Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard signal processing and calculation methods for spirometry and oximetry data, without mentioning any AI or ML algorithms. The performance study focuses on the accuracy of SpO2 measurements against a reference standard, not on the performance of any learning-based system.

Therapeutic

No.
The device is intended to test lung function and measure oxygen saturation and pulse rate, which are diagnostic and monitoring functions, not therapeutic.

Diagnostic

Yes

The device is intended to test lung function and to perform spot-checking of oxygen saturation and pulse rate, which are diagnostic indicators of a patient's health. It is used to monitor physical conditions and is used by physicians or patients under a physician's prescription.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is made up of a central unit, a removable sensor for respiratory air flow and volume, and a pulse oximetry sensor, all of which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Spirobank Oxi Spirometer and Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Spirobank Oxi Function: The Spirobank Oxi measures lung function (spirometry) and oxygen saturation/pulse rate (oximetry) directly from the patient's body (breathing and finger). It does not analyze specimens taken from the body.

The device's function falls under the category of physiological monitoring devices rather than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

BZG, DQA

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. -

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient finger

Indicated Patient Age Range

adult and pediatric patients greater than 5 years.

Intended User / Care Setting

used by a physician or by a patient under the prescribed use of a physician.
physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Testing:
Study type: single arm desaturation study
Sample size: 10 healthy volunteers (five males and five females)
Data source: Clinimark Desaturation Laboratory (Site ID# 001, Louisville, CO 80027, USA)
Key results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pulse rate accuracy: The maximum absolute error measured during the tests was as high as 36pm, at a simulated pulse rate of 200 bpm.
SpO2 accuracy: Total Arms: 1.9004; Arms 90%-100%: 1.4861; Arms 80%-90%: 1.7059; Arms 70%-80%: 2.3315

Predicate Device(s)

K103530

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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

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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)

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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

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	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, T120BPM,
Ev120BPM,
%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: 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
1. 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.