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.

AI/ML Overview

The provided text is a U.S. FDA 510(k) summary for a medical device called "Proxima". It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory clearance.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or algorithmic performance study, as typically seen for AI/ML-enabled devices.

The "acceptance criteria" section you're asking for typically refers to the pre-defined performance thresholds (e.g., minimum accuracy, sensitivity, specificity, or clinically relevant metrics) that an AI/ML algorithm must meet on a test set to be considered acceptable. The "study that proves the device meets the acceptance criteria" would detail the methodology of that study, including test set characteristics, ground truth establishment, expert involvement, and the actual performance metrics achieved by the device.

The provided document focuses on bench testing for the Proxima device, which is an oxygen conserving device, not an AI/ML diagnostic or prognostic tool. The performance testing mentioned (ISO 80601-2-67) evaluates physical parameters like pulse volume, breath rate, oxygen delivery, continuous flow, leak compensation, and breath trigger pressure. These are engineering and functional performance tests for a hardware device, not a performance study for an AI/ML algorithm.

Therefore, based solely on the provided text, I cannot extract the information required to populate your requested table and answer questions 1-9 about AI/ML device performance studies. The document describes a traditional medical device clearance, not an AI/ML device.

If the "Proxima" device were an AI/ML product, the information would typically be found in sections detailing clinical performance studies, often in the "Performance Data" or "Clinical Data" sections of a 510(k) summary, which are absent or not relevant in this document for the type of device described.

Summary

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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:Dynasthetics LLC3487 West 2100 South #300Salt Lake City, UT 84119Tel - 801-484-3820
Official Contact:	Joseph OrrPresident, Dynasthetics, LLC
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:Common/Usual Name:Classification CFR:Classification Code:Classification Name:	Proxima™ Model-100 Smart Supplemental Oxygen SystemOxygen Conserver21 CFR 868.5905NFBConserver, Oxygen
Predicate Device:Proprietary or Trade Name:Common/Usual Name:Classification CFR:Classification Code:Classification Name:	Inovo Evolution Electronic Oxygen Conserver, K113111Proxima™ Model-100 Smart Supplemental Oxygen SystemOxygen Conserver21 CFR 868.5905NFBConserver, Oxygen

Device Description:

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 ElectronicOxygen Conserver
Model	100	OM-900
510(k) Number	K220591	K113111
Deviceclassification andProduct Code	NFB868.5905	NFB868.5905
Indications for use	The Proxima is intended for prescription useonly, to be used for adult patients that requiresupplemental oxygen in a hospital setting.	The Inovo Evolution Motion is intended forprescription use only, to be used as part of aportable oxygen delivery system forpatients that require supplemental oxygenup to 7 liters per minute, in their home andfor ambulatory use.	SimilarThe indications for use are similar for the subject andpredicate devices. Both provide an option for continuousflow oxygen delivery and bolus inspiration only mode.The predicate device is designed to be used in a hospitalor at the patient's home. The subject device is designedto be used in a hospital setting only by trainedprofessionals.
Patient population	Any adult patient for whom supplementaloxygen is indicated	Any patient for whom up to 6 L/min ofoxygen has been prescribed	Similar
Environment foruse	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 lifesupporting.NOT INTENDED for use in patients whocannot maintain a patent airwayNOT INTENDED for applications requiringless than 1 L/min of supplemental oxygenNOT INTENDED for home use	Not to be used for life support applications.In addition, it is not intended for use bypatients who breathe more than 40 breathsper minute or who consistently fail totrigger the device. It is not to be used whileasleep.	SimilarThe predicate and the subject device both state that thedevices should not be used as life support devices.Subject device is not intended for home use.
Constant oxygenflow mode	1-15 L/pm	Continuous flow of 2 L/pm ± 0.5 L/pm	Similar
Pulsed oxygenmode	1, 2, 4, 6 10 and 15 L/min equivalent oxygenflowVolume of oxygen pulses are selected to equal40% of the set oxygen flow over one minute.Pulse volumes are adjusted according to the setoxygen flow rate and the time since theprevious pulse	1, 2, 3, 4, 5, 6 L/min equivalent oxygenflow	Subject device has the option to deliver higher oxygenflow 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 predicateFlow 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 rateBreath rate (Synchronized breath mode)	Set oxygen flow rate	Similar
Attribute	Subject Device	Predicate Device	Comments
Option forcontinuous flowwhen breaths notdetected	Yes, automaticIf inhalation is not detected after 15 seconds,mandatory continuous flow is automaticallygiven 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 patientinhalation	Negative inspiratory effort from patientinhalation	Similar
Trigger sensitivity	0.05 cm H2O	0.5 cm H2O	The subject device requires less pressure drop to triggerbreaths
Peak pulse oxygenflow	30 L/min	Unspecified	Similar
Continuous flowsettings	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 volumeselector	Similar function different technology
Housing	Injection molded plastic enclosure	Injection molded plastic enclosure	Similar
Pre-valve manifoldmaterial	Machined aluminum	Brass	Similar
Integral pressureregulator	None	Brass C36000 high-pressure components	Similar
Oxygen pressuregauge	None	0-300 PSI	Similar
Primary powersource	Low DC voltage external double insulatedmedical grade power adapter	2 "AA" disposable/rechargeable batteries(user changeable)	SimilarBoth the subject and predicate devices can be operatedusing battery power. The subject device is designed to beoperated using an external DC power supply
Battery	Internal IEC 62133 certified rechargeablebackup battery (not user changeable)	2 "AA" disposable/rechargeable batteries	Both the subject and predicate can operate on batterypower.
Battery life	Backup battery life > 30 minutes	2 years	Battery life is different since the subject device is limitedto hospital settings, the length of backup battery power isless critical.Subject device battery is backup only (non-primary powersource)

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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.

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).