. Job
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 your o begin maketing 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,
Clare
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):
Sandman Pocket Device Name:
Indications For Use:
Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is indended 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 on 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.
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)
busiom
(Sign-Off)
en of Anesthesiology, General Hospital,
Con Control, Dental Devices
Number: K061996