Proxima
Device Facts
| Record ID | K220591 |
|---|---|
| Device Name | Proxima |
| Applicant | Dynasthetics, LLC |
| Product Code | NFB · Anesthesiology |
| Decision Date | Dec 15, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
Device Story
Proxima Model-100 is an electronic oxygen conserving device for hospital use. It uses a pressure sensor to detect patient inhalation and an electronic valve to deliver precise oxygen boluses via a dual-lumen nasal cannula. In pulsed mode, it delivers oxygen equivalent to 1-15 L/min; if no inhalation is detected for 15 seconds, it automatically switches to continuous flow. The device features a graphical touch screen for settings and monitoring. It is powered by an external 9V DC supply with an internal backup battery. Alarms indicate low battery, low supply pressure, dislodged cannula, lack of inhalation, or low nasal airflow. Operated by healthcare professionals, the device assists in oxygen therapy by optimizing delivery based on patient breath rate, potentially reducing oxygen waste compared to continuous flow systems.
Clinical Evidence
Bench testing only. Testing verified performance against ISO 80601-2-67 (pulse volume, breath rate, oxygen delivery, continuous flow, leak compensation, breath trigger pressure), fire propagation, and cleaning durability. Biocompatibility evaluated per ISO 10993-1 and ISO 18562-1/2/3. Electrical safety and EMC/EMI testing performed per ANSI/AAMI/ES 60601-1, IEC 60601-1-2, AIM 7351731, and IEC 60601-1-8.
Technological Characteristics
Electronic oxygen conserver; microprocessor-controlled valve; pressure sensor trigger (0.05 cm H2O sensitivity). Materials: machined aluminum pre-valve manifold, injection-molded plastic enclosure. Power: external 9V DC adapter, internal rechargeable backup battery (IEC 62133). Interface: capacitive touch screen. Connectivity: standalone. Standards: ISO 80601-2-67, ISO 10993-1, ISO 18562, ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-8.
Indications for Use
Indicated for adult patients in a hospital setting requiring supplemental oxygen. Not intended for life support, patients unable to maintain a patent airway, applications requiring less than 1 L/min, or home 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
- Inovo Evolution Electronic Oxygen Conserver (K113111)
Submission Summary (Full Text)
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December 15, 2022
Dynasthetics LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K220591
Trade/Device Name: Proxima Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: NFB Dated: November 11, 2022 Received: November 14, 2022
Dear Paul Dryden:
We have reviewed vour 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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 -S
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) K220591
Device Name Proxima
Indications for Use (Describe)
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
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: | 15-Dec-22 |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor:<br>Dynasthetics LLC<br>3487 West 2100 South #300<br>Salt Lake City, UT 84119<br>Tel - 801-484-3820 | |
| Official Contact: | Joseph Orr<br>President, Dynasthetics, LLC |
| Submission Correspondent: | Paul Dryden<br>ProMedic, LLC |
| Proprietary or Trade Name:<br>Common/Usual Name:<br>Classification CFR:<br>Classification Code:<br>Classification Name: | Proxima™ Model-100 Smart Supplemental Oxygen System<br>Oxygen Conserver<br>21 CFR 868.5905<br>NFB<br>Conserver, Oxygen |
| Predicate Device:<br>Proprietary or Trade Name:<br>Common/Usual Name:<br>Classification CFR:<br>Classification Code:<br>Classification Name: | Inovo Evolution Electronic Oxygen Conserver, K113111<br>Proxima™ Model-100 Smart Supplemental Oxygen System<br>Oxygen Conserver<br>21 CFR 868.5905<br>NFB<br>Conserver, Oxygen |
#### Device Description:
The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.
#### Indications for Use:
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
We present the proposed device vs. the predicate in table below.
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## 510(k) Summary Page 2 of 6
## Table of Comparison and Differences
The table below outlines the features of the Dynasthetics Proxima and compares it to the predicate device to establish substantial equivalence.
| Attribute | Subject Device | Predicate Device | Comments |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proxima™ Oxygen Delivery System | Chad Therapeutic Evolution Electronic<br>Oxygen Conserver | |
| Model | 100 | OM-900 | |
| 510(k) Number | K220591 | K113111 | |
| Device<br>classification and<br>Product Code | NFB<br>868.5905 | NFB<br>868.5905 | |
| Indications for use | The Proxima is intended for prescription use<br>only, to be used for adult patients that require<br>supplemental oxygen in a hospital setting. | The Inovo Evolution Motion is intended for<br>prescription use only, to be used as part of a<br>portable oxygen delivery system for<br>patients that require supplemental oxygen<br>up to 7 liters per minute, in their home and<br>for ambulatory use. | Similar<br><br>The indications for use are similar for the subject and<br>predicate devices. Both provide an option for continuous<br>flow oxygen delivery and bolus inspiration only mode.<br><br>The predicate device is designed to be used in a hospital<br>or at the patient's home. The subject device is designed<br>to be used in a hospital setting only by trained<br>professionals. |
| Patient population | Any adult patient for whom supplemental<br>oxygen is indicated | Any patient for whom up to 6 L/min of<br>oxygen has been prescribed | Similar |
| Environment for<br>use | Hospital setting | For hospital, home and ambulatory use | Subject device is only for use in a hospital setting |
| Contraindications | NOT INTENDED to be life sustaining or life<br>supporting.<br><br>NOT INTENDED for use in patients who<br>cannot maintain a patent airway<br><br>NOT INTENDED for applications requiring<br>less than 1 L/min of supplemental oxygen<br><br>NOT INTENDED for home use | Not to be used for life support applications.<br>In addition, it is not intended for use by<br>patients who breathe more than 40 breaths<br>per minute or who consistently fail to<br>trigger the device. It is not to be used while<br>asleep. | Similar<br><br>The predicate and the subject device both state that the<br>devices should not be used as life support devices.<br><br>Subject device is not intended for home use. |
| Constant oxygen<br>flow mode | 1-15 L/pm | Continuous flow of 2 L/pm ± 0.5 L/pm | Similar |
| Pulsed oxygen<br>mode | 1, 2, 4, 6 10 and 15 L/min equivalent oxygen<br>flow<br><br>Volume of oxygen pulses are selected to equal<br>40% of the set oxygen flow over one minute.<br>Pulse volumes are adjusted according to the set<br>oxygen flow rate and the time since the<br>previous pulse | 1, 2, 3, 4, 5, 6 L/min equivalent oxygen<br>flow | Subject device has the option to deliver higher oxygen<br>flow rates |
| Attribute | Subject Device | Predicate Device | Comments |
| Pulse accuracy | Greater of 3 mL or ±10% of the nominal bolus volume | Not specified | Pulse volume accuracy is similar |
| Continuous flow settings | 1, 2, 4, 6, 10 and 15 L/min | 2 L/min | Similar |
| Continuous flow accuracy | The greater of ±0.25 l/min or ±10% of the set flow rate for flows between 1 and 15 L/min | N/A | Subject has more continuous flow settings than predicate<br>Flow rate accuracy of the subject device is similar to that of the predicate device |
| Oxygen Savings ratio | 2.5:1 regardless of breath rate | 2.5:1 to 5.0:1 depending on breath rate | Similar |
| Initiation of Bolus | At onset of inhalation | At onset of inhalation | Similar |
| Oxygen Bolus Size | Variable | Variable | Similar |
| Automatic bolus size adjustment? | Yes | Yes | Similar |
| Oxygen Bolus Volume by setting at 20 breaths/min | Setting 1: 20 mL | Setting 1: 10-15 mL | Similar |
| | Setting 2: 40 mL | Setting 2: 20-25 mL | |
| | --- | Setting 3: 30-35 mL | |
| | Setting 4: 80 mL | Setting 4: 40-50 mL | |
| | --- | Setting 5: 50-60 mL | |
| | Setting 6: 160 mL | Setting 6: 60-75 mL | |
| | --- | Setting 7: 70-80 mL | |
| | Setting 10: 320 mL | --- | |
| | Setting 15: 400 mL | --- | |
| Maximum bolus volume | 425 mL | 75 mL | A larger bolus volume allows for a broader range of patients |
| Breathing frequency | Up to 40 breaths per minute | Up to 40 breaths per minute | Similar |
| Microprocessor controlled | Yes | Yes | Similar |
| Oxygen Flow control | Electronically controlled valve | Electronically controlled valve | Similar |
| Breath trigger detection method | Electronic pressure sensor | Electronic pressure sensor | Similar |
| Oxygen cannula | Any standard, dual-lumen demand nasal cannula, for example the Salter Labs 4807 or similar. | Any single lumen oxygen cannula | Overall function and performance are similar |
| Alarms indicators? | Yes | Yes | Similar |
| User interface | Touch screen button and slider | Touch button and rotary knob | Similar |
| Displayed parameters | Set oxygen flow rate<br>Breath rate (Synchronized breath mode) | Set oxygen flow rate | Similar |
| Attribute | Subject Device | Predicate Device | Comments |
| Option for<br>continuous flow<br>when breaths not<br>detected | Yes, automatic<br><br>If inhalation is not detected after 15 seconds,<br>mandatory continuous flow is automatically<br>given at the set flow rate | Yes, manual | Similar |
| Gas source | Regulated low pressure hospital oxygen supply<br>(50-55 PSI) | High-pressure unregulated oxygen cylinders<br>(200 to 3000 PSI) | Similar |
| Trigger Method | Negative inspiratory effort from patient<br>inhalation | Negative inspiratory effort from patient<br>inhalation | Similar |
| Trigger sensitivity | 0.05 cm H2O | 0.5 cm H2O | The subject device requires less pressure drop to trigger<br>breaths |
| Peak pulse oxygen<br>flow | 30 L/min | Unspecified | Similar |
| Continuous flow<br>settings | 0, 1, 2, 4, 6, 10 and 15 L/min | 2 L/min | Similar |
| Keypad | On/off button, Capacitive touch screen | Rest and active buttons, pulse volume<br>selector | Similar function different technology |
| Housing | Injection molded plastic enclosure | Injection molded plastic enclosure | Similar |
| Pre-valve manifold<br>material | Machined aluminum | Brass | Similar |
| Integral pressure<br>regulator | None | Brass C36000 high-pressure components | Similar |
| Oxygen pressure<br>gauge | None | 0-300 PSI | Similar |
| Primary power<br>source | Low DC voltage external double insulated<br>medical grade power adapter | 2 "AA" disposable/rechargeable batteries<br>(user changeable) | Similar<br><br>Both the subject and predicate devices can be operated<br>using battery power. The subject device is designed to be<br>operated using an external DC power supply |
| Battery | Internal IEC 62133 certified rechargeable<br>backup battery (not user changeable) | 2 "AA" disposable/rechargeable batteries | Both the subject and predicate can operate on battery<br>power. |
| Battery life | Backup battery life > 30 minutes | 2 years | Battery life is different since the subject device is limited<br>to hospital settings, the length of backup battery power is<br>less critical.<br><br>Subject device battery is backup only (non-primary power<br>source) |
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## 510(k) Summary Page 3 of 6
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## 510(k) Summary Page 4 of 6
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### Substantial Equivalence Discussion
As described in the table above the Proxima is viewed as substantially equivalent to the predicate device because:
#### Indications -
- . The intended therapeutic use of the predicate and subject devices are similar:
- . Discussion - both the subject and predicate devices provide supplemental oxygen therapy to patients. Both the subject and predicate devices are intended for use by healthcare providers to administer supplemental oxygen to patients. The subject device is intended to be used only for adult patients in a hospital environment and both are to be used for patients requiring supplemental oxygen.
#### Environment of Use -
- The subject and predicate devices both include hospital environments. ● Discussion - The predicate device includes home and ambulatory use, this does not impact substantial equivalence
#### Technology -
- The technological principles of delivering oxygen in a pulsed dose to the patient by ● sensing inhalation. Oxygen is delivered via nasal cannula to the nostrils. Discussion - The devices are the similar.
#### Non-clinical Testing Summary -
#### Biocompatibility
The Proxima Oxygen Conserver has several component which have patient contact. According to ISO 10993-1 and ISO 18562-1 for the materials in patient contact. They are:
- . Main unit
- o Dry gas pathway
- Externally Communicating, Tissue O
- Duration of use is permanent (>30 days). o
Testing included:
- ISO 18562-2 PM ●
- ISO 18562-3 VOCs ●
Discussion - Testing has shown that particulate and VOC emissions do not create a significant risk to patients.
#### Electrical, EMC, EMI testing
- . We have evaluated the proposed device per ANSI/AAMI/ES 60601-1, IEC 60601-1-2, AIM Standard 7351731, IEC 60601-1-8 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 included:
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#### 510(k) Summary Page 6 of 6
- . ISO 80601-2-67:2020 - Medical Electrical Equipment - Part 2-67: Particular Requirements For Basic Safety And Essential Performance Of Oxygen-Conserving Equipment
- o Pulse Volume
- Breath Rate O
- Oxygen Delivery O
- Continuous Flow о
- o Leak Compensation
- Breath Trigger Pressure o
- Fire Propagation ●
- Cleaning Durability .
Discussion - The proposed device was tested to assure that it meets performance specifications. Upon completion of the tests, it was found to meet its performance requirements.
## Discussion of Differences
There are no significant differences in critical function between the proposed device and the predicate device. Differences are discussed in Table above.
The performance testing has demonstrated that the subject device met the applicable standard performance requirements. We have not identified any new or different risks compared to the predicate in the comparative table or risk analysis.
## 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.
