Who is the manufacturer of SLEEPFLO, MODEL 101501?

Biomec, Inc. filed the 510(k) submission for SLEEPFLO, MODEL 101501 (K020607).

What is the FDA product code for SLEEPFLO, MODEL 101501?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for SLEEPFLO, MODEL 101501?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for SLEEPFLO, MODEL 101501?

Pro-Tech Pressure Transducer Airflow Sensor (K982293); Pro-Tech SPI Sensor (K940013); Pro-Tech Crystal Trace® Piezo Respiratory Effort Sensor (K923402).

Who can help prepare an FDA 510(k) submission like SLEEPFLO, MODEL 101501?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SLEEPFLO, MODEL 101501

K020607 · Biomec, Inc. · MNR · Aug 30, 2002 · Anesthesiology

Device Facts

Record ID	K020607
Device Name	SLEEPFLO, MODEL 101501
Applicant	Biomec, Inc.
Product Code	MNR · Anesthesiology
Decision Date	Aug 30, 2002
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

SleepFLO is a ventilatory effort recorder used in sleep disorder clinics to monitor respiratory signals. Inputs include nasal airflow (via cannula pressure), thoracic/abdominal effort (via piezoelectric belts), and body position (via ball switches). The device consists of a sensor unit and a battery unit connected by cable. The sensor unit captures raw signals; the battery unit houses snore detection circuitry, which band-pass filters the airflow signal to derive snore output. The device outputs five signals (airflow, snore, thoracic effort, abdominal effort, body position) to a polysomnograph (PSG) system via standard 1.5 mm recessed plugs. Operated by clinical staff, the device provides continuous physiological data to the PSG, assisting clinicians in diagnosing sleep disorders. Patient benefits include non-invasive monitoring of respiratory effort and airflow during sleep studies.

Clinical Evidence

Bench and clinical testing compared SleepFLO against predicate devices. Testing demonstrated that SleepFLO's electrical output signals for respiratory airflow, effort, body position, and snore provided equivalent informational content to the predicate devices. No specific sensitivity, specificity, or AUC metrics were reported.

Technological Characteristics

Device uses solid-state pressure transducers for airflow, piezoelectric sensors for respiratory effort, and ball switches for body position. Powered by 2 AA batteries (3V DC). Outputs are 1V max. Connectivity via 1.5 mm recessed plugs to PSG. Single-use nasal cannula includes a 0.2-micron hydrophobic filter. Enclosures are non-conducting plastic. No direct electrical patient connection.

Indications for Use

Indicated for patients 2 years and older who are candidates for sleep diagnostic evaluation. Not indicated for infants or pediatric patients less than 2 years of age, including SIDS monitoring.

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

Pro-Tech Pressure Transducer Airflow Sensor (K982293)
Pro-Tech SPI Sensor (K940013)
Pro-Tech Crystal Trace® Piezo Respiratory Effort Sensor (K923402)

Related Devices

K191095 — Maxxi Snore Sensor · Neurovirtual USA, Inc. · Jan 16, 2020
K983449 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR · Gereonics, Inc. · Feb 8, 1999
K220631 — NomadAir PMU810 · Neurotronics, Inc. · Jul 15, 2022
K971501 — SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER · Bio-Logic Systems Corp. · Oct 14, 1997
K040194 — COMPUMEDICS SUMMIT IP · Compumedics USA, Ltd. · Apr 23, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ 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: {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: 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