(186 days)
Not Found
No
The device description details traditional sensor technology and signal processing (band pass filtering for snore detection) without mentioning any AI or ML components or algorithms. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is used for diagnosis (detecting breathing signals during sleep disorder studies), not for treatment.
Yes
The device is intended for use during sleep disorder studies to detect breathing signals and gather information relevant to sleep disorder diagnosis procedures. It collects data on airflow, body position, thoracic effort, abdominal effort, and snore, all of which are diagnostic indicators for sleep disorders.
No
The device description clearly outlines physical hardware components including sensors, enclosures, cables, belts, and batteries, indicating it is not a software-only device.
Based on the provided information, the SleepFLO device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SleepFLO device directly measures physiological signals from the patient's body (airflow, body position, thoracic effort, abdominal effort, snore) using external sensors and belts. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for detecting breathing signals during sleep disorder studies. This is a physiological measurement and monitoring function, not an in vitro diagnostic test.
- The device description details sensors and belts that are applied externally to the patient. This further supports that it is not analyzing samples taken from the body.
Therefore, the SleepFLO device falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
Product codes (comma separated list FDA assigned to the subject device)
MNR, BZQ
Device Description
The SleepFLO device is a compact breathing sensor used during sleep disorder diagnosis procedures. The device senses airflow, snore (derived from the airflow), body position, thoracic effort, and abdominal effort. The device consists of two enclosures - a sensor unit and a battery unit, and two respiratory effort belts. A 7-foot, eight-conductor cable connects the sensor unit and the battery unit; a 1-foot two-conductor cable connects each of the respiratory sensor belts to the sensor unit.
The sensor unit houses the airflow pressure sensor, the body position sensors, and the connectors for both effort belts (abdominal and thoracic). Airflow is measured using a pressure-based technique. Patients wear a nasal cannula that carries breathing air fluctuations to a pressure sensor inside the sensor unit. The cannula attaches to the sensor unit via a luer lock. The pressure measurements are used to indicate airflow and to derive the snore output. The cannula is a one-time use device and contains a 0.2-micron filter. The position sensors utilize miniaturized ball switches that detect five body positions: upright, supine, prone, left, and right. The effort belt connectors (thoracic and abdominal) are used to pass the signal of the effort belts to the polysomnograph system (PSG) device.
The two respiratory effort belts use a piezoelectric sensor attached to an elastic belt. The elastic sensor belt is held in place with a Velcro® strap about the thorax and abdomen.
The battery unit houses the snore detection circuitry, the connectors to the PSG, and the batteries that power the device (both the sensor unit and the battery unit). The sensor unit signals (airflow, thoracic effort, abdominal effort, and body position) are passed to the battery unit via the interconnecting eight-conductor cable. The battery unit receives these signals and delivers them to the appropriate output cables, which are connected to the PSG. In the case of the snore, the airflow signal is band pass filtered to generate a snore signal, which is then passed to the PSG via the snore output cable.
The connections to the PSG junction box are accomplished via five (5) pairs of cables. All five-cable pairs are terminated with standard PSG pluqs (1.5 mm recessed). The battery compartment can be attached to the junction box with Velcro®.
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
2 yrs and older
Intended User / Care Setting
Not Found
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)
The SleepFLO device was used in place of the predicate devices in laboratory and clinical testing. These tests showed that the electrical output signals from the SleepFLO device provided equivalent informational content as the electrical output signals from the predicate devices. The testing compared respiratory airflow and effort along with body position and snore.
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
AUG 3 0 2002
BIOMEC
A BIOMEDICAL PRODUCT DEVELOPMENT AND COMMERCIALIZATION COMPANY
510(K) Summary Safety and Effectiveness Data Summary
Prepared By:
Telephone Number: Fax Number:
216.937.2800 216.937.2812
1771 E. 30th Street
BIOMEC Inc.
Contact Person:
Proprietary Name: Classification Name: Common Name:
Classification: Requlation Number: Product Code:
Performance Standards:
Tracey H. Wielinski, RAC
Cleveland, OH 44114 USA
SleepFLO Ventilatory Effort Recorder Airflow Sensor
Class II 868.2375 MNR, BZQ
EN 60601-1 Medical Electrical Equipment- Part 1: General Requirements for Safety
EN 60601-1-2 Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic compatibility -Requirements and tests
Pro-Tech Pressure Transducer Airflow Sensor 510(k) Number: K982293
Pro-Tech SPI Sensor 510(k) Number: K940013
Pro-Tech Crystal Trace® Piezo Respiratory Effort Sensor 510(k) Number: K923402
BIOMEC Inc., 1771 East 30th Street, Cleveland, Ohio 44114 U.S.A. Telephone: 216 / 937-2800 Facsimile: 216 / 937-2812
020071
Substantial Equivalence:
1
Description of the Device:
The SleepFLO device is a compact breathing sensor used during sleep disorder diagnosis procedures. The device senses airflow, snore (derived from the airflow), body position, thoracic effort, and abdominal effort. The device consists of two enclosures - a sensor unit and a battery unit, and two respiratory effort belts. A 7-foot, eight-conductor cable connects the sensor unit and the battery unit; a 1-foot two-conductor cable connects each of the respiratory sensor belts to the sensor unit.
The sensor unit houses the airflow pressure sensor, the body position sensors, and the connectors for both effort belts (abdominal and thoracic). Airflow is measured using a pressure-based technique. Patients wear a nasal cannula that carries breathing air fluctuations to a pressure sensor inside the sensor unit. The cannula attaches to the sensor unit via a luer lock. The pressure measurements are used to indicate airflow and to derive the snore output. The cannula is a one-time use device and contains a 0.2-micron filter. The position sensors utilize miniaturized ball switches that detect five body positions: upright, supine, prone, left, and right. The effort belt connectors (thoracic and abdominal) are used to pass the signal of the effort belts to the polysomnograph system (PSG) device.
The two respiratory effort belts use a piezoelectric sensor attached to an elastic belt. The elastic sensor belt is held in place with a Velcro® strap about the thorax and abdomen.
The battery unit houses the snore detection circuitry, the connectors to the PSG, and the batteries that power the device (both the sensor unit and the battery unit). The sensor unit signals (airflow, thoracic effort, abdominal effort, and body position) are passed to the battery unit via the interconnecting eight-conductor cable. The battery unit receives these signals and delivers them to the appropriate output cables, which are connected to the PSG. In the case of the snore, the airflow signal is band pass filtered to generate a snore signal, which is then passed to the PSG via the snore output cable.
The connections to the PSG junction box are accomplished via five (5) pairs of cables. All five-cable pairs are terminated with standard PSG pluqs (1.5 mm recessed). The battery compartment can be attached to the junction box with Velcro®.
2
Intend d Use:
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
Patient Population:
SleepFLO can be used to monitor the respiration for patients who are candidates for Sleep Diagnostic evaluation. SleepFLO is indicated for use in patients two (2) years and older. The device is not indicated for use in infant or pediatric patients less than two (2) years of age. SleepFLO is not for use by pediatrics and infants below two years of age for SIDS monitoring.
Safety and Effectiveness:
The maximum voltage inside the SleepFLO is 3-volts DC. This is because the device uses two (2) AA batteries in series. There are no direct electrical connections to the patient since the airflow pressure input uses a cannula made from non-conducting plastic, the respiratory sensor belts use an insulated piezoelectric device surrounded by cloth material for comfort, and the body position sensors are housed inside a non-conducting plastic enclosure. The maximum output voltage for all five (5) signals is 1-volt. Due to these low voltages and the insulation material, there is no danger to the patient or provider of serious injury due to electrical shock.
The cannula is a single use only device with a 0.2-micron hydrophobic filter permanently attached. Due to the single use only cannula and integral filter. there is no danger to the patient of serious illness due to cross contamination.
The SleepFLO device was used in place of the predicate devices in laboratory and clinical testing. These tests showed that the electrical output signals from the SleepFLO device provided equivalent informational content as the electrical output signals from the predicate devices. The testing compared respiratory airflow and effort along with body position and snore.
Summary of Technological Characteristics:
The following comparison is provided as a summary of the technological characteristics relative to the predicate devices. This is to demonstrate that
3
the BIOMEC SleepFLO has no significant differences from the predicate
devices that would adversely affect product safety and effectiveness.
| Comparison
Parameter | BIOMEC
SleepFLO | Pro-Tech
PTAFlite | Pro-Tech
SPI Sensor | Pro-Tech
Crystal Trace
Piezo
Respiratory
Effort Sensor |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for
use during
sleep disorder
studies to
detect up to
five breathing
signals:
airflow, snore,
thoracic effort,
abdominal
effort, and
body position
for recording
onto a
physiological
recorder. | Intended for
use during
sleep
disorder
studies to
detect
respiratory
airflow and
snoring via
nasal
pressure
changes for
recording
onto a
physiological
recorder. | Intended for
use in sleep
disorder
testing to
detect
positions of
sleep and to
provide an
output
voltage for
recording
onto a
compatible
computerized
polygraph. | Intended for
use during
sleep disorder
studies to
detect
respiratory
effort for
recording onto
a physiological
recorder. |
| Population | 2 yrs and
older | 2 yrs and
older | 2 yrs and
older | 2 yrs and older |
| Number of
Channels | 4 inputs (air
pressure,
abdominal
effort, thoracic
effort, and
body position)
5 outputs
(airflow,
snore,
abdominal
effort, thoracic
effort, and
body position) | 1 input (air
pressure)
2 outputs
(airflow &
snore) | 1 input (body
position)
1 output
(body
position) | 2 Inputs
(abdominal
and thoracic
effort)
2 outputs
(abdominal
and thoracic
effort) |
| Method of
Connection to
Patient | Plastic tubing
and cannula
set for airflow
and snore.
Elastic cloth
material for
effort belts (2) | Plastic tubing
and cannula
set for airflow
and snore. | | Elastic cloth
material for
effort belts (2) |
| Comparison
Parameter | BIOMEC
SleepFLO | Pro-Tech
PTAFlite | Pro-Tech
SPI Sensor | Pro-Tech
Crystal Trace
Piezo
Respiratory
Effort Sensor |
| | Body position
sensors
enclosed in
plastic case,
which
attaches to
respiratory
effort belt. | | A padded
sensor
pillow, which
mounts to
most
respiratory
effort belts. | |
| Safety
Characteristics | Connects to
physiological
recorder. | Connects to
physiological
recorder | Connects to
physiological
recorder. | Connects to
physiological
recorder |
| | Uses plastic
tubing to
insure patient
isolation.
Uses a 0.2-
micron
hydrophobic
filter on
cannula to
prevent cross
contamination
of patients. | Uses plastic
tubing to
ensure
patient
isolation | | |
| | Ball switches
used for body
position
sensors are
enclosed in a
plastic
housing to
insure patient
isolation. | | Ball bearing
rotary sensor
permanently
encapsulated
to ensure
patient
isolation. | |
| | Uses
insulated
piezoelectric
sensor on
effort belts to
ensure patient
isolation. | | | Uses insulated
piezoelectric
sensor on
effort belts to
ensure patient
isolation. |
| Comparison
Parameter | BIOMEC
SleepFLO | Pro-Tech
PTAFlite | Pro-Tech
SPI Sensor | Pro-Tech
Crystal Trace
Piezo
Respiratory
Effort Sensor |
| Re-Use | Disposable
tubing and
Cannula set
(single use
only).
Monitoring
Device and
respiratory
effort belts
and straps
can be re-
used | Disposable
tubing and
Cannula set
(single use
only).
Monitoring
Device can
be re-used | Sensor pillow
and wire can
be re-used. | Effort belts
and straps can
be re-used. |
| Sensor
Technology | Uses solid-
state pressure
transducer
that converts
small changes
in air pressure
into small
voltage
changes. | Uses solid-
state
pressure
transducer
that converts
small
changes in
air pressure
into small
voltage
changes | Uses Gold
plated ball
bearing
rotary sensor
to detect 5
body
positions. | Uses
piezoelectric
transducer that
converts small
movements of
the chest and
abdomen into
small voltage
changes. |
| | Uses
piezoelectric
transducer
that converts
small
movements of
the chest and
abdomen into
small voltage
changes. | | | |
| | Uses ball
(non-mercury)
switches to
detect 5 body
positions | | | |
4
5
6
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The figure is positioned to the right of the circular seal, which contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
AUG 3-0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracey H. Wielinski Director, Regulatory Affairs and Quality Assurance BioMec. Incorporated 1771 East 30th Street Cleveland, Ohio 44114-4407
Re: K020607
Trade/Device Name: SleepFLO, Model 101501 Regulation Number: 868.2375 -Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: June 17, 2002 Received: June 17, 2002
Dear Ms. Wielinski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
7
Page 2 - Ms. Wielinski
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski
Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Intended Use:
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
PRESCRIPTION USE
✓
(Division Sign-Off) Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: _
020070