(175 days)
Not Found
No
The description focuses on data recording and display, with no mention of AI/ML algorithms for analysis, interpretation, or prediction.
No.
The device is a data gathering and information display system that records patient and oxygen delivery data for clinicians, but it does not directly provide therapy. Its "Intended Use" states it is "not to be used as a diagnostic tool."
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state: "It is not to be used as a diagnostic tool."
No
The device description explicitly states that the CODR consists of two components: an interface module and PC based data display software. The interface module is a physical, portable, battery-powered hardware component containing sensors, connectors, and an SD card slot.
Based on the provided text, the Clinical Oxygen Dose Recorder (CODR) Model 300-CR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The text explicitly states, "It is not to be used as a diagnostic tool." IVD devices are specifically intended for diagnostic purposes, typically by examining specimens taken from the human body.
- Device Description: The CODR records physiological data (heart rate, oxygen saturation, breath rate, I:E ratio) and oxygen delivery system data (flow, pressure). It displays this data to help clinicians view the effects of oxygen delivery on a patient. This is a monitoring and data recording function, not a diagnostic one.
- No mention of analyzing biological samples: The description focuses on monitoring external systems (oxygen delivery) and physiological parameters measured by other devices (pulse oximeter). There is no indication that the CODR analyzes any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
Therefore, the CODR falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR - 868.2375
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 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.
Intended User / Care Setting
trained clinicians in the hospital, clinical or home care environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051313 - Salter BiNAPS, K061996 - EB Neuro - Sandman
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Non-Confidential Summary of Safety and Effectiveness Page 1 of 4 19-Dec-08
MAR 2 3 2009
| Inspired Technologies, Inc.
1061 Main Street - #24
N. Huntingdon, PA 15642 | Tel - 724-861-5510
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
MNR - 868.2375 |
| Predicate Devices: | K051313 - Salter BiNAPS
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.
-
- 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.
1
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.
2
K082853 CODR
Non-Confidential Summary of Safety and Effectiveness
| Features | Proposed Device
CODR | Predicate -EB Neuro Sandman
K061996 | Predicate - Salter BINAPS
K051313 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 (I: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. | Intended to collect physiological data to
be used in PSG and sleep disorder
studies. | Is an accessory intended for use with
PSG equipment during sleep disorder
studies for the purpose of detecting and
amplifying breathing signals and
detection of snoring of a sleeping patient |
| Environment of
Use | Hospital, health care facilities, home care | Hospital, health care facilities, home care | Hospital, health care facilities, home care |
| Patient
Population | For the patient population the CODR will have the same
indications for use as the oxygen source to which it is
attached. | Pediatric to adults | Not specified |
| Contraindications | None | None | None |
| Software driven
Components | Yes
Interface module - collects data
Data display software
Sensors
Nasal cannula to patient
Oxygen tubing from oxygen source
Pulse Oximeter | Yes
Interface module - collects data
Recorder unit
Sensors | Yes
Interface module
Nasal cannula |
| Prescriptive
Communication
interface | Yes
Physiological data from pulse oximeter and sensors
Measures parameters from the oxygen source | Yes
Physiological data from pulse oximeter
and sensors | Yes
Physiological data from pulse oximeter
and sensors |
| Features | Proposed Device
CODR | Predicate -EB Neuro Sandman
K061996 | Predicate - Salter BiNAPS
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 |
Page S1.245
3
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
4
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.
5
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
6
Indications for Use Statement
Page 1 of 1
510(k) Number:
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.
Page S1.242