CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR

K082853 · Inspired Technologies, Inc. · MNR · Mar 23, 2009 · Anesthesiology

Device Facts

• Record ID: K082853
• Device Name: CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
• Applicant: Inspired Technologies, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (1:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool. The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments. For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.

Device Story

CODR Model 300-CR is a portable, battery-powered data gathering system; functions as an adjunct to pulse oximetry and oxygen delivery systems. Inputs: heart rate/SpO2 from external pulse oximeter; flow/pressure data from oxygen delivery tubing via nasal cannula. Device tracks breath rate and I:E ratio. Data recorded to SD card; displayed via PC software. Used by clinicians in hospital, clinical, or home environments to evaluate oxygen delivery performance during patient rest and exercise. Output allows clinicians to visualize device performance; not for diagnostic use. Benefits include objective monitoring of oxygen therapy efficacy in ambulatory settings.

Clinical Evidence

Bench testing only. Performance and verification/validation testing conducted using various pulse oximeters and oxygen source systems. Tests included data measurement accuracy, data transmission/collection accuracy, EMC/EMI, and mechanical/environmental testing. No clinical study data provided.

Technological Characteristics

Portable, battery-powered (4 AA batteries) interface module (6"x4"x2"). Connects to oxygen source and pulse oximeter. Uses nasal cannula for flow/pressure sensing. Data storage via SD card. PC-based display software. No alarms. Class II device.

Indications for Use

Indicated for patients requiring oxygen therapy, matching the population of the specific oxygen source used. Used by clinicians in hospital, clinical, or home settings to monitor oxygen delivery performance during rest and exercise.

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

• Salter BiNAPS (K051313)
• EB Neuro - Sandman (K061996)

Submission Summary (Full Text)

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## Non-Confidential Summary of Safety and Effectiveness Page 1 of 4 19-Dec-08

MAR 2 3 2009

| Inspired Technologies, Inc.<br>1061 Main Street - #24<br>N. Huntingdon, PA 15642 | Tel - 724-861-5510<br>Fax - 724-861-5530 |
|----------------------------------------------------------------------------------|---------------------------------------------------------|
| Official Contact: | Rick Confer - Director RA/QA |
| Proprietary or Trade Name: | CODR Model 300-CR |
| Usual Name: | breathing frequency monitor |
| Classification Name: | breathing frequency monitor<br>MNR - 868.2375 |
| Predicate Devices: | K051313 - Salter BiNAPS<br>K061996 - EB Neuro - Sandman |

### Device Description:

The Inspired Technologies Clinical Oxygen Dose Recorder (CODR) Model 300 CR is a portable data gathering and information display system which is intended to be used as an adjunct to commercially available pulse oximetry and oxygen delivery systems to enable the clinician to record and view the gathered data together.

The CODR records heart rate and oxygen saturation data provided by a cleared Pulse Oximetry system, flow and pressure data from the oxygen delivery system, and tracks breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. The CODR displays this data in real time to enable the clinician to view the effects of the oxygen device's delivery performance on a patient as they rest and exercise. It is not to be used as a diagnostic tool. The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.

The CODR consists of two components; (1) an interface module and (2) PC based data display software.

- 1. The interface module is a portable, battery powered module which is in line with Oxygen Source and is used to connect various oxygen sources, including LOX portables, standard oxygen cylinders, and oxygen concentrators. Standard, commercially available, single or dual lumen nasal cannula can be used with the interface module. The CODR interface module also has capability of connecting a Pulse Oximeter. The interface module is designed to be worn by the patient during evaluation of the system. It is approximately 6" X 4" X 2" deep and contains the pressure and flow sensors, a connector for the pulse oximeter, and a Secure Digital (SD) card slot for use in data recording. The interface module is powered by four AA batteries. Either alkaline or rechargeable batteries can be used.
- The PC based data display software 2.

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 19-Dec-08

## Indications for Use:

The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (1:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool.

The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.

For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.

## Patient Population:

For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.

Environment of Use: Hospital, clinical or home care

Contraindications: None

### Performance testing to support substantial equivalence:

Performance and verification / validation testing was performed with various pulse oximeters and oxygen source systems. These tests included:

- Accuracy of data measured .
- . Data transmission / collection accuracy
- EMC / EMI ●
- Mechanical and environmental testing .

In all cases the CODR meet the specified performance criteria and was found to be substantially equivalence to the predicates.

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K082853 CODR

# Non-Confidential Summary of Safety and Effectiveness

| Features | Proposed Device<br>CODR | Predicate -EB Neuro Sandman<br>K061996 | Predicate - Salter BINAPS<br>K051313 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The Clinical Oxygen Dose Recorder (CODR) Model<br>300-CR records heart rate and oxygen saturation data<br>provided by a Pulse oximeter; flow and pressure data<br>from the oxygen delivery system; and measures breath<br>rate and inhale/exhale ratio (I:E ratio) by monitoring the<br>flow in the oxygen delivery tubing. Data is presented to<br>enable the clinician to view the effects of the oxygen<br>device's delivery performance on a patient in different<br>ambulatory settings, i.e., rest and exercise. It is not to be<br>used as a diagnostic tool. | Intended to collect physiological data to<br>be used in PSG and sleep disorder<br>studies. | Is an accessory intended for use with<br>PSG equipment during sleep disorder<br>studies for the purpose of detecting and<br>amplifying breathing signals and<br>detection of snoring of a sleeping patient |
| Environment of<br>Use | Hospital, health care facilities, home care | Hospital, health care facilities, home care | Hospital, health care facilities, home care |
| Patient<br>Population | For the patient population the CODR will have the same<br>indications for use as the oxygen source to which it is<br>attached. | Pediatric to adults | Not specified |
| Contraindications | None | None | None |
| Software driven<br>Components | Yes<br>Interface module - collects data<br>Data display software<br>Sensors<br>Nasal cannula to patient<br>Oxygen tubing from oxygen source<br>Pulse Oximeter | Yes<br>Interface module - collects data<br>Recorder unit<br>Sensors | Yes<br>Interface module<br>Nasal cannula |
| Prescriptive<br>Communication<br>interface | Yes<br>Physiological data from pulse oximeter and sensors<br>Measures parameters from the oxygen source | Yes<br>Physiological data from pulse oximeter<br>and sensors | Yes<br>Physiological data from pulse oximeter<br>and sensors |
| Features | Proposed Device<br>CODR | Predicate -EB Neuro Sandman<br>K061996 | Predicate - Salter BiNAPS<br>K051313 |
| Data recording | SD card and PC file | Internal flash chip | Not specified |
| Configuration | Wearable | Wearable | Not specified |
| Power | Battery | Battery | Battery |
| Sensors | Commercially available | Commercially available | Not specified |
| Patient interface | Nasal cannula | Electrodes | Nasal cannula |
| Data recorded | SpO2 | SpO2 | Flow |
| | Flow | Flow | Pressure |
| | Pressure | Pressure | Breathe rate |
| | Breathe rate | Breathe rate | |
| | I:E ratio | | |
| Connects to | Cleared pulse oximeter | Cleared pulse oximeter | Not specified |
| Alarms | None | None | None |

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082853 CODR

# on-Confidential Summary of Safety and Effectivenes

# ifferences Between Other Legally Marketed Predicate Devices

The proposed device is viewed as substantially equivalent to the predicate devices, K051313 and K06199

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devi

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

## Public Health Service

MAR 2 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inspired Technologies, Incorporated C/o Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K082853

> Trade/Device Name: Clinical Oxygen Dose Recorder (CODR) Model 300-CR Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: February 24, 2009 Received: February 26, 2009

Dear Mr. Dryden:

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.

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# Page 2 - Mr. Dryden

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. 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), 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,

Syate Y. Michael Ows.

Ginette Y. Michaud, M.D. Acting 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 Statement

Page 1 of 1

# 510(k) Number:

K082853

Device Name:

Clinical Oxygen Dose Recorder (CODR) Model 300-CR

Indications for Use:

The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (1:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool.

The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.

For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

Allian

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number.

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