Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.

Device Description

The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable.

Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Rugged Oxygen Generator (ROG) based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
% Oxygen	96% (Predicate: 99%. Note: USP defines medical oxygen purity as > 93%)
Flow rate minimum	6 LPM
Duration	At least 15 minutes
Initiation of oxygen flow	5 seconds
Housing temperature	<45°C Maximum
Temperature of gas at outlet	<40°C Maximum
Storage temperatures	0° to + 40°C / 32° to +104°F

Study Information

The provided document describes non-clinical bench testing to demonstrate that the subject device met its acceptance criteria. This is not a study on diagnostic accuracy or comparative human-AI performance.

Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical bench testing of a physical device. The testing was conducted by the sponsor, Molecular Products Ltd. (UK).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance features like oxygen purity, flow rate, and temperature is established through direct measurement and adherence to specifications.
Adjudication method for the test set: Not applicable for non-clinical bench testing. Performance metrics are measured directly.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an oxygen generator, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluates the device's inherent performance.
The type of ground truth used: Direct physical measurements and adherence to engineering and performance specifications (e.g., flow rate, purity, temperature limits). Biocompatibility testing was also performed, where the ground truth is established by relevant ISO standards (ISO 18562-2 and ISO 18562-3) and their pass/fail criteria.
The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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December 6, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Molecular Products Ltd. % Paul Dryden President ProMedic. LLC 131 Bay Point Drive NE Saint Petersburg, Florida 33704

Re: K240561

Trade/Device Name: Rugged Oxygen Generator (ROG) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable oxygen generator Regulatory Class: Class II Product Code: CAW Dated: November 7, 2024 Received: November 8, 2024

Dear Paul 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia. Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240561

Device Name Rugged Oxygen Generator (ROG)

Indications for Use (Describe)

Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv Page 1 of 4

Date Prepared:	December 4, 2024
Sponsor:	Molecular Products Ltd.Parkway, Harlow Business Park, Harlow.Essex, CM19 5FR, UK
Sponsor Contact:	Joe Atkinson - Technical ManagerPhone - +44 (0)1279 401236
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:Common/Usual Name:Classification Name:Product Code:Regulation Number:	Rugged Oxygen Generator (ROG)Oxygen GeneratorGenerator, Oxygen, PortableCAW21 CFR 868.5440
Predicate Device:Proprietary or Trade Name:Common/Usual Name:Classification Name:Product Code:Regulation Number:	ROGS - K131016Rugged Oxygen Generator (ROG)Oxygen GeneratorGenerator, Oxygen, PortableCAW21 CFR 868.5440

Device Description

Principle of Operation

The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.

Indications for Use:

Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.

Patient Population:

For individuals 17 years and older requiring emergency or supplemental oxygen.

Environments of use:

Emergency use, home use, and commercial use

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510(k) Summary Page 2 of 4

	Subject Device	Predicate device	Comparison
	Molecular Products	Molecular Products ROG
	Rugged Oxygen Generator (ROG)
K#	K240561	K131016
Product Code	CAW	CAW	Identical
CFR	21 CFR 868.5440	21 CFR 868.5440	Identical
Indications for Use	Intended to produce oxygen for emergency use at 6LPM flow rate for at least 15 minutes (90 liters) forindividuals 17 years and older requiring emergency orsupplemental oxygen	Intended to produce oxygen for emergency use at 6LPM flow rate for at least 15 minutes (90 liters)	SimilarPopulation was not specified
Patient Population	For individuals 17 years and older requiringemergency or supplemental oxygen.	Individuals requiring emergency or supplementaloxygen.	SimilarPopulation was not specified
Environment of Use	Emergency, OTC, home and commercial settings	Emergency, OTC, home and commercial settings	Identical
Contraindications	Same	Same	Identical
Method for oxygengeneration	Chemical reaction	Chemical reaction	Identical
Patient Interface	Standard oxygen mask	Standard oxygen mask or nasal Standard oxygenmask or nasal cannula	The subject device does notoffer a nasal cannula for use,which does not raise differentsafety or efficacy as a mask isstill available for use like thepredicate.
Specifications	% Oxygen - 96%Flow rate minimum - 6 LPMDuration at least 15 minutesInitiation of oxygen flow - 5 seconds	% Oxygen - 99%Flow rate minimum - 6 LPMDuration at least 15 minutesInitiation of oxygen flow - 5 seconds	Oxygen purity is not a FDAguidance specification. USPdefines medical oxygen purityas > 93%. This change in thespecification does notRaise different risk concerns.
Single Use, Disposable	Yes	Yes	Identical
OTC	Yes	Yes	Identical
VOC / PM Testing	Yes	Yes	Identical
Housing temperature	<45°C Maximum	<45°C Maximum	Identical
Temperature of gas atoutlet	<40°C Maximum	<40°C Maximum	Identical
Storage temperatures	0° to + 40°C / 32° to +104°F	0° to + 40°C / 32° to +104°F	Identical
Dimensions	28.5 cm x 11.5 cm	28.5 cm x 11.5 cm	Similar
Gross weight	1.5kg	1.5kg	Similar
Accessories	None - User supplied	Mask and oxygen cannula	Mask and tubing are usersupplied

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Substantial Equivalence Discussion

The table above compares the key features of the proposed device with the identified predicate -ROG - K131016. The comparison demonstrates that the subject device can be found to be substantially equivalent to the predicate device.

Indications for Use -

The indications for use are similar for the subject device when compared to the predicate device.

Discussion - The indications for use are similar.

Technology and construction -

The technology and principle of operation is similar for the subject device when compared to the predicate device. Discussion - Both the subject and predicate device have identical principles of Operation.

Environment of Use -

The environments of use are identical to predicate, which are Emergency, OTC, home and commercial settings.

Discussion - The environments of use are the identical.

Patient Population -

The patient population is similar for individuals requiring emergency oxygen. Discussion - The subject and predicate device patient populations are similar.

Non-Clinical Testing Summarv

Bench testing -

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Casing, Gas at patient temperature testing .
Shock and Vibration
Drop Testing .
Sand and Rain Blow Testing ●
Flow Duration .

Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria.

Biocompatibility -

The sponsor performed ISO 18562-2 and ISO 18562-3 testing.

Discussion - The subject device was found to meet the applicable requirements for biocompatibility safety for the intended population

Discussion of Differences

The subject does not include oxygen tubing and mask as was included by the predicate device. The oxygen percent is 96% as compared to the predicate, which was 99%. The flow rate minimum, duration, and initiation of oxygen remain unchanged. The subject device also incorporates design updates from Molecular Product's own device - the predicate ROG - K131016.

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The changes incorporated in the subject device do not raise any new concerns of safety of effectiveness.

Substantial Equivalence Conclusion

Through testing outlined above, the sponsor has demonstrated that the subject device comparably performs to the predicate, and the subject device do not raise any new concerns of safety of effectiveness when compared to the predicate ROG - K131016.

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).