The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Description

The SeQual Model Number 1000 OMNI Portable Oxygen Concentrator is a 3 Liter per minute (LPM) continuous flow and 6 LPM demand flow oxygen concentrator that is of the pressure swing adsorption (PSA) type. The OMNI Portable Oxygen Concentrator operates from AC power, DC power or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. The Model Number 1000, OMNI Portable Oxygen System consists of pneumatic and electrical components. The system has 5 major pneumatic components: inlet filtration, air compressor and heat exchanger, Synthetic Zeolite molecular sieve beds with a distribution valve module, outlet filtration, and flow delivery and measurement components. The electrical system consists of: motor controls, power sources for AC and DC power, rechargeable batteries, sensing systems to measure pressure, temperature, flow and oxygen concentration, and a software controlled user interface. The unit is double insulated and uses a two-conductor power cable. In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down. Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The document is a 510(k) premarket notification for the SeQual Model 1000 OMNI Portable Oxygen Concentrator. It aims to demonstrate substantial equivalence to previously marketed devices. However, it's important to note that this document does not detail specific acceptance criteria with numerical targets and corresponding measured device performance in a table format, nor does it describe a detailed clinical study with human subjects validating the device against specific ground truth.

Instead, the submission relies on technical specifications, bench testing, and comparison to predicate devices to assert substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Provides supplemental oxygen to patients.	Delivers supplemental oxygen.
Continuous flow: 3 Liters per minute (LPM).	Device Specification: "3 Liter per minute (LPM) continuous flow"
Demand flow: 6 Liters per minute (LPM).	Device Specification: "6 LPM demand flow oxygen concentrator"
Oxygen concentration: Greater than 90%.	Device Specification: "delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration." Testing: "Device monitoring circuits are included to measure oxygen concentration..." "The results of the oxygen concentration testing... will confirm that the device will meet the specifications..."
Operates from AC power.	Device Specification: "operates from AC power"
Operates from DC power.	Device Specification: "operates from DC power"
Operates from rechargeable batteries.	Device Specification: "operates... or rechargeable batteries." "The major changes to the device have been the reduction in the size of the molecular sieve tanks and the capability to operate on rechargeable batteries."
Incorporates molecular sieve beds for oxygen concentration.	Device Description: "delivers supplemental oxygen for patients through the molecular sieve beds" "Synthetic Zeolite molecular sieve beds with a distribution valve module"
Includes demand flow valve (similar to predicate).	Device Description: "designed to conserve the use of oxygen while operating in a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. This conserving feature is similar to the Sim Italia Travelair." "operates comparably to the SeQual Integra concentrators with the addition of a demand flow valve delivery system"
Not life-supporting nor life-sustaining.	Intended Use: "Oxygen concentrators are not life-supporting nor life sustaining devices." "The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities."
Activates visual and audio alarms in case of malfunction.	Device Monitoring: "In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down."
Device monitoring for oxygen concentration, flow rates, battery capacity, internal temperatures.	Device Monitoring: "Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures."
Conforms to ISO 8359 and ASTM F1464 standards.	Performance Data: "The results of the oxygen concentration testing and thorough series of testing, ISO 8359 and ASTM F1464 will confirm that the device will meet the specifications and will be substantially equivalent to the predicate devices."
Substantially equivalent to predicate devices.	Conclusion: "Based on the design, performance specifications, testing and intended use, the Model 1000, OMNI Portable Oxygen Concentrator will be substantially equivalent to the currently marketed devices."

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

Sample Size: Not specified. The document refers to "thorough series of testing" and "oxygen concentration testing" using the device itself, not a dataset of patient data.
Data Provenance: Not applicable. The testing appears to be primarily laboratory/bench testing of the device's technical specifications and electrical safety, not clinical data from patients.

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

Not applicable. Ground truth, in the context of clinical expert consensus for AI/diagnostic devices, is not relevant here as this is a physical medical device (oxygen concentrator) and the testing described is primarily bench testing for functionality and safety, not a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as there isn't a complex diagnostic outcome requiring multiple expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes technical testing of the device's physical and functional characteristics, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an oxygen concentrator, a physical medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and electrical design.

7. The Type of Ground Truth Used

Device Specifications and Industry Standards: The "ground truth" for this type of device and submission is implicitly its own stated technical specifications (e.g., flow rate, oxygen concentration) and adherence to recognized industry standards (ISO 8359, ASTM F1464).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model, 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.

Summary

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MAR 2 7 2002

510(k) Summary

Submitter Information:

Submitter:	SeQual Technologies, Inc.11436 Sorrento Valley RoadSan Diego, CA 92121
Contact:Phone:	Pam Jackson, Director of Portable Systems(858) 202-3100
FAX:	(858) 558-1915
Date of Summary:	November 1, 2001
Device Name:
Proprietary Name:Common Name:Classification of Device:	Model 1000 OMNI Portable Oxygen ConcentratorOxygen concentratorPortable Oxygen Generator (73 CAW) as per 21 CFR 868.5440

Predicate Device Equivalence:

SeQual Technologies is claiming substantial equivalence to the SeQual Technologies Model 6400-OM Oxygen Concentrators, 510(k) Number K003472 and the Sim Italia, Travelair Portable Oxygen Concentrator, 510(k) Number K963042.

Description of Device:

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Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen without a continuous source of liquid or gaseous purified oxygen. Oxygen concentrators are not life-supporting nor life sustaining devices. An oxygen concentrator is a device that draws in normal ambient room air, filters it and separates the nitrogen from the air under pressure, allowing only oxygen and trace gases to pass through to the oxygen outlet connection to the patient. The nitrogen enriched air is then exhausted back into the room. The air we encounter in nature is a mixture of roughly 78% nitrogen, 21% oxygen and 1% other trace gases..

The Model Number 1000, OMNI Portable Oxygen System consists of pneumatic and electrical components. The system has 5 major pneumatic components: inlet filtration, air compressor and heat exchanger, Synthetic Zeolite molecular sieve beds with a distribution valve module, outlet filtration, and flow delivery and measurement components. The electrical system consists of: motor controls, power sources for AC and DC power, rechargeable batteries, sensing systems to measure pressure, temperature, flow and oxygen concentration, and a software controlled user interface.

The unit is double insulated and uses a two-conductor power cable. In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down. Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures.

The major changes to the device have been the reduction in the size of the molecular sieve tanks and the capability to operate on rechargeable batteries.

Intended Use:

Oxygen concentrators are intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. The device delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration. It is used at a patients home or for their portable needs outside the home and can also be used in

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institutions such as nursing homes or sub-acute care facilities. Oxygen concentrators are not considered life supporting nor life sustaining. The device has no contraindications.

Technological Characteristics:

The Model 1000, OMNI Oxygen System operates comparably to the SeQual Integra concentrators with the addition of a demand flow valve delivery system and with the capability of being operated from various power sources, AC, DC and rechargeable batteries. The technology employed to generate the oxygen is well established, therefore, raises no new questions of safety and effectiveness. The technology has been used in the predicate devices as well as other legally marketed products.

Performance Data:

The results of the oxygen concentration testing and thorough series of testing, ISO 8359 and ASTM F1464 will confirm that the device will meet the specifications and will be substantially equivalent to the predicate devices.

Conclusion:

Based on the design, performance specifications, testing and intended use, the Model 1000, OMNI Portable Oxygen Concentrator will be substantially equivalent to the currently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Ms. Pamela J. Jackson Director, Quality and Regulatory Affairs SeQual Technologies, Inc. 11436 Sorrento Valley Road San Diego, CA 92121

Re: K013931

OMNI Oxygen System, Model 1000 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II (two) Product Code: 73 CAW Dated: March 18, 2002 Received: March 19, 2002

Dear Ms. Jackson:

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. Pamela J. Jackson

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) 594-4646. 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,

Elias Mallin

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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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Indications for Use Statement

Verl 3 - 4/24/96

Applicant: SeQual Technologies Inc.

510(k) Number (if known): ¥01393

Device Name: Omni Oxygen System

Indications For Use:

The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Prescription legend required.

Division of Cardiovascular & Respiratory Device Kci3931 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Elian Milles

Prescription Use x Emullis
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Int510k/induse

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).