Spirobank Oxi

{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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. December 15, 2023 MIR Medical International Research USA Alessio Segreto Quality & Regulatory Management Representative Viale Luigi Schiavonetti 270 - cap 00173, Rome, ITA Re: K230501 Trade/Device Name: Spirobank Oxi Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG, DQA Dated: November 16, 2023 Received: November 17, 2023 Dear Alessio Segreto: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230501 Device Name Spirobank Oxi ### Indications for Use (Describe) The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger . The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home. | 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) ## 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MIR. The logo consists of a stylized, interconnected symbol on the left and the word "MIR" in bold, sans-serif font on the right. Both the symbol and the text are in a dark blue color. MEDICAL INTERNATIONAL RESEARCH ## 510(k) Summary ### L SUBMITTER MIR Medical International Research USA, Inc 5462 S. Westridge Drive New Berlin. WI 53151 - USA Phone: +01 (262) 565-6797 Contact Person: Alessio Segreto Date Prepared: December 15th, 2023 ### DEVICE II. Name of Device: Spirobank Oxi Common Name: Spirometer and Pulse oximeter Classification Name: Spirometer and Oximeter Regulatory Class: II Regulation Number 21 CFR 868.1840 BZG, DQA Product Code #### PREDICATE DEVICE III. Company Name: Trade Name: 510(k) number: Regulation Number Product Code MIR - Medical International Research SPIRODOC K103530 21 CFR 868.1840 BZG, DQA ### IV. DEVICE DESCRIPTION Spirobank Oxi is a pocket-size spirometer and oximeter. The device is made up of: - a central unit which measures and collects information related to the state of health of the patient, using a microprocessor based system. It operates via a Bluetooth connection - a removable sensor for the measurement of respiratory air flow and volume, - a pulse oximetry sensor using reflective technology. - {4}------------------------------------------------ The device is powered by two AAA alkaline batteries. ## Functions of the device Spirometry: the device is equipped with a plastic mouthpiece connected to a turbine flow meter based on the infrared interruption principle. The device detects the signals generated by the turbine, and measures flow and volume. At the end of the expiration, the device calculates the respiratory parameters. Oximetry: the device measures functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) by means of a reflective light sensor. Specifically, it uses a two-wavelength sensor to measure the indicated parameters based on light reflection principles of oxygenated blood and deoxygenated blood, which generates a photoplethysmogram. From the photoplethysmogram the device calculates SpO2 and PR Spirobank Oxi connects via Bluetooth to a device (PC, tablet or smartphone) which allows to insert patient data, perform spirometry manoeuvres and oximetry tests, as well as display the results, including the relative graphs. ### V. INDICATIONS FOR USE: ## Subiect device The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger. The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home. ## VI. COMPARISON WITH THE PREDICATE DEVICE {5}------------------------------------------------ | | Spirodoc - (K103530) | Spirobank Oxi | SE discussion | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (predicate device) | (subject device) | | | Indications<br>for Use<br>Statement | The SPIRODOC Spirometer<br>and pulse oximeter is intended<br>to be used by a physician or by<br>a patient under the prescribed<br>use of a physician.<br>The device is intended to test<br>lung function and can perform<br>spirometry testing in adult and<br>pediatric patients, excluding<br>infants and neonates, and<br>oximetry readings in patients of<br>all ages. | The Spirobank Oxi<br>Spirometer and Pulse<br>Oximeter is intended to be<br>used by a physician or by a<br>patient under the prescribed<br>use of a physician. The<br>equipment is intended to test<br>lung function and can<br>perform tests in adult and<br>pediatric patients greater<br>than 5 years. When used as<br>Oximeter, the Spirobank Oxi<br>is intended for spot-checking<br>of functional oxygen<br>saturation of arterial<br>haemoglobin (SpO2) and<br>Pulse Rate (PR) from the<br>patient finger. The<br>Spirobank Oxi has been<br>designed for use in the<br>physician's office, in<br>hospital, or directly by the<br>patient to monitor her/his<br>physical conditions at home. | Substantially<br>Equivalent<br>Main functions<br>for spirometry<br>and oximetry are<br>the same.<br>The environment<br>of use is not<br>specified for the<br>predicate device,<br>but is reported in<br>the user manual<br>of the predicate,<br>and it's<br>equivalent. | | Product<br>codes | BZG, DQA | BZG, DQA | Substantially<br>Equivalent | | Device<br>principle of<br>operations | Spirometry: Infrared base<br>estimation of vane rotation<br>speed, proportional to the air<br>flow rate.<br>Transmission Oximetry | Spirometry: Infrared base<br>estimation of vane rotation<br>speed, proportional to the air<br>flow rate.<br>Reflection Oximetry | Substantially<br>Equivalent<br>Spirobank Oxi<br>meets the<br>accuracy<br>requirements of<br>the Guidance<br>document: Pulse<br>Oximeters -<br>Premarket<br>Notification<br>Submissions<br>[510(k)s] | | Type of Use | Prescription | Prescription | Substantially<br>Equivalent | | | Spirodoc - (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Patient<br>Population | Spirometry: people of all ages,<br>excluding infants and neonates.<br>Oximetry: people of all ages. | Spirometry and Oximetry:<br>people of all ages, excluding<br>children younger than 5<br>years. | Substantially<br>Equivalent.<br>Patient population<br>of the subject<br>device include<br>adult and<br>pediatric patients<br>greater than 5<br>years. This<br>difference does<br>not affect safety<br>and effectiveness. | | Use<br>Environment | Spirodoc has been designed for<br>use in the doctor's office, in a<br>hospital or directly by the<br>patient to monitor her/his<br>physical conditions during<br>routine daily activities. | Spirobank Oxi has been<br>designed for use in the<br>doctor's office, in a hospital<br>or directly by the patient to<br>monitor her/his physical<br>conditions at home | Substantially<br>Equivalent. | | Single<br>Patient Use | No | No | Substantially<br>Equivalent. | | System<br>Components<br>and<br>Accessories | USB Cable, Noseclip, Paper<br>Mouthpiece, Reusable Turbine,<br>Disposable Turbine and<br>Reusable Oximetry Sensor. | Reusable Turbine and Plastic<br>Mouthpiece. | Substantially<br>Equivalent. | | Measured<br>parameters:<br>Spirometry | Spirometry: it calculates more<br>than 20 parameters (see below)<br>Best FVC, Best FEV1, Best<br>PEF, FVC, FEV1, FEV1/FVC,<br>FEV1/VC, PEF, FEF2575,<br>FEF 25, FEF50, FEF75, FEV3,<br>FEV3/FVC, FEV6, FEV6%,<br>FET, EVol, FIVC, FIV1,<br>FIV1/FIVC, PIF, MVVcal,<br>VC, EVC, IVC, IC, ERV, TV,<br>VE, RR, tI, tE, TV/tI, tI/tTot. | Spirometry: it calculates more<br>than 20 parameters (see<br>below):<br>Best FVC, FEV1, PEF, FVC,<br>FEV1, FEV1/FVC,<br>FAV1/VC, PEF, FEF2575,<br>FEF25, FEF50, FEF75,<br>FEV3, FEV3/FVC, FEV6,<br>FEV6%, FET, Evol, FIVC,<br>FIV1, FIV1/FIVC, PIF,<br>MVVcal, ELA | Substantially<br>Equivalent. | | | Spirodoc – (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Measured<br>Parameters:<br>Oximetry | Oximetry: spot checking and<br>monitoring parameters (see below):<br>%SPO2 min, %SPO2 max,<br>BPM min, BPM max, %SPO2<br>mean, BPM mean, T Total, T<br>Analysis, T<90%, T<89%,<br>T<88%, T<87%,<br>Ev%SPO2<89, Δ Index,<br>T<40BPM, T>120BPM,<br>Ev<40BPM, Ev>120BPM,<br>%SPO2 start, %SPO2 end,<br>BPM end, %SPO2 Base, BPM<br>start, T Baseline, T Walking, T<br>Recovery, Distance, T2%Δ<br>SPO2, T4%Δ SPO2, Predicted,<br>Predicted min, % Predicted,<br>%Predicted min,<br>AUC/Distance*, Dyspnea<br>Base, Dyspnea End, Dyspnea<br>CHG, Fatigue Base, Fatigue<br>End, Fatigue CHG, Diastolic<br>Base, Systolic Base, Diastolic<br>Fine, Systolic Fine, Steps,<br>VMU**, O2-GAP***, O2,<br>SPO2 Base, BPM Base, ODI,<br>Mean Dur. Desat., Tot<br>Desaturat., Longest Desat.,<br>Desatur. Peak, BPM Index,<br>Mean Desaturat, Mean Drop,<br>Max Drop, BPM Variation,<br>NOD4%, NOD89%,<br>NOD90%, t.NOD4%,<br>t.NOD89%, t.NOD90%. | Oximetry: spot checking<br>parameters (see below):<br>%SpO2 min, %SpO2 max,<br>BPM min, BPM max,<br>%SpO2 mean, BPM mean, T<br>Total. | Substantially<br>Equivalent | | Range of<br>Measurement<br>: Spirometry | Volume: 10L<br>Flow: ± 16 L/s | Volume: 10L<br>Flow: ± 16 L/s | Substantially<br>Equivalent | | | Spirodoc – (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Range of<br>Measurement<br>:Oximetry | Range of measurement<br>%SpO2: 0 – 99%<br><br>Range of measurement of<br>cardiac pulse: 30 – 254 BPM. | Range of measurement<br>%SpO2: 70 – 100%<br><br>Range of measurement of<br>Pulse Rate: 30 – 200 BPM. | Substantially<br>Equivalent | | | Spirodoc - (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Test<br>Accuracy:<br>Spirometry | American Thoracic Society<br>(ATS) Statement on the<br>"Standardization of Spirometry<br>– 1994 Update | American Thoracic Society<br>(ATS) Statement on the<br>"Standardization of<br>Spirometry – 2019 update | Substantially<br>Equivalent<br><br>Spirobank Oxi<br>meets the<br>accuracy<br>requirements of<br>the current ATS<br>guidelines. | | | Spirometry Volume:<br>Volume accuracy: $\pm$ 3.0% or $\pm$<br>50 mL<br>Linearity: $\pm$ 3%<br>Repeatability: $\pm$ 0,05L or $\pm$ 3%<br>Expiratory Impedance: < 0,15<br>kPa/(L/s) | Spirometry Volume:<br>Volume accuracy: $\pm$ 2.5%<br>Linearity: $\pm$ 2.5%<br>Repeatability: $\pm$ 2.5%<br>Expiratory Impedance: < 0,15<br>kPa/(L/s) | | | | Spirometry Flow:<br>Flow accuracy: $\pm$ 5% or $\pm$ 200<br>mL/s<br>Dynamic resistance at 12 L/s:<br><0.5 cm H2O/L/s<br>Linearity: $\pm$ 5% or $\pm$ 0.17L/s<br>Resistance to Flow: <0.36<br>kPa/(L/s)<br>Frequency response: $\pm$ 12% or<br>$\pm$ 0.25L/s | Spirometry Flow:<br>Flow accuracy: $\pm$ 5% or $\pm$<br>200 mL/s<br>Dynamic resistance at 12 L/s:<br><0.5 cm H2O/L/s<br>Linearity: $\pm$ 5% or $\pm$ 0.17L/s<br>Resistance to Flow: <0.36<br>kPa/(L/s)<br>Frequency response: $\pm$ 12%<br>or $\pm$ 0.25L/s | | | | Spirodoc - (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Test<br>Accuracy:<br>Oximetry | SpO2<br>$\pm$ 2% between 70-100% | SpO2<br>70% - 100 %: $\pm$ 1.90%<br>70% - 80 %: $\pm$ 2.33%<br>80% - 90 %: $\pm$ 1.71%<br>90% -100 %: $\pm$ 1.49% | Substantially<br>Equivalent | | | Pulse Rate:<br>$\pm$ 2 BPM or 2% whichever is<br>greater | Pulse Rate: $\pm$ 3% | Spirobank Oxi<br>meets the<br>accuracy<br>requirements of<br>the Guidance<br>document: Pulse<br>Oximeters -<br>Premarket<br>Notification<br>Submissions<br>[510(k)s] | | Data<br>transmission | USB or Bluetooth | Bluetooth 4.0 | Substantially<br>Equivalent<br>Spirobank Oxi<br>has been qualified<br>according to<br>Bluetooth SIG.<br>Spirobank Oxi<br>data transmission<br>integrity has been<br>thoroughly tested. | | | Spirodoc - (K103530)<br>(predicate device) | Spirobank Oxi<br>(subject device) | SE discussion | | Materials | Main parts and materials | Main parts and materials | Case: different materials. | | | Case: PC+ABS: -<br>LUPOY® HP-5004I (white parts), LUPOY® GP-<br>2102 (orange part) | Case: plastic (PC + ABS -<br>Bayblend) | Turbine: same<br>Mouthpiece: same | | | Turbine: polycarbonate resin - Makrolon 2805<br>(orange part) , LEXAN<br>121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor: Polymers<br>and Plastic Resins -HYSOL<br>MG18 CLEAR | Turbine: polycarbonate resin - Makrolon 2805<br>(orange part) , LEXAN<br>121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor:<br>Transaprent Polyamide<br>(Trogamid) | Oxymetry finger<br>sensor: different<br>materials.<br>Biocompatibility<br>tested in<br>accordance with<br>ISO 10993-1.<br>Mechanical<br>characteristics<br>were tested in<br>accordance with<br>IEC 60601-1. | | User<br>interface | Touch screen LCD display,<br>resolution 160 x 80 or<br>PC or mobile phone screen via<br>Bluetooth Connection | Smartphone, PC or tablet<br>display via Bluetooth<br>Connection | Substantially<br>Equivalent | | Power supply | Two Rechargeable AAA LiPo<br>batteries | Two alkaline AAA batteries | Substantially<br>Equivalent | | Weight | 150 g (including batteries) | 60.7 g (including batteries). | Substantially<br>Equivalent | | Dimensions | 48 (W) x 148 (L) x 25 (H) mm | 49 (W) x 109(L) x 21 (H) mm | Substantially<br>Equivalent | | Data storage | Up to 10000 measurements | >1000 measurements,<br>depending on the memory of<br>the smartphone | Substantially<br>Equivalent | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ The subject device, Spirobank Oxi, and the Predicate, Spirodoc - K103530, have the following key similarities: - Both devices have the same intended use as spirometer and oximeter; ● - Both devices have the same technological characteristics with respect to spirometry: the . principle of operation is the same: the air flow passes through the turbine and makes the blade of the turbine rotate. Rotation speed which is in linear relationship with the air flow rate is measured by photodetectors. {12}------------------------------------------------ The different technological characteristics do not raise different questions of safety and effectiveness. ### PERFORMANCE DATA. VII. The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility testing Biocompatibility of the materials has been tested for cytotoxicity, irritation, and sensitization according to ISO 10993-1: 2009. following FDA's guidance document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Results of the tests show that materials are biocompatible. Also, the standards ISO 18562 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - part 1, 2 and 3, have been followed to assess the biocompatibility evaluation of breathing gas pathways. ## Electrical safety and electromagnetic compatibility (EMC) Electrical Safety and Electromagnetic compatibility testing was conducted in accordance with EN 60601-1:2005 + Amd 2012 (identical to IEC 2005 + Amd 2012) and EN 60601-1-2:2015 (identical to IEC 60601-1-2:2014). In addition, the following FDA guidance documents were to directly applicable to the Spirobank Oxi: - Electromagnetic Compatibility (EMC) of Medical Devices, June 2022 1. - 2 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, August 2013 - 3. Design Considerations for Devices Intended for Home Use Guidance for Industry and Food and Drug Administration Staff, November 2014 The results demonstrates that the Spirobank Oxi complies with the guidelines and standards referenced…