(270 days)
Not Found
No
The summary describes a device that senses airflow and makes a breath-to-breath determination based on dynamic changes. While this involves processing sensory input and making decisions, the description of the "Embedded Processor" and the performance studies (focused on mechanical, electrical, and software verification/validation) do not mention or suggest the use of AI or ML algorithms for this determination. The decision-making process appears to be based on pre-programmed logic rather than learned patterns.
No
The device is a gas conserver and delivery device for medical grade oxygen, which is a supportive rather than a therapeutic function.
No
The device description indicates it is a gas conserver intended as a delivery device for medical grade oxygen, sensing airflow to deliver oxygen. Its purpose is to provide supplemental oxygen, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a Control Unit, Control Board, and Embedded Processor, and the performance studies include electrical safety, EMC, and mechanical testing, indicating it is a physical device with embedded software, not a software-only device.
Based on the provided information, the Apogee device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Apogee is a "gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders." This describes a device used to deliver a substance to the body, not to perform tests on samples taken from the body.
- Device Description: The description details how the device senses airflow in the nostrils and delivers oxygen. This is a mechanism for delivering therapy, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) or detecting specific analytes.
- Performance Studies: The performance studies focus on aspects like biocompatibility, electrical safety, software validation, mechanical testing, and oxygen delivery performance. These are typical tests for a medical device that delivers a substance, not for an IVD.
In summary, the Apogee is a device for delivering oxygen to a patient, which falls under the category of a therapeutic or delivery device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NFB
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.
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
Not Found
Intended User / Care Setting
hospital, healthcare facilities, or home care environments.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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)
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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FORM FDA 3881 (7/17)
3
| Date Prepared: | 13-Nov-2020 |
|---|---|
| I | |
| Submitter | |
| Incoba, LLC d/b/a Dynaris | |
| Spirit 40 Park Dr., Suite 260 | |
| Chesterfield, MO 63005 | |
| T – 636-778-1926 | |
| Sponsor Contact: | Lon Aylsworth, CEO |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| II Device | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Regulatory Class: | |
| Product Code: | Apogee |
| Oxygen Conserver | |
| Oxygen Conserver (21 CFR 868.5905) | |
| II | |
| 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.
4
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.
5
K200401 510(k) Summary Page 3 of 5
Table 1 - Table of the Similarities and Differences of Predicate vs. Proposed Device
| | Proposed
Apogee | Predicate
Inspired Technologies
Model 350G – K090421 | Comments |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Product Classification | NFB - conserver, oxygen
Regulation Description - Noncontinuous
ventilator (IPPB)
CFR 868.5905 | NFB - conserver, oxygen
Regulation Description - Noncontinuous
ventilator (IPPB)
CFR 868.5905 | Similar |
| 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. | The Inspired Technologies 350G Gas
Conserver is intended as a delivery medial-
grade device for oxygen from high-pressure
oxygen cylinders. This is an ambulatory
device, which allows patients to ambulate
longer than they would with a continuous
flow regulator on the same cylinder.
The 350G Gas Conserver is intended to be
used in the hospital, healthcare facilities, or
home care environments. | Similar |
| Environments of use | Hospital, healthcare facilities, or
home care environments | Hospital, healthcare facilities, or
home care environments | Similar |
| Population | Patients that require supplemental oxygen | Patients that require supplemental oxygen | |
| Prescriptive | Yes | Yes | Similar |
| Technology and
Principle of Operation | Delivers oxygen in a pulsed dose to the patient
by sensing inhalation. | Delivers oxygen in a pulsed dose to the
patient by sensing inhalation. | Similar technology |
| | Delivers oxygen via a user supplied nasal
cannula to either nostril | Delivers oxygen via nasal cannula to both
nostril | Different in delivery to the nostrils but
includes the use of 2 sensors for detecting
the start of a breath |
| | Uses 2 pressure sensors | Uses 2 pressure sensors | |
| Patient Oxygen Outlet
Pressure | 19-30 psig | 19-25 psig | Similar |
| Software driven | Yes | Yes | Similar |
| | Proposed
Apogee | Predicate
Inspired Technologies
Model 350G – K090421 | Comments |
| Dosing algorithm and
number 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, 6
Sport modes | Similar dosing algorithm
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
Both have means for back-up mode |
| Power source | 3 – "AA" | 4 – "AA" | Similar |
| Status Indicators | Device "on"
Low battery
No flow
Audible beeps | Device "on" patient setting-valve activation
Battery status
No audible alarms | |
| Breath sensing |