The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

The DOC Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and oxygen for paliente procente oxygen.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Demand Oxygen Conserving Device (DOCD). Unfortunately, the supplied text is quite limited regarding detailed study information, especially for what would typically be considered "acceptance criteria" in a medical device study (e.g., specific quantitative benchmarks like sensitivity, specificity, accuracy, etc., for a diagnostic device). This document focuses more on the functional performance of the device and its substantial equivalence to existing predicate devices.

Summary of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional Performance	Detect patient inhalation and deliver oxygen for 1 second. Conserve oxygen during exhalation.	The DOCD is a battery-operated, microprocessor-controlled device with a capacitive breath sensor and a normally closed valve. It detects inhalation, opens the valve for 1 second, and delivers the set flow rate of oxygen. The valve closes during exhalation to conserve oxygen. Extensive functional testing "demonstrated that it meets its performance objectives."
Oxygen Conservation	Reduce or conserve the amount of oxygen used by the patient.	The device functions by delivering oxygen only during inhalation (1 second pulse), thus "conserv[ing] the oxygen that would have been wasted during exhalation."
Alarm Mechanisms	Alert the user for cannula disconnection/restriction or device malfunction.	Produces an audible alarm if no sufficient negative pressure is detected within 30 seconds (cannula issue). Produces an intermittent audible tone if the continuous self-check detects a microprocessor/software malfunction.
Battery Status	Provide indication of battery condition and low battery warning.	A selector switch setting ("Bat") illuminates a battery status light. In "On" position, a flashing Red light indicates low battery (below 1.10V). Power supply testing "included battery life testing and low power indicator testing."
Environmental Durability	Withstand various environmental conditions (impact/drop, storage temperature, EMI, ESD, surface temperature).	Testing "under various environmental conditions, including impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing and surface temperature testing" was performed and "demonstrated that it meets its performance objectives."
Power Supply	Adequate battery life and accurate low power indication.	"Power supply testing was also performed; these tests included battery life testing and low power indicator testing." This testing "demonstrated that it meets its performance objectives."
Substantial Equivalence	Be substantially equivalent in intended use and principle of operation to predicate devices (Invacare IPD Oxygen Conserving Device (K953852) and CHAD Therapeutics Oxymatic Electronic Oxygen Conserver (K852650)).	The DOCD is considered substantially equivalent. It shares the intended use (oxygen conservation) and principle of operation (electronic, breath sensor, normally closed valve) with the predicates. Specifically, like the Invacare IPD, it opens the valve for 1 second during inhalation.

In-Depth Analysis of Study Information:

Based on the provided text, the "study" conducted for the Demand Oxygen Conserving Device (DOCD) primarily consisted of "Extensive functional testing" and environmental/power supply testing. This appears to be more of a verification and validation (V&V) effort against design specifications rather than a clinical trial or a formal statistical study with defined acceptance criteria for diagnostic accuracy or clinical outcomes.

Here's what can be extracted based on your requested points:

A table of acceptance criteria and the reported device performance
- See table above. The acceptance criteria are inferred from the description of the device's intended function and the types of tests explicitly mentioned. Specific quantitative thresholds for these criteria are largely absent from this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "Extensive functional testing" and lists various categories of tests (environmental, power supply). It does not indicate the number of devices or test conditions used for this testing.
- Data Provenance: Not specified. Given the nature of V&V testing, it would generally be prospective data generated in a lab setting, likely at the manufacturer's facility in Torrance, California, USA (Medical Electronic Devices Corp. location).
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 specified. This device performs a mechanical/electronic function (oxygen delivery based on breath detection) rather than an interpretative or diagnostic one that would typically require expert ground truth. The "truth" in this context would be whether the device correctly detects a breath, whether it opens the valve for 1 second, whether alarms function, etc., which are measurable physical parameters.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies where there is subjective interpretation or borderline cases (e.g., image reading). For functional and environmental testing of a mechanical device, performance is typically objectively measured against pre-defined specifications.
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. This type of study (MRMC, AI assistance) is not relevant to a Demand Oxygen Conserving Device, which is a therapeutic rather than a diagnostic or imaging-assistance device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence. The "Extensive functional testing" and environmental/power supply testing represent the standalone performance of the device. The device's operation (detecting breath, opening valve, alarming) is algorithmic/automatic based on its programming and sensor input, without continuous human intervention during its core function. The reported performance relates to the device operating independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance testing would be objective physical measurements and adherence to design specifications. Examples would include:
  - Breath Detection: Verified by simulating inhalation (negative pressure) and observing if the valve opens.
  - Oxygen Delivery Duration: Measuring the actual valve open time (e.g., using a flow sensor and timer) to confirm it is 1 second.
  - Alarm Functionality: Triggering specific conditions (e.g., no detected breath for 30s, low battery voltage) and verifying the correct alarm output.
  - Environmental Performance: Exposing the device to specified conditions (e.g., temperature ranges, drop height) and then verifying continued functional operation.
The sample size for the training set
- Not specified. This device does not appear to employ machine learning algorithms that require a "training set" in the conventional sense. Its operation is based on pre-programmed logic and sensor thresholds.
How the ground truth for the training set was established
- Not applicable, as there's no mention of a traditional "training set" for a machine learning model. The device operates based on fixed engineering principles and pre-set parameters.

Summary

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MEDICAL ELECTRONIC DEVICES CORP.

Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters, which appears to be a code or identifier. The characters are 'K983601', written in a bold, somewhat rough style. The characters are distinct, but the handwriting gives them a slightly irregular appearance.

Demand Oxygen Conserving Device 510(k) Summary

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

Submitter

Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court., "D6" Torrance, California 90503 (310)618-0306 Telephone: Facsimile: (310)618-1034

Contact Person

Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court., "D6" Torrance, California 90503 Telephone: (310)618-0306 (310)618-1034 Facsimile:

Date Prepared

October 15, 1998.

Name of Device

Trade Name:	Demand Oxygen Conserving Deviceor "DOCD" or "The DOC"
Common name:	Oxygen Conserver
Classification name:	Ventilator, Non-Continuous (Respirator)21CFR 868.5905

Predicate Devices

(1) Invacare IPD Oxygen Conserving Device (K953852)

(2) CHAD Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650)

Intended Use

The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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MEDICAL ELECTRONIC DEVICES CORP.

Technological Characteristics and Substantial Equivalence

The Demand Oxygen Conserving Device or "DOCD" 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 DOCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive 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 for 1 second and delivers the flow rate of oxygen set at the regulator to the patient. The valve closes and conserves the oxygen that would have been wasted during exhalation. The 1 second valve open time was chosen based on the typical breathing pattern of inhalation for 1/3 of the time and exhalation for 2/3 of the time and a typical breath rate of 20 per minute and is equivalent to the predicate Impulse Venture Demand Oxygen Delivery Device.

The DOCD is intended to be used with USP bottled oxygen and nasal cannulas and is installed as shown in Figure 1.

Image /page/1/Figure/4 description: The image shows a diagram of an oxygen delivery system. The system includes a USP bottled oxygen tank connected to a pressure regulator and valve assembly. Oxygen flows through tubing to a DOCD oxygen conserver, and then to a nasal cannula (Hudson RCI No. 1103 or equivalent).

The front panel of the DOCD has a selector switch and a battery status light. When the selector switch is set to the "Bat" position the battery status light will illuminate to give the user an indication of the condition of the battery in the device. In addition to providing battery status information to the user while in the "Bat" setting, the DOCD will indicate a low battery condition by flashing the battery status light Red if the unit is in "On" position and the battery voltage falls below 1.10V.

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

The capacitive pressure transducer changes its capacitance in response to the negative pressure produced by the user's inhalation effort. This change in capacitance is converted into a change in voltage and is amplified. When this amplified voltage exceeds the reference voltage of the comparator, the comparator's output changes state. This change is input into the microprocessor. The microprocessor then opens the valve for 1 second and waits for the next negative pressure.

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MEDICAL ELECTRONIC DEVICES CORP.

The DOCD contains an alarm package which is designed to alert the user in the event of disconnection or restriction of the cannula or unit malfunction. The DOCD will produce an audible alarm tone to alert the user if it has not detected sufficient negative pressure to cause the comparator output to change states within 30 seconds. The DOCD will also produce an intermittent audible tone if the device's continuous self check routine has detected a malfunction in the microprocessor or software control code.

The DOCD is substantially equivalent in intended use and principal of operation to other oxygen conserving devices including the Invacare IPD Oxygen Conserving Device (K953852) and the CHAD Therapeutics Oxymatic Electronic Oxygen Conserver (K852650). These predicate devices, like the DOCD, are electronic products that use a breath sensor and normally closed valve. Additionally, the Invacare IPD Oxygen Conserving Device, like the DOCD, opens the valve for 1 second and delivers the oxygen flow set on the regulator to the patient on every detected inhalation.

Performance Data

Extensive functional testing of the DOCD 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 quidelines.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is aligned to the left. The text is likely part of a document or letterhead from a government agency.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Thomas Wenzel Medical Electronic Devices Corp. 2807 Oregon Court D6 Torrance, CA 90503

Re: K983601

Demand Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB

Dear Mr. Wenzel:

This letter corrects our substantially equivalent letter of December 15, 1998, regarding the Demand Oxygen Conserving Machine. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.

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. Thomas Wenzel

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Dana Telh

for Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Medical Electronic Devices Corp. Medical Lieban Conserving Device 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 DOC Demand Oxygen Conserving Device is indicated for use to conserve
s and The DOC Demand Oxygen Conserving Device is indicated for as on the lossess.
oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and oxygen for paliente procente oxygen.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

and Neurological Devices

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(Division Sign-Off) Division of Cardiovascular, Respiratory,

510(k) Number _

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(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).