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.

AI/ML Overview

The provided text describes the ROGS portable oxygen generator, a chemical-based device intended for emergency oxygen production. The acceptance criteria and the study proving it meets these criteria are outlined through a comparison to a predicate device (Molecular Products - POGS - K062153) and performance testing.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Predicate/Proposed Device)	Reported Device Performance (ROGS)
% Oxygen	99%	>99% generated
Flow Rate minimum	6 lpm	> 6 lpm
Duration of flow	At least 15 minutes	At least 15 minutes
Total Oxygen generated	90 liters (implied from 6 lpm for 15 minutes)	At least 90 liters (6 lpm for at least 15 minutes)
Time to start of gas flow	60 seconds (Predicate)	5 seconds
VOC / PM2.5 / Ozone	Yes (tested)	Met and passed criteria; does not generate unwanted particulate matter or undesirable gases
Environmental testing	High and low temperature conditions	Met and passed criteria (Storage: -20° to +40°C; Operating: 0° to +40°C)
Mechanical testing	Vibration	Met and passed criteria
External container temperature	<45°C Maximum	<45°C Maximum (Met and passed criteria)
Outlet gas temperature	<40°C Maximum	<40°C Maximum (Met and passed criteria)
Single use, disposable	Yes	Yes
OTC designation	Yes	Yes
Indications for Use	To produce oxygen for emergency use	Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters). Identical to predicate.
Environment of Use	Home, emergency locations	Home, emergency locations. Identical to predicate.
Patient Population	Any individual	Any individual requiring oxygen in an emergency setting. Identical to predicate.
Contraindications	None	None
Method for oxygen generation	Chemical reaction	Chemical reaction (solid chemicals ignited to generate oxygen). Identical technology to predicate.
Patient interface	Standard oxygen mask or nasal cannula	Standard oxygen mask or nasal cannula.
Materials	Tested for VOC and PM2.5	Materials in gas pathway tested via VOC and PM2; similar to predicate, demonstrating no unwanted particulate matter or undesirable gases.
Dimensions	35 cm x 10 cm (Predicate)	28.5 cm x 11.5 cm
Gross weight	1.8 kg (Predicate)	1.5 kg
Accessories	Mask or Oxygen cannula	Mask or Oxygen cannula

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a specific "sample size" for a test set in the traditional statistical sense for device performance. Instead, it mentions "Performance testing was performed" and lists various tests, implying that units of the ROGS device were tested against the specified parameters. The provenance of the data is retrospective, as the testing was performed and then summarized for the 510(k) submission. The country of origin for the device's manufacturer is the United Kingdom.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a portable oxygen generator, not a diagnostic or AI-driven decision support system that would require expert-established ground truth for a test set. The "ground truth" here is objective physical and chemical measurements (e.g., % oxygen purity, flow rate, temperature).

4. Adjudication Method for the Test Set:

Not applicable. Given the nature of the device (physical oxygen generator), the performance evaluation relies on direct measurement against predefined specifications, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks involving multiple human readers and imaging cases. The ROGS is a standalone physical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is not an algorithm-only device. It is a physical device where its performance is inherently "standalone" in the sense that its oxygen generation function operates independently of human intervention during its use, once activated. The performance testing described (flow rate, purity, temperature, etc.) represents the intrinsic performance of the device itself.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the ROGS device is objective physical and chemical measurements against engineering specifications and regulatory requirements. This includes metrics such as:

Percent oxygen generated
Flow rate (liters per minute)
Duration of flow
Temperature measurements (external container, outlet gas)
Presence of VOCs, PM2.5, and Ozone.
Resistance to environmental conditions (temperature, vibration).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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 GeneratorCAW – 868.5440Class 2
Predicate Devices:	Molecular Products - POGS - K062153

Device Description

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	PredicateMolecular ProductsPOGS K062153	Proposed DeviceROGSOTC - Emergency Use
Indications for use	To produce oxygen for emergencyuse	To produce oxygen for emergencyuse
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 nasalcannula	Standard oxygen mask or nasalcannula
Specifications	% Oxygen - 99%Flow rate minimum - 6 lpmDuration at least 15 minutesInitiation of oxygen flow - 60 secs	% Oxygen - 99%Flow rate minimum - 6 lpmDuration at least 15 minutesInitiation 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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 (301) 443-6740

Regulation Number and Section

§ 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).