(299 days)
Propeller System Model 2 OTC K142516
Not Found
No
The summary describes a system for recording and monitoring inhaler usage and providing feedback based on this data. There is no mention of AI or ML being used for analysis, prediction, or complex pattern recognition. The functions described are data logging, transmission, review, and simple feedback like reminders and notifications.
No.
The device is described as an "accessory device" that records and monitors actuations of prescribed MDI usage and assists in the management of respiratory health symptoms and exacerbations by providing feedback. It specifically states, "The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication." This indicates it does not directly treat or diagnose.
No
The text explicitly states: "The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician." It is used to record and monitor inhaler usage and assist in managing respiratory health symptoms, not to diagnose a condition.
No
The device description explicitly states the system includes the "Ochsner Connected Inhaler Sensor," which is described as an "accessory device." The performance studies also detail testing of this sensor, including safety, EMC, and biocompatibility, indicating it is a physical hardware component.
Based on the provided information, the Ochsner Connected Inhaler Sensor System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to assist in recording and monitoring MDI usage, reporting on usage events, and providing feedback for managing respiratory health symptoms. It explicitly states that the output is not intended to diagnose or replace a diagnosis.
- Device Description: The description reinforces the intended use as an accessory for tracking MDI usage and providing information to the user and healthcare providers.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimens.
The device's function is to track the mechanical action of an inhaler and provide data and feedback related to that usage, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers.
When used with a prescribed MDL, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The System is intended to be used in populations from Child (>2 years) to adult.
The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.
The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor. The Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers.
When used with a prescribed MDI, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
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
Child (>2 years) to adult
Intended User / Care Setting
physicians and patients; home, work, and clinical settings, as well as on aircraft.
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)
Software Testing: Non-clinical testing has been carried out to cover functional verification and device performance. This included completion of software verification and validation procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the Ochsner System according to the requirements.
Electrical Safety Testing: The Ochsner Sensor has successfully completed patient safety testing according to IEC 60601-1.
Electrical Compatibility Testing: The Ochsner Sensor has successfully completed EMC testing Compatibility according to IEC 60601-1-2.
Performance Testing - Bench: The Ochsner System has successfully completed performance testing according to applicable standards and internal testing. Important to highlight in this summary, is the successful performance testing that was completed for wireless/Bluetooth technology in accordance with specifications and also with, "FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices". In addition, tests required for FCC licensing were successful.
Clinical Testing: No clinical testing was required.
Hazard Analysis for OTC: Hazard Analysis for OTC included a review of existing hazards as well as how the patient obtains and learns about the system, registers for the system, installs the sensor, uses the Ochsner System to track MDI medication use, shares data with their physician/care team and obtains help & support with OTC labeling. No concerns of safety with the proposed OTC indication were found.
Conclusion: Hardware testing carried out for the Ochsner System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Ochsner System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, and wireless technology in medical devices.
Based upon this comparison of the predicate, and the accompanying testing results for the Ochsner Connected Inhaler Sensor, the Ochsner System is substantially equivalent to the predicate device.
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.
Propeller System Model 2 OTC K142516
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Ochsner Clinic Foundation Hakm Murad Bioengineer 1514 Jefferson Hwy New Orleans, Louisiana 70121
Re: K223367
Trade/Device Name: Ochsner Connected Inhaler Sensor Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 10, 2023 Received: July 25, 2023
Dear Hakm Murad:
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
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,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223367
Device Name Ochsner Connected Inhaler Sensor
Indications for Use (Describe)
The Ochsner Connected Inhaler Sensor System includes the Ochsner Connected Inhaler Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring actuations of prescribed MDI usage.
The Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Sensors to a remote storage system. With the Mobile Application, the user can review information collected from the Sensors and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physicians, and health care providers.
When used with a prescribed MDL, the System can report on information captured during the normal course of use, such as the time between actuations, that can be helpful in assessing MDI technique.
When used under the care of a physician with a prescribed MDI, the System can assist in the management of respiratory health symptoms and exacerbations by providing feedback through reminders, notifications, and self-management education.
The System is intended to be used in populations from Child (>2 years) to adult.
The System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.
The System may also be used in clinical trials where researchers need to know information about the use of MDI medications by a participant.
The output of the System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
| Prepared Date: | 8/28/23 |
|---|---|
| Submitter: | Ochsner Clinic Foundation |
| 1514 Jefferson Highway | |
| New Orleans, LA 70121 | |
| Official Contact: | Hakm Murad, Ph.D. |
| Biomedical Engineering Mgr. | |
| Ochsner Clinic Foundation | |
| 1514 Jefferson Highway | |
| New Orleans, LA 70121 | |
| 5048427785 | |
| Hakm.murad@ochsner.org | |
| Trade Name: | |
| Common Name: | |
| Classification Name: | |
| Classification Regulation: | |
| Product Code: | |
| Device Description: | |
| Predicate Device: | |
| Intended Use: | Ochsner Connected Inhaler Sensor |
| Nebulizer Accessory | |
| Nebulizer | |
| 21 CFR §868.5630 | |
| CAF | |
| Electronic MDI Accessory | |
| Propeller System Model 2 OTC K142516 | |
| The Ochsner Connected Inhaler Sensor System includes the Ochsner | |
| Connected Inhaler Sensor. The Sensor is an accessory device intended for | |
| single-patient use to assist physicians and patients in recording and | |
| monitoring actuations of prescribed MDI usage. | |
| The Ochsner Connected Inhaler Sensor Mobile Application records, | |
| stores, and transmits usage events from the Sensors to a remote storage | |
| system. With the Mobile Application, the user can review information | |
| collected from the Sensors and report and review symptoms and other | |
| information about their disease management and its impact. The user may | |
| also share their information with their caregivers, physicians, and health | |
| care providers. | |
| When used with a prescribed MDI, the System can report on information | |
| captured during the normal course of use, such as the time between | |
| actuations, that can be helpful in assessing MDI technique. | |
| When used under the care of a physician with a prescribed MDI, the | |
| System can assist in the management of respiratory health symptoms and | |
| exacerbations by providing feedback through reminders, notifications, | |
| and self-management education. | |
| The System is intended to be used in populations from Child (>2 years) | |
| to adult. | |
| The System can be used both indoors and outdoors; home, work, and | |
| clinical settings, as well as on aircraft. | |
| The System may also be used in clinical trials where researchers need to | |
| know information about the use of MDI medications by a participant. | |
| The output of the System is not intended to diagnose or replace a | |
| diagnosis provided by a licensed physician. The System is not intended | |
| for use as an MDI or inhaled medication dose counter, nor is it intended | |
| to indicate the quantity of medication remaining in an MDI or inhaled | |
| medication. | |
| Technology Comparison | |
| and Device Description: | The subject device uses technology similar to the predicate device, |
| Propeller System Model 2 OTC, including Bluetooth wireless | |
| connectivity which connects to a similar mobile application. Like the | |
| predicate device, the Ochsner Connected Inhaler Sensor has an enclosure | |
| to fit to inhalers and a button for detecting use. | |
| Technological characteristics of the Ochsner System and the Comparison | |
| Propeller System are largely equivalent. Similarities include the | |
| indications for use, basic principle of operation, data collection | |
| information, time of data recording via internal clock, utilization of | |
| software for varying types of data review and modification, | |
| nonrechargable batteries, and the use of Bluetooth, low energy. The | |
| Ochsner System employs these technological characteristics in a similar | |
| way to the predicate device. | |
| By reviewing the recorded data displayed by the Ochsner System, the | |
| physician or care provider can identify that a patient's state is worsening, | |
| and as a result, may choose to take action, such as contacting their | |
| patient. These aspects of the device have been verified and validated in | |
| order to establish equivalent performance to the equivalent device. This | |
| information indicates that the Ochsner System is equivalent to the | |
| predicate device in terms of device safety and effectiveness. |
5
Comparison Table
| Technology Characteristics | Predicate Device: | Candidate Device: | Comparison |
|---|---|---|---|
| Propeller System, | |||
| Propeller Sensor | |||
| Model 2 OTC | Ochsner Connected | ||
| Inhaler Sensor | N/A | ||
| 510(k) Number: | 510(k) Number: | ||
| K142516 | K223367 | ||
| Prescription/OTC | OTC | ||
| Indications for Use | The Propeller | ||
| System includes the | The Ochsner | ||
| Connected Inhaler | Similar: The | ||
| Ochsner | |||
| Propeller MDI | Sensor System | Connected | |
| Model 2 Sensor. The | |||
| sensor is an | |||
| accessory device | |||
| intended for single- | |||
| patient use to assist | |||
| physicians and | |||
| patients in | |||
| recording and | |||
| monitoring the | |||
| actuations of | |||
| prescribed MDI | |||
| usage. | includes the Ochsner | ||
| Connected Inhaler | |||
| Sensor. The Sensor | |||
| is an accessory | |||
| device intended for | |||
| single-patient use to | |||
| assist physicians and | |||
| patients in recording | |||
| and monitoring | |||
| actuations of | |||
| prescribed MDI | |||
| usage. | Inhaler | ||
| System does | |||
| not include a | |||
| Web | |||
| Application. | |||
| The | |||
| functionalities | |||
| of the web | |||
| application | |||
| are contained | |||
| entirely within | |||
| the Ochsner | |||
| Connected | |||
| The Propeller | |||
| Mobile Application | |||
| records, stores, and | |||
| transmits usage | The Ochsner | ||
| Connected Inhaler | |||
| Sensor Mobile | |||
| Application records, | |||
| stores, and transmits | Inhaler | ||
| Mobile | |||
| events from | |||
| Propeller Sensors, | |||
| or via manual user | |||
| entry, to a remote | |||
| storage system. | |||
| With the Propeller | |||
| Mobile Application | |||
| the user can review | |||
| information | |||
| collected from the | |||
| MDI sensor, and | |||
| report and review | |||
| symptoms and | |||
| other information | |||
| about their disease | |||
| management and its | |||
| impact. The user | |||
| may also share their | |||
| information with | |||
| their caregivers, | |||
| physician, and | |||
| healthcare | |||
| providers. | usage events from | ||
| the Sensors to a | |||
| remote storage | |||
| system. With the | |||
| Mobile Application, | |||
| the user can review | |||
| information | |||
| collected from the | |||
| Sensors and report | |||
| and review | |||
| symptoms and other | |||
| information about | |||
| their disease | |||
| management and its | |||
| impact. The user | |||
| may also share their | |||
| information with | |||
| their caregivers, | |||
| physicians, and | |||
| health care | |||
| providers. | |||
| When used with a | |||
| prescribed MDI, the | |||
| System can report on | |||
| information captured | Application | ||
| since mobile | |||
| application is | |||
| necessary for | |||
| device use. It | |||
| was | |||
| determined | |||
| that there | |||
| would be no | |||
| increase in | |||
| risk for users | |||
| from this | |||
| change. | |||
| Otherwise the | |||
| IFUs for both | |||
| products | |||
| contain the | |||
| same purpose | |||
| for the | |||
| devices, | |||
| patient | |||
| populations, | |||
| and use | |||
| environments. | |||
| The Propeller Web | |||
| Application is | |||
| software that, like | during the normal |
6
7
| the Propeller
Mobile Application,
is intended to allow
users to review the
collected
information and
characteristics of
their MDI and its
use, to capture
other patient-
reported
information and
outcomes, and to
allow that
information to be
shared with their
caregivers,
physicians, and
health care
providers. | course of use, such
as the time between
actuations, that can
be helpful in
assessing MDI
technique.
When used under the
care of a physician
with a prescribed
MDI, the System can
assist in the
management of
respiratory health
symptoms and
exacerbations by
providing feedback
through reminders,
notifications, and
self-management
education. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When together with
a prescribed MDI,
the system can
report on
information
captured during the
normal course of
use, such as the
time between
actuations that can
be helpful in
assessing MDI
technique. | The System is
intended to be used
in populations from
Child (>2 years) to
adult.
The System can be
used both indoors
and outdoors; home,
work, and clinical
settings, as well as
on aircraft. |
| When together with
a prescribed MDI,
the system can be
used to reduce the
frequency of
respiratory health
symptoms and
exacerbations by
increasing
adherence to MDI | The System may
also be used in
clinical trials where
researchers need to
know information
about the use of MDI
medications by a
participant.
The output of the
System is not |
| medications
through the use of
feedback such as
reminders and
notifications, and
self-management
education.
The Propeller
System is intended
to be used in
populations from
Child (>2 years) to
Adult.
The Propeller
System can be used
both indoors and
outdoors; home,
work, and clinical
settings, as well as
on aircraft.
The Propeller
System may also be
used in clinical
trials where
researchers need to
know information
about the use of
MDI medication(s)
by a participant.
The output of the
Propeller System is
not intended to
diagnose or replace
a diagnosis
provided by a
licensed physician.
The Propeller
System is not
intended for use as
an MDI dose
counter, nor is it
intended to indicate | intended to diagnose
or replace a
diagnosis provided
by a licensed
physician. The
System is not
intended for use as
an MDI or inhaled
medication dose
counter, nor is it
intended to indicate
the quantity of
medication
remaining in an MDI
or inhaled
medication. |
8
9
| | the quantity of
medication
remaining in an
MDI or inhaled
medication. | | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Design - Attachment to
Medication Dispenser | Physically attached
to dispenser without
inhibiting patient use | Physically attached
to dispenser without
inhibiting patient use | Equivalent |
| Principle of Operation | Attaches to the top of
the medication
canister and performs
wireless uploading of
usage history of the
inhaler | Attaches to the top
of the medication
canister and
performs wireless
uploading of usage
history of the inhaler | Equivalent |
| Output Port and Computer
Interface | Wireless uploading
to database; viewed
by PC or other
internet-capable
devices | N/A | Different: The
candidate
device is not
web-based |
| Data Collection Technology | Records date and
time of MDI usage
with button press
switch | Records date and
time of MDI usage
with button press
switch | Equivalent |
| Mobile Platforms | iOS version 7 or
higher
Android operating
system version 4.3 or
higher | iOS version 14 or
higher
Android operating
system version 11 or
higher | Different: The
candidate
device
supports more
recent
versions of
mobile
platforms |
| Required Off-the-Shelf
Hardware | Apple smartphones
or devices with
Bluetooth, iOS 7 or
higher
Android smartphones
or devices with
Bluetooth
Internet capable
device; no processor
or memory | Apple smartphones
or devices with
Bluetooth, iOS 14 or
higher
Android
smartphones or
devices with
Bluetooth, version
11 or higher | Similar: The
candidate
device only
works on
mobile and
thus only
requires apple
and android
hardware. |
| | requirements (see Required Browser) | | |
| Required Browser | Firefox, Chrome, Safari, Internet Explorer | N/A | Different: The candidate device is not web-based |
| Mobile Application | Propeller Health Mobile Application records, stores, and transmits usage events from the Propeller Health Sensor via a feature or smartphone and can be used to review the information captured when using a smartphone | Ochsner Connected Inhaler Sensor Mobile Application records, stores, and transmits usage events from the Ochsner Connected Inhaler Sensor via a feature or smartphone and can be used to review the information captured when using a smartphone | Equivalent |
| Software | The Propeller Health Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed. | N/A, not web based. But the mobile application allows the user to share information with their provider and add other details related to their condition for which their MDI medication(s) are prescribed. | Different: The candidate device is not web based. But its mobile application allows the user to share information with their provider and add other details related to their condition for which their MDI medication(s) are prescribed. |
| Dose Counter | No | No | Equivalent |
| Records Usage | Yes | Yes | Equivalent |
| Records Location of Usage (GPS Coordinates) | Geographic coordinates can be | Geographic coordinates can be | Equivalent |
| | wireless device if
paired with a Sensor | wireless device if
paired with a Sensor | |
| | | | |
| Keyboard/Input Interface | Dual button
interface: primary
button and secondary
button | Single button
interface | Similar: The
candidate
device also
uses buttons
as input, but
only 1. |
| Digital Display | No | No | Equivalent |
| Power Source | Single 3V DC Li-ion
battery | Single 3V DC Li-ion
battery | Equivalent |
| Battery Life | 1.5 years | 1 year | Similar |
| Low Battery Indicator | Yes, light
combination;
software display of
battery life | Software displays
battery life, no on
device indicator | Similar:
Candidate
device only
uses software
to display
battery, while
the predicate
also has a
light-based
indicator |
| Patient Reminder | Yes | Yes | Equivalent |
| Support | Yes | Yes | Equivalent |
| Patient Data Storage with
Software | Yes | Yes | Equivalent |
| Patient Data Report
Generation with Software | Yes | Yes | Equivalent |
| Patient Data Graphs
Generation | Yes | Yes | Equivalent |
| Data Retrieval from Device
with Software | Yes | Yes | Equivalent |
| Case Material - Patient
Contact by Intact Skin
(Hands) | Lexan polycarbonate | Silicon Rubber | Different: The
candidate
device uses a
different but
also
biocompatible
case material |
| Electrical Safety | IEC 60601 | IEC 60601 | Equivalent |
| Biocompatibility | ISO 10993 | ISO 10993 | Equivalent |
| Sterility | Non sterile | Non sterile | Equivalent |
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11
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| Test Summary: | Test results indicate that the Ochsner Sensor and its predicate Propeller
Sensor Model comply with predetermined specifications. Software
verification and validation testing confirms this result. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Testing: | Non-clinical testing has been carried out to cover functional verification
and device performance. This included completion of software verification
and validation procedures, with performance testing of the MDI actuation
sensor system to ensure data is logged accurately for MDI usage. This
established correct functionality of the Ochsner System according to the
requirements. Third party testing of the Ochsner System for compliance to
IEC 60601 series standards for general safety and electromagnetic
compatibility and ISO 10993 series standards for biocompatibility was
completed by accredited laboratories prior to this submission. Complete,
detailed reports are included in the application for clearance; summary
information is included below. |
| | |
| Software Testing: | The above testing confirms that the device is substantially equivalent to
the predicate device.
Software and Firmware for the Ochsner System was designed and
developed according to a robust software development process aligned
with "Design Control Guidance for Medical Device Manufacturers" "The
Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices", "Guidance for Off the Shelf Software Use
in Medical Devices", and verified and validated using guidance from the
"General Principles of Software Validation" as recommended by FDA.
Test results indicate that the Ochsner System complies with its
predetermined specifications. |
| Electrical Safety Testing: | The Ochsner Sensor has successfully completed patient safety testing
according to IEC 60601-1. |
| Electrical Compatibility
Testing: | The Ochsner Sensor has successfully completed EMC testing
Compatibility according to IEC 60601-1-2. |
| Performance Testing -
Bench: | The Ochsner System has successfully completed performance testing
according to applicable standards and internal testing. Important to
highlight in this summary, is the successful performance testing that was
completed for wireless/Bluetooth technology in accordance with
specifications and also with, "FDA's Guidance on Radio-Frequency
Wireless Technology in Medical Devices". In addition, tests required for
FCC licensing were successful. |
| Clinical Testing: | No clinical testing was required. |
| Hazard Analysis for
OTC: | Hazard Analysis for OTC included a review of existing hazards as well as
how the patient obtains and learns about the system, registers for the
system, installs the sensor, uses the Ochsner System to track MDI
medication use, shares data with their physician/care team and obtains
help & support with OTC labeling. No concerns of safety with the
proposed OTC indication were found. |
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- Hardware testing carried out for the Ochsner System indicates it meets Conclusion: design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Ochsner System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, and wireless technology in medical devices.
Based upon this comparison of the predicate, and the accompanying testing results for the Ochsner Connected Inhaler Sensor, the Ochsner System is substantially equivalent to the predicate device.