The Economizer Conserving Requlator is used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

Device Description

The Inovo, Inc., Economizer Conserving Regulator is a high pressure oxygen requlator and conserving device that is combined into a single compact unit. It operates in the same manner as traditional oxygen pressure regulators with the added benefit of having a conserving device included. It is constructed with an aluminum one piece body with all brass in the high pressure zones. The system is designed for an ambulatory patient with a high pressure oxygen cylinder. This unit requires no electrical power source. It operates with an operating pressure of 200 to 3000 psig and a nominal outlet pressure of 22 psi.

The device can function as a standard continuous flow regulator or as a conserving device which will double a patient's ambulatory time over that of a continuous oxygen system.

In conserving mode, the flow of oxygen is controlled by the patients inhalation and exhalation, which triggers a sensing diaphragm within the control module. As a result, the unit starts flowing oxygen when the user begins the inhalation cycle. Conversely, the unit shuts off the flow of oxygen when the user ceases inhalation.

It includes a click style flow control with selectable outlet flow that ranges 1 to 6 LPM by .5 LPM increments. The device can easily be switched between continuous or conserve mode without turning the device off.

The device uses a dual lumen cannula attached to two outlet ports. The first port senses the inhalation of the patient . The second port delivers the oxygen. In the "Conserve" mode, the device should be used only with the Hudson Dual Lumen Cannula (K# 961150) or a cannula with the same pneumatic characteristics.

AI/ML Overview

The provided text describes a 510(k) summary for the Inovo, Inc. Economizer Conserving Regulator. This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It explicitly states "Clinical Tests Performed: Not Applicable," meaning no human studies were conducted for this submission.

Therefore, an acceptance criteria table and information regarding human study parameters (sample size, experts, adjudication, MRMC studies, standalone performance) cannot be extracted from this document, as such studies were not performed or reported.

However, based on the non-clinical tests performed, we can infer the types of acceptance criteria that would have been used for each test.

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

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance/Rationale for Acceptance
Material & Safety	ASTM G175	Not explicitly stated; implied to meet standard requirements for oxygen service materials.
Conserving Function	Conservation Test	Not explicitly stated; implied to achieve desired oxygen conservation (e.g., doubling ambulatory time).
Flow Accuracy	Flow Regulation Test	Not explicitly stated; implied to deliver prescribed flow accurately (1 to 6 LPM by .5 LPM increments).
Responsiveness	Flow Response Test	Not explicitly stated; implied to have appropriate response time for sensing inhalation and delivering oxygen.
Durability/Pressure	Proof Pressure Test	Not explicitly stated; implied to withstand specified proof pressure.
Structural Integrity	Hydrostatic Test	Not explicitly stated; implied to withstand specified hydrostatic pressure.
Environmental Robustness	Environment Testing	Not explicitly stated; implied to perform reliably under various environmental conditions.
Overall Equivalence	Comparison to Predicate Devices	"No differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. The efficacy and safety were evaluated through non-clinical (bench) testing, not on a human test set.
Data Provenance: Not applicable for human data. All data is from non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable. No human test set requiring adjudication was used.

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:

Not applicable. This device is an oxygen conserving regulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

The "standalone performance" in this context refers to the device's function as an oxygen conserving regulator. All the performance tests listed (Conservation Test, Flow Regulation Test, Flow Response Test, etc.) represent the device's standalone performance in a simulated or bench environment.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was established by engineering specifications, industry standards (e.g., ASTM G175), and established criteria for functional performance of oxygen delivery devices. For example, a flow regulation test would be evaluated against calibrated flow meters, and a conservation test against expected oxygen consumption metrics.

8. The sample size for the training set:

Not applicable. This device is a mechanical/pneumatic device and does not involve machine learning or an algorithm that requires a "training set" in the computational sense.

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

Not applicable, as there is no training set for this type of device.

Summary

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SEP 1 5 2003

Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "K031983" and is written in a slightly tilted orientation. The handwriting is bold and clear, making the characters easily distinguishable against the white background.

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Submitter's Identification: 1.

Inovo, Inc. 3786 Mercantile Avenue Naples, FL 34104

Date Summary Prepare: June 25, 2003

Contact Person: Mr. Kevin Confoy General Manager

2. Name of the Device:

Inovo, Inc. Economizer Conserving Regulator

3. Predicate Device Information:

1. K#010747, OPC Oxygen Conserving Regulator, Model AHG, Western Medica, West Lake, Ohio
1. K#992659, O₂n Demand II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II) Victor Equipment Company, Denton, Texas

4. Device Description:

The device can function as a standard continuous flow regulator or as a conserving device which will double a patient's ambulatory time over that of a continuous oxygen system.

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5. Intended Use:

6. Comparison to Predicate Devices:

The Inovo. Inc. Economizer Conserving Requlator is substantially equivalent to the Western Medica OPC Oxygen Conserving Regulator, K#010747 and the Victor Equipment Company O2n Demand II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II), K# 992659. These predicate devices were cleared with the same indications for use as our device.

Similarities include features of the device, input operating pressure, outlet pressure, selectable outlet flows, oxygen conservation, inlet configuration, outlet connection, gauge and trigger point. There are few differences such as unit weight and response time. A major feature is a compact aluminum body with brass in all high pressure zones.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Performance Testing Included:

ASTM G175 (formerly PS 127.00) .
Conservation Test .
. Flow Regulation Test
. Flow Response Test
Proof Pressure Test ●
Hydrostatic Test .

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Environment Testing .

Discussion of Clinical Tests Performed: 8.

Not Applicable

Conclusions: 9.

The subject device, the Inovo, Inc. Economizer Conserving Regulator has the same intended use as the predicate devices, the Western Medica OCD Oxygen Conserving Regulator and the Victor O₂n Demand II OCPR-II. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness. Thus, the Inovo, inc. Economizer Conserving Regulator is substantially equivalent to the predicate devices.

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Image /page/3/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a bird or a human figure with three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

SEP 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inovo, Incorporated c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Incorporated 55 Northern Blvd, Suite 200 Great Neck, New York 11021

Re: K031983

Trade/Device Name: Economizer Conserving Regulator Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: June 25, 2003 Received: June 26, 2003

Dear Ms. Goldstein-Falk:

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 - Ms. Susan D. Goldstein-Falk

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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runne

Susan Runner, DDS, MA Interim 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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Exhibit B

Page __ 1__ of __ 1 __ 1 __

510(k) Number (if known): __ Ko31983 ______________________________________________________________________________________________________________________________________________________________________________

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Device Name: Inovo, Inc. Economizer Conserving Regulator

Indications For Use:

The Economizer Conserving Regulator is used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:	K031983
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Prescription Use	OR	Over-The Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

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).