(195 days)
No
The summary describes a microprocessor-controlled oxygen conserver system with a regulator. It mentions bench testing for performance metrics like trigger delay and pulse volume, but there is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML in medical devices. The focus is on the mechanical and control aspects of oxygen delivery.
Yes
The device is intended to "deliver medical-grade oxygen for patients that require supplemental oxygen," which directly addresses a health condition or need.
No
The device is an oxygen conserver system designed to deliver medical-grade oxygen to patients requiring supplemental oxygen, not to diagnose a medical condition.
No
The device description explicitly states it is a "microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Effortless Oxygen Conserver Systems are designed to deliver medical-grade oxygen directly to a patient's respiratory system. It is a device that provides therapy, not a test performed on a sample.
- Intended Use: The intended use clearly states the device is for "deliver[ing] medical-grade oxygen for patients that require supplemental oxygen." This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electronic components that regulate and deliver oxygen. There is no mention of analyzing biological samples.
Therefore, the Effortless Oxygen Conserver Systems fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NFB
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.
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
Not Found
Intended User / Care Setting
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.
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)
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.
The performance testing has demonstrated that the subject device met the applicable standard performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Trigger sensing:
§ 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).
0
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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 (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
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) | |
|---|---|
| ☑ 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, LLC |
| 251 E Sierra Dr. | |
| Phoenix, AZ 85012 | |
| Official Contact: | Samir Ahmad |
| Submission Correspondent: | Paul Dryden |
| ProMedic, 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:
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.
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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:
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.
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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.
| | Proposed
Effortless Pro and Mobile | Predicate
Inspired Technologies
Model 350G - K090421 | Comments |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | NFB - conserver, oxygen
Regulation Description - Noncontinuous
ventilator (IPPB)
CFR 868.5905 | NFB - conserver, oxygen
Regulation Description - Noncontinuous
ventilator (IPPB)
CFR 868.5905 | Similar |
| Indications for Use | The Effortless Oxygen Conserver System is
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. | The Inspired Technologies 350G Gas
Conserver is intended as a delivery medial-
grade device for oxygen from high-pressure
oxygen cylinders. This is an ambulatory
device, which allows patients to ambulate
longer than they would with a continuous
flow regulator on the same cylinder.
The 350G Gas Conserver is intended to be
used in the hospital, healthcare facilities, or
home care environments. | Similar |
| Environments of use | Hospital, healthcare facilities, or
home care environments depending upon the
model | Hospital, healthcare facilities, or
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
by sensing inhalation.
Delivers oxygen via nasal cannula to both
nostrils | Delivers oxygen in a pulsed dose to the
patient by sensing inhalation.
Delivers oxygen via nasal cannula to both
nostrils | Similar technology |
| Software driven | Yes | Yes | Similar |
| 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 |
| | Proposed
Effortless Pro and Mobile | Predicate
Inspired Technologies
Model 350G – K090421 | Comments |
| Alarms | Trigger rate - Low if no trigger 30 / min
Loss of Oxygen Pressure
Low Battery | Visual battery low alert
No audible alarms | Similar |
| Back-up mode | Pro Model - 1, 2, 3, 4, 5, 7, 9, 11, 13, 15 (Liters
per 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 which
provides a continuous flow of oxygen
controlled by a purely mechanical valve that
does not require electrical power and operates
independently of the electronic system.
It is typically used on low or no battery
situations. | Back-up Mode is a user activated mode which
provides a continuous flow of oxygen
controlled by a purely mechanical valve that
does not require electrical power and operates
independently of the electronic system. | Similar |
| Power source | Rechargeable Li battery | 4 – “AA” | Similar |
| Status Indicators | Alarm status
Pulse setting
Low battery
Low pressure of gas source
Audible beeps
Breath rate alarm | Device “on” patient setting-valve activation
Battery status
No audible alarms | Different, the subject device has more
indicators which would be considered to be
a benefit and not raise different concerns or
risks |
| Trigger sensing |