(117 days)
Not Found
No
The summary describes a chemical-based oxygen generator with no mention of AI or ML technology.
Yes
The device is intended to produce oxygen for emergency use, which addresses a medical need and thus qualifies as a therapeutic function.
No
The device is described as an oxygen generator for emergency use, producing oxygen for at least 15 minutes. It does not perform any diagnostic functions like detecting, monitoring, or analyzing health conditions.
No
The device description clearly states it is a "chemical based portable oxygen generator" and a "self-contained device," indicating it is a hardware device that produces oxygen.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce oxygen for emergency use". This is a therapeutic or life-support function, not a diagnostic one.
- Device Description: The device generates oxygen for breathing. This is a direct intervention on the patient, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended to provide oxygen directly to a patient, which falls under the category of a medical device for therapeutic or life-support purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.
Product codes
CAW
Device Description
The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Any individual
Intended User / Care Setting
Any environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Test flow rate: 6 Lpm
Duration: At least 15 minutes
% Oxygen: 99%
External canister temperature:
§ 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
510(k) Summary 5
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 25-Jul-06
| Molecular Products Ltd.
Mill End
Thaxted, Essex CM6 2LT UK | Tel -- 011-44-1371-830676
Fax - 011-44-1371-830998 | | NOV 21 2006 |
|------------------------------------------------------------------|-------------------------------------------------------|--|-------------|
| Official Contact: | Mandy Crudace, PhD, Technical Manager | | |
| Proprietary or Trade Name: | POG | | |
| Common/Usual Name: | Portable oxygen generator | | |
| Classification Name: | Portable oxygen generator | | |
| Device: | POG | | |
| Predicate Devices: | OxySure Systems - OxySure - K052396 | | |
| Device Description: | | | |
The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
| Indications for Use: | |
|---|---|
| Indicated Use -- | Intended to produce oxygen for emergency use. |
| Patient Population -- | Any individual |
| Environment of Use -- | Any environment |
| Contraindications -- | None |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 25-Jul-06
Device Attributes:
| Over-the-counter (OTC) | Yes |
|---|---|
| ------------------------ | ----- |
Design
| Dry chemical based technology | Yes |
|---|---|
| Portable | Yes |
Testing
| Test flow rate | 6 Lpm |
|---|---|
| Duration | At least 15 minutes |
| % Oxygen | 99% |
| External canister temperature |