(294 days)
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.
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. -
The device is powered by two AAA alkaline batteries.
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.
Acceptance Criteria and Study for Spirobank Oxi
This document describes the acceptance criteria and a detailed study supporting the substantial equivalence of the Spirobank Oxi device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Spirobank Oxi) | Complies? |
|---|---|---|---|
| Spirometry | |||
| Volume Accuracy | American Thoracic Society (ATS) 2019 guidelines | $\pm$ 2.5% | Yes |
| Linearity | ATS 2019 guidelines | $\pm$ 2.5% | Yes |
| Repeatability | ATS 2019 guidelines | $\pm$ 2.5% | Yes |
| Expiratory Impedance | ATS 2019 guidelines: < 0.15 kPa/(L/s) | < 0.15 kPa/(L/s) | Yes |
| Flow Accuracy | ATS 2019 guidelines: $\pm$ 5% or $\pm$ 200 mL/s | $\pm$ 5% or $\pm$ 200 mL/s | Yes |
| Dynamic Resistance | ATS 2019 guidelines (at 12 L/s): < 0.5 cm H2O/L/s | < 0.5 cm H2O/L/s | Yes |
| Linearity (Flow) | ATS 2019 guidelines: $\pm$ 5% or $\pm$ 0.17L/s | $\pm$ 5% or $\pm$ 0.17L/s | Yes |
| Resistance to Flow | ATS 2019 guidelines: <0.36 kPa/(L/s) | <0.36 kPa/(L/s) | Yes |
| Frequency Response | ATS 2019 guidelines: $\pm$ 12% or $\pm$ 0.25L/s | $\pm$ 12% or $\pm$ 0.25L/s | Yes |
| Pulse Oximetry (SpO2) | |||
| SpO2 Accuracy (Overall) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.9004% | Yes |
| SpO2 Accuracy (90%-100%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.4861% | Yes |
| SpO2 Accuracy (80%-90%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 1.7059% | Yes |
| SpO2 Accuracy (70%-80%) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | A_rms = 2.3315% | Yes |
| Pulse Rate (PR) | ISO 80601-2-61:2017 and FDA Guidance for Pulse Oximeters | $\pm$ 3% (Maximum absolute error up to 3 bpm at 200 bpm, conforming to standard) | Yes |
| Biocompatibility | ISO 10993-1:2009 (cytotoxicity, irritation, sensitization) | Materials are biocompatible. Conformance to ISO 18562-1, -2, -3 followed. | Yes |
| Electrical Safety & EMC | EN 60601-1:2005 + Amd 2012, EN 60601-1-2:2015 | Complies with referenced guidelines and standards. Performs within specifications. | Yes |
| Software V&V | FDA Guidance "Content of Premarket Submissions for Software" | Conducted and documented for "moderate" level of concern. | Yes |
| Cybersecurity | FDA Guidance "Postmarket Management of Cybersecurity" | Conducted and documented. | Yes |
| Human Factors | FDA Guidance "Applying Human Factors and Usability Engineering" | Conducted. | Yes |
| Cleaning & Disinfection | FDA Guidance "Reprocessing Medical Devices..." | Validated. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
Spirometry Testing:
- Sample Size: Not explicitly stated as a "test set" sample size of human subjects. The testing was conducted on a bench using a Pulmonary Waveform Generator.
- Data Provenance: Conducted in MIR facilities.
Pulse Oximetry Clinical Performance Testing:
- Sample Size: 10 healthy volunteers (5 males, 5 females). The study explicitly states meeting the requirement of at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
- Data Provenance: Single-arm desaturation study conducted in the US, at the Clinimark Desaturation Laboratory (Louisville, CO 80027, USA). The study was prospective as it involved inducing hypoxia in volunteers for data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Spirometry Testing:
- Ground Truth: Established by conformance to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019", ISO 26782:2009, and ISO 23747:2015, utilizing a Pulmonary Waveform Generator for bench testing. This implies widely accepted industry standards and validated equipment serve as the "ground truth" rather than individual experts.
- Experts: Not applicable in the context of expert review for ground truth, as it's a bench test against standardized waveforms and parameters.
Pulse Oximetry Clinical Performance Testing:
- Ground Truth: Established by Reference CO-Oximetry using arterial blood samples drawn from the subjects. This value was obtained as the mean of the SaO2 values measured by Radiometer ABL 80 Flex OSM and Instrumentation Laboratory IL 682.
- Experts: Not explicitly mentioned in terms of "experts establishing ground truth". However, the use of two "Reference CO-Oximeters" suggests a highly calibrated and standardized method, likely operated by qualified laboratory personnel, which serves as the gold standard for oxygen saturation measurement. The qualifications of the operators of these reference devices are not specified but are presumed to be appropriate for clinical laboratory analysis.
4. Adjudication Method for the Test Set
Spirometry Testing: Not applicable, as judgment is based on objective measurements against engineering standards.
Pulse Oximetry Clinical Performance Testing: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth (SaO2) is established by highly accurate chemical analysis (Reference CO-Oximetry) rather than subjective expert interpretation from multiple individuals. The methodology involves direct comparison of the device's SpO2 readings with the objective SaO2 values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The studies described are focused on verifying the technical performance of the device against established industry standards and, for oximetry, against a "gold standard" clinical measurement, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies are explicitly standalone performance evaluations of the device's measurement capabilities.
- Spirometry: Bench testing against ATS standards.
- Pulse Oximetry: Comparison of the device's automated SpO2 calculation against reference CO-Oximetry, without human interpretation of the device's raw outputs for diagnosis. The device generates the SpO2 values directly.
7. The Type of Ground Truth Used
- Spirometry: Objective, standardized measurements against a Pulmonary Waveform Generator adhering to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019" and ISO 26782:2009, ISO 23747:2015.
- Pulse Oximetry: Physiological/Outcomes Data (Reference CO-Oximetry) from arterial blood samples, which is considered the gold standard for functional oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not mention any "training set" or "training data" for the device. This implies that the device's algorithms or measurement principles are based on established scientific and engineering principles rather than machine learning models that require a distinct training phase on a dataset. For example, spirometry uses infrared interruption principles, and oximetry uses reflection principles and calibration functions.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model, this question is not applicable. The device relies on established physical and biological measurement principles rather than learned patterns from a training dataset requiring ground truth establishment.
{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) | ||
| Indicationsfor UseStatement | The SPIRODOC Spirometerand pulse oximeter is intendedto be used by a physician or bya patient under the prescribeduse of a physician.The device is intended to testlung function and can performspirometry testing in adult andpediatric patients, excludinginfants and neonates, andoximetry readings in patients ofall ages. | The Spirobank OxiSpirometer and PulseOximeter is intended to beused by a physician or by apatient under the prescribeduse of a physician. Theequipment is intended to testlung function and canperform tests in adult andpediatric patients greaterthan 5 years. When used asOximeter, the Spirobank Oxiis intended for spot-checkingof functional oxygensaturation of arterialhaemoglobin (SpO2) andPulse Rate (PR) from thepatient finger. TheSpirobank Oxi has beendesigned for use in thephysician's office, inhospital, or directly by thepatient to monitor her/hisphysical conditions at home. | SubstantiallyEquivalentMain functionsfor spirometryand oximetry arethe same.The environmentof use is notspecified for thepredicate device,but is reported inthe user manualof the predicate,and it'sequivalent. |
| Productcodes | BZG, DQA | BZG, DQA | SubstantiallyEquivalent |
| Deviceprinciple ofoperations | Spirometry: Infrared baseestimation of vane rotationspeed, proportional to the airflow rate.Transmission Oximetry | Spirometry: Infrared baseestimation of vane rotationspeed, proportional to the airflow rate.Reflection Oximetry | SubstantiallyEquivalentSpirobank Oximeets theaccuracyrequirements ofthe Guidancedocument: PulseOximeters -PremarketNotificationSubmissions[510(k)s] |
| Type of Use | Prescription | Prescription | SubstantiallyEquivalent |
| Spirodoc - (K103530)(predicate device) | Spirobank Oxi(subject device) | SE discussion | |
| PatientPopulation | Spirometry: people of all ages,excluding infants and neonates.Oximetry: people of all ages. | Spirometry and Oximetry:people of all ages, excludingchildren younger than 5years. | SubstantiallyEquivalent.Patient populationof the subjectdevice includeadult andpediatric patientsgreater than 5years. Thisdifference doesnot affect safetyand effectiveness. |
| UseEnvironment | Spirodoc has been designed foruse in the doctor's office, in ahospital or directly by thepatient to monitor her/hisphysical conditions duringroutine daily activities. | Spirobank Oxi has beendesigned for use in thedoctor's office, in a hospitalor directly by the patient tomonitor her/his physicalconditions at home | SubstantiallyEquivalent. |
| SinglePatient Use | No | No | SubstantiallyEquivalent. |
| SystemComponentsandAccessories | USB Cable, Noseclip, PaperMouthpiece, Reusable Turbine,Disposable Turbine andReusable Oximetry Sensor. | Reusable Turbine and PlasticMouthpiece. | SubstantiallyEquivalent. |
| Measuredparameters:Spirometry | Spirometry: it calculates morethan 20 parameters (see below)Best FVC, Best FEV1, BestPEF, 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 morethan 20 parameters (seebelow):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 | SubstantiallyEquivalent. |
| Spirodoc – (K103530)(predicate device) | Spirobank Oxi(subject device) | SE discussion | |
| MeasuredParameters:Oximetry | Oximetry: spot checking andmonitoring parameters (see below):%SPO2 min, %SPO2 max,BPM min, BPM max, %SPO2mean, BPM mean, T Total, TAnalysis, 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, BPMstart, T Baseline, T Walking, TRecovery, Distance, T2%ΔSPO2, T4%Δ SPO2, Predicted,Predicted min, % Predicted,%Predicted min,AUC/Distance*, DyspneaBase, Dyspnea End, DyspneaCHG, Fatigue Base, FatigueEnd, Fatigue CHG, DiastolicBase, Systolic Base, DiastolicFine, Systolic Fine, Steps,VMU**, O2-GAP***, O2,SPO2 Base, BPM Base, ODI,Mean Dur. Desat., TotDesaturat., 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 checkingparameters (see below):%SpO2 min, %SpO2 max,BPM min, BPM max,%SpO2 mean, BPM mean, TTotal. | SubstantiallyEquivalent |
| Range ofMeasurement: Spirometry | Volume: 10LFlow: ± 16 L/s | Volume: 10LFlow: ± 16 L/s | SubstantiallyEquivalent |
| Spirodoc – (K103530)(predicate device) | Spirobank Oxi(subject device) | SE discussion | |
| Range ofMeasurement:Oximetry | Range of measurement%SpO2: 0 – 99%Range of measurement ofcardiac pulse: 30 – 254 BPM. | Range of measurement%SpO2: 70 – 100%Range of measurement ofPulse Rate: 30 – 200 BPM. | SubstantiallyEquivalent |
| Spirodoc - (K103530)(predicate device) | Spirobank Oxi(subject device) | SE discussion | |
| TestAccuracy:Spirometry | American Thoracic Society(ATS) Statement on the"Standardization of Spirometry– 1994 Update | American Thoracic Society(ATS) Statement on the"Standardization ofSpirometry – 2019 update | SubstantiallyEquivalentSpirobank Oximeets theaccuracyrequirements ofthe current ATSguidelines. |
| Spirometry Volume:Volume accuracy: $\pm$ 3.0% or $\pm$50 mLLinearity: $\pm$ 3%Repeatability: $\pm$ 0,05L or $\pm$ 3%Expiratory Impedance: < 0,15kPa/(L/s) | Spirometry Volume:Volume accuracy: $\pm$ 2.5%Linearity: $\pm$ 2.5%Repeatability: $\pm$ 2.5%Expiratory Impedance: < 0,15kPa/(L/s) | ||
| Spirometry Flow:Flow accuracy: $\pm$ 5% or $\pm$ 200mL/sDynamic resistance at 12 L/s:<0.5 cm H2O/L/sLinearity: $\pm$ 5% or $\pm$ 0.17L/sResistance to Flow: <0.36kPa/(L/s)Frequency response: $\pm$ 12% or$\pm$ 0.25L/s | Spirometry Flow:Flow accuracy: $\pm$ 5% or $\pm$200 mL/sDynamic resistance at 12 L/s:<0.5 cm H2O/L/sLinearity: $\pm$ 5% or $\pm$ 0.17L/sResistance to Flow: <0.36kPa/(L/s)Frequency response: $\pm$ 12%or $\pm$ 0.25L/s | ||
| Spirodoc - (K103530)(predicate device) | Spirobank Oxi(subject device) | SE discussion | |
| TestAccuracy:Oximetry | SpO2$\pm$ 2% between 70-100% | SpO270% - 100 %: $\pm$ 1.90%70% - 80 %: $\pm$ 2.33%80% - 90 %: $\pm$ 1.71%90% -100 %: $\pm$ 1.49% | SubstantiallyEquivalent |
| Pulse Rate:$\pm$ 2 BPM or 2% whichever isgreater | Pulse Rate: $\pm$ 3% | Spirobank Oximeets theaccuracyrequirements ofthe Guidancedocument: PulseOximeters -PremarketNotificationSubmissions[510(k)s] | |
| Datatransmission | USB or Bluetooth | Bluetooth 4.0 | SubstantiallyEquivalentSpirobank Oxihas been qualifiedaccording toBluetooth SIG.Spirobank Oxidata transmissionintegrity has beenthoroughly 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: sameMouthpiece: same | |
| Turbine: polycarbonate resin - Makrolon 2805(orange part) , LEXAN121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor: Polymersand Plastic Resins -HYSOLMG18 CLEAR | Turbine: polycarbonate resin - Makrolon 2805(orange part) , LEXAN121R (deflector) Mouthpiece: plastic (PP) Oximeter sensor:Transaprent Polyamide(Trogamid) | Oxymetry fingersensor: differentmaterials.Biocompatibilitytested inaccordance withISO 10993-1.Mechanicalcharacteristicswere tested inaccordance withIEC 60601-1. | |
| Userinterface | Touch screen LCD display,resolution 160 x 80 orPC or mobile phone screen viaBluetooth Connection | Smartphone, PC or tabletdisplay via BluetoothConnection | SubstantiallyEquivalent |
| Power supply | Two Rechargeable AAA LiPobatteries | Two alkaline AAA batteries | SubstantiallyEquivalent |
| Weight | 150 g (including batteries) | 60.7 g (including batteries). | SubstantiallyEquivalent |
| Dimensions | 48 (W) x 148 (L) x 25 (H) mm | 49 (W) x 109(L) x 21 (H) mm | SubstantiallyEquivalent |
| Data storage | Up to 10000 measurements | >1000 measurements,depending on the memory ofthe smartphone | SubstantiallyEquivalent |
{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
-
- 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 and that it performs within its specifications.
Spirometry Testing
Performance test has been carried out on the bench according to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019". The test has been conducted in MIR facilities using a Pulmonary Waveform Generator. In accordance with ATS 2019, the subject device was also tested and demonstrated conformance to standards ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and ISO 23747:2015 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans.
Pulse rate accuracy
Testing was conducted in accordance FDA guidance for Pulse Oximeters and ISO 80601-2-61: Medical
{13}------------------------------------------------
Electrical Equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment. The accuracy of Spirobank Oxi pulse rate measurements has been evaluated using a functional tester which allows evaluation of pulse rate over the claimed display range for the device (30 - 200 bpm). The maximum absolute error measured during the tests was as high as 36pm, at a simulated pulse rate of 200 bpm. The results demonstrate conformance to the standard and that the Spirobank Oxi performs within its specifications.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the software for this device was considered as a "moderate" level of concern.
Cybersecurity Testing and Validation were conducted and documented in accordance to FDA Guidance, Postmarket Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, December 2016.
Human Factor testing
Human Factors testing has been carried out to assure that the subject medical device is safe and effective for the intended users, uses, and use environments. Human factor testing has been performed following the recommendation of the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", February 2016.
Cleaning and Disinfection
Validation of Cleaning methods used for the SpirobankOxi were validated in accordance with FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.
Clinical Performance Testing
Determination of substantial equivalence for Oximetry is based on assessment of clinical data, as per Pulse Oximeters - Premarket Notifications [510(k)s] Guidance for Industry and Food and Drug Administration Staff (2013) and ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The data have been collected from a single arm desaturation study conducted in the US, at the Clinimark Desaturation Laboratory (Site ID# 001, , Louisville, CO 80027, USA).
Primary Endpoint: evaluation of pulse oximeter accuracy of Spirobank Oxi using data from desaturation study in healthy volunteers, according to the procedure reported in Annex EE of ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Study Population: the data was collected from 10 healthy volunteers (five males and five females). The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
The Spirobank Oxi pulse oximetry system was placed on the finger of the subject to evaluate the SpO2
{14}------------------------------------------------
accuracy performance during steady state non-motion conditions. RED and IRED signals were collected from the subject device. A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws and the real time oxygen saturation status. The gas mixture was controlled to various levels of induced hypoxia resulting in stable oxygen saturation plateaus between 100% and 67% SaO2. Arterial blood samples were drawn during simultaneous data collection from the control pulse oximeter and from the subject device. The blood was immediately analyzed by Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison. This value is obtained as the mean of the SaO2 values measured by Radiometer ABL 80 Flex OSM and Instrumentation Laboratory IL 682. The Sp02 values of each volunteer were then calculated for the subject device by applying its calibration function using the RED signals collected during the desaturation study.
The study met the primary endpoint. The SpO2 values measured by subject device were compared with the SaO2. using the formula for determination of root mean square difference (Arms) indicated in the ISO 80601-2-61:2017. The following Arms were obtained:
| Total Arms | 1.9004 |
|---|---|
| Arms 90%-100% | 1.4861 |
| Arms 80%-90% | 1.7059 |
| Arms 70%-80% | 2.3315 |
The SpO2 Accuracy analysis for the Spirobank Oxi resulted in an Arms value of 1.9004, thus complying with the ISO 80601-2-61 and the FDA Guidance.
There were no adverse events and complications.
Summarv
Based on the clinical performance as documented in the clinical study, the Spirobank Oxi device was found to have a safety and effectiveness profile as the predicate device.
VIII. Conclusions
The non-clinical data support the safety of the device and software verification and validation demonstrate that the Spirobank Oxi device performs as intended in the specified use conditions. The clinical data demonstrate that the Spirobank Oxi device performs comparably to the predicate device that is currently marketed for the same intended use.
Based on these results, the Spirobank Oxi device is substantially equivalent to the predicate device.
§ 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).