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.

Device Description

The FloCHANNEL, FC-100, Sleep Diagnostic Device accomplishes its intended purpose by providing a measure nasal airflow resistance effects. The device simultaneously measures relative airflow of isolated left, right, and oral passages. The FloCHANNEL, FC-100, provides analog voltage out hardware amplified analog voltages from three all now sensors, hardware analog voltages to aid in scoring the respiration of a patient. 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 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 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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study report with performance metrics. The document is a 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100, focusing on demonstrating substantial equivalence to a predicate device.

However, I can extract the information requested as much as possible based on the available text, and note where information is not present.

Acceptance Criteria and Device Performance Study in 510(k) Summary for Dormio Tech FloCHANNEL Model FC-100

The provided 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100 states that "The FloCHANNEL passed all of the tests and acceptance criteria as outlined in the test procedures. Test data demonstrates equivalence to the predicate device." However, the document does not explicitly define the specific acceptance criteria or provide the detailed reported device performance against those criteria. It focuses on claiming substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Concept)	Reported Device Performance
Performs as intended	Passed all established test criteria and design verification/validation activities. Clinically equivalent or superior to the predicate device.
No new issues regarding safety or effectiveness	Differences from predicate device do not raise new safety or effectiveness issues. Utilizes filtered cannula; low-powered; no direct electrical contact with patient.
Equivalence to predicate device	Passed all tests and acceptance criteria. Test data demonstrates equivalence.
Output voltage ranges	Ability to create four different output voltage ranges.
Airflow sensor resolution	State-of-the-art airflow sensor provides output signals that exceed the resolution of the predicate device.
Filter efficacy	Patient interface unit filter prevents transfer of particles greater than or equal to 0.1 microns in size.

Missing Information: The document does not provide quantitative acceptance criteria (e.g., specific accuracy thresholds, signal-to-noise ratios, or other performance specifications) nor does it provide quantitative performance data (e.g., specific numerical results from tests).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document states "All risk assessment, design verification and validation activities were conducted in accordance with the device product requirements" and "The FloCHANNEL was proven clinically equivalent or superior to the predicate device." This suggests validation data was collected, but details on the nature (retrospective/prospective, country of origin, etc.) are absent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: Not mentioned. The submission focuses on device equivalence, not human reader improvement with AI assistance. The device is a "Breathing Frequency Monitor" (ventilatory effort recorder), which typically involves direct physiological measurement rather than image interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: The device itself is a standalone hardware device that provides analog voltage outputs. "Standalone performance" in the context of an algorithm or AI is not applicable here as the device is a sensor and signal conditioner for direct physiological measurement, without embedded AI for interpretation. It outputs raw data ("low-voltage signals") to a physiological recorder for subsequent analysis by other systems or human experts.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a breathing frequency monitor, ground truth would typically refer to highly accurate reference measurements of airflow or ventilatory effort, likely from established medical equipment or gold-standard methodologies, which the device's output signals are compared against.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware sensor and signal conditioner, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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Kosit17<

10200 MASON AVE, SUITE 114 CHATSWORTH, CA 91311 PHONE: 800-871-8484 FAX: 818.882.1809

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:	(800) 871-8484
FAX:	(818) 882-1809
E-mail:	kmcculloh@dormiotech.com

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 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:

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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

Page 1 of 1

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).