Who is the manufacturer of Spirobank Oxi?

Mir Medical International Research USA filed the 510(k) submission for Spirobank Oxi (K230501).

What is the FDA product code for Spirobank Oxi?

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Spirobank Oxi?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Spirobank Oxi?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Spirobank Oxi

Q: What are the predicate devices for Spirobank Oxi?

MIR - Medical International Research SPIRODOC (K103530).

K230501 · Mir Medical International Research USA · BZG · Dec 15, 2023 · Anesthesiology

Device Facts

Record ID	K230501
Device Name	Spirobank Oxi
Applicant	Mir Medical International Research USA
Product Code	BZG · Anesthesiology
Decision Date	Dec 15, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

Spirobank Oxi is a pocket-sized spirometer and pulse oximeter; measures respiratory airflow/volume via turbine flow meter (infrared interruption principle) and SpO2/PR via reflective light sensor (two-wavelength). Device connects via Bluetooth to smartphone, tablet, or PC; user inputs patient data, performs maneuvers, and views results/graphs. Used in physician offices, hospitals, or home by patients/clinicians. Provides objective lung function and oxygenation data to assist clinical decision-making; enables remote monitoring of physical conditions. Powered by two AAA alkaline batteries.

Clinical Evidence

Single-arm clinical desaturation study (n=10 healthy volunteers, 5 male/5 female, diverse skin tones) conducted at Clinimark. Primary endpoint: SpO2 accuracy vs. CO-Oximetry reference (Radiometer ABL 80 Flex OSM/IL 682) during induced hypoxia (100%-67% SaO2). Results: Total Arms 1.90% (1.49% for 90-100% range, 1.71% for 80-90%, 2.33% for 70-80%). No adverse events reported.

Technological Characteristics

Materials: PC+ABS (Bayblend) case, polycarbonate turbine (Makrolon 2805), transparent polyamide (Trogamid) oximeter sensor. Sensing: Infrared turbine rotation for spirometry; two-wavelength reflective light sensor for oximetry. Power: 2x AAA alkaline batteries. Connectivity: Bluetooth 4.0. Dimensions: 49x109x21 mm. Weight: 60.7g. Standards: ISO 10993-1, ISO 18562, IEC 60601-1, IEC 60601-1-2, ISO 26782, ISO 23747, ISO 80601-2-61.

Indications for Use

Indicated for lung function testing and spot-checking of SpO2 and pulse rate in adult and pediatric patients >5 years. Designed for use in physician offices, hospitals, or home environments.

Regulatory Classification

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.

Predicate Devices

MIR - Medical International Research SPIRODOC (K103530)

Related Devices

K130784 — SPIROTEL · Mir Medical Intl. Research Srl · Oct 30, 2013
K061712 — SPIROBANK II · Mir Medical Intl. Research Srl · Dec 1, 2006
K031515 — SPIROPRO SPO2 · Viasys Healthcare GmbH · Nov 14, 2003
K043528 — SPIROTEL · Mir Medical Intl. Research Srl · Jul 19, 2005
K103530 — SPIRODOC · Medical International Research USA, Inc. · Nov 21, 2011

Submission Summary (Full Text)

{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 for Use Statement | The SPIRODOC Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages. | 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. | Substantially Equivalent Main functions for spirometry and oximetry are the same. The environment of use is not specified for the predicate device, but is reported in the user manual of the predicate, and it's equivalent. | | Product codes | BZG, DQA | BZG, DQA | Substantially Equivalent | | Device principle of operations | Spirometry: Infrared base estimation of vane rotation speed, proportional to the air flow rate. Transmission Oximetry | Spirometry: Infrared base estimation of vane rotation speed, proportional to the air flow rate. Reflection Oximetry | Substantially Equivalent Spirobank Oxi meets the accuracy requirements of the Guidance document: Pulse Oximeters - Premarket Notification Submissions [510(k)s] | | Type of Use | Prescription | Prescription | Substantially Equivalent | | | Spirodoc - (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Patient Population | Spirometry: people of all ages, excluding infants and neonates. Oximetry: people of all ages. | Spirometry and Oximetry: people of all ages, excluding children younger than 5 years. | Substantially Equivalent. Patient population of the subject device include adult and pediatric patients greater than 5 years. This difference does not affect safety and effectiveness. | | Use Environment | Spirodoc has been designed for use in the doctor's office, in a hospital or directly by the patient to monitor her/his physical conditions during routine daily activities. | Spirobank Oxi has been designed for use in the doctor's office, in a hospital or directly by the patient to monitor her/his physical conditions at home | Substantially Equivalent. | | Single Patient Use | No | No | Substantially Equivalent. | | System Components and Accessories | USB Cable, Noseclip, Paper Mouthpiece, Reusable Turbine, Disposable Turbine and Reusable Oximetry Sensor. | Reusable Turbine and Plastic Mouthpiece. | Substantially Equivalent. | | Measured parameters: Spirometry | Spirometry: it calculates more than 20 parameters (see below) Best FVC, Best FEV1, Best PEF, FVC, FEV1, FEV1/FVC, FEV1/VC, PEF, FEF2575, FEF 25, FEF50, FEF75, FEV3, FEV3/FVC, FEV6, FEV6%, FET, EVol, FIVC, FIV1, FIV1/FIVC, PIF, MVVcal, VC, EVC, IVC, IC, ERV, TV, VE, RR, tI, tE, TV/tI, tI/tTot. | Spirometry: it calculates more than 20 parameters (see below): Best FVC, FEV1, PEF, FVC, FEV1, FEV1/FVC, FAV1/VC, PEF, FEF2575, FEF25, FEF50, FEF75, FEV3, FEV3/FVC, FEV6, FEV6%, FET, Evol, FIVC, FIV1, FIV1/FIVC, PIF, MVVcal, ELA | Substantially Equivalent. | | | Spirodoc – (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Measured Parameters: Oximetry | Oximetry: spot checking and monitoring parameters (see below): %SPO2 min, %SPO2 max, BPM min, BPM max, %SPO2 mean, BPM mean, T Total, T Analysis, T<90%, T<89%, T<88%, T<87%, Ev%SPO2<89, Δ Index, T<40BPM, T>120BPM, Ev<40BPM, Ev>120BPM, %SPO2 start, %SPO2 end, BPM end, %SPO2 Base, BPM start, T Baseline, T Walking, T Recovery, Distance, T2%Δ SPO2, T4%Δ SPO2, Predicted, Predicted min, % Predicted, %Predicted min, AUC/Distance*, Dyspnea Base, Dyspnea End, Dyspnea CHG, Fatigue Base, Fatigue End, Fatigue CHG, Diastolic Base, Systolic Base, Diastolic Fine, Systolic Fine, Steps, VMU**, O2-GAP***, O2, SPO2 Base, BPM Base, ODI, Mean Dur. Desat., Tot Desaturat., Longest Desat., Desatur. Peak, BPM Index, Mean Desaturat, Mean Drop, Max Drop, BPM Variation, NOD4%, NOD89%, NOD90%, t.NOD4%, t.NOD89%, t.NOD90%. | Oximetry: spot checking parameters (see below): %SpO2 min, %SpO2 max, BPM min, BPM max, %SpO2 mean, BPM mean, T Total. | Substantially Equivalent | | Range of Measurement : Spirometry | Volume: 10L Flow: ± 16 L/s | Volume: 10L Flow: ± 16 L/s | Substantially Equivalent | | | Spirodoc – (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Range of Measurement :Oximetry | Range of measurement %SpO2: 0 – 99% Range of measurement of cardiac pulse: 30 – 254 BPM. | Range of measurement %SpO2: 70 – 100% Range of measurement of Pulse Rate: 30 – 200 BPM. | Substantially Equivalent | | | Spirodoc - (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Test Accuracy: Spirometry | American Thoracic Society (ATS) Statement on the "Standardization of Spirometry – 1994 Update | American Thoracic Society (ATS) Statement on the "Standardization of Spirometry – 2019 update | Substantially Equivalent Spirobank Oxi meets the accuracy requirements of the current ATS guidelines. | | | Spirometry Volume: Volume accuracy: $\pm$ 3.0% or $\pm$ 50 mL Linearity: $\pm$ 3% Repeatability: $\pm$ 0,05L or $\pm$ 3% Expiratory Impedance: < 0,15 kPa/(L/s) | Spirometry Volume: Volume accuracy: $\pm$ 2.5% Linearity: $\pm$ 2.5% Repeatability: $\pm$ 2.5% Expiratory Impedance: < 0,15 kPa/(L/s) | | | | Spirometry Flow: Flow accuracy: $\pm$ 5% or $\pm$ 200 mL/s Dynamic resistance at 12 L/s: <0.5 cm H2O/L/s Linearity: $\pm$ 5% or $\pm$ 0.17L/s Resistance to Flow: <0.36 kPa/(L/s) Frequency response: $\pm$ 12% or $\pm$ 0.25L/s | Spirometry Flow: Flow accuracy: $\pm$ 5% or $\pm$ 200 mL/s Dynamic resistance at 12 L/s: <0.5 cm H2O/L/s Linearity: $\pm$ 5% or $\pm$ 0.17L/s Resistance to Flow: <0.36 kPa/(L/s) Frequency response: $\pm$ 12% or $\pm$ 0.25L/s | | | | Spirodoc - (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Test Accuracy: Oximetry | SpO2 $\pm$ 2% between 70-100% | SpO2 70% - 100 %: $\pm$ 1.90% 70% - 80 %: $\pm$ 2.33% 80% - 90 %: $\pm$ 1.71% 90% -100 %: $\pm$ 1.49% | Substantially Equivalent | | | Pulse Rate: $\pm$ 2 BPM or 2% whichever is greater | Pulse Rate: $\pm$ 3% | Spirobank Oxi meets the accuracy requirements of the Guidance document: Pulse Oximeters - Premarket Notification Submissions [510(k)s] | | Data transmission | USB or Bluetooth | Bluetooth 4.0 | Substantially Equivalent Spirobank Oxi has been qualified according to Bluetooth SIG. Spirobank Oxi data transmission integrity has been thoroughly tested. | | | Spirodoc - (K103530) (predicate device) | Spirobank Oxi (subject device) | SE discussion | | Materials | Main parts and materials | Main parts and materials | Case: different materials. | | | Case: PC+ABS: - LUPOY® HP-5004I (white parts), LUPOY® GP- 2102 (orange part) | Case: plastic (PC + ABS - Bayblend) | Turbine: same Mouthpiece: same | | | Turbine: polycarbonate resin - Makrolon 2805 (orange part) , LEXAN 121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor: Polymers and Plastic Resins -HYSOL MG18 CLEAR | Turbine: polycarbonate resin - Makrolon 2805 (orange part) , LEXAN 121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor: Transaprent Polyamide (Trogamid) | Oxymetry finger sensor: different materials. Biocompatibility tested in accordance with ISO 10993-1. Mechanical characteristics were tested in accordance with IEC 60601-1. | | User interface | Touch screen LCD display, resolution 160 x 80 or PC or mobile phone screen via Bluetooth Connection | Smartphone, PC or tablet display via Bluetooth Connection | Substantially Equivalent | | Power supply | Two Rechargeable AAA LiPo batteries | Two alkaline AAA batteries | Substantially Equivalent | | Weight | 150 g (including batteries) | 60.7 g (including batteries). | Substantially Equivalent | | Dimensions | 48 (W) x 148 (L) x 25 (H) mm | 49 (W) x 109(L) x 21 (H) mm | Substantially Equivalent | | Data storage | Up to 10000 measurements | >1000 measurements, depending on the memory of the smartphone | Substantially 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…