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.

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.

AI/ML Overview

The Inovo Evolution OM-900M is an oxygen conserver. The provided text describes the device, its intended use, and a comparison to predicate devices, focusing on the addition of a motion detection feature.

Here's an analysis to extract the requested information regarding acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary (K113111) for the Inovo Evolution OM-900M does not explicitly state a table of quantifiable acceptance criteria with corresponding device performance metrics for the overall device or its new motion detection feature. Instead, it relies on demonstrating substantial equivalence to predicate devices through verification and validation activities.

However, based on the text, the implicit acceptance criteria are that the modifications (motion detection software and hardware) do not introduce new safety and effectiveness issues and that the device functions as intended, similar to the predicate devices.

The "reported device performance" is broadly stated as passing all tests outlined in the validation protocols. Specific quantitative performance targets for the motion detection feature itself (e.g., accuracy of motion detection, response time to motion, or how much oxygen delivery increases) are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a separate "test set" in the context of and AI/algorithm-focused study with a defined sample size of patients or images. The verification and validation activities (PV-192 and PV-193) are described as testing the software and hardware of the device. This implies engineering or laboratory testing rather than a clinical trial with human subjects.

Therefore, information on sample size for a "test set" and data provenance (country of origin, retrospective/prospective) related to AI/algorithm performance is not applicable or provided in this 510(k) summary. These types of details are typically found in clinical study reports, which are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set (e.g., for image interpretation or disease diagnosis). The verification and validation activities are for the device's functional performance, not for an AI algorithm making diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is also not applicable as there is no mention of a test set requiring adjudication of findings, which is typical for clinical studies involving multiple reviewers or diagnostic outputs.

5. 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, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. The Inovo Evolution OM-900M is an oxygen conserver with a motion detection feature, not an AI-powered diagnostic tool in that sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's motion detection feature can be considered a standalone algorithmic component that senses motion and automatically adjusts oxygen delivery without direct human intervention once activated. The "Non Clinical Verification" section describes that the software for the motion detection algorithm underwent full Software Verification and Validation (PV-192), and the hardware was tested via Product Validation (PV-193).

However, the nature of these tests is focused on the correct functioning of the motion detection system (e.g., does it detect motion, does it switch to active mode, does it revert to rest mode correctly) rather than a comparative performance against a "ground truth" of human activity, or direct clinical outcomes. The document does not provide specifics on the metrics used to assess this "standalone" performance beyond stating that it "passed all tests."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification and validation of the motion detection feature, the "ground truth" would likely be based on engineering specifications and predefined performance thresholds for the accelerometer and associated software.

For software verification (PV-192), the ground truth for tests would be the expected software behavior based on the Software Requirements Specification (SP-210) and Software Design Description (SP-209). For example, if a specific motion is simulated, the device should switch to active mode.
For hardware validation (PV-193), the ground truth would involve confirming that the accelerometer correctly senses motion within specified parameters and that the additional button functions as intended.

It is not based on expert consensus, pathology, or clinical outcomes in the traditional sense of a diagnostic AI system study.

8. The sample size for the training set

This information is not applicable. The motion detection functionality appears to be based on an algorithm that processes accelerometer data rather than a machine learning model that requires a "training set" of data to learn from. The description suggests a rule-based or threshold-based system rather than a deep learning approach.

9. How the ground truth for the training set was established

This information is not applicable as there is no mention of a training set for a machine learning algorithm.

Summary

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K113111

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

mdildine@inovoinc.com

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

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Device Description:

Intended 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 .

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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: 10mlSetting 2: 20mlSetting 3: 30mlSetting 4: 40mlSetting 5: 50ml	Setting 1: 10-15mlSetting 2: 20-25mlSetting 2.5: 25-30mlSetting 3: 30-35mlSetting 4: 40-50ml	Setting 1: 10-15mlSetting 2: 20-25mlSetting 3: 30-35mlSetting 4: 40-50mlSetting 5: 50-60ml
	Setting 6: 60ml	Setting 5: 50-60mlSetting 6: 60-75mlSetting 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/PulseMode Switch	Yes.	Yes, ability to switch from pulsed to continuous flow set at 2lpm.	Same as primary predicate device.
Estimated AverageOxygen Savings	5:1	5:1	Same as primary predicate device.
Regulator OutletPressure	$25 \pm 5$ psig	$25 \pm 5$ psig	Same as primary predicate device.
		Technology
Motion detectionfeature	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 regulatorbody	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

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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.

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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. .

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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.

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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

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Indications for Use

510(k) Number (if known):

Device Name: Chad Therapeutics Evolution Model OM-900M

Indications for Use: KII 3 ١١١

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:

Regulation Number and Section

§ 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).