SpiroHome Personal, SpiroHome Clinic

{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. 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 {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, 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 {2}------------------------------------------------ # 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) | | |-------------------------------------------------|-------------| | <div></div> | <div></div> | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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.S<br>Üniversiteler Mahallesi,<br>İhsan Doğramacı Bulvarı,<br>ODTÜ Teknokent Silikon Blok No:17/115,<br>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,<br>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 {4}------------------------------------------------ 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. {5}------------------------------------------------ Table 1. Comparison of subject device attributes to predicate device and reference device | Attribute | Subject Device<br>Spirohome | Predicate Device<br>GoSpiro (K163249) | Reference Device<br>(K161536) | Similarities /<br>Differences | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Intended to be used by<br>adults and children<br>over 5 years old<br>in physician's offices,<br>clinics and home<br>setting to conduct<br>basic lung function and<br>spirometry testing. | Intended to be used by<br>adults and children<br>over 5 years old in<br>physician's offices,<br>clinics and home<br>settings to conduct<br>basic lung function and<br>spirometry testing. It is<br>a single-patient<br>use device. | The EasyOne Air<br>spirometer is intended<br>for prescription use only<br>to conduct diagnostic<br>spirometry testing of<br>adults and pediatric<br>patients over 4 years<br>old. The EasyOne Air<br>spirometer is used by<br>general practitioners,<br>specialists, and health<br>care professionals, in<br>hospitals and clinics, in<br>pharmacies, and in<br>clinical settings in<br>occupational medicine. | Identical for<br>subject and<br>predicate. | | 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 for<br>subject and<br>predicate. | | Environment of Use | Clinic or home | Clinic or home | Clinic | Identical for<br>subject and<br>predicate. | | Principle of<br>Operation | Spirometer is designed<br>for pulmonary function<br>tests. It is a portable<br>spirometer capable of<br>generating Pulmonary<br>Function Test (PFT)<br>data based on the air<br>flow and volume. The | Spirometer is designed<br>for pulmonary function<br>tests. It is a portable<br>spirometer capable of<br>generating Pulmonary<br>Function Test (PFT)<br>data based on the air<br>flow and volume. The | Spirometer is designed<br>for pulmonary function<br>tests. It is a portable<br>spirometer capable of<br>generating Pulmonary<br>Function Test (PFT)<br>data based on the air<br>flow and volume The | Identical for<br>subject and<br>predicate and<br>similar to<br>reference device. | | Attribute | Subject Device<br>Spirohome | Predicate Device<br>GoSpiro (K163249) | Reference Device<br>(K161536) | Similarities /<br>Differences | | | device measures a<br>patient's lung function<br>values and compares it<br>to their predicted<br>values (obtained<br>from internationally<br>accepted lung function<br>test equations). The<br>portable spirometer<br>pairs to smart devices<br>running the associated<br>apps. | device measures a<br>patient's lung function<br>values and compares it<br>to their predicted<br>values (obtained from<br>internationally accepted<br>lung function test<br>equations). The<br>portable spirometer<br>pairs to smart devices<br>running the associated<br>apps. | device measures a<br>patient's lung function<br>values and compares it<br>to their predicted values<br>(obtained<br>from internationally<br>accepted lung function<br>test equations). The<br>portable spirometer has<br>on-device screen<br>display. | | | Conditions of Use | Spirometer is available<br>for home use or clinical<br>use. Clinic use is<br>indicated for healthcare<br>professionals (HCPs)<br>to use with patients<br>(pediatric between the<br>ages of 5-21 and adults<br>over the age of 21) who<br>may have<br>been diagnosed with a<br>chronic<br>pulmonary disease.<br>Clinic use is intended<br>to be used in a clinical<br>setting multiple times a<br>day by multiple<br>patients. The home<br>user, after it is<br>prescribed by a<br>clinical/professional,<br>will be used by patients<br>at home. Home users<br>are (pediatric between<br>the ages of 5-21 and<br>adults over the age of | Spirometer is available<br>for home use or clinical<br>use. Clinic use is<br>indicated for healthcare<br>professionals (HCPs)<br>to use with patients<br>(pediatric between the<br>ages of 5-21 and adults<br>over the age of 21) who<br>may have been<br>diagnosed with a<br>chronic pulmonary<br>disease. Clinic use is<br>intended to be used in<br>a clinical setting<br>multiple times a day by<br>multiple patients. The<br>home user, after it is<br>prescribed by a<br>clinical/professional,<br>will be used by patients<br>at home. Home users<br>are (pediatric between<br>the ages of 5-21 and<br>adults over the age of<br>21) who may have | Spirometer is<br>available for only<br>clinical use. Clinic use<br>is indicated<br>for healthcare<br>professionals (HCPs)<br>to use with patients<br>(pediatric between the<br>ages of 4-21 and<br>adults over the age of<br>21) who may have<br>been diagnosed with<br>a chronic pulmonary<br>disease. Clinic use is<br>intended to be used in<br>a clinical setting<br>multiple times a day<br>by multiple patients.<br>Users need to interact<br>with the device to<br>assemble the device by<br>inserting batteries,<br>turning on the device,<br>and go through the<br>device set up | Identical for<br>subject and<br>predicate. | | Attribute | Subject Device<br>Spirohome | Predicate Device<br>GoSpiro (K163249) | Reference Device<br>(K161536) | Similarities /<br>Differences | | | 21) who may have<br>been diagnosed with<br>a chronic pulmonary<br>disease. Patients or<br>their care<br>providers/legal<br>guardians will use the<br>device multiple times<br>a day by a single<br>patient. Users need<br>to interact with the<br>device to assemble the<br>device by inserting<br>batteries, turning on<br>the device, and go<br>through the device set<br>up procedure in the<br>app. Users then<br>perform spirometry test<br>by breathing into the<br>device and<br>receive feedback on<br>their performance<br>though the app. Users<br>will clean the device<br>as instructed. | been diagnosed with a<br>chronic<br>pulmonary disease.<br>Patients or their care<br>providers/legal<br>guardians will use<br>the device multiple<br>times a day by a<br>single patient. Users<br>need to interact with<br>the device to assemble<br>the device by<br>inserting batteries,<br>turning on the device,<br>and go through the<br>device set up<br>procedure in the app.<br>Users then perform<br>spirometry test<br>by breathing into the<br>device and<br>receive feedback on<br>their performance<br>though the app. Users<br>will clean the device<br>as instructed. | procedure. Users then<br>perform a spirometry<br>test by breathing into<br>the device and<br>receive feedback on<br>their performance<br>though the app. Users<br>will clean the device<br>as instructed. | | | Software | Mobile Medical App<br>(MMA) | Mobile Medical App<br>(MMA) | Mobile Medical App<br>(MMA) | Identical | | Software LOC | Moderate | Moderate | Moderate | Identical | | Bluetooth | Yes | Yes | Yes | Identical | | Used with PFT filter and / or mouthpiece | Mouthpiece Disposable<br>or Reusable | Mouthpiece Disposable<br>and Mouthport<br>Reusable | Mouthpiece Disposable | Similar for subject<br>and predicate.<br>Predicate<br>mouthpiece has a<br>reusable<br>(mouthport) and<br>disposable<br>component and is | | Attribute | Subject Device<br>Spirohome | Predicate Device<br>GoSpiro (K163249) | Reference Device<br>(K161536) | Similarities /<br>Differences | | Configuration | Hand-held, portable | Hand-held, portable | Hand-held, portable | Identical | | Patient<br>Population | Over 5 years old | Over 5 years old | Over 4 years old | Identical for<br>subject and<br>predicate. | | Sensor<br>Technology | Transit-time Ultrasound | Turbine | Transit-time Ultrasound | Identical for<br>subject and<br>reference device. | | Recalibration | Not required | Required | Not required | Identical for<br>subject and<br>reference. | | Measured<br>Parameters | FVC, FEV0.75,<br>FEV1, FEV3,<br>FEV6,<br>FEV0.75/FVC,<br>FEV1/FVC,<br>FEV3/FVC,<br>FEV6/FVC, PEF | FVC, FEV0.75, FEV1,<br>FEV3, FEV6,<br>FEV0.75/FVC,<br>FEV1/FVC, FEV3/FVC,<br>FEV6/FVC, PEF,<br>MMEF, FEF25, FEF50,<br>FEF75, FEF25-75 | *BEV, EOTV, FEF10,<br>FEF25, FEF25-75,<br>FEF25-75/FVC,<br>FEF40, FEF50,<br>FEF50/FVC, FEF60,<br>FEF75, FEF80, FET, | Similar parameters<br>for subject,<br>predicate and<br>reference devices.<br>Differences do<br>not affect the safe<br>and effective use<br>for single- patient<br>use. Subject<br>device has<br>reusable<br>mouthpiece for<br>home use and a<br>disposable<br>mouthpiece for<br>clinic use, both are<br>for single-patient<br>use. Reference<br>device has only a<br>single-patient<br>disposable<br>mouthpiece. No<br>concerns raised<br>regarding subject<br>device safety or<br>effectiveness due<br>to mouthpiece<br>differences. | | Attribute | Subject Device<br>Spirohome | Predicate Device<br>GoSpiro (K163249) | Reference Device<br>(K161536) | Similarities /<br>Differences | | | MMEF, FEF25,<br>FEF50, FEF75<br>, FEF25-75,<br>MET25-75,<br>FEV0.75/FEV6<br>, FEV1/FEV6,<br>FEF50/FVC,<br>MMEF/FVC, FET, BEV,<br>FIV1, FIVC, PIF,<br>FIF25-75, FIV1/FIVC,<br>R50 (FEF50/FIF50),<br>VC, VCin, VCex<br>, ERV, IRV, IC, Rf,<br>VT, MVV, MVV6,<br>MVVtime | FIV1, FIVC,<br>PIF, FIF25-75, FIF25,<br>FIF50, FIF75, MET25-<br>75, FEV0.75/FEV6,<br>FEV1/FEV6,<br>FEF50/FVC<br>, FIV1/FIVC, R50<br>(FEF50/FIF50), FET,<br>MVV | FET25-75, FEV.25,<br>FEV.5,<br>FEV.5/FVC, FEV.75,<br>FEV.75/FVC, FEV1,<br>FEV1/FEV6,<br>FEV1/FIV1,<br>FEV1/FVC,<br>FEV3, FEV3/FVC,<br>FEV6, FIF25, FIF50,<br>FIF50/FEF50, FIF75,<br>FIV.25, FIV.5, FIV1,<br>FVC, FVC6, FVC,<br>FVC6, MEF20,<br>MEF25, MEF40,<br>MEF50,<br>MEF60, MEF75,<br>MEF90, MIF25, MIF50,<br>MIF75, MMEF, PEF,<br>PEFT, t0, MVV, MVV6,<br>MVVtime, Rf, ERV, IC,<br>IRV, Rf, VC, VCex,<br>VCin, VCmax, VT | of the subject<br>device. | | Power | 2 x AAA Alkaline and<br>Rechargeable<br>Batteries | Rechargeable lithium-<br>ion batteries…