The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.

Device Description

The 6203 with integrated pressure regulator is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The 6203 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.

AI/ML Overview

This device is an oxygen conserver and its performance is described in terms of its functional capabilities, alarm system, and environmental robustness, rather than diagnostic accuracy. As such, the typical acceptance criteria and study components requested for AI/ML devices (like sample size for test sets, expert ground truth, MRMC studies, or standalone performance) are not applicable or provided in this 510(k) summary.

Here's an analysis based on the provided text, focusing on what is relevant for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance
Functional Performance	Delivering appropriate bolus size for given liter flow settings (1-6 lpm)	Met performance objectives; Chart 1 details bolus sizes delivered (e.g., 1 lpm: 15 ml, 6 lpm: 81 ml).
Alarm System	Detect insufficient negative pressure (apnea) within 45 seconds	Produces audible alarm tone if no sufficient negative pressure detected within 45 seconds.
	Detect microprocessor failure	Flow/apnea light lights steady red if microprocessor fails.
Environmental Robustness	Impact/drop testing	Demonstrated that it meets its performance objectives.
	Storage temperature testing	Demonstrated that it meets its performance objectives.
	Electromagnetic interference testing	Demonstrated that it meets its performance objectives.
	Electrostatic discharge testing	Demonstrated that it meets its performance objectives.
	Surface temperature testing	Demonstrated that it meets its performance objectives.
Power Supply	Battery life testing	Demonstrated that it meets its performance objectives.
	Low power indicator testing	Battery LED winks every 2 seconds (3 hours remaining), every 1 second (30 minutes remaining), then lights steady (unit shut down).

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. The submission describes "Extensive functional testing" and testing under "various environmental conditions" for device performance. There is no mention of a human-centric or data-driven "test set" in the context of an AI/ML diagnostic device. The testing appears to be engineering and design validation on the physical device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. See point 2. The "ground truth" here is the device's adherence to its design specifications and safety standards, validated through engineering tests, not expert consensus on medical images or patient data.

4. Adjudication Method for the Test Set

Not Applicable. See point 2 and 3.

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 is a demand oxygen conserving device, not an AI/ML diagnostic or assistive tool for human readers.

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

Not Applicable. This is a physical electronic device, not a standalone algorithm. Its performance is inherent to its design and function. The device's operation is "algorithm only" in the sense that its microprocessor controls the valve based on its internal programming (e.g., the bolus size chart).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is its engineering specifications and design requirements. This includes:
- Validated bolus delivery volumes corresponding to specified liter flow settings (Chart 1).
- Accurate detection of pressure changes indicating inhalation.
- Reliable alarm activation for apnea/disconnection and microprocessor failure.
- Durability and resilience to environmental factors (impact, temperature, EMI/ESD).
- Correct indication of battery status and low power.

8. The Sample Size for the Training Set

Not Applicable. As a hardware device with embedded software (not a machine learning model), there is no concept of a "training set" in the conventional AI/ML sense. The device's software logic is developed based on engineering principles and validated through testing.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8. The "ground truth" for the device's design would be derived from clinical requirements for oxygen delivery, respiratory physiology, and safety standards for medical devices, which informed the device's engineering specifications.

Summary

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K022865

Demand Oxygen Conserving Device 510(k) Summary

FEB 1 3 2003

Submitter's Name, Address, Telephone Number and Contact Person

Submitter
Barry A. Schwartz
Contemporary Products, Inc.
470 Riverside Street
Portland, ME 04103
Telephone:	207-797-4647
Facsimile:	207-797-9411
FDA Establishment No.: 1223412

Contact Person
Barry A. Schwartz
Contemporary Products, Inc.
470 Riverside Street
Portland, ME 04103
Telephone: 207-797-4647
Facsimile: 207-797-9411

Date Prepared

August 27, 2002

Name of Device

Trade Name:	6203
Common Name:	Oxygen Conserver
Classification Name:	Ventilator, Non-Continuous (Respirator)21CFR 868.5905
Product Code:	73 NFB

Predicate Device

Contemporary Products, Inc., OCD2001 (K992935)

Intended Use

The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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Technological Characteristics and Substantial Equivalence

The 6203 is intended to be used with USP bottled oxygen and nasal cannulas and is installed as shown in the following figure:

Image /page/1/Figure/3 description: This figure shows a diagram of an oxygen conservation device. The diagram includes a nasal cannula, an oxygen conserving device, and an oxygen supply. The figure is labeled as "Figure 1" and includes the number "1" and "23456" in the upper right corner.

The side panel of the 6203 has a selector switch, battery status light and flow fault/apnea light. The battery LED winks every two (2) seconds when about 3 hours remain in the batteries and once every second when about 30 minutes

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remain. It then lights steady if batteries can no longer properly power the unit informing the patient that the unit has shut down.

When the selector switch is set to "ON" the device operates as follows:

The sensing diaphragm closes its circuit in response to .5cm negative pressure produced by the user's inhalation effort. This circuit closing is input into the microprocessor. The microprocessor then opens the valve to allow the appropriate bolus of oxygen to flow (based upon the chart that follows) and then waits for the next negative pressure.

Chart 1

Liter Flow Setting	Bolus Size
1 Ipm	15 ml
2 Ipm	28 ml
3 Ipm	41 ml
4 Ipm	55 ml
5 Ipm	68 ml
6 lpm	81 ml

The 6203 contains an alarm package that is designed to alert the user in the event of disconnection of the cannula or unit malfunction. The 6203 will produce an audible alarm tone to alert the user if it has not detected sufficient negative pressure to close the circuit on the sensing diaphragm within 45 seconds. The 6203 will cause the flow/apnea light to light a steady red if the microprocessor should fail.

The 6203 is substantially equivalent in intended use and principal of operation to other oxygen conserving devices including our own device, the OCD2001 referenced above (K992935 now marketed as the 6200); the Invacare IPD Oxygen Conserving Device (K953852) and the Chad Therapeutics Oxymatic Electronic Oxygen Conserver (K852650). These predicate devices, like the 6203, are electronic products that use a breath sensor and normally closed valve. Additionally, the Invacare IPD Oxygen Conserving Device, like the 6203 opens the valve and delivers the oxygen to the patient on every detected inhalation.

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Performance Data

Extensive functional testing of the 6203 has been performed. In addition, testing of the device has been performed under various environmental conditions, including impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing and surface temperature testing. Power supply testing was also performed; these tests included battery life testing and low power indicator testing. The functional, environmental and power supply testing performed on the device demonstrated that it meets its performance objectives and complies with applicable FDA guidelines.

The electronic components and software design are identical to the Contemporary Products, Inc. predicate device, OCD2001 (6200).

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2003

·Mr. Barry A. Schwartz President Contemporary Products, Incorporated 470 Riverside Street Portland, Maine 04103

Re: K022865

Trade/Device Name: 6203 Demand Oxygen Conservation Device Regulation Number: 21 CFR 868.5905 Regulation Name: Oxygen Conserver Regulatory Class: II Product Code: 73 NFB Dated: December 3, 2002 Received: December 4, 2002

Dear Mr. Schwartz:

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 - Mr. Schwartz

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Susan Runoe

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

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Contemporary Products, Inc.

Wave Conserver Model 6203

Indications for Use Statement

510(k) Reference Number:

This is an initial submission; no number has yet been assigned

Statement of Indications for Use:

The Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.

(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 Cardiovascular, Respiratory and Neurological Devices

510(k) Number:

Prescription Use	OR
(Per 21 CFR 801.109)

Over-the Counter Use

Hua Ruto 2/12/03

(Optional Format 1-2-96)

. General Hospital

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).