The Omni-5 Total O2 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.

Device Description

The Omni 5 Total O2 Delivery System is comprised of conventional pressure adsorption technology which supplies low pressure oxygen to a nasal cannula and/or an intensifier which compresses a small portion of the gas to pressures up to 2015 psig in an oxygen gas cylinder for ambulatory use. The Omni 5 Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily and safely connected to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O₂ oxygen cylinders can only be filled through the unique fill port with the Total O₂ Delivery System. The original Total O2 Delivery System allowed for continuous oxygen flows and settings from 0 - 3 liters per minute, the modified Total O2 Delivery System (Omni 5 Total O2 Delivery System) allows for continuous oxygen flows and settings from 0 - 5 liters per minute. Additionally, the Omni 5 Total O2 Delivery System incorporates an automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted).

AI/ML Overview

The provided document is a 510(k) summary for the "Respironics Omni 5 Total O2 Delivery System." This is a premarket notification for a medical device modification, not a study evaluating an AI algorithm or a diagnostic tool. Therefore, much of the requested information, such as acceptance criteria for AI performance metrics, sample sizes for test sets in an AI context, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, is not applicable to this type of regulatory submission.

The document focuses on demonstrating substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a legally marketed device. This is achieved through design verification tests and a comparison of technological characteristics.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Design verification tests were performed on the Respironics Omni 5 Total O2 Delivery System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the specific quantitative acceptance criteria and the detailed test results are not provided in this summary. The summary focuses on the modifications and their impact rather than a complete performance study for a novel device.

The key modifications and their implied performance improvements are:

Acceptance Criteria (Implied)	Reported Device Performance
Modification #1: Continuous oxygen flow range (0-5 lpm)	Allows continuous oxygen flows and settings from 0 - 5 liters per minute (upgraded from 0-3 lpm)
Modification #2: Automatic cylinder filling restart function	Incorporates an automatic cylinder filling restart feature when oxygen purity recovers above acceptable limits.
Overall Safety and Effectiveness	Device is concluded to be safe and effective for its intended use.
Compliance with Predicate Device's Safety & Effectiveness	Substantially equivalent to the predicate device (Total O2 Delivery System, K013472).

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

This is not applicable as this is a device modification submission, not a study on an AI algorithm's performance on a dataset. The "test set" refers to design verification tests performed on the physical device and its software, not a dataset of medical images or patient information.
The document mentions "Design verification tests," which implies physical and functional testing of the device itself.
No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not relevant to this type of device submission.

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

This is not applicable. The "ground truth" for a physical device's performance against design requirements is established through engineering specifications, standards compliance, and measurement instruments, not expert consensus on medical data.

4. Adjudication method for the test set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI, where the effectiveness of human readers with and without AI assistance is compared. The device in question is an oxygen delivery system, not a diagnostic tool.

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

This question is based on the premise of an AI algorithm. The device, while containing software, is a physical medical device. The software modifications are for control and functionality (like automatic restart), not for independent diagnostic or predictive tasks that would typically constitute "standalone algorithm performance" in the context of an AI submission.
"Software verification and validation" were conducted, which assesses the software's performance against its requirements, but not in a "standalone algorithm" sense as applied to diagnostic AI.

7. The type of ground truth used:

For the hardware modifications (e.g., flow rate), the ground truth would be established by direct measurement using calibrated equipment against engineering specifications.
For software modifications (e.g., automatic restart), the ground truth would be established by testing the software's logic and behavior against its functional requirements and design specifications, simulating conditions where purity falls/recovers.
This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm developed through machine learning on a training set of data.

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

Not applicable for the reasons stated above.

In Summary:

The provided document describes a 510(k) submission for a modification to a portable oxygen generator. The device's acceptance criteria are based on its mechanical performance, safety, and functionality, as demonstrated through design verification tests and comparison to a predicate device. The information requested regarding AI particularities (test set sample size, expert ground truth, MRMC, training sets) is not relevant to this type of medical device regulatory filing.

Summary

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JUL 2 3 2009

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Official Contact

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

724-387-4120 724-387-7490 (fax) Email: Zita.Yurko@Respironics.com

Classification Reference 21 CFR 868 5440

CAW - Portable Oxygen Generator Product Code

Common/Usual Name Portable Oxygen Generator

Proprietary Name Respironics Omni 5 Total O2 Delivery System

Chad Therapeutics Total O2 Delivery System (K013472/K971889) Predicate Device(s)

Reason for submission

Modified design.

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Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate device:

O Same intended use.
D Same operating principle.
O Same technology.
D Same manufacturing process.

Design verification tests were performed on the Respironics Omni 5 Total O2 Delivery System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2005.

Predicate Device Equivalence:

Substantial equivalence is claimed to the Total O2 Delivery System, cleared for commercial distribution per K013472.

Device Description

The Omni 5 Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O- Delivery System has been designed to reduce the need for bulk storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen tanks. The Ornni 5 Total O2 Delivery System is comprised of conventional pressure adsorption technology which supplies low pressure oxygen to a nasal cannula and/or an intensifier which compresses a small portion of the gas to pressures up to 2015 psig in an oxygen gas cylinder for ambulatory use.

The Omni 5 Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily and safely connected to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O₂ oxygen cylinders can o̲nly be filled through the unique fill port with the Total O₂ Delivery System.

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The original Total O2 Delivery System allowed for continuous oxygen flows and settings from 0 - 3 liters per minute, the modified Total O2 Delivery System (Omni 5 Total O2 Delivery System) allows for continuous oxygen flows and settings from 0 - 5 liters per minute. Additionally, the Omni 5 Total O2 Delivery System incorporates an automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted).

Indications for Use:

Intended Use:

The oxygen supplied by the Omni 5 Total O2 Delivery System is supplemental and is not considered to be life supporting and not intended to be used with air or any life support applications or in the presence of flammable anesthetics. Geriatric, pediatic or other patients unable to communicate discomfort may require additional monitoring as with the case with oxygen concentrators currently in use. The device is not sold sterile or intended to be sterilized.

. Comparison of Technological Characteristics:

The Omni 5 Total O2 Delivery System has the same technological characteristics as the predicate device.

The hardware portions of the device are identical except for the following:

The continuous oxygen outlet flow meter has changed from 0 3 liters per minute to 0 5 liters per t minute (Modification #1 in the submittal).
The software was modified to include:
. An automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted) (Modification #2 in the submittal).

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Summary of Testing:

Performance, mechanical, electromagnetic compatibility, environmental testing and software verification and validation were conducted to demonstrate that the Omni 5 Total O2 Delivery System would perform as intended.

Conclusions:

Based on the above, we concluded that the Omni 5 Total O2 Delivery System is substantially equivalent to the Total O₂ Delivery System and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Director of Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

JUL 2 3 2009

Re: K091028

Trade/Device Name: Respironics Omni 5 Total O2 Delivery System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 19, 2009 Received: June 22, 2009

Dear Ms. Yurko:

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 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. Yurko

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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for.

Susan Runner, D.D.S., M.A. Acting 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): K091028

Device Name: Respironics Omni 5 Total O2 Delivery System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schalter

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

510(k) Number: K091028

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).