(559 days)
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
The SpiroHome Ultrasonic Spirometer's acceptance criteria and performance are detailed in comparison to predicate and reference devices, and through various performance, electrical, and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (from Subject Device - SpiroHome) | Reported Device Performance (from Subject Device - SpiroHome) |
|---|---|---|
| Functional Requirements | ATS 2019 / ERS waveform simulator testing | Meets |
| ISO 26782:2009 | Meets | |
| ISO 23747:2015 | Meets | |
| High Altitude Performance | Meets | |
| Flow Resistance | Meets | |
| Electrical Requirements | AAMI ANSI ES 60601-1 | Meets |
| IEC 60601-1-11 | Meets | |
| IEC 60601-1-2 | Meets | |
| Biocompatibility | ISO 10993-1 | Meets |
| (Contact Type & Duration: | ISO 10993-3 | Meets |
| Surface Contact, Mucosa, | ISO 10993-5 | Meets |
| Externally Communicating, | ISO 10993-10 | Meets |
| Tissue; permanent (>30 days)) | ISO 10993-11 | Meets |
| ISO/FDIS 18562-1 | Meets | |
| ISO/FDIS 18562-2 | Meets | |
| ISO/FDIS 18562-3 | Meets | |
| Shipping Requirements, | ASTM D4332 | Meets |
| Packaging and Distribution | ASTM D7386 | Meets |
| ASTM F1886/F1886M | Meets | |
| ISO 17664 | Meets | |
| ISO 11737-1 | Meets | |
| Cleaning | ISO 17664 | Meets |
| AAMI TIR30 | Meets | |
| AAMI TIR12 | Meets | |
| ASTM E2314 | Meets | |
| ISO 15883-1 | Meets | |
| ISO 11737-1 | Meets | |
| ISO/TS 15883-5 | Meets | |
| Software and System | Guidance for the Content of Premarket Submissions for | Meets |
| Verification and Validation | Software Contained in Medical Devices | |
| IEC 62304 | Meets | |
| Human Factors Study | Guidance for Applying Human Factors and Usability | Meets |
| Engineering to Medical Devices | ||
| AAMI/ANSI HE75:2009 | Meets | |
| ANSI/AAMI/IEC 62366-1:2015 | Meets | |
| Volume Range & Accuracy | 0-10 L, ± 2.5% or ± 0.050 L | Conforms to permissible margins in ATS guidelines and ISO 286782 |
| Flow Range & Accuracy | 0 - 14 L/s, ±10% or ± 170 mL/s | Conforms to permissible margins in ISO 286782 |
Note: The document states "Meets" for all listed performance and safety standards, implying the device successfully passed the tests conducted against these criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for any specific test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The performance data seems to be based on compliance with established standards (e.g., ATS, ERS, ISO) rather than expert-established ground truth from a test set of patient data.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it appears to rely on objective testing against technical and safety standards rather than expert consensus on diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study focuses on demonstrating substantial equivalence through technical and performance comparisons with predicate and reference devices, and by meeting various regulatory standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
The document does not specifically detail a standalone algorithm-only performance study. The performance testing section outlines functional, electrical, biocompatibility, shipping, cleaning, software, and human factors tests. For a device like a spirometer, "standalone" performance typically refers to the accuracy of its physical measurements and calculations, which are covered by the functional and electrical requirements. The software verification and validation would also assess the algorithm's performance.
7. The Type of Ground Truth Used:
For the technical performance of the device (e.g., volume and flow accuracy), the ground truth appears to be based on internationally accepted performance standards and guidelines, such as ATS guidelines and ISO 286782. For other aspects like electrical safety and biocompatibility, the ground truth is adherence to the specified IEC, AAMI, and ISO standards.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document refers to the device's technological characteristics and its compliance with standards, not typically a "training set" in the machine learning sense for a diagnostic device that performs direct physiological measurements.
9. How the Ground Truth for the Training Set Was Established:
As there's no mention of a training set for an AI/ML algorithm in the context of this traditional medical device submission, the method for establishing ground truth for a training set is not applicable or provided. The device's operation is based on ultrasonic sensor technology and PFT equations, not a learning algorithm that requires a labeled training set.
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June 12, 2023
Inofab Saglik Teknolojileri A.S % Ray Kelly Consultant Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach, Florida 32168
Re: K213754
Trade/Device Name: SpiroHome Ultrasonic SpiroHome Clinic, SpiroHome Personal Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: January 17, 2023 Received: January 23, 2023
Dear Ray Kelly:
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,
Rachana Visaria -S
Rachana Visaria, 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) K213754
Device Name
SpiroHome Ultrasonic Spirometer, SpiroHome Clinic, SpiroHome Personal
Indications for Use (Describe)
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 21 CFR 807.92
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
l. Submitter Information
Submitter Name:
| Inofab Health Sağlik Teknolojileri A.SÜniversiteler Mahallesi,İhsan Doğramacı Bulvarı,ODTÜ Teknokent Silikon Blok No:17/115,06800 Çankaya/Ankara, Türkiye | |
|---|---|
| Phone: | +90 312 988 03 08 |
| Contact Person: | Ray Kelly |
| Date Prepared: | June 09, 2023 |
II. Device Information:
| Name of Device: | SpiroHome Ultrasonic Spirometer,SpiroHome Clinic, SpiroHome Personal |
|---|---|
| Common Name: | Spirometer |
| Classification Name: | Diagnostic Spirometer (21 CFR 868.1840) |
| Regulatory Class: | II |
| Product Code: | BZG |
III. Predicate Device:
GoSpiro, K163249
IV. Reference Device:
EasyOne Air Spirometer, K161536
V. Device Description
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are
İnofab Sağlık Teknolojileri A.Ş. Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 ODTÜ Teknokent Silikon Blok Çankaya / ANKARA +90 312 988 0 308 info@inofab.health · wwwinofab.health F-129 R.00 / 2022.08.25
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obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
VI. Indication for Use:
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
VII. Comparison of technological characteristics with the predicate and reference device:
The subject device has the same spirometry functions with the same test types, test parameters and utilize the same interpretation algorithms as the predicate device, however, the ultrasonic sensor technology used in the subject device is different to that of the predicate device which utilizes a turbine-based sensor. The subject device has the same technological characteristics with regards to spirometry testing as the reference device, in particular the same sensor technology is used for spirometry testing. The differences in sensor measurement technology do not raise concerns of safety and effectiveness for the subject device.
The subject device and predicate device both use Bluetooth-connected devices as displays in comparison to the reference device which has a touch-enabled display on the device. Each model of the subject device operates with its own respective application version whereas the predicate device has only one application with which it operates.
The subject device and predicate device both use off-the-shelf standard batteries whereas the reference device uses a rechargeable battery pack.
Each model of the subject device is used with its own respective mouthpiece model. The personal model of the subject device is used with a reusable mouthpiece and the clinic model is used with a disposable mouthpiece. The predicate device mouthpiece is constructed from both reusable and disposable components, and the reference device is used only with disposable mouthpieces. Design verification and validation demonstrates that the SpiroHome spirometer used in combination with the SpiroWay mouthpiece provides the same spirometry test results as the predicate and reference devices used in combination with their respective mouthpieces and is therefore substantially equivalent to the predicate and reference devices.
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Table 1. Comparison of subject device attributes to predicate device and reference device
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
|---|---|---|---|---|
| Indications for Use | Intended to be used byadults and childrenover 5 years oldin physician's offices,clinics and homesetting to conductbasic lung function andspirometry testing. | Intended to be used byadults and childrenover 5 years old inphysician's offices,clinics and homesettings to conductbasic lung function andspirometry testing. It isa single-patientuse device. | The EasyOne Airspirometer is intendedfor prescription use onlyto conduct diagnosticspirometry testing ofadults and pediatricpatients over 4 yearsold. The EasyOne Airspirometer is used bygeneral practitioners,specialists, and healthcare professionals, inhospitals and clinics, inpharmacies, and inclinical settings inoccupational medicine. | Identical forsubject andpredicate. |
| Common Name | Spirometer, Diagnostic | Spirometer, Diagnostic | Spirometer, Diagnostic | Identical |
| Regulation | 868.1840 | 868.1840 | 868.1840 | Identical |
| Product Code | BZG | BZG | BZG | Identical |
| Classification | II | II | II | Identical |
| Review Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical |
| Intended User | HCP or patient | HCP or patient | HCP | Identical forsubject andpredicate. |
| Environment of Use | Clinic or home | Clinic or home | Clinic | Identical forsubject andpredicate. |
| Principle ofOperation | Spirometer is designedfor pulmonary functiontests. It is a portablespirometer capable ofgenerating PulmonaryFunction Test (PFT)data based on the airflow and volume. The | Spirometer is designedfor pulmonary functiontests. It is a portablespirometer capable ofgenerating PulmonaryFunction Test (PFT)data based on the airflow and volume. The | Spirometer is designedfor pulmonary functiontests. It is a portablespirometer capable ofgenerating PulmonaryFunction Test (PFT)data based on the airflow and volume The | Identical forsubject andpredicate andsimilar toreference device. |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| device measures apatient's lung functionvalues and compares itto their predictedvalues (obtainedfrom internationallyaccepted lung functiontest equations). Theportable spirometerpairs to smart devicesrunning the associatedapps. | device measures apatient's lung functionvalues and compares itto their predictedvalues (obtained frominternationally acceptedlung function testequations). Theportable spirometerpairs to smart devicesrunning the associatedapps. | device measures apatient's lung functionvalues and compares itto their predicted values(obtainedfrom internationallyaccepted lung functiontest equations). Theportable spirometer hason-device screendisplay. | ||
| Conditions of Use | Spirometer is availablefor home use or clinicaluse. Clinic use isindicated for healthcareprofessionals (HCPs)to use with patients(pediatric between theages of 5-21 and adultsover the age of 21) whomay havebeen diagnosed with achronicpulmonary disease.Clinic use is intendedto be used in a clinicalsetting multiple times aday by multiplepatients. The homeuser, after it isprescribed by aclinical/professional,will be used by patientsat home. Home usersare (pediatric betweenthe ages of 5-21 andadults over the age of | Spirometer is availablefor home use or clinicaluse. Clinic use isindicated for healthcareprofessionals (HCPs)to use with patients(pediatric between theages of 5-21 and adultsover the age of 21) whomay have beendiagnosed with achronic pulmonarydisease. Clinic use isintended to be used ina clinical settingmultiple times a day bymultiple patients. Thehome user, after it isprescribed by aclinical/professional,will be used by patientsat home. Home usersare (pediatric betweenthe ages of 5-21 andadults over the age of21) who may have | Spirometer isavailable for onlyclinical use. Clinic useis indicatedfor healthcareprofessionals (HCPs)to use with patients(pediatric between theages of 4-21 andadults over the age of21) who may havebeen diagnosed witha chronic pulmonarydisease. Clinic use isintended to be used ina clinical settingmultiple times a dayby multiple patients.Users need to interactwith the device toassemble the device byinserting batteries,turning on the device,and go through thedevice set up | Identical forsubject andpredicate. |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| 21) who may havebeen diagnosed witha chronic pulmonarydisease. Patients ortheir careproviders/legalguardians will use thedevice multiple timesa day by a singlepatient. Users needto interact with thedevice to assemble thedevice by insertingbatteries, turning onthe device, and gothrough the device setup procedure in theapp. Users thenperform spirometry testby breathing into thedevice andreceive feedback ontheir performancethough the app. Userswill clean the deviceas instructed. | been diagnosed with achronicpulmonary disease.Patients or their careproviders/legalguardians will usethe device multipletimes a day by asingle patient. Usersneed to interact withthe device to assemblethe device byinserting batteries,turning on the device,and go through thedevice set upprocedure in the app.Users then performspirometry testby breathing into thedevice andreceive feedback ontheir performancethough the app. Userswill clean the deviceas instructed. | procedure. Users thenperform a spirometrytest by breathing intothe device andreceive feedback ontheir performancethough the app. Userswill clean the deviceas instructed. | ||
| Software | Mobile Medical App(MMA) | Mobile Medical App(MMA) | Mobile Medical App(MMA) | Identical |
| Software LOC | Moderate | Moderate | Moderate | Identical |
| Bluetooth | Yes | Yes | Yes | Identical |
| Used with PFT filter and / or mouthpiece | Mouthpiece Disposableor Reusable | Mouthpiece Disposableand MouthportReusable | Mouthpiece Disposable | Similar for subjectand predicate.Predicatemouthpiece has areusable(mouthport) anddisposablecomponent and is |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| Configuration | Hand-held, portable | Hand-held, portable | Hand-held, portable | Identical |
| PatientPopulation | Over 5 years old | Over 5 years old | Over 4 years old | Identical forsubject andpredicate. |
| SensorTechnology | Transit-time Ultrasound | Turbine | Transit-time Ultrasound | Identical forsubject andreference device. |
| Recalibration | Not required | Required | Not required | Identical forsubject andreference. |
| MeasuredParameters | FVC, FEV0.75,FEV1, FEV3,FEV6,FEV0.75/FVC,FEV1/FVC,FEV3/FVC,FEV6/FVC, PEF | FVC, FEV0.75, FEV1,FEV3, FEV6,FEV0.75/FVC,FEV1/FVC, FEV3/FVC,FEV6/FVC, PEF,MMEF, FEF25, FEF50,FEF75, FEF25-75 | *BEV, EOTV, FEF10,FEF25, FEF25-75,FEF25-75/FVC,FEF40, FEF50,FEF50/FVC, FEF60,FEF75, FEF80, FET, | Similar parametersfor subject,predicate andreference devices.Differences donot affect the safeand effective usefor single- patientuse. Subjectdevice hasreusablemouthpiece forhome use and adisposablemouthpiece forclinic use, both arefor single-patientuse. Referencedevice has only asingle-patientdisposablemouthpiece. Noconcerns raisedregarding subjectdevice safety oreffectiveness dueto mouthpiecedifferences. |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| MMEF, FEF25,FEF50, FEF75, FEF25-75,MET25-75,FEV0.75/FEV6, FEV1/FEV6,FEF50/FVC,MMEF/FVC, FET, BEV,FIV1, FIVC, PIF,FIF25-75, FIV1/FIVC,R50 (FEF50/FIF50),VC, VCin, VCex, ERV, IRV, IC, Rf,VT, MVV, MVV6,MVVtime | FIV1, FIVC,PIF, FIF25-75, FIF25,FIF50, FIF75, MET25-75, FEV0.75/FEV6,FEV1/FEV6,FEF50/FVC, FIV1/FIVC, R50(FEF50/FIF50), FET,MVV | FET25-75, FEV.25,FEV.5,FEV.5/FVC, FEV.75,FEV.75/FVC, FEV1,FEV1/FEV6,FEV1/FIV1,FEV1/FVC,FEV3, FEV3/FVC,FEV6, FIF25, FIF50,FIF50/FEF50, FIF75,FIV.25, FIV.5, FIV1,FVC, FVC6, FVC,FVC6, MEF20,MEF25, MEF40,MEF50,MEF60, MEF75,MEF90, MIF25, MIF50,MIF75, MMEF, PEF,PEFT, t0, MVV, MVV6,MVVtime, Rf, ERV, IC,IRV, Rf, VC, VCex,VCin, VCmax, VT | of the subjectdevice. | |
| Power | 2 x AAA Alkaline andRechargeableBatteries | Rechargeable lithium-ion batteries | Rechargeable batterypack | The difference inpower sourcesbetween devicesdoes not raiseconcerns of safetyor effectiveness ofthe subject deviceas validated by theelectrical safety,performance, andEMC testing. |
| Air Resistance | 48.54 Pa*s/L(Highest ExpiratoryImpedance) | 137 Pa*s/L | *0.3 cm H2O/L/s at 16L/s | Differences indynamic airresistancebetween devicesbased on design |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| Volume Range & Accuracy | 0-10 L,± 2.5% or ± 0.050 L | 0-8 L,± 3% or ± 0.050 L | ±12 L,±2% or 0.050 L | Differencebetween volumerange andaccuracybetween devicesare minor, thesubject devicemeets permissiblemargins given inATS guidelinesand ISO 286782. |
| Flow Range & Accuracy | 0 - 14 L/s,±10% or ± 170 mL/s | 0 - 14 L/s,±5% or 200 mL/s | ±16 L/s±2% or 0.020 L/s(except PEF)*±5% or 0.200 L/s PEFaccuracy | Differencebetween flowrange andaccuracybetween devicesare minor, thesubject deviceconforms topermissiblemargins given inISO 286782. |
| DisplayType/Size | Mobile app | Mobile app | Touch-enabled displayon device | Identical forsubject andpredicate devices. |
| Flow-Volume Loop | During test and testreview | During test and testreview | *During test and testreview | Identical |
| Volume-Time Curve | During test and testreview | During test and testreview | *During test and testreview | Identical |
| Dimensions W x D x H | 110mm x 40.8m x63.3mm | 88.9mm x 114.3mm x50mm | *87mm x 155mm x36mm | Subject device issmaller in overallvolume than both |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| predicate andreference devices.Difference in sizedoes not raiseconcerns forsubject devicesafety andeffectiveness asdemonstrated inusability andperformance tests. | ||||
| Weight | 90g (with batteries) | 300g (with batteries) | *356 g (with batteries) | Subject deviceweighs less thanboth predicate andreference devices.Difference inweight does notraise concerns forsubject devicesafety andeffectiveness asdemonstrated inusability andperformance tests. |
| Connection to patient | Mouthpiece | Mouthpiece | Mouthpiece | Identical |
| StorageTemperature | -20°C to 60°C | *-20°C to 70°C | *-20°C to 50°C | Minor differences.Differences do notaffect the safetyand effectivenessof the subjectdevice asdemonstrated inproduct testing. |
| StorageHumidity (RH) | 5% to 85% | 15% to 95% | *5% to 90% | Minor differences.Differences do notaffect the safetyand effectiveness |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| OperationalTemperature | 15°C to 35°C | 17°C to 35°C | *0°C to 40°C | of the subjectdevice asdemonstrated inproduct testing.Minor differences.Differences do notaffect the safetyand effectivenessof the subjectdevice asdemonstrated inproduct testing. |
| OperationalHumidity (RH) | 30% to 85% | 30% to 75% | *5% to 90% | Minor differences.Differences do notaffect the safetyand effectivenessof the subjectdevice asdemonstrated inproduct testing. |
| ExpectedService Life | 5 years | Not Provided | *7 years | Similar for subjectand referencedevice, differencedoes not affect thesafety oreffectiveness ofthe subjectdevice. |
| Water IngressProtection | IP22 | IP22 | Not Provided | Identical forsubject andpredicate. |
| Electrical safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Meets IEC 60601-1 | Identical |
| EMC safety | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Identical |
| Home use | Meets IEC 60601-1-11 | Meets IEC 60601-1-11 | Not Provided | Identical forsubject andpredicate device. |
| Biocompatibility | Meets ISO 10993-1,ISO 10993-5, ISO | Meets ISO 10993-1,ISO 10993-5 | ISO 10993-1, ISO10993-5, ISO 10993-10 | Subject, predicateand reference |
| Attribute | Subject DeviceSpirohome | Predicate DeviceGoSpiro (K163249) | Reference Device(K161536) | Similarities /Differences |
| 10993-10, ISO 10993-11, ISO 18562- 1, ISO18562-2, ISO 18562-3,USP 43-NF 38 (2020)<85> and EP2.6.14 (EP 10.3) | ISO 10993-10, VolatileOrganicCompounds (VOC),CO, CO2, Ozone, andPM2.5 testing | ISO 10993-18,ISO/FDIS 18562-2,ISO/FDIS 18562-3 | devices meetrequirements ofISO 10993-1 andISO 18562-1.Subject devicealso meetspyrogen and LALtestingrequirements. |
İnofab Sağlık Teknolojileri A.Ş. Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 ODTÜ Teknokent Silikon Blok Çankaya / ANKARA +90 312 988 0 308 · info@inofab.health · wwwinofab.health F-129 R.00 / 2022.08.25
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VII. PERFORMANCE DATA
The SpiroHome Ultrasonic Spirometer was tested against criteria for:
- · Functional Requirements
- ATS 2019 / ERS waveform simulator testing o
- ISO 26782:2009 o
- ISO 23747:2015 O
- High Altitude Performance O
- O Flow Resistance
- · Electrical Requirements
- o AAMI ANSI ES 60601-1
- O IEC 60601-1-11
- IEC 60601-1-2 o
- Biocompatibility
Contact Type and Duration: Surface Contact, Mucosa, Externally Communicating, Tissue; permanent (>30 days)
- ISO 10993-1 O
- ISO 10993-3 o
- ISO 10993-5 O
- O ISO 10993-10
- ISO 10993-11 O
- ISO/FDIS 18562-1 O
- ISO/FDIS 18562-2 o
- ISO/FDIS 18562-3 ೧
- · Shipping Requirements, Packaging and Distribution
- ASTM D4332 o
- ASTM D7386 O
- ASTM F1886/F1886M O
- ISO 17664 O
- ISO 11737-1 o
- · Cleaning
- ISO 17664 O
- AAMI TIR30 O
- AAMI TIR12 o
- ASTM E2314 O
- ISO 15883-1 O
- O ISO 11737-1
- ISO/TS 15883-5 O
- Software and System Verification and Validation
- Guidance for the Content of Premarket Submissions for Software Contained in o Medical Devices
- IEC 62304 o
- Human Factors Study
- Guidance for Applying Human Factors and Usability Engineering to Medical Devices o
- AAMI/ANSI HE75:2009 O
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ANSI/AAMI/IEC 62366-1:2015 O
VIII. CONCLUSIONS
Based upon the foregoing performance testing and comparison to the legally marketed predicate device, and reference device, for indications for use, technology, and performance, we believe we have demonstrated that the Spirometer is substantially equivalent to the predicate device.
İnofab Sağlık Teknolojileri A.Ş. Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 ODTÜ Teknokent Silikon Blok Çankaya / ANKARA +90 312 988 0 308 info@inofab.health · wwwinofab.health o F-129 R.00 / 2022.08.25
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).