The Chad Therapeutics Evolution Model OM-900 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

Device Description

The Inovo Evolution 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 convert 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 7 liters per minute depending on the flow rate setting

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Inovo Evolution OM-900 Series:

Disclaimer: The provided text is a 510(k) summary from 2010. It focuses on demonstrating substantial equivalence to a predicate device, which means it might not contain the detailed, quantitative acceptance criteria and study results typically found in full clinical study reports or newer FDA submissions. Much of the information requested (e.g., sample sizes for training/test sets, expert qualifications, specific metrics for acceptance criteria) is not present in the provided document.

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Inovo Evolution OM-900 Series is primarily a submission for substantial equivalence. It does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results in the way a performance study might. Instead, it relies on demonstrating that its design, function, and features are comparable to the predicate device (Chad Therapeutic Lotus Models OM-700 & OM-700S) and that testing confirms it performs as intended and meets the same "performance criteria" as the predicate.

The key acceptance criteria, as implied by the document, revolve around:

Same Intended Use: The device must serve the same purpose for the same patient population.
Basic Modes and Settings: It must offer comparable operational modes and settings.
Similar Materials: The materials used should be equivalent.
Equivalent Oxygen Delivery Method: The fundamental way it delivers oxygen should be the same.
Performance (General): Testing must demonstrate it meets performance criteria and functions as intended, implying that its oxygen delivery characteristics (bolus size, equivalence to L/min, breath detection) are comparable to the predicate.

Since no specific quantitative metrics or a comparative table are provided in the document, I cannot populate a table with "acceptance criteria" vs. "reported performance" with specific numbers. The document states a general conclusion:

"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."

This indicates that internal testing was conducted to ensure the device performs similarly to the predicate, particularly regarding breath detection (even though the circuitry is new) and bolus sizes. The bolus sizes are explicitly mentioned as "the same with the exception of one additional setting No. 7."

Detailed Study Information (Based on Available Text)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "results of testing," but does not specify the type of testing (e.g., in vitro, animal, human clinical), sample size, or data provenance. Given the nature of a 510(k) for an oxygen conserver, it's likely initial testing focused on engineering and performance verification in a lab setting, possibly with some human-factors or usability testing, rather than a large clinical trial with patient data.
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)
- Not applicable/Not provided. This type of information is usually relevant for studies involving image interpretation or diagnostic accuracy where expert consensus is needed to establish ground truth. For an oxygen conserver, ground truth would likely be established through objective measurements of oxygen delivery, breath detection accuracy, and functionality, rather than expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish ground truth. This is not the type of study described or implied for this device.
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 is not mentioned and is not relevant for an oxygen conserver device, which is a therapeutic device, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in this context. While the device is microprocessor-controlled and has "breath detection circuitry," it's a medical device delivering oxygen, not an AI algorithm generating a diagnosis or prediction without human interaction. Performance testing would have evaluated the device's standalone operation and its ability to deliver oxygen accurately based on detected breaths. However, the term "standalone" in the context of AI performance metrics (algorithm only) is not relevant here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Measurements/Engineering Specifications. For an oxygen conserver, ground truth would be established through objective measurements based on engineering specifications and physiological principles. This would include accurately measuring:
  - Oxygen flow rates and bolus sizes
  - Accuracy of breath detection
  - Battery life
  - Pressure regulation
  - Safety parameters (e.g., leaks, pressure limits)
- The document implies that these measurements were compared against the predicate device's known performance characteristics and relevant standards.
The sample size for the training set
- Not applicable/Not provided. This device is hardware-based with microprocessor control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves design, engineering, and iterative testing/refinement of the hardware and embedded software.
How the ground truth for the training set was established
- Not applicable/Not provided. As above, the concept of a "training set" and its "ground truth" is not directly applicable to this type of device development process. Ground truth for the underlying principles (e.g., desired oxygen bolus sizes, breath detection sensitivity) would be established by medical standards, physiological requirements, and the performance characteristics of the predicate device.

Summary

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K103392

DEC 1 7 2010

510(k) Summary

Inovo, Inc.

Date Prepared:

November 15, 2010

Submitter Information:

Official Contact:

Phone: FAX: E-mail:

Proprietary Names:

Common Name:

Inovo Model Number

Classification Name:

lnovo, Inc. 2975 S. Horseshoe Dr. Naples Fl. 34104

Michael T. Dildine Director, Quality Assurance (239) 643-6577 (239) 643-6530 mdildine@inovoinc.com

Chad Therapeutic Evolution Electronic Oxygen Conserver

Oxygen Conserver

OM-900 Series

Class II, 21 CFR 868.5905 Non Continuous Ventilator

Product Code:

ﮯ ﺑﮩ

NFB

Predicate Device Equivalence:

K042142 - Chad Therapeutic Lotus Models OM-700 & OM-700S

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Device Description:

Intended Use:

The Inovo Evolution 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.

Comparison of Device Technological Characteristics to Predicate Devices:

The submitted Inovo Evolution OM-900 Series has the following similarities to the predicate OM-700 Series

Has the same intended use .
Incorporates the same basic modes and settings .
Incorporates similar materials ●
Oxygen delivery method is fundamentally equivalent .

There is a technological characteristic difference between the Evolution and the predicate device. The breath detection circuitry and sensors utilized in the Evolution are new but are based on the same operating principles of the Lotus breath detection circuitry and sensor. The bolus sizes for the Evolution are the same with the exception of one additional setting No. 7. The software and electronics have been modified to extend battery life

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Statement of Safety and Effectiveness

Analysis of comparison of design, function and features of the Inovo Evolution OM-900 Series to the (K042142) Lotus OM-700, OM700S Series Electronic Conserver, 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.

Conclusion

Based on the above, we conclude that the Inovo Evolution OM-900 Series 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized symbol to the right of the text. The symbol consists of three curved lines that resemble a stylized human figure. The text is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609

Silver Spring, MD 20993-0002

DEC 1 7 2010

Mr. Michael T. Dildine Director, Quality Assurance Inovo. Incorporated 2975 S. Horseshoe Drive, Suite 600 Naples, Florida 34104

Re: K103392

Trade/Device Name: Chad Therapeutics Evolution Model OM-900 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: November 15, 2010 Received: November 19, 2010

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 (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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours

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-900

Indications for 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)

Concurrence of OORH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page 1 of __

510(k) Number: K103392

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).