(49 days)
No
The device description mentions a microprocessor, breath detection circuitry, inhalation sensors, and a 3-axis accelerometer to detect motion and adjust oxygen delivery. While this involves automated decision-making based on sensor input, it does not describe the use of AI or ML algorithms for learning or complex pattern recognition beyond simple threshold-based logic for motion detection. The technology for motion detection is explicitly stated as being taken from a previously cleared device, suggesting a more traditional algorithmic approach rather than a learned model.
Yes
The device is intended for patients who require supplemental oxygen, delivering precise amounts during the breathing cycle for therapeutic purposes.
No
The device is described as an oxygen delivery system that conserves and delivers supplemental oxygen based on breath detection and motion, not for diagnosing medical conditions.
No
The device description explicitly states it is a "microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver," and mentions "breath detection circuitry and inhalation sensors," and "Motion Detection Hardware." The performance studies also include "Hardware: Performed product validation to test new Motion Detection Hardware." This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver supplemental oxygen to patients, which is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device is described as an oxygen pressure regulator and oxygen conserver, focusing on the delivery and regulation of oxygen flow. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device's function is to provide a medical treatment (oxygen therapy), not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
Product codes (comma separated list FDA assigned to the subject device)
NFB
Device Description
The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery (active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting (rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.
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
Not Found
Intended User / Care Setting
prescription use only, in their home and for ambulatory use
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)
Non Clinical Verification:
Software: The OM-900M software is the same as the OM-900 software with the addition of a motion detection algorithm. Possible new risks, such as the OM-900M does not respond to patient motion, were reviewed and documented in SP-206 Risk/Hazard Analysis. OM-900 SERIES Oxygen Conserving Device Revision C. The following verification activities were then performed:
Performed full Software Verification and Validation: PV-192 Software Verification & Validation Protocol For OM-900 Series Electronic Oxygen Conserving Device Revision E.
Updated Risk/Hazard Analysis: SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C.
-Added Types of hazards and Intervening Mechanisms/Risk Reduction Methods to the Usability Hazard table.
Updated Software Design Description: SP-209 Software Design Description, Evolution OM-900 SERIES Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
Updated Software Requirements: SP-210 Software Requirements Specification EVOLUTION OM-900 Series Electronic Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
The OM-900M passed all tests as outlined in PV-192 Software Verification & Validation Protocol for OM-900 Series Electronic Oxygen Conserving Device Revision E.
Hardware: Motion Detection hardware was added to the OM-900 platform (creating the OM-900M). The additional hardware includes a turnkey accelerometer and an extra button on the user keypad. Possible new risks, such as the OM-900M does not respond to patient motion, were reviewed and documented in SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C. The following verification activities were then performed:
Performed product validation to test new Motion Detection Hardware: PV-193 Product Validation OM-900 SERIES Evolution Oxygen Conserving Device Revision B.
Updated FMEA: SP-211, Failure Modes and Effects Analysis, EVOLUTION OM-900 Oxygen Conserving Device Revision C. -Added Motion Detection hardware to "Critical Level Component Failures" list in Appendix A.
Updated Risk/Hazard Analysis: SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C.
-Added Types of hazards and Intervening Mechanisms/Risk Reduction Methods to the Usability Hazard table.
Updated Engineering Requirements: SP-208 Engineering Specification, OM-900 SERIES Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
Please Description/requirements that relate to the motion detection feature.
The OM-900M passed all tests as outlined in PV-193 Product Validation OM-900 Series Evolution Oxygen Conserving Device Revision B. Results of these tests can be found in TR-202 VALIDATION, Evolution OM-900 SERIES OCD Revision B.
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.
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.
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
DEC - 8 2011
510(k) Summary
Inovo, Inc.
Date Prepared:
October 19, 2011
Naples FI. 34104
Michael T. Dildine
(239) 643-6577
(239) 643-6530
Oxygen Conserver
2975 S. Horseshoe Dr.
Director, Quality Assurance
Inovo, Inc.
Submitter Information:
Official Contact:
Phone: FAX: E-mail:
Proprietary Names :
Chad Therapeutic Evolution Electronic Oxygen Conserver
Common Name:
Inovo Model Number
Classification Name:
OM-900M
Class II, 21 CFR 868.5905 Non Continuous Ventilator
Product Code:
NFB
Predicate Device Equivalence:
K103302 - Chad Therapeutic Evolution Model OM-900
1
Device Description:
The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery(active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.
Intended Use:
The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
Comparison of Device Technological Characteristics to Predicate Devices:
The submitted Inovo Evolution OM-900M has the following similarities to the predicate Inovo Evolution OM-900 and Sage TD-100
- Has the same intended use .
- Incorporates the same basic modes and settings .
- Incorporates similar materials .
- Oxygen delivery method is fundamentally equivalent .
2
| Description | Previously Cleared Device | Predicate Device | Modified Device |
|---|---|---|---|
| Device Name | Chad Sage Model TD-100 | Chad Evolution Model OM-900 | Chad Evolution Model OM-900M |
| 510(k) Number | K033364 | K103392 | Not yet assigned |
| Prescription device | Yes | Yes | Yes |
| Indications for use | The Chad Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity. | The device is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 7 liters per minute, in their home and for ambulatory use. | Same as predicate device. |
| Contraindications | Not to be used for life support applications. | ||
| In addition, it is not intended for use by patients who breathe more than 40 breaths of who consistently fail to trigger the device. | Not to be used for life support applications. | ||
| In addition, it is not intended for use by patients who breathe more than 40 breaths of who consistently fail to trigger the device. | |||
| It is not to be used while asleep. | Not to be used for life support applications. | ||
| In addition, it is not intended for use by patients who breathe more than 40 breaths of who consistently fail to trigger the device. | |||
| It is not to be used while asleep. | |||
| Patient population | Any patient for whom up to 6 Ipm of supplemental oxygen has been prescribed. | Any patient for whom up to 7 Ipm of supplemental oxygen has been prescribed. | Same as predicate device. |
| Environment | Home and ambulatory use | Home and ambulatory use | Same as primary predicate device. |
| Oxygen supply | Compressed oxygen cylinder 200 to 3000 psi | Compressed oxygen cylinder 500 to 3000 psi | Same as primary predicate device. |
| Weight in pounds (with batteries) | 1.25 lbs | 0.8 lbs | Same as primary predicate device |
| Dimensions (L x W x H) in inches | 6.0in x 4.5in x 2.1 | Approx. 6.1in x 3.1in x 2.7in | Same as primary predicate device |
| Device setting | 1, 2, 3, 4, 5, 6 | 1, 2, 3, 4, 5, 6, 7 | 1, 2, 3, 4, 5, 6 |
| Oxygen Bolus Size (ml) | Setting 1: 10ml | ||
| Setting 2: 20ml | |||
| Setting 3: 30ml | |||
| Setting 4: 40ml | |||
| Setting 5: 50ml | Setting 1: 10-15ml | ||
| Setting 2: 20-25ml | |||
| Setting 2.5: 25-30ml | |||
| Setting 3: 30-35ml | |||
| Setting 4: 40-50ml | Setting 1: 10-15ml | ||
| Setting 2: 20-25ml | |||
| Setting 3: 30-35ml | |||
| Setting 4: 40-50ml | |||
| Setting 5: 50-60ml | |||
| Setting 6: 60ml | Setting 5: 50-60ml | ||
| Setting 6: 60-75ml | |||
| Setting 7: 70-90ml | Setting 6: 60-75ml | ||
| Pulse Frequency | Once every breath at all settings. | Once every breath at all settings. | Same as primary predicate device. |
| Continuous/Pulse | |||
| Mode Switch | Yes. | Yes, ability to switch from pulsed to continuous flow set at 2lpm. | Same as primary predicate device. |
| Estimated Average | |||
| Oxygen Savings | 5:1 | 5:1 | Same as primary predicate device. |
| Regulator Outlet | |||
| Pressure | $25 \pm 5$ psig | $25 \pm 5$ psig | Same as primary predicate device. |
| Technology | |||
| Motion detection | |||
| feature | Based on an accelerometer providing a signal to the microprocessor. | None. | Based on an accelerometer providing a signal to the microprocessor. |
| Keypad | Rest and Active Buttons. | One button. | |
| (Same button for Rest/Active) | Rest and Active Buttons. | ||
| Housing | Injection molded plastic enclosure. | Injection molded plastic enclosure. | Same as primary predicate device. |
| Microprocessor- | |||
| controlled | Yes | Yes | Yes |
| Attached devices: | |||
| Cannula | Single lumen cannula. | Standard single lumen cannula, | |
| 4ft to 7ft long | Same as primary predicate device. | ||
| Integral regulator | |||
| body | All brass | Brass C36000 High-pressure components | Same as primary predicate device. |
| Oxygen Pressure | Yes. | Yes, 0 to 3000 psi | Same as primary predicate device. |
| Gauge | One 1.5 volt "C" size alkaline battery | Two 1.5 VDC Alkaline "AA-size" batteries | Same as primary predicate device |
| Power |
.
·
Predicate Device Comparisor
3
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:
.
.
4
Statement of Safety and Effectiveness
Analysis of comparison of design, function and features of the Inovo Evolution OM-900M to the (K103302) Evolution OM-900, and (K033364) Sage TD-100. together with the results of testing demonstrates the device to be substantially equivalent to the predicate device in terms of meeting performances criteria and functioning as intended.
Non Clinical Verification
Software: The OM-900M software is the same as the OM-900 software with the addition of a motion detection algorithm. Possible new risks, such as the OM-900M does not respond to patient motion, were reviewed and documented in SP-206 Risk/Hazard Analysis. OM-900 SERIES Oxygen Conserving Device Revision C. The following verification activities were then performed:
Performed full Software Verification and Validation: PV-192 Software Verification & Validation Protocol For OM-900 Series Electronic Oxygen Conserving Device Revision E.
Updated Risk/Hazard Analysis: SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C.
-Added Types of hazards and Intervening Mechanisms/Risk Reduction Methods to the Usability Hazard table.
Updated Software Design Description: SP-209 Software Design Description, Evolution OM-900 SERIES Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
Updated Software Requirements: SP-210 Software Requirements Specification EVOLUTION OM-900 Series Electronic Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
The OM-900M passed all tests as outlined in PV-192 Software Verification & Validation Protocol for OM-900 Series Electronic Oxygen Conserving Device Revision E.
5
Hardware: Motion Detection hardware was added to the OM-900 platform(creating the OM-900M). The additional hardware includes a turnkey accelerometer and an extra button on the user keypad. Possible new risks, such as the OM-900M does not respond to patient motion, were reviewed and documented in SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C. The following verification activities were then performed:
Performed product validation to test new Motion Detection Hardware: PV-193 Product Validation OM-900 SERIES Evolution Oxygen Conserving Device Revision B.
Updated FMEA: SP-211, Failure Modes and Effects Analysis, EVOLUTION OM-900 Oxygen Conserving Device Revision C. -Added Motion Detection hardware to "Critical Level Component Failures" list in Appendix A.
Updated Risk/Hazard Analysis: SP-206 Risk/Hazard Analysis, OM-900 SERIES Oxygen Conserving Device Revision C.
-Added Types of hazards and Intervening Mechanisms/Risk Reduction Methods to the Usability Hazard table.
Updated Engineering Requirements: SP-208 Engineering Specification, OM-900 SERIES Oxygen Conserving Device Revision C. -Added Descriptions/requirements that relate to the motion detection feature.
Please Description/requirements that relate to the motion detection feature.
The OM-900M passed all tests as outlined in PV-193 Product Validation OM-900 Series Evolution Oxygen Conserving Device Revision B. Results of these tests can be found in TR-202 VALIDATION, Evolution OM-900 SERIES OCD Revision B.
Conclusion
Based on the above, we conclude that the Inovo Evolution OM-900M Electronic Conserver is substantially equivalent to the predicate device listed and does not raise any new issues of safety and effectiveness. .
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or waves, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael T. Dildine Director, Quality Assurance Inovo, Incorporated 2975 South Horseshoe Drive, Suite 600 Naples, Florida 34104
DEC - 8 2011
Re: K113111
Trade/Device Name: Chad Therapeutics Evolution Model OM-900M Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: November 28, 2011 Received: November 28, 2011
Dear Mr. Dildine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
7
Page 2 - Mr. Dildine
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Device Name: Chad Therapeutics Evolution Model OM-900M
Indications for Use: KII 3 ١١١
The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
L. Schult Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: