The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.

Device Description

The proposed device, Apogee, senses each nostril independently through a bifurcated cannula and responds to the dynamic changes in nasal air-flow making a breath-to-breath determination of where to deliver the next bolus of oxygen: to the left, the right, or both nostrils. The Apogee Device is composed of the main components as detailed below: Control Unit, Control Board (Regulated Voltage Supply), Embedded Processor, User supplied Demand Cannula, The Apogee Bypass Cannula and Restrictor and Cylinder Tubing.

AI/ML Overview

This document is an FDA 510(k) summary for the Apogee oxygen conserver. It describes the device, its intended use, and compares it to a predicate device (Inspired Technologies Model 350G). The information provided focuses on the device's design, technology, and non-clinical performance testing rather than clinical study results involving human patients or complex AI algorithms with specific performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details) are not applicable or not present in this type of regulatory document concerning a mechanical-electronic medical device like an oxygen conserver. The "performance data" section primarily refers to engineering and safety bench testing, not clinical performance studies with diagnostic accuracy targets for AI.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Apogee Oxygen Conserver

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing. It does not contain specific "acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) for an AI algorithm. Instead, the "acceptance criteria" are implied by compliance with recognized standards and comparable performance to the predicate device in bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI, mechanical-electronic device, the acceptance criteria are not typically expressed as diagnostic accuracy metrics. Instead, they relate to engineering specifications and performance in bench testing to ensure safety and effectiveness comparable to the predicate. The document highlights the following:

Acceptance Criteria (Implied by Standards/Predicate Comparison)	Reported Device Performance	Comments
Electrical Safety & EMC Compliance(e.g., AAMI ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2)	Complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012, IEC 60601-1-11, and IEC 60601-1-2: 2014.	Demonstrated compliance with relevant electrical safety and electromagnetic compatibility standards.
Software Verification & Validation(for "moderate" level of concern software)	Verification and validation testing conducted.	Software testing completed for safety and functionality.
Mechanical Integrity & Durability(e.g., storage, aging, drop, durability)	Testing performed related to storage, effects of aging, drop, and durability.	Device withstands expected physical stresses.
Biocompatibility(for patient-contacting materials - permanent duration)	Testing included: - Gas emission VOC- Particulate Matter (PM2.5)- Inorganic gases CO, CO2 and Ozone- Toxicological Risk Assessment	Materials are safe for patient contact.
Oxygen Bolus Delivery Equivalence(compared to predicate, volume and time)	Bench testing demonstrated that both devices (Apogee and predicate) delivered an equivalent amount of oxygen bolus to the patient in the same time.	Key functional performance matched the predicate.
Trigger Sensitivity(compared to predicate)	Bench testing performed, details not quantified but implied comparable to predicate (-0.3 cmH2O for Apogee vs. +0.03 to -0.2 cmH2O for predicate).	Demonstrated a similar ability to sense patient inhalation.
Volume Flow Performance	Bench testing performed.	Functional flow characteristics validated.
Performance Pre- and Post-Cleaning	Bench testing performed.	Device maintains performance after cleaning.
Breath Range Capability(e.g., up to 35 BPM for predicate)	Apogee: Up to 40 BPM	Apogee performs across a relevant physiological breath rate range, slightly better than predicate.
Patient Oxygen Outlet Pressure(e.g., 19-25 psig for predicate)	Apogee: 19-30 psig	Comparable and within safe operating range.
Water Ingress Protection(e.g., IPX1 for predicate)	Apogee: IP22	Improved liquid ingress capability (IP22 for Apogee vs. IPX1 for predicate). No differences in safety or effectiveness found due to this improvement.

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical bench tests and compliance assessments against recognized industry standards, rather than a diagnostic accuracy or comparative effectiveness study involving human subjects or AI-assisted diagnostic tasks.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in terms of patient data. The "test set" refers to physical units of the device tested in a lab setting. The number of units tested is not provided, but it would typically be a small number of engineering samples.
Data Provenance: Not applicable in the context of patient data. This involves laboratory bench testing of physical device units, not patient data sets. The testing was presumably conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. Ground truth for an oxygen conserver's performance in bench testing is based on engineering specifications, calibrated measurement equipment, and industry standards, not expert interpretation of medical images or clinical data.
Qualifications of Experts: Not applicable. The "ground truth" for this device's performance is objective measurement against engineering specifications.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This is not a study where human interpretations are being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No. This type of study is typically performed for diagnostic devices (e.g., imaging AI) where human readers' performance is evaluated with and without an AI assist. This document concerns a therapeutic mechanical device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance: The "software" in this device controls the mechanical function (sensing breath and delivering oxygen bolus). Its "standalone performance" is implicitly assessed through the bench testing described (e.g., bolus delivery accuracy, trigger sensitivity). It's not a diagnostic algorithm with standalone performance metrics like sensitivity/specificity.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for this device's performance is based on engineering specifications, physical measurements from calibrated instruments, and compliance with recognized national and international standards for medical device safety and performance (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-11, ISO 80601-2-67).

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is a non-AI mechanical device. The "software" mentioned is embedded control software, not a machine learning model that requires a training set in the conventional sense of AI development.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable. As there's no machine learning training set, no such ground truth establishment occurred. The control logic for the device's functions (e.g., breath sensing, oxygen delivery) is derived from engineering design principles, physiological understanding, and validated algorithms for precise control, not from a data-driven training process.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

November 14, 2020

Incoba Ltd. d/b/a Dynaris % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K200401

Trade/Device Name: Apogee Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NFB Dated: October 19, 2020 Received: October 20, 2020

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,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Apogee

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| XX Prescription Use (Part 21 CFR 801 Subpart D)

| | 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."

FORM FDA 3881 (7/17)

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

Date Prepared:	13-Nov-2020
ISubmitterIncoba, LLC d/b/a DynarisSpirit 40 Park Dr., Suite 260Chesterfield, MO 63005T – 636-778-1926
Sponsor Contact:	Lon Aylsworth, CEO
Submission Correspondent:	Paul DrydenProMedic, LLC
II Device
Proprietary or Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:	ApogeeOxygen ConserverOxygen Conserver (21 CFR 868.5905)IINFB
III Predicate Device:	K090421 - Inspired Technologies Model 350G

IV Device Description:

The Apogee Device is composed of the main components as detailed below:

. Control Unit The control unit will house the main control electronics and interface ports that are needed to perform oxygen conservation. The main components of the control unit are: AA batteries, main control board with an embedded processor, ON/Off switch, cannula interface tube and oxygen regulator.
Control Board (Regulated Voltage Supply) ● The control board contains a microprocessor and circuitry to take the input voltages from three (3) AA batteries to provide all the regulated voltages for the Apogee Device.
. Embedded Processor The embedded processor is the master controller of the Apogee Device.
User supplied Demand Cannula The user supplies a standard bifurcated nasal cannula.
The Apogee Bypass Cannula and Restrictor and Cylinder Tubing
- The Apogee Bypass Cannula is to be used in a Continuous mode and connects to o one end of the Apogee Bypass Cannula restrictor.

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

V Indications for Use:

VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 is a comparison - Subject Device vs. the Predicate including technological characteristics and performance.

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

K200401 510(k) Summary Page 3 of 5

Table 1 - Table of the Similarities and Differences of Predicate vs. Proposed Device

	ProposedApogee	PredicateInspired TechnologiesModel 350G – K090421	Comments
Product Classification	NFB - conserver, oxygenRegulation Description - Noncontinuousventilator (IPPB)CFR 868.5905	NFB - conserver, oxygenRegulation Description - Noncontinuousventilator (IPPB)CFR 868.5905	Similar
Indications for Use	The Apogee is a gas conserver intended as adelivery device for medical grade oxygen froma high-pressure oxygen cylinders. Apogee is anambulatory device which allows patients toambulate longer than they would withcontinuous flow regulator on the same cylinder.The Apogee is intended to be used in thehospital, healthcare facilities, or home careenvironments.	The Inspired Technologies 350G GasConserver is intended as a delivery medial-grade device for oxygen from high-pressureoxygen cylinders. This is an ambulatorydevice, which allows patients to ambulatelonger than they would with a continuousflow regulator on the same cylinder.The 350G Gas Conserver is intended to beused in the hospital, healthcare facilities, orhome care environments.	Similar
Environments of use	Hospital, healthcare facilities, orhome care environments	Hospital, healthcare facilities, orhome care environments	Similar
Population	Patients that require supplemental oxygen	Patients that require supplemental oxygen
Prescriptive	Yes	Yes	Similar
Technology andPrinciple of Operation	Delivers oxygen in a pulsed dose to the patientby sensing inhalation.	Delivers oxygen in a pulsed dose to thepatient by sensing inhalation.	Similar technology
	Delivers oxygen via a user supplied nasalcannula to either nostril	Delivers oxygen via nasal cannula to bothnostril	Different in delivery to the nostrils butincludes the use of 2 sensors for detectingthe start of a breath
	Uses 2 pressure sensors	Uses 2 pressure sensors
Patient Oxygen OutletPressure	19-30 psig	19-25 psig	Similar
Software driven	Yes	Yes	Similar
	ProposedApogee	PredicateInspired TechnologiesModel 350G – K090421	Comments
Dosing algorithm andnumber of settings	16 cc/lpm (accuracy not provided)Setting (lpm)1, 1.5, 2, 2.5, 3, 4, 5, 6	16 cc/lpm (accuracy not provided)Setting (lpm)1, 1.5, 2, 2.5, 3, 4, 5, 6Sport modes	Similar dosing algorithmSimilar range of settings
Back-up mode	Continuous flow in by-pass – 3 Lpm	Continuous flow - 2 Lpm	Subject device does not have sport modeBoth have means for back-up mode
Power source	3 – "AA"	4 – "AA"	Similar
Status Indicators	Device "on"Low batteryNo flowAudible beeps	Device "on" patient setting-valve activationBattery statusNo audible alarms
Breath sensing	< -0.3 cmH2O	+0.03 to -0.2 cmH2O	Similar
Breath range	Up to 40 BPM	Up to 35 BPM	Similar
Patient interface	User supplied bifurcated nasal cannulaDelivers oxygen to one nostril	Nasal CannulaDelivers oxygen to both nostrils	Similar
Operating conditions	5°C to 40°CRH 15-90%Atm Pressure range - 700 to 1060 hPa	N/A	Apogee complies with Home healthcareenvironment requirements per IEC 60601-1-11ed 2
Size (LxWxH) mm	Size – 146 x 72.3 x 39 mmWeight – 321 grams	Size – 152.4 x 101.6 x 88.9 mmWeight - 630.5 grams	Apogee is smaller in size
Water Ingress	IP22	IPX1	Improved liquid Ingress capability. Nodifferences of safety or effectiveness.
Accessories	User supplied Nasal cannula, single patient,multi-use	Nasal cannula, single patient, multi-use	Similar
Performance	IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-67	Not applicable	IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-67
Biocompatibility	Externally communicating, TissueDuration – permanent	Externally communicating, TissueDuration - permanent	Similar

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

K200401 510(k) Summary Page 4 of 5

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

VII Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility - The materials in patient contact are considered Externally communicating / Tissue Permanent duration of use. The testing included:

Gas emission VOC ●
. Particulate Matter (PM2.5)
Inorganic gases CO, CO2 and Ozone ●
Toxicological Risk Assessment

Electrical Safety and EMC

Electrical safety and EMC testing were conducted on the subject device. The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-1-11 standards for safety and IEC 60601-1-2: 2014 for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted. The software for this device was considered as a "moderate" level of concern.

Mechanical, Animal, and Clinical Testing

Testing related to storage, effects of aging, drop and durability were performed. There were no animal or clinical testing was performed.

Bench Testing

Bench testing was performed to verify the performance to specifications of the proposed device and the predicate. Testing demonstrated that both devices delivered an equivalent amount of oxygen bolus to the patient in the same time. Testing included: Bolus, Volume Flow, Trigger sensitivity, performance pre- and post-cleaning.

VIII Conclusions

Discussion of Differences -

The proposed device differs from the predicate which delivers the both nostrils where not all oxygen is entrained to the lungs as one nostril make be restricted. Whereas the subject device delivers the same total size bolus only to the nostril that the pressure sensors senses as patent, delivering the same bolus to the most patent nostril.

Substantial Equivalence Conclusion

The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be 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).