(289 days)
Not Found
No
The description focuses on sensor-based detection and rule-based logic for oxygen delivery and safety features. There is no mention of AI, ML, or learning from data.
Yes
The device delivers oxygen for medical purposes to adult patients in a hospital setting, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an oxygen conserving device designed to deliver oxygen to patients. While it displays warning messages for various issues, these warnings are about the device's operational status and the patient's interaction with the device (e.g., lack of inhalation, low nasal airflow), not for diagnosing a medical condition. Its primary function is therapeutic (oxygen delivery), not diagnostic.
No
The device description clearly outlines hardware components such as a pressure sensor, electronic valve, graphical touch screen interface, external power supply, and internal back-up battery. It also mentions bench testing related to hardware performance (e.g., ISO 80601-2-67).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to adult patients in a hospital setting. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device is an electronic oxygen conserving device that delivers oxygen based on detecting inhalation. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic markers, or any function related to diagnosing a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver oxygen, which is a treatment, not a diagnostic process.
N/A
Intended Use / 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.
Product codes
NFB
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.
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
adult patients
Intended User / Care Setting
prescription use only, in a hospital 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: Tested per ISO 10993-1 and ISO 18562-1, including ISO 18562-2 PM and 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: Evaluated per ANSI/AAMI/ES 60601-1, IEC 60601-1-2, AIM Standard 7351731, IEC 60601-1-8 and ISO 80601-2-67. Discussion: The proposed device met the requirements of the standards and is considered safe.
- Bench testing: Performed to verify the performance to specifications of the proposed device, including:
- ISO 80601-2-67:2020 - Medical Electrical Equipment - Part 2-67: Particular Requirements For Basic Safety And Essential Performance Of Oxygen-Conserving Equipment (covering Pulse Volume, Breath Rate, Oxygen Delivery, Continuous Flow, Leak Compensation, Breath Trigger Pressure).
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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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
1
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
2
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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3
| Date Prepared: | 15-Dec-22 |
|---|---|
| Sponsor: | |
| Dynasthetics LLC | |
| 3487 West 2100 South #300 | |
| Salt Lake City, UT 84119 | |
| Tel - 801-484-3820 | |
| Official Contact: | Joseph Orr |
| President, Dynasthetics, LLC | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification CFR: | |
| Classification Code: | |
| Classification Name: | Proxima™ Model-100 Smart Supplemental Oxygen System |
| Oxygen Conserver | |
| 21 CFR 868.5905 | |
| NFB | |
| Conserver, Oxygen | |
| Predicate Device: | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification CFR: | |
| Classification Code: | |
| Classification Name: | Inovo Evolution Electronic Oxygen Conserver, K113111 |
| Proxima™ Model-100 Smart Supplemental Oxygen System | |
| Oxygen Conserver | |
| 21 CFR 868.5905 | |
| NFB | |
| 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.
4
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 | |
| Oxygen Conserver | |||
| Model | 100 | OM-900 | |
| 510(k) Number | K220591 | K113111 | |
| Device | |||
| classification and | |||
| Product Code | NFB | ||
| 868.5905 | NFB | ||
| 868.5905 | |||
| 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. | The Inovo Evolution Motion is intended for | ||
| prescription use only, to be used as part of a | |||
| portable oxygen delivery system for | |||
| patients that require supplemental oxygen | |||
| up to 7 liters per minute, in their home and | |||
| for ambulatory use. | Similar |
The indications for use are similar for the subject and
predicate devices. Both provide an option for continuous
flow oxygen delivery and bolus inspiration only mode.
The predicate device is designed to be used in a hospital
or at the patient's home. The subject device is designed
to be used in a hospital setting only by trained
professionals. |
| Patient population | Any adult patient for whom supplemental
oxygen is indicated | Any patient for whom up to 6 L/min of
oxygen has been prescribed | Similar |
| Environment for
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
supporting.
NOT INTENDED for use in patients who
cannot maintain a patent airway
NOT INTENDED for applications requiring
less than 1 L/min of supplemental oxygen
NOT INTENDED for home use | Not to be used for life support applications.
In addition, it is not intended for use by
patients who breathe more than 40 breaths
per minute or who consistently fail to
trigger the device. It is not to be used while
asleep. | Similar
The predicate and the subject device both state that the
devices should not be used as life support devices.
Subject device is not intended for home use. |
| Constant oxygen
flow mode | 1-15 L/pm | Continuous flow of 2 L/pm ± 0.5 L/pm | Similar |
| Pulsed oxygen
mode | 1, 2, 4, 6 10 and 15 L/min equivalent oxygen
flow
Volume of oxygen pulses are selected to equal
40% of the set oxygen flow over one minute.
Pulse volumes are adjusted according to the set
oxygen flow rate and the time since the
previous pulse | 1, 2, 3, 4, 5, 6 L/min equivalent oxygen
flow | Subject device has the option to deliver higher oxygen
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
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
Breath rate (Synchronized breath mode) | Set oxygen flow rate | Similar |
| Attribute | Subject Device | Predicate Device | Comments |
| Option for
continuous flow
when breaths not
detected | Yes, automatic
If inhalation is not detected after 15 seconds,
mandatory continuous flow is automatically
given at the set flow rate | Yes, manual | Similar |
| Gas source | Regulated low pressure hospital oxygen supply
(50-55 PSI) | High-pressure unregulated oxygen cylinders
(200 to 3000 PSI) | Similar |
| Trigger Method | Negative inspiratory effort from patient
inhalation | Negative inspiratory effort from patient
inhalation | Similar |
| Trigger sensitivity | 0.05 cm H2O | 0.5 cm H2O | The subject device requires less pressure drop to trigger
breaths |
| Peak pulse oxygen
flow | 30 L/min | Unspecified | Similar |
| Continuous flow
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
selector | Similar function different technology |
| Housing | Injection molded plastic enclosure | Injection molded plastic enclosure | Similar |
| Pre-valve manifold
material | Machined aluminum | Brass | Similar |
| Integral pressure
regulator | None | Brass C36000 high-pressure components | Similar |
| Oxygen pressure
gauge | None | 0-300 PSI | Similar |
| Primary power
source | Low DC voltage external double insulated
medical grade power adapter | 2 "AA" disposable/rechargeable batteries
(user changeable) | Similar
Both the subject and predicate devices can be operated
using battery power. The subject device is designed to be
operated using an external DC power supply |
| Battery | Internal IEC 62133 certified rechargeable
backup battery (not user changeable) | 2 "AA" disposable/rechargeable batteries | Both the subject and predicate can operate on battery
power. |
| Battery life | Backup battery life > 30 minutes | 2 years | Battery life is different since the subject device is limited
to hospital settings, the length of backup battery power is
less critical.
Subject device battery is backup only (non-primary power
source) |
5
510(k) Summary Page 3 of 6
6
510(k) Summary Page 4 of 6
7
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:
8
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.