FLOCHANNEL

K081176 · Chad Therapeutics, Inc. · MNR · Jul 28, 2008 · Anesthesiology

Device Facts

• Record ID: K081176
• Device Name: FLOCHANNEL
• Applicant: Chad Therapeutics, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Jul 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FloCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder.

Device Story

FloCHANNEL FC-100 is a breathing frequency monitor used in sleep disorder studies. Device accepts pneumatic inputs from a three-channel nasal/oral cannula (left nasal, right nasal, oral) via a patient interface unit with independently sealed chambers to prevent cross-flow. Internal sensors measure relative airflow; hardware-based signal conditioning transforms pneumatic inputs into analog voltage outputs. Device features a DIP switch for configuring four output voltage ranges. Six output connectors provide signals for Left Nasal, Right Nasal, Oral Airflow, Summed Airflow, Relative Tidal Volume, and IE Marker. Used in clinical settings by healthcare professionals; outputs are fed into a physiological recorder to assist in scoring respiration. Benefits include improved resolution of airflow measurement compared to single-channel sensors, allowing for more detailed respiratory pattern detection.

Clinical Evidence

Bench testing only. Design verification and validation activities confirmed the device met all performance requirements and was clinically equivalent or superior to the predicate device.

Technological Characteristics

Breathing frequency monitor; pneumatic sensing principle; three-channel input (left/right nasal, oral); analog voltage output; six output connectors; DIP switch for signal conditioning configuration; filtered disposable cannula interface; low-power, non-conductive patient connection.

Indications for Use

Indicated for pediatric patients (2 years and older), adults, and geriatric patients undergoing sleep disorder studies to detect respiratory airflow. Contraindicated for infants and children under 2 years of age for respiration or 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 Services, Inc. Pressure Transducer Airflow Sensor (K982293)

Submission Summary (Full Text)

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Kosit17<

10200 MASON AVE, SUITE 114 CHATSWORTH, CA 91311 PHONE: [phone] FAX: [phone]

## 510(k) SUMMARY

# DORMIO TECH A division of Chad Therapeutics, Inc.

JUL 2 8 2008

# FloCHANNEL Model FC-100

Date Prepared: April 22, 2008

DORMIO TECH

INNOVATIVE SLEEP TECHNOLOGY

A Division of Chad Therapeutics, Inc.

Submitter Information: Dormio Tech A division of Chad Therapeutics, Inc. 10200 Mason Ave, Suite 114 Chatsworth, CA 91311

Official Contact: Kevin McCulloh Sr. Vice President of R&D, Engineering & RA

| Phone: | [phone] |
|---------|--------------------------|
| FAX: | [phone] |
| E-mail: | [e-mail] |

| Device Name: | FloCHANNEL Model FC-100 |
|---------------------------|-----------------------------|
| Common Name: | Breathing Frequency Monitor |
| Classification Name: | Ventilatory Effort Recorder |
| Classification Reference: | Class II, 21 CFR 868.2375 |

Predicate Device Equivalence:

Product Code:

Substantial equivalence is claimed to the Pro-Tech Services, Inc. Pressure Transducer Airflow Sensor, 510(k) # K982293.

MNR

ISO 13485 CERTIFIED COMPANY WWW.CTUHOLDINGSUSA.COM

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## Device Description:

The FloCHANNEL, FC-100, Sleep Diagnostic Device accomplishes its intended purpose The I look I \/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\/\ by providing a measure nasal airflow resistance effects. The device simultaneously measures relative airflow of isolated left, right, and oral passages. The FloCHANNEL, measures relative annow of loolated for methods of scoring sleep disordered PC-100, provides analog voltage out hardware amplified analog voltages from three breathing. The outputs provided an have a summed output, and two microprocessor all now sensors, hardware analog voltages to aid in scoring the respiration of a patient.

The FloCHANNEL, FC-100, is dependent on the patient interface unit to be able to compute and detect the respiration patterns of the patient. This accessory is three air compute and delove the respirately pannula. The cannula is of one-piece construction that allows independent pneumatic fluid connection between the FloCHANNEL, FC-100, that the patient's left nasal airway, right nasal airway, and oral airway. The filter shall arra the patient of on habat all ways greater than or equal to 0.1 microns in size between prevent the transfer or partiountios groater and filter per channel on the patient interface unit with independently sealed chambers to prevent cross flow between pneumatic channels.

The FloCHANNEL has an output selection switch that is accessible from the outside of The I loon ANNEE has an ourportion two-selector right-angled DIP switch. The purpose of the enclosure and to a lour pockibility in the output options to be able to configure to a the switch to to ano it signal conditioners. With this switch there is the ability to create four different output voltage ranges.

There are six (6) output connectors on the FloCHANNEL, FC-100. All output connectors There are Six (0) output oonnoctors on the reach output. The outputs are Left Nasal are Nort Julier. This re Nasal Processed Airflow, Oral Airway Processed Airflow, Sum r 10003500 Airflow and Right Nasal Processed Airflow, Relative Tidal Volume, and IE Marker.

#### Intended Use:

The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory rifle i loon a nNVEE is intended for estable nasal/oral cannula attaches to all now onto a pryelence the input of the FloCHANNEL device. The outputs of the the patient and connected into the the that are intended to be input into a physiological recorder.

#### Contraindications:

The FloCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.

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## Comparison of Technological Characteristics:

Both the Dormio Tech FloCHANNEL and the predicate device are prescription devices, have similar indications for use, similar contradictions, patient populations, patient connections, operating environments, operating temperatures, similar outlet signal voltages and connect to the same physiological recorders for use in sleep disorder studies.

The device has many similar technological characteristics as the predicate device, except that the FloCHANNEL has a relative left naris, right naris and an oral flow input and output signal, whereas the predicate device has only one naris input and output. The FloCHANNEL device also incorporates a state of the art airflow sensor for output signals that that exceed the resolution of the predicate device. The FloCHANNEL device also has two additional low-voltage output signal settings for connection to the widest range of physiological recorders.

#### Summary of Testing:

All risk assessment, design verification and validation activities were conducted in accordance with the device product requirements to demonstrate that the Dormio Tech FloCHANNEL would perform as intended.

- > The FloCHANNEL passed all of the test criteria established in the FloCHANNEL design verification and validation tests.
- The FloCHANNEL was proven clinically equivalent or superior to the predicate device.
- > The differences in the new device and the predicate device do not raise new issues regarding safety or effectiveness. Both devices utilize a filtered patient cannula and are low-powered devices that do not have any direct electrical connections or conductive electrical connections to the patient.

#### Substantial Equivalence:

The device has a similar indications statement as the predicate device. The differences in the device and the predicate device do not alter the effect or raise new issues of safety or effectiveness.

The FloCHANNEL passed all of the tests and acceptance criteria as outlined in the fest procedures. Test data demonstrates equivalence to the predicate device.

Based on the above, we have concluded that the Dormio Tech FloCHANNEL is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use.

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Image /page/3/Picture/1 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 wing and tail feathers. The eagle faces left and is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 8 2008

Mr. Kevin McCulloh Senior Vice President of R&D, Engineering & RA Chad Therapeutics, Incorporated Dormio Tech 21622 Plummer Street Chatsworth, California 91311

Re: K081176

Trade/Device Name: FloCHANNEL Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 22, 2008 Received: July 23, 2008

Dear Mr. McCulloh:

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 vour 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. McCulloh

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complics 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 you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

V.A. Samuels-Lendi, m.d. fac//

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):

Device Name:

FloCHANNEL

Indications For Use:

The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FloCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder.

The FloCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.

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)

Zakhumbler for MH)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081176

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