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The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or travel environments.
The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

The Delphi Portable Oxygen Concentrator is lightweight and can deliver ≥ 87% oxygen to a patient through a standard single-lumen nasal cannula. The device detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period.
The device can be set to deliver flowrates between 1-5 LPM with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.
The Delphi Portable Oxygen Concentrator (POC) uses Pressure Swing Adsorption technology to deliver concentrated oxygen. A series of chambers and valves allows pressurized air to enter the sieve bed assembly, effectively separating nitrogen from the air. When one chamber is receiving pressurized air, the other is purging nitrogen back into the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in a chamber to be delivered to a patient when the device detects a patient breath.

The provided text describes a 510(k) summary for the Delphi Portable Oxygen Concentrator, but it does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The document primarily focuses on:

• Administrative details: Submitter information, contact, date prepared, device name, classification, and predicate device.
• Intended Use Statement: "The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or travel environments."
• Device Description: Lightweight, delivers ≥ 87% oxygen, detects patient breath, delivers oxygen bolus during inhalation, flow rates 1-5 LPM (0.5 LPM increments), powered by AC/DC or DC automotive adaptor, and includes a rechargeable battery.
• Indications for Use Statement: "The POC is a prescription only device and not intended for life-supporting or life-sustaining. The users of the Delphi Portable Oxygen Concentrator are adults requiring oxygen therapy to treat conditions such as COPD. The POC is designed to enable its users to be more mobile in their daily activities both indoors and outdoors."
• Technological Characteristics: Uses Pressure Swing Adsorption technology to separate nitrogen from air, concentrates oxygen, and stores it for delivery upon patient breath detection.
• FDA Premarket Notification Letter: Confirming substantial equivalence to a predicate device.

To answer your request, I would need a section of the 510(k) submission or a related document that details performance testing results, acceptance criteria, and study methodology.

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