The Aer X oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Aer X may be used in home, institution, vehicle and various mobile environments.

Device Description

The Aer X oxygen concentrator utilies a molecular sieve and a differential pressure swing adsorption methodology to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94% in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device, the Aer X Portable Oxygen Concentrator. It does not contain the specific details of a clinical study demonstrating the device's performance against detailed acceptance criteria that would typically be found in a clinical trial report.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (VBOX Trooper) through bench testing and technical comparison, which is a different regulatory pathway than requiring a full clinical effectiveness study with defined acceptance criteria for effectiveness.

Therefore, many of the requested elements for a study proving the device meets acceptance criteria are not present in this type of submission. However, I can extract the information available regarding the functional and performance aspects of the device and how conformity was demonstrated.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" for a clinical performance study. Instead, it lists technical specifications and demonstrates that the device meets these specifications which are consistent with the predicate and industry standards.

Acceptance Criteria (Implied / Stated Specification)	Reported Device Performance (Aer X)
Oxygen Concentration (% O2)	87-94% at all settings (Industry Standard)
Oxygen Flow Rate	5 settings: 1 to 5 (equivalent to 1 LPM to 5 LPM)
Trigger Sensitivity	0.13 cm water (12.7 Pa)
Output gas composition (VOCs, particulate matter, ozone/carbon monoxide/carbon dioxide content)	Bench testing performed to confirm conformity to requirements for intended use. (Specific values not provided in this summary)
User display and LED functions	Bench testing performed to confirm conformity to requirements for intended use. (Specific values not provided in this summary)
Electromagnetic compatibility and electrical safety	Underwent testing in accordance with IEC 60601-1, IEC 60601-1-2, etc.
Functional performance	Bench testing performed to confirm conformity to requirements for intended use. (Specific values not provided in this summary)
Output gas temperature	Bench testing performed to confirm conformity to requirements for intended use. (Specific values not provided in this summary)
Biocompatibility	Underwent testing in accordance with applicable industry standards.
Electrical Safety	Underwent testing in accordance with IEC 60601-1, IEC 60601-1-2, etc.
Mechanical Testing	Underwent testing in accordance with applicable industry standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes bench testing, not a human-subject clinical trial.

Sample Size: Not specified for bench testing, typically involves a small number of production or early-stage devices to verify specifications.
Data Provenance: Not applicable for bench testing. Bench tests are typically conducted in a laboratory environment, not involving patient data.
Retrospective/Prospective: Not applicable for bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Bench testing relies on objective measurements against established technical standards, not expert interpretation of results on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this was bench testing, not a clinical study requiring adjudication of expert opinions.

5. 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 concentrator, not an AI diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device does not involve an "algorithm only" component in the sense of AI or diagnostic interpretation. Its performance is intrinsic to its mechanical and electrical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance specifications (e.g., oxygen concentration, flow rate) is defined by technical standards and industry benchmarks for portable oxygen concentrators. Bench testing physically measures the device's output and compares it to these predetermined specifications (e.g., a gas analyzer for oxygen purity, flow meters for flow rate).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

3B Medical Inc. Yasser Estafanous QA/RA Director 203 Avenue A NW, Suite 300 Winter Haven, Florida 33881

Re: K200496

Trade/Device Name: Aer X Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: June 22, 2020 Received: June 24, 2020

Dear Yasser Estafanous:

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,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200496

Device Name Aer X

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for 3B Medical. The logo consists of the text "3B Medical" in a blue, sans-serif font. To the left of the text is a stylized graphic of three concentric arcs, also in blue, that appear to be orbiting the "3B" portion of the text. The "TM" symbol is located to the upper right of the "3B".

510(k) Summary

Submitter:	3B Medical Inc.203 Avenue A NW Suite 300Winter Haven, FL 33881
Contact Person:	Yasser EstafanousDirector of QA/RATelephone: 863-226-6285Fax: 863-226-6284Email: yestafanous@3bproducts.com
Date Prepared:	July 17, 2020
Trade Name:	Aer X Portable Oxygen Concentrator
Common Name:	Oxygen Concentrator
Classification:	Class II
Product Code:	CAW, 21 CFR 868.5440
Predicate Device(s):	The subject device is equivalent to the following devices:• VBOX Trooper (K121260)
Device Description:	The Aer X oxygen concentrator utilies a molecular sieve and adifferential pressure swing adsorption methodology to separatethe gases in ambient air. The device takes the room air andconcentrates the oxygen portion to produce a pulseof oxygenbetween 87-94% in purity. When the patient inhales, the devicesenses the pressure change and is triggered to release the oxygenpulse. In between breaths, the device regenerates an oxygenpulse and waits for the next inhalation breath before dispensingit

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Image /page/4/Picture/1 description: The image shows the logo for 3B Medical. The logo is in blue and features the text "3B Medical". To the left of the text is a circular design with three curved lines that resemble a globe. The logo is simple and modern.

Comparison to the Predicate Device

Table 1. Comparison to Predicate Device

	Aer X Oxygen Concentrator(Subject Device)	VBOX Trooper OxygenConcentrator(Predicate Device)
510(k) Number	K200496	K121260
Decision Date
Manufacturer	3B Medical Inc.	VBOX
Classification	Class II	Class II
Product Code	CAW	CAW
Regulation	21 CFR 868.5440	21 CFR 868.5440
Indications for Use	The Aer X oxygen concentratordevice is used on a prescriptivebasis by patients requiringsupplemental oxygen. Itsupplies a high concentration ofoxygen and is used with a nasalcannula to channel oxygen fromthe concentrator to the patient.The Aer X may be used inhome, institution, vehicle andvarious mobile environments.	The Trooper oxygenconcentrator device is used on aprescriptive basis by patientsrequiring supplemental oxygen.It supplies a high concentrationof oxygen and is used with anasal cannula to channeloxygen from the concentrator tothe patient. The Trooper may beused in home, institution,vehicle and various mobileenvironments.
Prescription Required	Yes	Yes
Patient Interface	Same Standard nasal Cannula	Standard nasal cannula
Dimensions (LxWxH)	7.125"x8.25"x2.75"inches	6 x 2.5 x 6.25 inches
Weight	4.2 lbs (includes battery)	3.2 lbs (includes battery)
Materials
Sieve Bed	Synthetic zeolite	Synthetic zeolite
Sieve bed cartridge	Adsorbent Cartiradges	Adsorbent Cartiradges
Battery	Li-Ion	Li-Ion
Performance Specifications
Method of oxygenconcentration	Molecular sieve (mechanical)	Molecular sieve (mechanical)
Process by whichOxygen is released	Differential pressure swingadsorption	Differential pressure swingadsorption
Flow Rate	5 settings: 1 to 5 (flow ratesequivalent to 1 LPM to 5 LPM)	5 settings: 1 to 5 (flow ratesequivalent to 1 LPM to 5 LPM)
Duration of flow	Pulsed	Pulsed
Trigger Sensitivity	0.13 cm water (12.7 Pa)	0.13 cm water (12.7 Pa)
Oxygen concentration(% O2)	87-94% at all settings	87-94% at all settings
Software/ Hardware	Analog and digital electronicswith microprocessor	Analog and digital electronicswith microprocessor
Rechargeable Battery	Yes	Yes
Power Options	Battery, AC	Battery, AC
Technological charactartristics Summary
Produce of high purityO2	Differential pressure vacuumswing adsorption method	Differential pressure vacuumswing adsorption method
Flow	Pulsed	Pulsed
Cycles to produceconcentrated O2	1) Dispense, 2) Evacuate and 3)Pressurize	1) Dispense, 2) Evacuate and 3)Pressurize
Material insideadsorbent cartridge	Synthetic Zeolite	Synthetic Zeolite

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Image /page/5/Picture/1 description: The image shows the logo for 3B Medical. The logo consists of the text "3B Medical" in a blue sans-serif font. To the left of the text is a stylized graphic of three concentric circles, also in blue. The letters "3B" are inside the circles, and the letters "TM" are in superscript to the right of the "B".

Table 1. Comparison to Predicate Device

A summary of technological Characteristics of the new device in comparison to those of the predicate device.

New Changes to the Aer X as compared to the VBOX TROOPER

1.Exterior Shape- The exterior housing shape was required to change due to the Battery change below and the Keypad/ Display change below. The material for the exterior housing is PolyCarb/ ABS with the same fire-retardant rating as was the original device.

Battery Location changed from an exterior position with cord and plug to an integrated separate battery chamber with protected style of plug that does not require user to maneuver the plug into position.
LCD display with Keypad was updated to more tactile buttons and a color LCD in place of a segmented display.
Magnetic Cannula is a new feature to create a "breakaway" cannula that will protect the user and device in the event of the cannula tubing being "caught" on an object. The shape of the cannula plug is shaped to fit the industry standard cannula profile. The cannula plug was also changed to anodized aluminum to keep with industry standards for that component.
new design for the Carry Bag needed to change to fit the new exterior shape, also to have a flap that covers the display keypad.

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Image /page/6/Picture/1 description: The image shows the logo for 3B Medical. The logo consists of the text "3B Medical" in a blue sans-serif font. To the left of the text is a circular graphic made of blue lines that appear to be emanating from a central point. The "TM" symbol is located to the upper right of the "3B" text.

Technology not changed:

. Battery Power: 18650 Li Ion cells in a battery Pack that is user changeable and user chargeable, as before.
. O2 Production-Separation uses the same Vacuum Pressure swing, purge and repressurizing algorithm employing LILSX adsorbent with high nitrogen capacity. Valving and timing to provide purge and blow down technology is also employed, as before.
O2 Product Flow Rate: Oxygen is delivered by the Aer X device via a nasal cannula the same standard 2 prong cannula, the Oxygen is delivered in pulse mode a bolus of oxygen at the beginning of each inhalation. The purity of the oxygen is 90% +4% -3% (87-94%) which is also an industry standard for portable oxygen concentrators. The oxygen flow rate is in 5 settings 1 to 5 to be equivalent to 1 LPM to 5 LPM.

To verify that the modified device design met it's functional and Functional and performance requirements, representative samples of the device Safety Testing: underwent biocompatibility, electrical, and mechanical testing in accordance with applicable industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, and ISO 80601-2-69.

Non-clinical testing(Bench testing)

Bench testing was performed to provide assurance that the proposed device confirm to the requirements for its intended use. This include the following

. Output gas composition (e.g. VOCs, particulate matter, ozone/carbon monoxide/carbon dioxide content).
User display and LED functions
Oxygen flow rate and concentration
Electromagnetic compatibility and electrical safety
Functional performance ●
Output gas temperature.

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K200496

Image /page/7/Picture/1 description: The image shows the logo for 3B Medical. The logo consists of the text "3B Medical" in blue font. To the left of the text is a circular graphic made of curved blue lines. The "TM" symbol is located to the upper right of the "3B" text.

Summary of results :

As outlined above, the principles of operation, technology, materials and indications for use of the subject device are equivalent to those of the predicate device. The differences in size, weight, LCD & Keypad, exterior housing, carry bag, and the cannula port do not introduce any different questions of safety and effectiveness over the predicate device. The information demonstrates that the subject device is substantially equivalent to the predicate device.

3B Medical Inc. considers the Aer X to be substantially Conclusion: equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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).