(224 days)
The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.
The Inogen Satellite Conserver intended to be used as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses the Inogen One Oxygen Concentrator as its oxygen supply and is connected by an oxygen supply tube. The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. Upon detecting the beginning of inhalation, the device delivers a bolus of oxygen that is equivalent in most users to 1 to 5 liters per minute constant flow, depending on the flow setting.
This 510(k) premarket notification for the Inogen Satellite Conserver does not contain the results of a study with acceptance criteria and device performance.
The document is a submission to the FDA claiming substantial equivalence to predicate devices (Medical Electronic Devices Corporation unmodified POCD and the Airsep Lifestyle Oxygen Concentrator). The content focuses on:
- Device Description: The Inogen Satellite Conserver is an accessory to an oxygen concentrator, designed to conserve oxygen by delivering a bolus during inhalation. It's microprocessor-controlled with a breath sensor and valve.
- Technological Characteristics: Claims identical electronic circuitry to a predicate, with software modifications to control the valve for oxygen bolus delivery. The dosing algorithm is stated to be identical to another predicate device.
- Summary of Testing: A statement is made that "Appropriate performance, mechanical, and electrical testing was performed to demonstrate that the Inogen Satellite Conserver would perform as intended." However, no specific acceptance criteria or detailed results of these tests are provided in this document.
- Conclusion: Based on the above, the manufacturer concludes the device is substantially equivalent to marketed devices and is safe and effective.
- FDA Response: The FDA's letter acknowledges receipt and review, confirming substantial equivalence based on the provided information, but does not detail the specific testing or acceptance criteria.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details. This document is a regulatory submission, not a study report.
§ 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).