K Number
K131016
Device Name
ROGS
Date Cleared
2013-11-27

(230 days)

Product Code
Regulation Number
868.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).
Device Description
The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
More Information

No
The device description and performance studies focus on chemical and mechanical properties, with no mention of AI or ML.

Yes
The device is intended to produce oxygen for emergency use, which addresses a physiological need, classifying it as a therapeutic device.

No
The device is described as an oxygen generator for emergency use, and its performance metrics relate to oxygen production, flow rate, and temperature, not to the diagnosis of a medical condition.

No

The device description clearly states it is a "chemical based portable oxygen generator" and describes physical components and performance testing related to hardware (temperature, flow rate, mechanical testing).

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
  • Device Function: The device described is an oxygen generator. Its function is to produce oxygen for breathing, which is a therapeutic intervention, not a diagnostic test performed on a sample.
  • Intended Use: The intended use is to "produce oxygen for emergency use," which is a direct treatment or support function, not a diagnostic one.
  • Device Description: The description focuses on the generation and delivery of oxygen, not on analyzing biological samples.
  • Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.

Therefore, based on the provided information, this device clearly falls outside the definition and scope of an In Vitro Diagnostic. It is a therapeutic or life-support device.

N/A

Intended Use / Indications for Use

Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).

Product codes

CAW

Device Description

The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via 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

Environment of Use Emergency - OTC - home and emergency settings

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)

Performance testing was performed:

  • . VOC / PM 2.5 / Ozone
  • Environmental testing high and low temperature conditions .
  • . Mechanical testing - vibration
  • Flow rate and flow duration ●
  • . External container temperature
  • Outlet gas temperature ●
  • % oxygen generated .

The proposed device met and passed all the performance testing as outlined above.

Non-clinical Performance Testing -
The ROGS for Emergency Use - OTC has the minimum performance specifications required to meet emergency use, which are - at least a flow rate of 6 lpm for at least 15 minutes. This is identical to the predicate - K062153.

We performed the following bench tests:

  • . VOC / PM 25 / Ozone
  • Environmental testing high and low temperature conditions .
  • . Mechanical testing - vibration
  • Flow rate and flow duration .
  • External container temperature .
  • Outlet gas temperature .
  • % oxygen generated .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062153

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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 Page 1 of 3 25-Nov-13

MOLECULAR PRODUCTS LTD Parkway, Harlow Business Park Harlow, UNITED KINGDOM CM19 5FR

Tel - 011 44 1279 401200 Fax - 011 44 1279 401231

NOV 27 2013

Official Contact:Dr. Mandy Humphreys, Technical Director
Proprietary or Trade Name:ROGS
Common/Usual Name:Portable oxygen generator
Classification Name:Portable Oxygen Generator
CAW – 868.5440
Class 2
Predicate Devices:Molecular Products - POGS - K062153

Device Description

The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.

Indications for Use

Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).

Environment of Use Emergency - OTC - home and emergency settings

Performance Testing

Performance testing was performed:

  • . VOC / PM 2.5 / Ozone
  • Environmental testing high and low temperature conditions .
  • . Mechanical testing - vibration
  • Flow rate and flow duration ●
  • . External container temperature
  • Outlet gas temperature ●
  • % oxygen generated .

The proposed device met and passed all the performance testing as outlined above.

1

510(k) Summary Page 2 of 3 25-Nov-13

Comparative Table - OTC - Emergency Use

| Features | Predicate
Molecular Products
POGS K062153 | Proposed Device
ROGS
OTC - Emergency Use |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Indications for use | To produce oxygen for emergency
use | To produce oxygen for emergency
use |
| Environment of Use | Home, emergency locations | Home, emergency locations |
| Patient Population | Any individual | Any individual |
| Contraindications | None | None |
| Method for oxygen generation | Chemical reaction | Chemical reaction |
| Patient interface | Standard oxygen mask or nasal
cannula | Standard oxygen mask or nasal
cannula |
| Specifications | % Oxygen - 99%
Flow rate minimum - 6 lpm
Duration at least 15 minutes
Initiation of oxygen flow - 60 secs | % Oxygen - 99%
Flow rate minimum - 6 lpm
Duration at least 15 minutes
Initiation of oxygen flow - 5 secs |
| Single use, disposable | Yes | Yes |
| OTC designation | Yes | Yes |
| Flow rate | > 6 lpm | > 6 lpm |
| Duration of flow | At least 15 minutes | At least 15 minutes |
| % oxygen purity | >99% | > 99% |
| VOC / PM2.5 testing | Yes | Yes |
| Housing temperature |