Apogee

K200401 · Incoba Ltd D/B/A Dynaris · NFB · Nov 14, 2020 · Anesthesiology

Device Facts

• Record ID: K200401
• Device Name: Apogee
• Applicant: Incoba Ltd D/B/A Dynaris
• Product Code: NFB · Anesthesiology
• Decision Date: Nov 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Apogee is an ambulatory oxygen conserver; connects to high-pressure oxygen cylinders via bifurcated nasal cannula. Device uses two pressure sensors to detect inhalation in each nostril independently. Embedded processor analyzes nasal airflow to determine breath-to-breath bolus delivery; directs oxygen bolus to the most patent nostril. Operates on 3 AA batteries. Provides pulsed oxygen delivery; includes continuous flow bypass mode (3 Lpm) for backup. Used by patients in hospital, healthcare, or home care environments. Healthcare providers or patients monitor device via status indicators (on, low battery, no flow) and audible beeps. Improves patient mobility by extending cylinder duration compared to continuous flow regulators.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench testing, including bolus volume, flow, trigger sensitivity, and performance pre/post-cleaning. Device complies with AAMI ANSI ES 60601-1, IEC 60601-1-11, and IEC 60601-1-2 standards. Biocompatibility testing included VOC gas emission, particulate matter, inorganic gases, and toxicological risk assessment.

Technological Characteristics

Oxygen conserver; 146 x 72.3 x 39 mm; 321g. Powered by 3 AA batteries. Sensing: 2 pressure sensors. Connectivity: None. Software: Embedded processor. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-67. Ingress protection: IP22.

Indications for Use

Indicated for patients requiring supplemental oxygen. Used in hospital, healthcare, or home care settings.

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

• Inspired Technologies Model 350G (K090421)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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| 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)

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.

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)

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| Date Prepared: | 13-Nov-2020 |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| I<br>Submitter<br>Incoba, LLC d/b/a Dynaris<br>Spirit 40 Park Dr., Suite 260<br>Chesterfield, MO 63005<br>T – 636-778-1926 | |
| Sponsor Contact: | Lon Aylsworth, CEO |
| Submission Correspondent: | Paul Dryden<br>ProMedic, LLC |
| II Device | |
| Proprietary or Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code: | Apogee<br>Oxygen Conserver<br>Oxygen Conserver (21 CFR 868.5905)<br>II<br>NFB |
| III Predicate Device: | K090421 - Inspired Technologies Model 350G |

#### IV 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 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.

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#### V Indications for Use:

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.

#### 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.

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# K200401 510(k) Summary Page 3 of 5

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

| | Proposed<br>Apogee | Predicate<br>Inspired Technologies<br>Model 350G – K090421 | Comments |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Product Classification | NFB - conserver, oxygen<br>Regulation Description - Noncontinuous<br>ventilator (IPPB)<br>CFR 868.5905 | NFB - conserver, oxygen<br>Regulation Description - Noncontinuous<br>ventilator (IPPB)<br>CFR 868.5905 | Similar |
| Indications for Use | The Apogee is a gas conserver intended as a<br>delivery device for medical grade oxygen from<br>a high-pressure oxygen cylinders. Apogee is an<br>ambulatory device which allows patients to<br>ambulate longer than they would with<br>continuous flow regulator on the same cylinder.<br>The Apogee is intended to be used in the<br>hospital, healthcare facilities, or home care<br>environments. | The Inspired Technologies 350G Gas<br>Conserver is intended as a delivery medial-<br>grade device for oxygen from high-pressure<br>oxygen cylinders. This is an ambulatory<br>device, which allows patients to ambulate<br>longer than they would with a continuous<br>flow regulator on the same cylinder.<br>The 350G Gas Conserver is intended to be<br>used in the hospital, healthcare facilities, or<br>home care environments. | Similar |
| Environments of use | Hospital, healthcare facilities, or<br>home care environments | Hospital, healthcare facilities, or<br>home care environments | Similar |
| Population | Patients that require supplemental oxygen | Patients that require supplemental oxygen | |
| Prescriptive | Yes | Yes | Similar |
| Technology and<br>Principle of Operation | Delivers oxygen in a pulsed dose to the patient<br>by sensing inhalation. | Delivers oxygen in a pulsed dose to the<br>patient by sensing inhalation. | Similar technology |
| | Delivers oxygen via a user supplied nasal<br>cannula to either nostril | Delivers oxygen via nasal cannula to both<br>nostril | Different in delivery to the nostrils but<br>includes the use of 2 sensors for detecting<br>the start of a breath |
| | Uses 2 pressure sensors | Uses 2 pressure sensors | |
| Patient Oxygen Outlet<br>Pressure | 19-30 psig | 19-25 psig | Similar |
| Software driven | Yes | Yes | Similar |
| | Proposed<br>Apogee | Predicate<br>Inspired Technologies<br>Model 350G – K090421 | Comments |
| Dosing algorithm and<br>number of settings | 16 cc/lpm (accuracy not provided)<br>Setting (lpm)<br>1, 1.5, 2, 2.5, 3, 4, 5, 6 | 16 cc/lpm (accuracy not provided)<br>Setting (lpm)<br>1, 1.5, 2, 2.5, 3, 4, 5, 6<br>Sport modes | Similar dosing algorithm<br>Similar range of settings |
| Back-up mode | Continuous flow in by-pass – 3 Lpm | Continuous flow - 2 Lpm | Subject device does not have sport mode<br>Both have means for back-up mode |
| Power source | 3 – "AA" | 4 – "AA" | Similar |
| Status Indicators | Device "on"<br>Low battery<br>No flow<br>Audible beeps | Device "on" patient setting-valve activation<br>Battery status<br>No 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 cannula<br>Delivers oxygen to one nostril | Nasal Cannula<br>Delivers oxygen to both nostrils | Similar |
| Operating conditions | 5°C to 40°C<br>RH 15-90%<br>Atm Pressure range - 700 to 1060 hPa | N/A | Apogee complies with Home healthcare<br>environment requirements per IEC 60601-<br>1-11ed 2 |
| Size (LxWxH) mm | Size – 146 x 72.3 x 39 mm<br>Weight – 321 grams | Size – 152.4 x 101.6 x 88.9 mm<br>Weight - 630.5 grams | Apogee is smaller in size |
| Water Ingress | IP22 | IPX1 | Improved liquid Ingress capability. No<br>differences of safety or effectiveness. |
| Accessories | User supplied Nasal cannula, single patient,<br>multi-use | Nasal cannula, single patient, multi-use | Similar |
| Performance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-67 | Not applicable | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-67 |
| Biocompatibility | Externally communicating, Tissue<br>Duration – permanent | Externally communicating, Tissue<br>Duration - permanent | Similar |

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# K200401 510(k) Summary Page 4 of 5

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#### 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.