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 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.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the CODR Model 300-CR:

Acceptance Criteria and Reported Device Performance

The provided document describes the device's performance testing generally, focusing on meeting "specified performance criteria" rather than presenting a detailed table of specific quantitative acceptance criteria and their corresponding results. The "specified performance criteria" are not explicitly defined with numerical targets in this summary.

Acceptance Criteria Category	Reported Device Performance
Accuracy of Data Measured	"In all cases the CODR meet the specified performance criteria"
Data Transmission / Collection Accuracy	"In all cases the CODR meet the specified performance criteria"
EMC / EMI	"In all cases the CODR meet the specified performance criteria"
Mechanical and Environmental Testing	"In all cases the CODR meet the specified performance criteria"

Note: The document only states that the device "meet the specified performance criteria" but does not detail what those specific criteria were (e.g., "±X% accuracy for heart rate").

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of patients or data points) used for the performance tests.
- The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing is described as "Performance and verification / validation testing," implying prospective testing conducted specifically for regulatory submission, but no details are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study appears to be a technical performance evaluation of the device's measurement capabilities against an assumed reference, rather than a clinical study requiring expert ground truth for interpretation of patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of the device (a data recorder), the primary "ground truth" would likely be from calibrated measurement instruments, not human adjudication of subjective findings.
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. A MRMC comparative effectiveness study was not done. This device is a data recording and display system, not an AI-powered diagnostic or assistive tool. It's intended to present data to clinicians, not to interpret or assist in interpretation in an "AI vs. human" context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Accuracy of data measured" and "Data transmission / collection accuracy" tests would constitute standalone performance evaluations, as they assess the device's ability to accurately record and transmit data independent of a clinician's interpretation. The device's primary function is as a standalone data recorder.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth. However, for "Accuracy of data measured," the ground truth would typically be derived from calibrated reference instruments that are considered the gold standard for measuring heart rate, oxygen saturation, flow, and pressure. Similarly, for "Data transmission / collection accuracy," the ground truth would be the original data intended for transmission/collection.
The sample size for the training set:
- This information is not applicable or provided. The CODR Model 300-CR is described as a data gathering and display system using sensors, not a device employing machine learning or AI that would require a "training set."
How the ground truth for the training set was established:
- This information is not applicable or provided, as the device does not use a training set for machine learning.

Summary

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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.1061 Main Street - #24N. Huntingdon, PA 15642	Tel - 724-861-5510Fax - 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 monitorMNR - 868.2375
Predicate Devices:	K051313 - Salter BiNAPSK061996 - EB Neuro - Sandman

Device Description:

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 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 DeviceCODR	Predicate -EB Neuro SandmanK061996	Predicate - Salter BINAPSK051313
Indications foruse	The Clinical Oxygen Dose Recorder (CODR) Model300-CR records heart rate and oxygen saturation dataprovided by a Pulse oximeter; flow and pressure datafrom the oxygen delivery system; and measures breathrate and inhale/exhale ratio (I:E ratio) by monitoring theflow in the oxygen delivery tubing. Data is presented toenable the clinician to view the effects of the oxygendevice's delivery performance on a patient in differentambulatory settings, i.e., rest and exercise. It is not to beused as a diagnostic tool.	Intended to collect physiological data tobe used in PSG and sleep disorderstudies.	Is an accessory intended for use withPSG equipment during sleep disorderstudies for the purpose of detecting andamplifying breathing signals anddetection of snoring of a sleeping patient
Environment ofUse	Hospital, health care facilities, home care	Hospital, health care facilities, home care	Hospital, health care facilities, home care
PatientPopulation	For the patient population the CODR will have the sameindications for use as the oxygen source to which it isattached.	Pediatric to adults	Not specified
Contraindications	None	None	None
Software drivenComponents	YesInterface module - collects dataData display softwareSensorsNasal cannula to patientOxygen tubing from oxygen sourcePulse Oximeter	YesInterface module - collects dataRecorder unitSensors	YesInterface moduleNasal cannula
PrescriptiveCommunicationinterface	YesPhysiological data from pulse oximeter and sensorsMeasures parameters from the oxygen source	YesPhysiological data from pulse oximeterand sensors	YesPhysiological data from pulse oximeterand sensors
Features	Proposed DeviceCODR	Predicate -EB Neuro SandmanK061996	Predicate - Salter BiNAPSK051313
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

Page S1.245

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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

Page S1,246

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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 (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,

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 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)

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.

Page S1.242

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).