(299 days)
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.
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 provided text describes the Ochsner Connected Inhaler Sensor, an accessory device to assist in recording and monitoring actuations of prescribed MDI usage. The document is a 510(k) summary for FDA clearance.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific acceptance criteria in a quantitative table format. Instead, it relies on demonstrating equivalence to a predicate device and adherence to general medical device standards. The "Comparison Table" provides a detailed comparison of technological characteristics between the Ochsner Connected Inhaler Sensor and its predicate device (Propeller System Model 2 OTC).
However, based on the "Test Summary" and "Software Testing" sections, the implied acceptance criteria revolve around:
- Compliance with Predetermined Specifications: The device must meet its own design specifications.
- Correct Functionality: The MDI actuation sensor system must accurately log data for MDI usage.
- Equivalence to Predicate Device: Performance should be equivalent to the predicate device.
- Adherence to Standards: Compliance with IEC 60601 series (electrical safety, EMC) and ISO 10993 series (biocompatibility).
- Wireless Technology Performance: Compliance with FDA's guidance on radio-frequency wireless technology and successful FCC licensing tests.
- Safety for OTC Use: No safety concerns for the proposed Over-The-Counter indication.
The table below summarizes the reported device performance in relation to these implied criteria:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| I. Functional Performance | |
| 1. Compliance with Predetermined Specifications | Test results indicate that the Ochsner Sensor complies with predetermined specifications. Software verification and validation testing confirms this result. The above testing confirms that the device is substantially equivalent to the predicate device. |
| 2. Correct Functionality (MDI actuation recording) | Performance testing of the MDI actuation sensor system ensured data is logged accurately for MDI usage. This established correct functionality of the Ochsner System according to the requirements. |
| 3. Equivalent Performance to Predicate Device | Technological characteristics are largely equivalent. The Ochsner System employs technological characteristics in a similar way to the predicate device. Verified and validated to establish equivalent performance. |
| 4. Wireless/Bluetooth Technology Performance | Successful performance testing for wireless/Bluetooth technology in accordance with specifications and "FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices". Tests required for FCC licensing were successful. |
| II. Safety & Compliance | |
| 5. Electrical Safety (IEC 60601-1) | The Ochsner Sensor has successfully completed patient safety testing according to IEC 60601-1. |
| 6. Electromagnetic Compatibility (IEC 60601-1-2) | The Ochsner Sensor has successfully completed EMC testing Compatibility according to IEC 60601-1-2. |
| 7. Biocompatibility (ISO 10993 series) | Third party testing for biocompatibility was completed by accredited laboratories. (Case Material - Patient Contact by Intact Skin (Hands) is Similar to predicate, even with different material (Silicon Rubber vs. Lexan polycarbonate), as both are biocompatible and meet ISO 10993). |
| 8. Safety for Over-The-Counter (OTC) Indication | Hazard Analysis for OTC included a review of existing hazards and how the patient interacts with the system (obtains, learns, registers, installs, uses, shares data, obtains help). No concerns of safety with the proposed OTC indication were found. |
| III. Software & Firmware Quality | |
| 9. Software/Firmware Development Process Compliance | 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". |
2. Sample size used for the test set and the data provenance
The document indicates "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." and "Performance Testing - Bench: The Ochsner System has successfully completed performance testing according to applicable standards and internal testing."
However, the specific sample size used for performance testing (test set) is not explicitly mentioned. The provenance of the data is also not specified beyond being "internal testing" and "third party testing." There is no indication of retrospective or prospective data collection from human subjects for these performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes device performance testing against engineering specifications and standards, not a diagnostic or interpretive task that would require expert-established ground truth for a test set in the same way a medical image analysis AI would. The "ground truth" for the MDI actuation sensor is the actual physical actuation of the inhaler, measured by the device itself or a reference system during bench testing.
4. Adjudication method for the test set
Not applicable. As noted above, the testing described is primarily engineering and performance verification against specifications, rather than a clinical interpretation task requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing: No clinical testing was required." The device is cleared based on substantial equivalence to a predicate device and non-clinical performance and safety testing. The device assists physicians and patients in recording and monitoring usage, rather than providing diagnostic interpretations that would typically be evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was conducted for the device's core functions. The "Software Testing" and "Performance Testing - Bench" sections indicate that the device's ability to log MDI usage accurately and its compliance with various standards (electrical safety, EMC, wireless technology) were evaluated independently. The device's primary function is to automatically record actuations, and this capability was tested on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing related to MDI actuation, the ground truth would likely be physical actuation events as detected by a controlled testing setup or a reference measurement system during bench testing. For compliance with standards like IEC 60601 and ISO 10993, the ground truth is adherence to the specific criteria outlined in those standards.
8. The sample size for the training set
Not applicable. This device is an electronic accessory sensor that detects physical inhaler actuations and transmits the data. It is not an AI/ML device that requires a "training set" in the conventional sense for learning algorithms (e.g., for image recognition or predictive analytics). Its software and firmware are developed and verified, but not "trained" on data in the same way an AI model would be.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The software and firmware are developed based on functional requirements and verified against those requirements.
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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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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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.
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510(k) Summary
| Prepared Date: | 8/28/23 |
|---|---|
| Submitter: | Ochsner Clinic Foundation1514 Jefferson HighwayNew Orleans, LA 70121 |
| Official Contact: | Hakm Murad, Ph.D.Biomedical Engineering Mgr.Ochsner Clinic Foundation1514 Jefferson HighwayNew Orleans, LA 701215048427785Hakm.murad@ochsner.org |
| Trade Name:Common Name:Classification Name:Classification Regulation:Product Code:Device Description:Predicate Device:Intended Use: | Ochsner Connected Inhaler SensorNebulizer AccessoryNebulizer21 CFR §868.5630CAFElectronic MDI AccessoryPropeller System Model 2 OTC K142516The Ochsner Connected Inhaler Sensor System includes the OchsnerConnected Inhaler Sensor. The Sensor is an accessory device intended forsingle-patient use to assist physicians and patients in recording andmonitoring actuations of prescribed MDI usage.The Ochsner Connected Inhaler Sensor Mobile Application records,stores, and transmits usage events from the Sensors to a remote storagesystem. With the Mobile Application, the user can review informationcollected from the Sensors and report and review symptoms and otherinformation about their disease management and its impact. The user mayalso share their information with their caregivers, physicians, and healthcare providers.When used with a prescribed MDI, the System can report on informationcaptured 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, theSystem can assist in the management of respiratory health symptoms andexacerbations 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, andclinical settings, as well as on aircraft. | |
| The System may also be used in clinical trials where researchers need toknow information about the use of MDI medications by a participant. | |
| The output of the System is not intended to diagnose or replace adiagnosis provided by a licensed physician. The System is not intendedfor use as an MDI or inhaled medication dose counter, nor is it intendedto indicate the quantity of medication remaining in an MDI or inhaledmedication. | |
| Technology Comparisonand Device Description: | The subject device uses technology similar to the predicate device,Propeller System Model 2 OTC, including Bluetooth wirelessconnectivity which connects to a similar mobile application. Like thepredicate device, the Ochsner Connected Inhaler Sensor has an enclosureto fit to inhalers and a button for detecting use. |
| Technological characteristics of the Ochsner System and the ComparisonPropeller System are largely equivalent. Similarities include theindications for use, basic principle of operation, data collectioninformation, time of data recording via internal clock, utilization ofsoftware for varying types of data review and modification,nonrechargable batteries, and the use of Bluetooth, low energy. TheOchsner System employs these technological characteristics in a similarway to the predicate device. | |
| By reviewing the recorded data displayed by the Ochsner System, thephysician or care provider can identify that a patient's state is worsening,and as a result, may choose to take action, such as contacting theirpatient. These aspects of the device have been verified and validated inorder to establish equivalent performance to the equivalent device. Thisinformation indicates that the Ochsner System is equivalent to thepredicate device in terms of device safety and effectiveness. |
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Comparison Table
| Technology Characteristics | Predicate Device: | Candidate Device: | Comparison |
|---|---|---|---|
| Propeller System,Propeller SensorModel 2 OTC | Ochsner ConnectedInhaler Sensor | N/A | |
| 510(k) Number: | 510(k) Number: | ||
| K142516 | K223367 | ||
| Prescription/OTC | OTC | ||
| Indications for Use | The PropellerSystem includes the | The OchsnerConnected Inhaler | Similar: TheOchsner |
| Propeller MDI | Sensor System | Connected | |
| Model 2 Sensor. Thesensor is anaccessory deviceintended for single-patient use to assistphysicians andpatients inrecording andmonitoring theactuations ofprescribed MDIusage. | includes the OchsnerConnected InhalerSensor. The Sensoris an accessorydevice intended forsingle-patient use toassist physicians andpatients in recordingand monitoringactuations ofprescribed MDIusage. | Inhaler | |
| System doesnot include aWebApplication.Thefunctionalitiesof the webapplicationare containedentirely withinthe Ochsner | |||
| Connected | |||
| The PropellerMobile Applicationrecords, stores, andtransmits usage | The OchsnerConnected InhalerSensor MobileApplication records,stores, and transmits | Inhaler | |
| Mobile | |||
| events fromPropeller Sensors,or via manual userentry, to a remotestorage system.With the PropellerMobile Applicationthe user can reviewinformationcollected from theMDI sensor, andreport and reviewsymptoms andother informationabout their diseasemanagement and itsimpact. The usermay also share theirinformation withtheir caregivers,physician, andhealthcareproviders. | usage events fromthe Sensors to aremote storagesystem. With theMobile Application,the user can reviewinformationcollected from theSensors and reportand reviewsymptoms and otherinformation abouttheir diseasemanagement and itsimpact. The usermay also share theirinformation withtheir caregivers,physicians, andhealth careproviders.When used with aprescribed MDI, theSystem can report oninformation captured | Applicationsince mobileapplication isnecessary fordevice use. Itwasdeterminedthat therewould be noincrease inrisk for usersfrom thischange.Otherwise theIFUs for bothproductscontain thesame purposefor thedevices,patientpopulations,and useenvironments. | |
| The Propeller WebApplication issoftware that, like | during the normal |
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| the PropellerMobile Application,is intended to allowusers to review thecollectedinformation andcharacteristics oftheir MDI and itsuse, to captureother patient-reportedinformation andoutcomes, and toallow thatinformation to beshared with theircaregivers,physicians, andhealth careproviders. | course of use, suchas the time betweenactuations, that canbe helpful inassessing MDItechnique.When used under thecare of a physicianwith a prescribedMDI, the System canassist in themanagement ofrespiratory healthsymptoms andexacerbations byproviding feedbackthrough reminders,notifications, andself-managementeducation. |
|---|---|
| When together witha prescribed MDI,the system canreport oninformationcaptured during thenormal course ofuse, such as thetime betweenactuations that canbe helpful inassessing MDItechnique. | The System isintended to be usedin populations fromChild (>2 years) toadult.The System can beused both indoorsand outdoors; home,work, and clinicalsettings, as well ason aircraft. |
| When together witha prescribed MDI,the system can beused to reduce thefrequency ofrespiratory healthsymptoms andexacerbations byincreasingadherence to MDI | The System mayalso be used inclinical trials whereresearchers need toknow informationabout the use of MDImedications by aparticipant.The output of theSystem is not |
| medicationsthrough the use offeedback such asreminders andnotifications, andself-managementeducation.The PropellerSystem is intendedto be used inpopulations fromChild (>2 years) toAdult.The PropellerSystem can be usedboth indoors andoutdoors; home,work, and clinicalsettings, as well ason aircraft.The PropellerSystem may also beused in clinicaltrials whereresearchers need toknow informationabout the use ofMDI medication(s)by a participant.The output of thePropeller System isnot intended todiagnose or replacea diagnosisprovided by alicensed physician.The PropellerSystem is notintended for use asan MDI dosecounter, nor is itintended to indicate | intended to diagnoseor replace adiagnosis providedby a licensedphysician. TheSystem is notintended for use asan MDI or inhaledmedication dosecounter, nor is itintended to indicatethe quantity ofmedicationremaining in an MDIor inhaledmedication. |
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| the quantity ofmedicationremaining in anMDI or inhaledmedication. | |||
|---|---|---|---|
| Design - Attachment toMedication Dispenser | Physically attachedto dispenser withoutinhibiting patient use | Physically attachedto dispenser withoutinhibiting patient use | Equivalent |
| Principle of Operation | Attaches to the top ofthe medicationcanister and performswireless uploading ofusage history of theinhaler | Attaches to the topof the medicationcanister andperforms wirelessuploading of usagehistory of the inhaler | Equivalent |
| Output Port and ComputerInterface | Wireless uploadingto database; viewedby PC or otherinternet-capabledevices | N/A | Different: Thecandidatedevice is notweb-based |
| Data Collection Technology | Records date andtime of MDI usagewith button pressswitch | Records date andtime of MDI usagewith button pressswitch | Equivalent |
| Mobile Platforms | iOS version 7 orhigherAndroid operatingsystem version 4.3 orhigher | iOS version 14 orhigherAndroid operatingsystem version 11 orhigher | Different: Thecandidatedevicesupports morerecentversions ofmobileplatforms |
| Required Off-the-ShelfHardware | Apple smartphonesor devices withBluetooth, iOS 7 orhigherAndroid smartphonesor devices withBluetoothInternet capabledevice; no processoror memory | Apple smartphonesor devices withBluetooth, iOS 14 orhigherAndroidsmartphones ordevices withBluetooth, version11 or higher | Similar: Thecandidatedevice onlyworks onmobile andthus onlyrequires appleand androidhardware. |
| 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 ifpaired with a Sensor | wireless device ifpaired with a Sensor | ||
| Keyboard/Input Interface | Dual buttoninterface: primarybutton and secondarybutton | Single buttoninterface | Similar: Thecandidatedevice alsouses buttonsas input, butonly 1. |
| Digital Display | No | No | Equivalent |
| Power Source | Single 3V DC Li-ionbattery | Single 3V DC Li-ionbattery | Equivalent |
| Battery Life | 1.5 years | 1 year | Similar |
| Low Battery Indicator | Yes, lightcombination;software display ofbattery life | Software displaysbattery life, no ondevice indicator | Similar:Candidatedevice onlyuses softwareto displaybattery, whilethe predicatealso has alight-basedindicator |
| Patient Reminder | Yes | Yes | Equivalent |
| Support | Yes | Yes | Equivalent |
| Patient Data Storage withSoftware | Yes | Yes | Equivalent |
| Patient Data ReportGeneration with Software | Yes | Yes | Equivalent |
| Patient Data GraphsGeneration | Yes | Yes | Equivalent |
| Data Retrieval from Devicewith Software | Yes | Yes | Equivalent |
| Case Material - PatientContact by Intact Skin(Hands) | Lexan polycarbonate | Silicon Rubber | Different: Thecandidatedevice uses adifferent butalsobiocompatiblecase material |
| Electrical Safety | IEC 60601 | IEC 60601 | Equivalent |
| Biocompatibility | ISO 10993 | ISO 10993 | Equivalent |
| Sterility | Non sterile | Non sterile | Equivalent |
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| Test Summary: | Test results indicate that the Ochsner Sensor and its predicate PropellerSensor Model comply with predetermined specifications. Softwareverification and validation testing confirms this result. |
|---|---|
| Software Testing: | Non-clinical testing has been carried out to cover functional verificationand device performance. This included completion of software verificationand validation procedures, with performance testing of the MDI actuationsensor system to ensure data is logged accurately for MDI usage. Thisestablished correct functionality of the Ochsner System according to therequirements. Third party testing of the Ochsner System for compliance toIEC 60601 series standards for general safety and electromagneticcompatibility and ISO 10993 series standards for biocompatibility wascompleted by accredited laboratories prior to this submission. Complete,detailed reports are included in the application for clearance; summaryinformation is included below. |
| Software Testing: | The above testing confirms that the device is substantially equivalent tothe predicate device.Software and Firmware for the Ochsner System was designed anddeveloped according to a robust software development process alignedwith "Design Control Guidance for Medical Device Manufacturers" "TheGuidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices", "Guidance for Off the Shelf Software Usein 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 itspredetermined specifications. |
| Electrical Safety Testing: | The Ochsner Sensor has successfully completed patient safety testingaccording to IEC 60601-1. |
| Electrical CompatibilityTesting: | The Ochsner Sensor has successfully completed EMC testingCompatibility according to IEC 60601-1-2. |
| Performance Testing -Bench: | The Ochsner System has successfully completed performance testingaccording to applicable standards and internal testing. Important tohighlight in this summary, is the successful performance testing that wascompleted for wireless/Bluetooth technology in accordance withspecifications and also with, "FDA's Guidance on Radio-FrequencyWireless Technology in Medical Devices". In addition, tests required forFCC licensing were successful. |
| Clinical Testing: | No clinical testing was required. |
| Hazard Analysis forOTC: | Hazard Analysis for OTC included a review of existing hazards as well ashow the patient obtains and learns about the system, registers for thesystem, installs the sensor, uses the Ochsner System to track MDImedication use, shares data with their physician/care team and obtainshelp & support with OTC labeling. No concerns of safety with theproposed 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.
§ 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).