The modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device is intended for use in the same manner as the unmodified device, i.e., to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

Device Description

The Medical Electronic Devices Corp. POCDFR 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 POCDEe is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. It delivers boluses of oxygen every breath that is equivalent to 1 to 4 liters per minute constant flow, depending on the flow setting.

AI/ML Overview

The provided text describes a Special 510(k) submission for a modified Pulsed Oxygen Conserving Device (POCDEB). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device that requires extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable in this context. The document primarily discusses device modifications and functional equivalence.

Here's a breakdown of the relevant information from the provided text, addressing the requested points where possible, and noting where information is not available or not applicable given the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This kind of table is not present in the document because the submission is for a modification of an existing device (POCD) and primarily claims substantial equivalence based on technological characteristics and functional testing, not on clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

The key "performance" aspect is that the modified software delivers oxygen on every breath, similar to another predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Technological Equivalence: Same technological characteristics as predicate device (POCD) except for software modification.	Hardware portion is identical to POCD except for labeling. Software modified to deliver a bolus of oxygen on every breath.
Dosing Algorithm Equivalence: New dosing algorithm should be identical to another predicate device's algorithm.	New dosing algorithm is identical to the algorithm used in the predicate device CHAD Therapeutics OXYMATIC Model 311.
Intended Use Equivalence: Performs as intended for oxygen conservation in patients prescribed 1 to 4 LPM supplemental oxygen using nasal cannulas and USP bottled oxygen.	"Appropriate performance, mechanical, electromagnetic and environmental testing was performed to demonstrate that the POCDEB would perform as intended."
Safety and Effectiveness: Safe and effective for its intended use.	"Based on the above, we concluded that the POCDEB is substantially equivalent to currently marketed devices and is safe and effective for its intended use."

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

Not applicable. This submission concerns a physical device modification, not an AI/ML algorithm requiring a test set of data for performance evaluation in the way a diagnostic device would. There is no mention of a "test set" in the context of data. The "testing" mentioned refers to functional, mechanical, electromagnetic, and environmental testing of the device itself.

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

Not applicable. There is no "ground truth" established by experts in the context of diagnostic data for this device. The evaluation is based on device functionality and equivalence to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of data requiring an adjudication method.

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 not an AI/ML diagnostic or assistive device. It is an oxygen conserver, and no MRMC study was performed or needed for this type of submission.

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

Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. The "algorithm" here refers to the device's dosing mechanism, which is embedded in its function.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" in the context of clinical outcomes, pathology, or expert consensus on diagnostic images is not relevant to this device's submission. The "truth" here is established by demonstrating that the device functions as described and is equivalent to predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model being trained with a dataset, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

Summary

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MED Corporation

OCT 2 5 2002

Special 510(K)

510(K) Summary

Medical Electronic Devices Corporation

Modified Medical Electronic Devices Corporation POCD Pulsed Oxygen Conserving Device

October 2, 2002

Submitter Information:

Medical Electronic Devices Corporation 2807 Oregon Court, D6 Torrance, California 90503

Submitter's Name:	Thomas Wenzel
Phone:	(310) 618-0306

Device Name:

Proprietary Name:	Medical Electronic Devices Corporation POCD EB
Common Name:	Oxygen Conserver
Classification Name:	Noncontinuous Ventilator

Predicate Device Equivalence:

Substantial equivalence is claimed to the Medical Electronic Devices Corporation unmodified POCD cleared for commercial distribution per K983459 and the CHAD Therapeutics OXYMATIC Model 311.

Device Description:

Intended Use:

The Medical Electronic Devices Corp. POCDEs is intended for to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.

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Comparison of Technological Characteristics:

The POCDEB has the same technological characteristics as the predicate device, i.e. the POCD. The hardware portion of the device is identical to the POCD except for labeling. The software has been modified to deliver a bolus of oxygen on every breath, rather than skipping breaths at lower flow rates. This dosing algorithm is identical to the algorithm used in the predicate device CHAD Therapeutics OXYMATIC Model 311.

Summary of Testing:

Appropriate performance, mechanical, electromagnetic and environmental testing was performed to demonstrate that the POCDEB would perform as intended.

Conclusions:

Based on the above, we concluded that the POCDEs is substantially equivalent to currently marketed devices and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2002

Mr. Thomas Wenzel President Medical Electronic Devices Corporation 2807 Oregon Court, D6 Torrance, California 90503

Re: K023420

Trade/Device Name: Pulsed Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: 73 NFB Dated: October 10, 2002 Received: October 11, 2002

Dear Mr. Wenzel:

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.

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.

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Page 2 - Mr. Wenzel - -

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) 594-4646. 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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MED Corporation

Medical Electronic Devices Corporation POCDEB Premarket Notification

Indications for Use Statement

K02켜.20

Device Name:

Modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device (i.e. POCDEB)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Richardson

sion Sign-Off) Division of Anesthesiology. General Hospital. Infection Control, Dental Devices

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).