The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.

Device Description

The Effortless Oxygen Conserver Systems (EOCS) is a microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver. Depending upon the model they have been designed for use in ambulatory, home and medical facility settings to supply medical-grade oxygen therapy to patients. The built in oxygen regulator reduces oxygen pressures from an oxygen cylinder or from hospital wall supplies. There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Effortless Oxygen Conserver System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with defined acceptance criteria for individual performance metrics like those typically outlined for AI/ML devices.

Therefore, the document does not contain the detailed information required to answer many of the questions, especially those pertaining to:

Acceptance criteria table with reported device performance: The document only provides a comparison table of features and specifications between the proposed device and a predicate, not performance metrics against specific acceptance criteria.
Sample size and data provenance for a test set: No test set (in the context of AI/ML or clinical efficacy) is mentioned. The "bench testing" refers to engineering verification.
Number of experts and qualifications for ground truth: Not applicable, as there's no mention of expert-established ground truth for a test set.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
Effect size of human readers improvement with AI assistance: Not applicable, as this is not an AI-assisted device in the diagnostic sense.
Standalone performance (algorithm only): Not applicable for this type of device.
Type of ground truth used: Not applicable.
Sample size for training set and how ground truth was established for training set: Not applicable, as this is not an AI/ML device that requires training.

What the document does describe are several non-clinical tests to demonstrate device performance and safety, primarily for substantial equivalence to a predicate device, not clinical efficacy or AI/ML performance.

Here's an attempt to extract relevant information, acknowledging the limitations based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the device's specifications and features, and states that various engineering and safety tests were performed to ensure it met applicable standards and performance requirements.

The "Table of Comparison and Differences" (Page 5-6) serves to show equivalence to the predicate device, not performance against specific criteria. However, for certain parameters, it implicitly suggests an acceptable range by stating what the device accomplishes.

Category	Proposed Effortless Pro and Mobile Performance/Specification	Predicate Inspired Technologies Model 350G – K090421 Performance/Specification	Implied "Acceptance" (demonstrates equivalence/conformance)
Dosing Algorithm and Number of Settings	1, 2, 3, 4, 5, 6 (Liters per Minute Equivalent at 16 ml per setting +/- 15%)	16 ml/lpm (accuracy not provided) Setting (lpm): 1, 1.5, 2, 2.5, 3, 4, 5, 6 Sport modes	Similar dosing algorithm, similar range of settings.
Alarms	Trigger rate - Low if no trigger < 15 sec, High if trigger rate > 30 / min; Loss of Oxygen Pressure; Low Battery	Visual battery low alert; No audible alarms	Similar (proposed device has more indicators, considered a benefit).
Back-up mode (Pro Model)	1, 2, 3, 4, 5, 7, 9, 11, 13, 15 (Liters per Minute, selectable) continuous flow. Mechanical valve, independent of electronics. Used for low/no battery.	Continuous flow - 2 Lpm; Mechanical valve, independent of electronics.	Both have a means for back-up mode (similar).
Trigger Sensing	<0.01 cmH2O	+0.03 to -0.2 cmH2O	Similar, subject device is more sensitive (a benefit).
Trigger Range	Up to 40 trigger event / min	Up to 35 trigger event / min	Similar.
Operating Conditions	10°C to 40°C; RH 10-90%; Altitude: -304.8 to 3,048 meters (-1,000 to 10,000 feet)	Not specified	Subject device meets typical operating ranges.
Biocompatibility	Materials in patient contact tested per ISO 18562-2 and 18562-3, meeting requirements.	Externally communicating, Tissue And Surface contact, Skin and Mucosa; Duration - permanent	Similar.
Electrical, EMC, EMI Testing	Evaluated per ANSI/AAMI/ES 60601-1, IEC 60601-1-2 and ISO 80601-2-67; performed as intended and met requirements.	IEC 60601-1	Subject device meets current standards and revisions.
Bench Testing	Performed to verify performance to specifications of: Trigger Delay, Trigger Sensitivity, Trigger Rate, Performance at Different Gas Source Pressures, Delivered Pressures at Nostrils, Continuous Flow Rate, Pulse Volume, Human Factors. Found to meet performance requirements.	(No direct comparative data for these specific tests in the table, but implied that predicate would also meet relevant performance for its design.)	Device met its performance requirements.

The "acceptance criterion" for this submission is primarily the demonstration of substantial equivalence to the predicate device, not meeting specific quantitative performance thresholds for diagnostic accuracy.

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

Not applicable. The document describes non-clinical bench testing, not a clinical study with patients or a test set of data (e.g., images for an AI/ML device). There is no mention of data provenance as it applies to clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert-established ground truth.

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

Not applicable.

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

No MRMC study was done, as this is not an AI-assisted diagnostic device.

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

Not applicable. This is not a software-only diagnostic algorithm.

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

For the physical and functional tests, the "ground truth" is measured physical parameters (e.g., pressure, flow rate, trigger sensitivity) compared against engineering specifications and applicable standards (e.g., ISO 80601-2-67).

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2022

Effortless Oxygen. LLC % Paul Dryden Consultant Effortless Oxygen. LLC c/o Promedic, LLC 131 Bav Point Dr NE Saint Petersburg, Florida 33704

Re: K221014

Trade/Device Name: Effortless Oxygen Conserver System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NFB Dated: September 16, 2022 Received: September 16, 2022

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,

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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) K221014

Device Name Effortless Oxygen Conserver Systems

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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Date Prepared:	17-Oct-22
Sponsor:	Effortless Oxygen, LLC251 E Sierra Dr.Phoenix, AZ 85012
Official Contact:	Samir Ahmad
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Effortless Oxygen Conserver Systems• Effortless Pro• Effortless Mobile
Common/Usual Name:	Oxygen Conserver
Classification CFR:	21 CFR 868.5905
Classification Code:	NFB
Classification Name:	Conserver, Oxygen
Predicate Device:	Inspired Model 350G Gas Conserver
510(k):	K090421
Common/Usual Name:	Oxygen Conserver
Classification CFR:	21 CFR 868.5905
Classification Code:	NFB
Classification Name:	Conserver, Oxygen

Device Description:

There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.

Users:

Mobile: The User of the Mobile is a patient or caregiver in any setting where tank of oxygen is available, including home and clinical settings. e.g., acute hospital facility, nursing home, or long-term care facility.

Pro Model: The Pro includes additional features for professional use only. The User of the Pro is a licensed medical Healthcare Professional (HCP) (i.e. physician, nurse, respiratory therapist or delegated medical professional) in a clinical setting e.g., acute hospital facility, nursing home, or long-term care facility. The Pro is not intended for use in a home-based setting.

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510(k) Summary Page 2 of 7

Patient Interface:

When connected to a standard oxygen nasal cannula, the device senses the inspiration of the patient using a flow sensor and delivers a precise bolus of oxygen to the patient. The device allows for settings of pulse flow oxygen therapy from 1-6.

The Effortless Pro and Mobile models are multi-patient multi-use, the cannula is single patient use.

The devices can be externally powered from an IEC 60601-1 power supply or powered from an integral rechargeable lithium-ion battery.

The devices use identical control modules, with the primary difference being in the display of Trigger rate (in the Pro) and mechanical connection to the oxygen source and pressure regulation

Indications for Use:

Patient Population:

Patients that require supplemental oxygen.

Environments of use:

Hospital, healthcare facilities, or home care (Mobile model only) environments.

We present the proposed device vs. the predicate in table below.

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510(k) Summary Page 3 of 7

Table of Comparison and Differences

The table below outlines the features of the Effortless Pro and Mobile and compares it to the predicate equivalence.

	ProposedEffortless Pro and Mobile	PredicateInspired TechnologiesModel 350G - K090421	Comments
Classification	NFB - conserver, oxygenRegulation Description - Noncontinuousventilator (IPPB)CFR 868.5905	NFB - conserver, oxygenRegulation Description - Noncontinuousventilator (IPPB)CFR 868.5905	Similar
Indications for Use	The Effortless Oxygen Conserver System isintended to deliver medical-grade oxygen forpatients that require supplemental oxygen fromoxygen gas sources. Pulsing oxygen allowspatients to ambulate longer than they wouldwith a continuous flow regulator on the samecylinder. The Effortless MOBILE may be usedin hospital, healthcare facilities, or home careenvironments. The Effortless PRO is onlyintended for hospital and healthcare facilitiesunder professional use.	The Inspired Technologies 350G GasConserver is intended as a delivery medial-grade device for oxygen from high-pressureoxygen cylinders. This is an ambulatorydevice, which allows patients to ambulatelonger than they would with a continuousflow regulator on the same cylinder.The 350G Gas Conserver is intended to beused in the hospital, healthcare facilities, orhome care environments.	Similar
Environments of use	Hospital, healthcare facilities, orhome care environments depending upon themodel	Hospital, healthcare facilities, orhome care environments	Similar
Population	Patients that require supplemental oxygen	Patients that require supplemental oxygen	Similar
Prescriptive	Yes	Yes	Similar
Technology	Delivers oxygen in a pulsed dose to the patientby sensing inhalation.Delivers oxygen via nasal cannula to bothnostrils	Delivers oxygen in a pulsed dose to thepatient by sensing inhalation.Delivers oxygen via nasal cannula to bothnostrils	Similar technology
Software driven	Yes	Yes	Similar
Dosing algorithm andnumber of settings	1, 2, 3, 4, 5, 6 (Liters per Minute Equivalent at16 ml per setting +/- 15%)	16 ml/lpm (accuracy not provided)Setting (lpm)1, 1.5, 2, 2.5, 3, 4, 5, 6Sport modes	Similar dosing algorithmSimilar range of settings
	ProposedEffortless Pro and Mobile	PredicateInspired TechnologiesModel 350G – K090421	Comments
Alarms	Trigger rate - Low if no trigger < 15 sec, Highif trigger rate > 30 / minLoss of Oxygen PressureLow Battery	Visual battery low alertNo audible alarms	Similar
Back-up mode	Pro Model - 1, 2, 3, 4, 5, 7, 9, 11, 13, 15 (Litersper Minute, selectable)Mobile Model – 2 Lpm continuous flow only	Continuous flow - 2 Lpm	Both have a means for back-up mode
	Back-up Mode is a user activated mode whichprovides a continuous flow of oxygencontrolled by a purely mechanical valve thatdoes not require electrical power and operatesindependently of the electronic system.It is typically used on low or no batterysituations.	Back-up Mode is a user activated mode whichprovides a continuous flow of oxygencontrolled by a purely mechanical valve thatdoes not require electrical power and operatesindependently of the electronic system.	Similar
Power source	Rechargeable Li battery	4 – “AA”	Similar
Status Indicators	Alarm statusPulse settingLow batteryLow pressure of gas sourceAudible beepsBreath rate alarm	Device “on” patient setting-valve activationBattery statusNo audible alarms	Different, the subject device has moreindicators which would be considered to bea benefit and not raise different concerns orrisks
Trigger sensing	<0.01 cmH2O	+0.03 to -0.2 cmH2O	Similar subject device is more sensitive
Trigger range	Up to 40 trigger event / min	Up to 35 trigger event / min	Similar
Operating conditions	10°C to 40°CRH 10-90%Altitude: -304 .8 (1.04 atmosphere) to 3,048meters (0.69 atmosphere) (-1,000 to 10,000feet)	Not specified	Subject device meets typical operatingranges
	ProposedEffortless Pro and Mobile	PredicateInspired TechnologiesModel 350G – K090421	Comments
Size	Pro Height: 90mm (3.5"), Width: 100mm (4"),Depth: 150mm (6")Weight – 0.7 Kilogram (1.5 Pounds)Mobile: Height: 90mm (3.5"), Width:100mm(4"), Depth: 150mm (6")Weight – 0.7 Kilogram (1.5 Pounds)	Not specified	Similar to be attached to a cylinder or t thewall gas outlet
Accessories	Nasal cannula, single patient, multi-use	Nasal cannula, single patient, multi-use	Similar, user supplied for subject device
Standards	IEC 60601-1: 2005 +A1:2012IEC 60601-1-2: 2014IEC 60601-1-11:2015ISO 80601-2-67: 2012	IEC 60601-1	Subject device meets current standards andrevisions
Biocompatibility	Externally communicating, TissueDuration - permanentISO 18562-2 – PMISO 18562-3 – VOC	Externally communicating, TissueAndSurface contact, Skin and MucosaDuration - permanent	Similar

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510(k) Summary Page 4 of 7

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510(k) Summary Page 5 of 7

Substantial Equivalence Discussion

The table above compares the key features of the predicate. The companson demonstrates that the proposed devices can be found to be substantially equivalent.

The EOCS is viewed as substantially equivalent to the predicate device because:

Indications –

· The EOCS is an oxygen conserving device.
Discussion – The indications for use are similar to the predicate K090421. The subject device is also indicated for wall oxygen, this has no bearing on the use or effect of the device.

Environment of Use –

· The subject and predicate devices have the same environments of use.
Discussion - The environments of use and personnel are similar to the predicate.

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Technology -

The technological principles of delivers oxygen in a pulsed dose to the patient by sensing ● inhalation. Oxygen is delivered via nasal cannula to the nostrils.
Trigger Rate
- When connected to a standard nasal cannula attached to a patient, the device o senses the inspiration of the patient using a flow sensor. When the flow sensor detects a drop in pressure, which occurs during the start of inspiration, it triggers the device to deliver the pre-set / prescribed bolus of oxygen to the patient.
- The Pro device displays a moving average of the last 3 triggers converted to O triggers per minute. The Mobile model is measuring trigger rate but is not displaying a numerical value.
- A trigger is defined as the system detecting inhalation and triggering a pulse of O oxygen. The trigger Rate (TR) is calculated as the time between triggers converted into triggers per minute and displayed as a moving average:

Discussion - The devices are the same.

Non-clinical Testing Summary -

Biocompatibility of Materials

The materials in patient contact have been tested to per ISO 18562-2 and 18562-3. .

Discussion - The materials met the requirements per the applicable standards.

Electrical, EMC, EMI testing

We have evaluated the proposed device per ANSI/AAMI/ES 60601-1, IEC 60601-1-2 ● and ISO 80601-2-67 the device performed as intended and met the requirements.
Discussion - The proposed device met the requirements of the standards and is considered safe.

Bench testing -

Bench testing was performed to verify the performance to specifications of the proposed . device. Testing include ISO 80601-2-67:
- o Testing includes:
- Trigger Delav O
- Trigger Sensitivity o
- Trigger Rate O
- Performance at Different Gas Source Pressures O
- ೧ Delivered Pressures at Nostrils
- Continuous Flow Rate O
- Pulse Volume O
- Human Factors O

Discussion - The proposed devices were tested to assure that they meet performance specifications. Upon completion of the tests, it was found to meet its performance requirements.

Discussion of Differences

There are no differences which raise different concerns or risk of safety or effectiveness between the proposed device and the predicate device.

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510(k) Summary Page 7 of 7

The performance testing has demonstrated that the subject device met the applicable standard performance requirements. The above table plus the risk analysis do not identify any different risks compared to the predicate.

Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).