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.

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®.

AI/ML Overview

The provided 510(k) summary for the BIOMEC SleepFLO device (K020607) focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to meet acceptance criteria with quantitative performance metrics.

However, based on the information provided, we can infer the acceptance criteria and the nature of the "study" that supports the device meeting those criteria.

Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "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."

This indicates that the acceptance criterion was functional equivalence to the predicate devices for each of the measured parameters. The "reported device performance" is a qualitative statement of equivalence rather than specific numerical metrics.

Acceptance Criterion (Inferred from "Safety and Effectiveness" section)	Reported Device Performance (From "Safety and Effectiveness" section)
Electrical output signals provide equivalent informational content as predicate devices for:
- Respiratory Airflow	- Provided equivalent informational content as the electrical output signals from the predicate devices.
- Respiratory Effort (Thoracic & Abdominal)	- Provided equivalent informational content as the electrical output signals from the predicate devices.
- Body Position	- Provided equivalent informational content as the electrical output signals from the predicate devices.
- Snore	- Provided equivalent informational content as the electrical output signals from the predicate devices.

The "Summary of Technological Characteristics" table further supports the claim of equivalence by highlighting similar intended use, patient population, channels, connection methods, safety characteristics, re-use status, and sensor technology. While not explicit performance metrics, the consistent comparison across these parameters implicitly serves as acceptance criteria.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document vaguely refers to "laboratory and clinical testing" but does not provide details on the number of subjects, cases, or recordings.
- Data Provenance: Not specified regarding country of origin. The testing included both "laboratory and clinical" components, suggesting a mix of controlled experimental data and real-world patient data. It is implied to be prospective for the purpose of this submission, as the device "was used" in these tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The 510(k) summary does not mention the use of experts to establish ground truth for performance evaluation in the context of human interpretation of signals. The focus is on the device's electrical output providing equivalent "informational content" to predicate devices, implying a more direct technical comparison of signal characteristics rather than subjective human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the evaluation (comparing electrical output signals for "informational content"), multi-reader adjudication methods typically used for image interpretation or diagnosis are not relevant here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not described or implied. The device is a sensor, not an AI interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was effectively a standalone performance evaluation in the sense that the device's output signals were compared to predicate device outputs. There isn't an "algorithm" in the sense of AI; rather, it's the raw signal generation by the sensor. The comparison was for the device's output directly, independent of a human interpreting those outputs (although humans would eventually interpret the final sleep study data).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the output signals from legally marketed predicate devices. The new device's output was compared to these established devices known to provide valid physiological information. This is a common approach for demonstrating substantial equivalence for sensor devices.
The sample size for the training set:
- Not applicable/Not specified. This is a sensor device, not an AI/machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no training set for this type of device.

Summary

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K020607

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:

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Description of the 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.

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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

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the BIOMEC SleepFLO has no significant differences from the predicate
devices that would adversely affect product safety and effectiveness.

ComparisonParameter	BIOMECSleepFLO	Pro-TechPTAFlite	Pro-TechSPI Sensor	Pro-TechCrystal TracePiezoRespiratoryEffort Sensor
Intended Use	Intended foruse duringsleep disorderstudies todetect up tofive breathingsignals:airflow, snore,thoracic effort,abdominaleffort, andbody positionfor recordingonto aphysiologicalrecorder.	Intended foruse duringsleepdisorderstudies todetectrespiratoryairflow andsnoring vianasalpressurechanges forrecordingonto aphysiologicalrecorder.	Intended foruse in sleepdisordertesting todetectpositions ofsleep and toprovide anoutputvoltage forrecordingonto acompatiblecomputerizedpolygraph.	Intended foruse duringsleep disorderstudies todetectrespiratoryeffort forrecording ontoa physiologicalrecorder.
Population	2 yrs andolder	2 yrs andolder	2 yrs andolder	2 yrs and older
Number ofChannels	4 inputs (airpressure,abdominaleffort, thoraciceffort, andbody position)5 outputs(airflow,snore,abdominaleffort, thoraciceffort, andbody position)	1 input (airpressure)2 outputs(airflow &snore)	1 input (bodyposition)1 output(bodyposition)	2 Inputs(abdominaland thoraciceffort)2 outputs(abdominaland thoraciceffort)
Method ofConnection toPatient	Plastic tubingand cannulaset for airflowand snore.Elastic clothmaterial foreffort belts (2)	Plastic tubingand cannulaset for airflowand snore.		Elastic clothmaterial foreffort belts (2)
ComparisonParameter	BIOMECSleepFLO	Pro-TechPTAFlite	Pro-TechSPI Sensor	Pro-TechCrystal TracePiezoRespiratoryEffort Sensor
	Body positionsensorsenclosed inplastic case,whichattaches torespiratoryeffort belt.		A paddedsensorpillow, whichmounts tomostrespiratoryeffort belts.
SafetyCharacteristics	Connects tophysiologicalrecorder.	Connects tophysiologicalrecorder	Connects tophysiologicalrecorder.	Connects tophysiologicalrecorder
	Uses plastictubing toinsure patientisolation.Uses a 0.2-micronhydrophobicfilter oncannula toprevent crosscontaminationof patients.	Uses plastictubing toensurepatientisolation
	Ball switchesused for bodypositionsensors areenclosed in aplastichousing toinsure patientisolation.		Ball bearingrotary sensorpermanentlyencapsulatedto ensurepatientisolation.
	Usesinsulatedpiezoelectricsensor oneffort belts toensure patientisolation.			Uses insulatedpiezoelectricsensor oneffort belts toensure patientisolation.
ComparisonParameter	BIOMECSleepFLO	Pro-TechPTAFlite	Pro-TechSPI Sensor	Pro-TechCrystal TracePiezoRespiratoryEffort Sensor
Re-Use	Disposabletubing andCannula set(single useonly).MonitoringDevice andrespiratoryeffort beltsand strapscan be re-used	Disposabletubing andCannula set(single useonly).MonitoringDevice canbe re-used	Sensor pillowand wire canbe re-used.	Effort beltsand straps canbe re-used.
SensorTechnology	Uses solid-state pressuretransducerthat convertssmall changesin air pressureinto smallvoltagechanges.	Uses solid-statepressuretransducerthat convertssmallchanges inair pressureinto smallvoltagechanges	Uses Goldplated ballbearingrotary sensorto detect 5bodypositions.	Usespiezoelectrictransducer thatconverts smallmovements ofthe chest andabdomen intosmall voltagechanges.
	Usespiezoelectrictransducerthat convertssmallmovements ofthe chest andabdomen intosmall voltagechanges.
	Uses ball(non-mercury)switches todetect 5 bodypositions

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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.

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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

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Intended Use:

K020607

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

Regulation Number and Section

§ 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).