(281 days)
Not Found
No
The device description and principle of operation detail a chemical reaction initiated by mechanical means. There is no mention of AI or ML in the document.
Yes
Explanation: The device is described as providing supplemental oxygen, which is a therapeutic intervention, for individuals requiring emergency or supplemental oxygen. It is designed to treat or alleviate a medical condition (lack of oxygen).
No
The device produces oxygen for emergency or supplemental use, it does not analyze or interpret medical data to diagnose a condition.
No
The device description clearly describes a physical, chemical oxygen generator with mechanical initiation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Rugged Oxygen Generator (ROG) produces oxygen for inhalation. It directly interacts with the patient's respiratory system, not with a specimen taken from the body.
- Intended Use: The intended use is to provide emergency or supplemental oxygen, which is a therapeutic intervention, not a diagnostic test.
- Device Description: The description focuses on the chemical process of generating oxygen and its delivery to the patient. There is no mention of analyzing biological samples.
Therefore, the ROG falls under the category of a therapeutic medical device, not an In Vitro Diagnostic 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) for individuals 17 years and older requiring emergency or supplemental oxygen.
Product codes
CAW
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.
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
17 years and older
Intended User / Care Setting
Emergency use, home use, and commercial use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ROGS - K131016
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
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
1
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
2
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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3
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 Manager |
| Phone - +44 (0)1279 401236 | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Product Code: | |
| Regulation Number: | Rugged Oxygen Generator (ROG) |
| Oxygen Generator | |
| Generator, Oxygen, Portable | |
| CAW | |
| 21 CFR 868.5440 | |
| Predicate Device: | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Product Code: | |
| Regulation Number: | ROGS - K131016 |
| Rugged Oxygen Generator (ROG) | |
| Oxygen Generator | |
| Generator, Oxygen, Portable | |
| CAW | |
| 21 CFR 868.5440 |
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.
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
4
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 6 | ||
| LPM flow rate for at least 15 minutes (90 liters) for | |||
| individuals 17 years and older requiring emergency or | |||
| supplemental oxygen | Intended to produce oxygen for emergency use at 6 | ||
| LPM flow rate for at least 15 minutes (90 liters) | Similar | ||
| Population was not specified | |||
| Patient Population | For individuals 17 years and older requiring | ||
| emergency or supplemental oxygen. | Individuals requiring emergency or supplemental | ||
| oxygen. | Similar | ||
| Population 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 oxygen | |||
| generation | Chemical reaction | Chemical reaction | Identical |
| Patient Interface | Standard oxygen mask | Standard oxygen mask or nasal Standard oxygen | |
| mask or nasal cannula | The subject device does not | ||
| offer a nasal cannula for use, | |||
| which does not raise different | |||
| safety or efficacy as a mask is | |||
| still available for use like the | |||
| predicate. | |||
| Specifications | % Oxygen - 96% | ||
| Flow rate minimum - 6 LPM | |||
| Duration at least 15 minutes | |||
| Initiation of oxygen flow - 5 seconds | % Oxygen - 99% | ||
| Flow rate minimum - 6 LPM | |||
| Duration at least 15 minutes | |||
| Initiation of oxygen flow - 5 seconds | Oxygen purity is not a FDA | ||
| guidance specification. USP | |||
| defines medical oxygen purity | |||
| as > 93%. This change in the | |||
| specification does not | |||
| Raise different risk concerns. | |||
| Single Use, Disposable | Yes | Yes | Identical |
| OTC | Yes | Yes | Identical |
| VOC / PM Testing | Yes | Yes | Identical |
| Housing temperature |