(116 days)
Not Found
No
The description focuses on the physical and pneumatic components of the oxygen generator, such as compressors, sieve beds, valves, and filters. There is no mention of AI, ML, or any software-based decision-making or learning capabilities. The pulse dose mode is described as a response to breath demand, which is a standard physiological trigger, not an AI/ML algorithm.
Yes
The device is an oxygen concentrator intended to deliver supplemental oxygen to patients. Oxygen therapy is a recognized medical treatment for various conditions, which classifies this device as therapeutic.
No
This device is an oxygen concentrator that provides supplemental oxygen. The "Intended Use" explicitly states, "The device is not intended for life support, nor does it provide any patient monitoring capabilities." This indicates it does not diagnose medical conditions. Its function is to deliver oxygen based on a physician's prescription, which is a therapeutic rather than a diagnostic action.
No
The device description explicitly lists numerous hardware components including a compressor, pressure vessel, sieve beds, batteries, filters, valves, and a touch control pad. The performance studies also focus on the physical and electrical characteristics of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The 2300 Series mGO Portable Oxygen Generator is a medical device that delivers supplemental oxygen to a patient. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it's for providing supplemental oxygen through a nasal cannula.
- Device Description: The description details the process of generating oxygen from ambient air and delivering it to the patient. There is no mention of analyzing patient samples.
The device is a therapeutic device used for respiratory support, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The 2300 Series mGO Portable Oxygen Generalor is 1-3 l./min continuous flow (1-6 l./min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based in molecular sieve technology. The patient the oxygen through a nasal cannula.
The device is not intended for life support, nor does it provide any patient monitoring capabilities.
The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.
A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow serings should be adjusted only under the direction of a Physician.
WARNING: Federal Law restricts this device to sale by or on order of a Physician
Product codes
CAW
Device Description
The 2300 Series mGO Portable Oxygen Generator delivers supplementary oxygen to casualties and patients at the point of need, eliminating the need for oxygen cylinders. It is designed to function in harsh environments for military users and agencies engaged in humanitarian and relief operations.
The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32. The 2300 Series mGO can deliver oxygen at flow rates between 1 and 3 litres per minute (L/min), continuous flow, or, in pulse dose mode, an oxygen bolus of up to 84 millilitres (ml) (14 ml multiplied by the setting value, maximum of 6) equivalent to a continuous flow of 6 L/min in response to breath demand. This is termed Pulse Oximetry.
The 2300 Series mGO is based on the pressure swing adsorption (PSA) principle. The 2300 Series mGQ delivers supplemental oxygen for patients through molecular sieve beds and is designed to conserve the use of oxygen in pulse dose mode. In pulse dose mode, oxygen is delivered to the patient through a pulse dose valve when a patient starts to inhale.
Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor.
A poppet-style solenoid valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases, while oxygen flows out of the sieve bed, thereby producing a highly enriched oxygen product. Simultaneously, in the second sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. The cycle continues by alternately swapping the absorption/desorption process from one sieve bed to the other, providing a flow of oxygen to a receiver and the patient through a bacteria filter.
The 2300 Series mGO consists of pneumatic and electrical components, a pressure and vacuum compressor, a pressure vessel, Synthetic Zeolite molecular sieve beds, two lithium ion batteries, dust separator and particulate inlet filter, valve assemblies, an outlet bacteria filter, electronic flow control, touch control pad, a cooling fan assembly, and audible/visual alarms.
The 2300 Series mGO operates from 100-240 Volts AC mains power, 24-28 Volts DC power or two removable rechargeable batteries. The 2300 Series mGO may be carried manually (weight
§ 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).
0
APR 2 5 20 1
Traditional 510(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator)
Section 5
510(k) Summary
| Written By | Title | Signature | Date |
|---|---|---|---|
| Callum Berryman | Mechanical Engineer | 24 April 2014 |
| Approval | |||
|---|---|---|---|
| Approved By | Title / Department | Signature | Date |
| A.N. Chilton | New Products Manager | 24 April 2014 | |
| John Evans | Quality Engineer / Quality | ||
| Assurance Department | 24 April 2014 |
| Revision History | ||
|---|---|---|
| Document | ||
| Version | Reason for Update | Date |
| 01 | Official issue | 23rd |
| December | ||
| 2013 | ||
| 02 | paras 5.1.3 & 5.1.5 amended; | |
| additional predicate device reference added | ||
| ("SAROS 3000, K083163") | 24th April 2014 |
Traditional 510(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator), Section 5: 510(k) Summary
Document Version - 02 Date - 24 April 2014
Page 1 of 12
1
5 Scope
This document details the 510(k) Summary for the 2300 Series mGO Portable Oxygen Generator (Concentrator) and constitutes part of Ultra Electronics Precision Air & Land System's Traditional 510(k) submission.
There have been no prior submissions for the 2300 Series mGO Portable Oxygen Generator (Concentrator).
5.1 510(k) Summary
This 510(k) summary has been prepared in accordance with the requirements of 21 CFR Part 807, Section 807.92 Content and Format of a 510(k) Summary. Responses to 807.92 (a) sections (1) to (6) and 807.92 (b) sections (1) to (3) are detailed below:
5.1.1 Submitter's Information
| Submitter's
Name | Ultra Electronics Limited Precision Air & Land
Systems |
|--------------------------------|--------------------------------------------------------------------------|
| Submitter's
Address | Arle Court
Hatherley Lane
Cheltenham
GL51 6PN
United Kingdom |
| Telephone
Number | Phone: 44 (0) 1242 221166 (Switchboard)
Fax: 44 (0) 1242 221167 |
| Contact Person | Alistair Barker
Alistair. Barker@ultra-pals.com |
| Summary
Preparation
Date | 24 April 2014 (Issue 2) |
5.1.2 Product Information
| Proprietary Name: | 2300 Series mGO Portable Oxygen
Generator (Concentrator) |
|---------------------------|-------------------------------------------------------------|
| Common Name: | 2300 Series mGO |
| Classification of Device: | Portable Oxygen Generator |
| | Class II |
| Classification Panel | Anesthesiology |
| CFR Regulation Number | 21 CFR 868.5440 |
| Panel Code | CAW |
Traditional 510(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator), Section 5: 510(k) Summary
Document Version - 02 Date – 24 April 2014
2
5.1.3 Predicate Device(s)
Ultra Electronics Limited Precision Air & Land Systems claims equivalence to the following legally marketed predicate device:
| Company Name | DeVilbiss Healthcare |
|---|---|
| Trade Name | iGO Portable Oxygen Generator |
| Model Number | 306 Series |
| Contact Name | Joseph E. Olsavsky |
| 510(k) Number | K081468 |
The 2300 Series mGO Portable Oxygen Generator is a ruggedized development of the 306 Series iGO Portable Oxygen Generator that uses many components common with the 306 Series iGO. The 2300 Series mGO Portable Oxygen Generator has been created with the full co-operation and support of DeVilbiss Healthcare.
Ultra Electronics Limited Precision Air & Land Systems claims equivalence to a second legally marketed predicate device, cleared to operate in a similar environment, as follows:
| Company Name | SeQual Technologies Inc. |
|---|---|
| Trade Name | SAROS 3000 |
| (aka OMNI 2 Oxygen System) | |
| Model Number | OMNI 2 |
| Contact Name | Brian Jarrell |
| 510(k) Number | K083163 (Oct 20 2009) |
5.1.4 Description
The 2300 Series mGO Portable Oxygen Generator delivers supplementary oxygen to casualties and patients at the point of need, eliminating the need for oxygen cylinders. It is designed to function in harsh environments for military users and agencies engaged in humanitarian and relief operations.
The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32. The 2300 Series mGO can deliver oxygen at flow rates between 1 and 3 litres per minute (L/min), continuous flow, or, in pulse dose mode, an oxygen bolus of up to 84 millilitres (ml) (14 ml multiplied by the setting value, maximum of 6) equivalent to a continuous flow of 6 L/min in response to breath demand. This is termed Pulse Oximetry.
Traditional 510(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator), Section 5: 510(k) Summary
Document Version - 02 Date - 24 April 2014
Page 3 of 12
3
The 2300 Series mGO is based on the pressure swing adsorption (PSA) principle. The 2300 Series mGQ delivers supplemental oxygen for patients through molecular sieve beds and is designed to conserve the use of oxygen in pulse dose mode. In pulse dose mode, oxygen is delivered to the patient through a pulse dose valve when a patient starts to inhale.
Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor.
A poppet-style solenoid valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases, while oxygen flows out of the sieve bed, thereby producing a highly enriched oxygen product. Simultaneously, in the second sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. The cycle continues by alternately swapping the absorption/desorption process from one sieve bed to the other, providing a flow of oxygen to a receiver and the patient through a bacteria filter.
The 2300 Series mGO consists of pneumatic and electrical components, a pressure and vacuum compressor, a pressure vessel, Synthetic Zeolite molecular sieve beds, two lithium ion batteries, dust separator and particulate inlet filter, valve assemblies, an outlet bacteria filter, electronic flow control, touch control pad, a cooling fan assembly, and audible/visual alarms.
The 2300 Series mGO operates from 100-240 Volts AC mains power, 24-28 Volts DC power or two removable rechargeable batteries. The 2300 Series mGO may be carried manually (weight Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@lda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (9/13)
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