Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

K221014 · Effortless Oxygen, LLC · NFB · Oct 17, 2022 · Anesthesiology

Device Facts

• Record ID: K221014
• Device Name: Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
• Applicant: Effortless Oxygen, LLC
• Product Code: NFB · Anesthesiology
• Decision Date: Oct 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Microprocessor-controlled oxygen conserver system; connects to oxygen cylinders or hospital wall supplies. Input: patient inhalation detected via flow sensor (pressure drop). Transformation: electronic control module triggers delivery of precise oxygen bolus via nasal cannula. Output: pulsed oxygen flow (settings 1-6). Pro model includes trigger rate display; Mobile model lacks display. Both feature mechanical back-up mode for continuous flow. Used in hospitals, healthcare facilities, or home (Mobile only). Operated by patients/caregivers (Mobile) or healthcare professionals (Pro). Benefits: allows longer patient ambulation compared to continuous flow regulators. Healthcare providers use output to manage supplemental oxygen therapy.

Clinical Evidence

Bench testing only. Testing verified performance against specifications including trigger delay, trigger sensitivity, trigger rate, gas source pressure performance, delivered pressures, continuous flow rate, pulse volume, and human factors. Biocompatibility testing performed per ISO 18562-2 and 18562-3. Electrical, EMC, and EMI testing performed per ANSI/AAMI/ES 60601-1 and IEC 60601-1-2.

Technological Characteristics

Microprocessor-controlled oxygen regulator and conserver. Materials tested per ISO 18562-2/3. Power: rechargeable Li-ion battery or IEC 60601-1 external supply. Dimensions: 90mm x 100mm x 150mm; Weight: 0.7kg. Sensing: flow sensor (<0.01 cmH2O sensitivity). Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-67.

Indications for Use

Indicated for patients requiring supplemental oxygen from gas sources. Mobile model for hospital, healthcare, or home use; Pro model for hospital and healthcare facilities under professional use.

Regulatory Classification

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.

Predicate Devices

• Inspired Model 350G Gas Conserver (K090421)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K221014

Device Name Effortless Oxygen Conserver Systems

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| Date Prepared: | 17-Oct-22 |
|----------------------------|--------------------------------------------------------------------------------|
| Sponsor: | Effortless Oxygen, LLC<br>251 E Sierra Dr.<br>Phoenix, AZ 85012 |
| Official Contact: | Samir Ahmad |
| Submission Correspondent: | Paul Dryden<br>ProMedic, LLC |
| Proprietary or Trade Name: | Effortless Oxygen Conserver Systems<br>• Effortless Pro<br>• 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:

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.

#### 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.

{4}------------------------------------------------

#### 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:

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.

## 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.

{5}------------------------------------------------

## 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.

| | Proposed<br>Effortless Pro and Mobile | Predicate<br>Inspired Technologies<br>Model 350G - K090421 | Comments |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | NFB - conserver, oxygen<br>Regulation Description - Noncontinuous<br>ventilator (IPPB)<br>CFR 868.5905 | NFB - conserver, oxygen<br>Regulation Description - Noncontinuous<br>ventilator (IPPB)<br>CFR 868.5905 | Similar |
| Indications for Use | The Effortless Oxygen Conserver System is<br>intended to deliver medical-grade oxygen for<br>patients that require supplemental oxygen from<br>oxygen gas sources. Pulsing oxygen allows<br>patients to ambulate longer than they would<br>with a continuous flow regulator on the same<br>cylinder. The Effortless MOBILE may be used<br>in hospital, healthcare facilities, or home care<br>environments. The Effortless PRO is only<br>intended for hospital and healthcare facilities<br>under professional use. | The Inspired Technologies 350G Gas<br>Conserver is intended as a delivery medial-<br>grade device for oxygen from high-pressure<br>oxygen cylinders. This is an ambulatory<br>device, which allows patients to ambulate<br>longer than they would with a continuous<br>flow regulator on the same cylinder.<br>The 350G Gas Conserver is intended to be<br>used in the hospital, healthcare facilities, or<br>home care environments. | Similar |
| Environments of use | Hospital, healthcare facilities, or<br>home care environments depending upon the<br>model | Hospital, healthcare facilities, or<br>home 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 patient<br>by sensing inhalation.<br>Delivers oxygen via nasal cannula to both<br>nostrils | Delivers oxygen in a pulsed dose to the<br>patient by sensing inhalation.<br>Delivers oxygen via nasal cannula to both<br>nostrils | Similar technology |
| Software driven | Yes | Yes | Similar |
| Dosing algorithm and<br>number of settings | 1, 2, 3, 4, 5, 6 (Liters per Minute Equivalent at<br>16 ml per setting +/- 15%) | 16 ml/lpm (accuracy not provided)<br>Setting (lpm)<br>1, 1.5, 2, 2.5, 3, 4, 5, 6<br>Sport modes | Similar dosing algorithm<br>Similar range of settings |
| | Proposed<br>Effortless Pro and Mobile | Predicate<br>Inspired Technologies<br>Model 350G – K090421 | Comments |
| Alarms | Trigger rate - Low if no trigger < 15 sec, High<br>if trigger rate > 30 / min<br>Loss of Oxygen Pressure<br>Low Battery | Visual battery low alert<br>No audible alarms | Similar |
| Back-up mode | Pro Model - 1, 2, 3, 4, 5, 7, 9, 11, 13, 15 (Liters<br>per Minute, selectable)<br>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 which<br>provides a continuous flow of oxygen<br>controlled by a purely mechanical valve that<br>does not require electrical power and operates<br>independently of the electronic system.<br><br>It is typically used on low or no battery<br>situations. | Back-up Mode is a user activated mode which<br>provides a continuous flow of oxygen<br>controlled by a purely mechanical valve that<br>does not require electrical power and operates<br>independently of the electronic system. | Similar |
| Power source | Rechargeable Li battery | 4 – “AA” | Similar |
| Status Indicators | Alarm status<br>Pulse setting<br>Low battery<br>Low pressure of gas source<br>Audible beeps<br>Breath rate alarm | Device “on” patient setting-valve activation<br>Battery status<br>No audible alarms | Different, the subject device has more<br>indicators which would be considered to be<br>a benefit and not raise different concerns or<br>risks |
| 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°C<br>RH 10-90%<br>Altitude: -304 .8 (1.04 atmosphere) to 3,048<br>meters (0.69 atmosphere) (-1,000 to 10,000<br>feet) | Not specified | Subject device meets typical operating<br>ranges |
| | Proposed<br>Effortless Pro and Mobile | Predicate<br>Inspired Technologies<br>Model 350G – K090421 | Comments |
| Size | Pro Height: 90mm (3.5"), Width: 100mm (4"),<br>Depth: 150mm (6")<br>Weight – 0.7 Kilogram (1.5 Pounds)<br><br>Mobile: Height: 90mm (3.5"), Width:100mm<br>(4"), Depth: 150mm (6")<br>Weight – 0.7 Kilogram (1.5 Pounds) | Not specified | Similar to be attached to a cylinder or t the<br>wall 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 +A1:2012<br>IEC 60601-1-2: 2014<br>IEC 60601-1-11:2015<br>ISO 80601-2-67: 2012 | IEC 60601-1 | Subject device meets current standards and<br>revisions |
| Biocompatibility | Externally communicating, Tissue<br>Duration - permanent<br>ISO 18562-2 – PM<br>ISO 18562-3 – VOC | Externally communicating, Tissue<br>And<br>Surface contact, Skin and Mucosa<br>Duration - permanent | Similar |

{6}------------------------------------------------

# 510(k) Summary Page 4 of 7

{7}------------------------------------------------

## 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.

{8}------------------------------------------------

## 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.

{9}------------------------------------------------

## 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.