ROGS

K131016 · Molecular Products , Ltd. · CAW · Nov 27, 2013 · Anesthesiology

Device Facts

• Record ID: K131016
• Device Name: ROGS
• Applicant: Molecular Products , Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ROGS is a self-contained, single-use, disposable chemical-based portable oxygen generator. Device operates via solid chemical reaction initiated by a starter; produces 99% pure oxygen at minimum 6 lpm flow rate for at least 15 minutes. Oxygen is delivered to the patient via standard oxygen face mask or nasal cannula. Intended for OTC emergency use in home or emergency settings by any individual. Device provides immediate oxygen supply (5-second initiation time) to assist patients during respiratory emergencies. Benefits include rapid, portable access to supplemental oxygen without external power or complex setup.

Clinical Evidence

Bench testing only. Testing included VOC/PM2.5/Ozone emissions, environmental stress (high/low temperature), mechanical vibration, flow rate/duration, external container temperature, outlet gas temperature, and oxygen purity. Results confirmed the device meets performance specifications.

Technological Characteristics

Chemical-based oxygen generator; solid chemical reactant; manual starter ignition. Dimensions: 28.5 cm x 11.5 cm; weight: 1.5 kg. Operating temperature: 0° to +40°C. Storage temperature: -20° to +40°C. Gas output: >99% purity, >6 lpm flow. Safety features: housing temperature <45°C, outlet gas temperature <40°C. No software or electronic components.

Indications for Use

Indicated for any individual requiring oxygen in an emergency setting. No contraindications.

Regulatory Classification

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).

Predicate Devices

• Molecular Products - POGS - K062153

Submission Summary (Full Text)

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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<br>CAW – 868.5440<br>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.

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

# Comparative Table - OTC - Emergency Use

| Features | Predicate<br>Molecular Products<br>POGS K062153 | Proposed Device<br>ROGS<br>OTC - Emergency Use |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Indications for use | To produce oxygen for emergency<br>use | To produce oxygen for emergency<br>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<br>cannula | Standard oxygen mask or nasal<br>cannula |
| Specifications | % Oxygen - 99%<br>Flow rate minimum - 6 lpm<br>Duration at least 15 minutes<br>Initiation of oxygen flow - 60 secs | % Oxygen - 99%<br>Flow rate minimum - 6 lpm<br>Duration at least 15 minutes<br>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 | <45°C Maximum | <45°C Maximum |
| Temperature of gas at outlet | <40°C Maximum | <40°C Maximum |
| Time to start of gas flow | 60 seconds | 5 seconds |
| Storage temperatures | -20° to + 40°C / -4° to +104°F | -20° to + 40°C / -4° to +104°F |
| Operating Temperatures | 0° to + 40°C / 32° to +104°F | 0° to + 40°C / 32° to +104°F |
| Dimensions | 35 cm x 10 cm | 28.5 cm x 11.5 cm |
| Gross weight | 1.8 kg | 1.5 kg |
| Accessories | Mask or Oxygen cannula | Mask or Oxygen cannula |

# OTC - Emergency Use Substantial Equivalence

The ROGS for Emergency Use - OTC is viewed as substantially equivalent to the predicate device because:

### Indications for Use -

The ROGS for Emergency Use - OTC has the identical indications for use as the predicate -K062153, namely for emergency use which permits it to be labeled OTC. Discussion - The indications for use are identical to the predicate - K062153.

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

#### Technology -

The ROGS for Emergency Use - OTC utilizes solid chemicals which are ignited when the starter is activated. There is a chemical reaction which generates oxygen. The chemical used in the chemical reaction to generate oxygen are identical technology to predicate - K062153. Discussion - The technology and mode of operation is identical to the predicate - K062153.

#### Materials -

The materials in the gas pathway have been tested via VOC and PM2 as is expected for such devices. The test results demonstrate that the ROGS for Emergency Use - OTC does not generate unwanted particulate matter or undesirable gases. This is similar to the predicate - K062153. Discussion - The materials are identical to the predicate - K062153.

#### Environment of Use -

The ROGS for Emergency Use - OTC has the identical environments of use. i.e. home and emergency settings, as does the predicate - K062153. Discussion - The environment of Use is identical to the predicate - K062153.

#### Patient Population -

The patient population is specified as "any individual" by the predicate in the 510(k) Summary but the intended use is for individuals requiring oxygen in an emergency setting. Discussion - The patient population is identical to the predicate - K062153.

### 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 .

## Substantial Equivalence Conclusion -

The Molecular Products ROGS for Emergency Use - OTC is equivalent to the predicate, K062153, based upon performance specifications and testing and the FDA Guidance requirements.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 27, 2013

Molecular Products, Limited C/O Mr. Paul Dryden Consultant 24301 Woodsage Dr. Bonita Springs, FL 34134

Re: K131016

Trade/Device Name: ROGS Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 29, 2013 Received: October 30, 2013

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/4/Picture/7 description: The image shows the word "ErifDXAith" in a bold, sans-serif font. The letters "Eri" and "ith" are in a standard font, while the letters "FDXA" are stylized with a geometric, blocky design. The overall image has a high contrast, with black text on a white background.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K131016

#### Device Name

ROGS portable oxygen generator - Emergency - OTC

#### Indications for Use (Describe)

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013

See PRA Statement on last page.

Type of Use (Select one or both, as applicable) [x] Over-The-Counter Use (21 CFR 801 Subpart C) [ ] Prescription Use (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. MENN 200 YEAR OR FOR FOR ED FOR EDALUSE ONLY . ME 200 YOUR 2007 2000 . CON 7 200 Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) tally signed by Chan O. Lee -2013.11.27 11:19:46 -05'00'

FORM FDA 3881 (9/13)

PSC Publishing Sersion [phone]