(559 days)
EasyOne Air Spirometer, K161536
No
The description focuses on ultrasonic measurement and comparison to standard equations, with no mention of AI/ML terms or related concepts like training/test sets.
No
The device is used for basic lung function and spirometry testing, which are diagnostic procedures, not therapeutic interventions.
Yes
The device is intended to be used for "basic lung function and spirometry testing," and it "derives pulmonary function data from airflow measurements" to "perform pulmonary function tests." These tests are used to assess the state of a patient's lungs, which is a diagnostic activity.
No
The device description explicitly states it is a "SpiroHome Ultrasonic Spirometer (SUS)" which is a portable spirometer that uses ultrasonic sensors to measure airflow. It also mentions associated accessories like a mouthpiece. This indicates a physical hardware component is central to the device's function, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SpiroHome Function: The SpiroHome device measures lung function by analyzing airflow during breathing. This is a direct measurement of a physiological process within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states it's for "conducting basic lung function and spirometry testing," which involves breathing into the device.
- Device Description: The description details how the device measures airflow using ultrasonic sensors, not how it analyzes biological samples.
Therefore, the SpiroHome Ultrasonic Spirometer falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
Product codes
BZG
Device Description
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children over 5 years old
Intended User / Care Setting
physician's offices, clinics and home setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SpiroHome Ultrasonic Spirometer was tested against criteria for:
- Functional Requirements
- ATS 2019 / ERS waveform simulator testing
- ISO 26782:2009
- ISO 23747:2015
- High Altitude Performance
- Flow Resistance
- Electrical Requirements
- AAMI ANSI ES 60601-1
- IEC 60601-1-11
- IEC 60601-1-2
- Biocompatibility
Contact Type and Duration: Surface Contact, Mucosa, Externally Communicating, Tissue; permanent (>30 days)- ISO 10993-1
- ISO 10993-3
- ISO 10993-5
- ISO 10993-10
- ISO 10993-11
- ISO/FDIS 18562-1
- ISO/FDIS 18562-2
- ISO/FDIS 18562-3
- Shipping Requirements, Packaging and Distribution
- ASTM D4332
- ASTM D7386
- ASTM F1886/F1886M
- ISO 17664
- ISO 11737-1
- Cleaning
- ISO 17664
- AAMI TIR30
- AAMI TIR12
- ASTM E2314
- ISO 15883-1
- ISO 11737-1
- ISO/TS 15883-5
- Software and System Verification and Validation
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- IEC 62304
- Human Factors Study
- Guidance for Applying Human Factors and Usability Engineering to Medical Devices
- AAMI/ANSI HE75:2009
- ANSI/AAMI/IEC 62366-1:2015
Based upon the foregoing performance testing and comparison to the legally marketed predicate device, and reference device, for indications for use, technology, and performance, we believe we have demonstrated that the Spirometer is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GoSpiro, K163249
Reference Device(s)
EasyOne Air Spirometer, K161536
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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June 12, 2023
Inofab Saglik Teknolojileri A.S % Ray Kelly Consultant Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach, Florida 32168
Re: K213754
Trade/Device Name: SpiroHome Ultrasonic SpiroHome Clinic, SpiroHome Personal Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: January 17, 2023 Received: January 23, 2023
Dear Ray Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213754
Device Name
SpiroHome Ultrasonic Spirometer, SpiroHome Clinic, SpiroHome Personal
Indications for Use (Describe)
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary 21 CFR 807.92
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
l. Submitter Information
Submitter Name:
| | Inofab Health Sağlik Teknolojileri A.S
Üniversiteler Mahallesi,
İhsan Doğramacı Bulvarı,
ODTÜ Teknokent Silikon Blok No:17/115,
06800 Çankaya/Ankara, Türkiye |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +90 312 988 03 08 |
| Contact Person: | Ray Kelly |
| Date Prepared: | June 09, 2023 |
II. Device Information:
| Name of Device: | SpiroHome Ultrasonic Spirometer,
SpiroHome Clinic, SpiroHome Personal |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Spirometer |
| Classification Name: | Diagnostic Spirometer (21 CFR 868.1840) |
| Regulatory Class: | II |
| Product Code: | BZG |
III. Predicate Device:
GoSpiro, K163249
IV. Reference Device:
EasyOne Air Spirometer, K161536
V. Device Description
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are
İnofab Sağlık Teknolojileri A.Ş. Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 ODTÜ Teknokent Silikon Blok Çankaya / ANKARA +90 312 988 0 308 info@inofab.health · wwwinofab.health F-129 R.00 / 2022.08.25
4
obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
VI. Indication for Use:
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing.
VII. Comparison of technological characteristics with the predicate and reference device:
The subject device has the same spirometry functions with the same test types, test parameters and utilize the same interpretation algorithms as the predicate device, however, the ultrasonic sensor technology used in the subject device is different to that of the predicate device which utilizes a turbine-based sensor. The subject device has the same technological characteristics with regards to spirometry testing as the reference device, in particular the same sensor technology is used for spirometry testing. The differences in sensor measurement technology do not raise concerns of safety and effectiveness for the subject device.
The subject device and predicate device both use Bluetooth-connected devices as displays in comparison to the reference device which has a touch-enabled display on the device. Each model of the subject device operates with its own respective application version whereas the predicate device has only one application with which it operates.
The subject device and predicate device both use off-the-shelf standard batteries whereas the reference device uses a rechargeable battery pack.
Each model of the subject device is used with its own respective mouthpiece model. The personal model of the subject device is used with a reusable mouthpiece and the clinic model is used with a disposable mouthpiece. The predicate device mouthpiece is constructed from both reusable and disposable components, and the reference device is used only with disposable mouthpieces. Design verification and validation demonstrates that the SpiroHome spirometer used in combination with the SpiroWay mouthpiece provides the same spirometry test results as the predicate and reference devices used in combination with their respective mouthpieces and is therefore substantially equivalent to the predicate and reference devices.
5
Table 1. Comparison of subject device attributes to predicate device and reference device
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended to be used by
adults and children
over 5 years old
in physician's offices,
clinics and home
setting to conduct
basic lung function and
spirometry testing. | Intended to be used by
adults and children
over 5 years old in
physician's offices,
clinics and home
settings to conduct
basic lung function and
spirometry testing. It is
a single-patient
use device. | The EasyOne Air
spirometer is intended
for prescription use only
to conduct diagnostic
spirometry testing of
adults and pediatric
patients over 4 years
old. The EasyOne Air
spirometer is used by
general practitioners,
specialists, and health
care professionals, in
hospitals and clinics, in
pharmacies, and in
clinical settings in
occupational medicine. | Identical for
subject and
predicate. |
| Common Name | Spirometer, Diagnostic | Spirometer, Diagnostic | Spirometer, Diagnostic | Identical |
| Regulation | 868.1840 | 868.1840 | 868.1840 | Identical |
| Product Code | BZG | BZG | BZG | Identical |
| Classification | II | II | II | Identical |
| Review Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical |
| Intended User | HCP or patient | HCP or patient | HCP | Identical for
subject and
predicate. |
| Environment of Use | Clinic or home | Clinic or home | Clinic | Identical for
subject and
predicate. |
| Principle of
Operation | Spirometer is designed
for pulmonary function
tests. It is a portable
spirometer capable of
generating Pulmonary
Function Test (PFT)
data based on the air
flow and volume. The | Spirometer is designed
for pulmonary function
tests. It is a portable
spirometer capable of
generating Pulmonary
Function Test (PFT)
data based on the air
flow and volume. The | Spirometer is designed
for pulmonary function
tests. It is a portable
spirometer capable of
generating Pulmonary
Function Test (PFT)
data based on the air
flow and volume The | Identical for
subject and
predicate and
similar to
reference device. |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| | device measures a
patient's lung function
values and compares it
to their predicted
values (obtained
from internationally
accepted lung function
test equations). The
portable spirometer
pairs to smart devices
running the associated
apps. | device measures a
patient's lung function
values and compares it
to their predicted
values (obtained from
internationally accepted
lung function test
equations). The
portable spirometer
pairs to smart devices
running the associated
apps. | device measures a
patient's lung function
values and compares it
to their predicted values
(obtained
from internationally
accepted lung function
test equations). The
portable spirometer has
on-device screen
display. | |
| Conditions of Use | Spirometer is available
for home use or clinical
use. Clinic use is
indicated for healthcare
professionals (HCPs)
to use with patients
(pediatric between the
ages of 5-21 and adults
over the age of 21) who
may have
been diagnosed with a
chronic
pulmonary disease.
Clinic use is intended
to be used in a clinical
setting multiple times a
day by multiple
patients. The home
user, after it is
prescribed by a
clinical/professional,
will be used by patients
at home. Home users
are (pediatric between
the ages of 5-21 and
adults over the age of | Spirometer is available
for home use or clinical
use. Clinic use is
indicated for healthcare
professionals (HCPs)
to use with patients
(pediatric between the
ages of 5-21 and adults
over the age of 21) who
may have been
diagnosed with a
chronic pulmonary
disease. Clinic use is
intended to be used in
a clinical setting
multiple times a day by
multiple patients. The
home user, after it is
prescribed by a
clinical/professional,
will be used by patients
at home. Home users
are (pediatric between
the ages of 5-21 and
adults over the age of
21) who may have | Spirometer is
available for only
clinical use. Clinic use
is indicated
for healthcare
professionals (HCPs)
to use with patients
(pediatric between the
ages of 4-21 and
adults over the age of
21) who may have
been diagnosed with
a chronic pulmonary
disease. Clinic use is
intended to be used in
a clinical setting
multiple times a day
by multiple patients.
Users need to interact
with the device to
assemble the device by
inserting batteries,
turning on the device,
and go through the
device set up | Identical for
subject and
predicate. |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| | 21) who may have
been diagnosed with
a chronic pulmonary
disease. Patients or
their care
providers/legal
guardians will use the
device multiple times
a day by a single
patient. Users need
to interact with the
device to assemble the
device by inserting
batteries, turning on
the device, and go
through the device set
up procedure in the
app. Users then
perform spirometry test
by breathing into the
device and
receive feedback on
their performance
though the app. Users
will clean the device
as instructed. | been diagnosed with a
chronic
pulmonary disease.
Patients or their care
providers/legal
guardians will use
the device multiple
times a day by a
single patient. Users
need to interact with
the device to assemble
the device by
inserting batteries,
turning on the device,
and go through the
device set up
procedure in the app.
Users then perform
spirometry test
by breathing into the
device and
receive feedback on
their performance
though the app. Users
will clean the device
as instructed. | procedure. Users then
perform a spirometry
test by breathing into
the device and
receive feedback on
their performance
though the app. Users
will clean the device
as instructed. | |
| Software | Mobile Medical App
(MMA) | Mobile Medical App
(MMA) | Mobile Medical App
(MMA) | Identical |
| Software LOC | Moderate | Moderate | Moderate | Identical |
| Bluetooth | Yes | Yes | Yes | Identical |
| Used with PFT filter and / or mouthpiece | Mouthpiece Disposable
or Reusable | Mouthpiece Disposable
and Mouthport
Reusable | Mouthpiece Disposable | Similar for subject
and predicate.
Predicate
mouthpiece has a
reusable
(mouthport) and
disposable
component and is |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| Configuration | Hand-held, portable | Hand-held, portable | Hand-held, portable | Identical |
| Patient
Population | Over 5 years old | Over 5 years old | Over 4 years old | Identical for
subject and
predicate. |
| Sensor
Technology | Transit-time Ultrasound | Turbine | Transit-time Ultrasound | Identical for
subject and
reference device. |
| Recalibration | Not required | Required | Not required | Identical for
subject and
reference. |
| Measured
Parameters | FVC, FEV0.75,
FEV1, FEV3,
FEV6,
FEV0.75/FVC,
FEV1/FVC,
FEV3/FVC,
FEV6/FVC, PEF | FVC, FEV0.75, FEV1,
FEV3, FEV6,
FEV0.75/FVC,
FEV1/FVC, FEV3/FVC,
FEV6/FVC, PEF,
MMEF, FEF25, FEF50,
FEF75, FEF25-75 | BEV, EOTV, FEF10,
FEF25, FEF25-75,
FEF25-75/FVC,
FEF40, FEF50,
FEF50/FVC, FEF60,
FEF75, FEF80, FET, | Similar parameters
for subject,
predicate and
reference devices.
Differences do
not affect the safe
and effective use
for single- patient
use. Subject
device has
reusable
mouthpiece for
home use and a
disposable
mouthpiece for
clinic use, both are
for single-patient
use. Reference
device has only a
single-patient
disposable
mouthpiece. No
concerns raised
regarding subject
device safety or
effectiveness due
to mouthpiece
differences. |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| | MMEF, FEF25,
FEF50, FEF75
, FEF25-75,
MET25-75,
FEV0.75/FEV6
, FEV1/FEV6,
FEF50/FVC,
MMEF/FVC, FET, BEV,
FIV1, FIVC, PIF,
FIF25-75, FIV1/FIVC,
R50 (FEF50/FIF50),
VC, VCin, VCex
, ERV, IRV, IC, Rf,
VT, MVV, MVV6,
MVVtime | FIV1, FIVC,
PIF, FIF25-75, FIF25,
FIF50, FIF75, MET25-
75, FEV0.75/FEV6,
FEV1/FEV6,
FEF50/FVC
, FIV1/FIVC, R50
(FEF50/FIF50), FET,
MVV | FET25-75, FEV.25,
FEV.5,
FEV.5/FVC, FEV.75,
FEV.75/FVC, FEV1,
FEV1/FEV6,
FEV1/FIV1,
FEV1/FVC,
FEV3, FEV3/FVC,
FEV6, FIF25, FIF50,
FIF50/FEF50, FIF75,
FIV.25, FIV.5, FIV1,
FVC, FVC6, FVC,
FVC6, MEF20,
MEF25, MEF40,
MEF50,
MEF60, MEF75,
MEF90, MIF25, MIF50,
MIF75, MMEF, PEF,
PEFT, t0, MVV, MVV6,
MVVtime, Rf, ERV, IC,
IRV, Rf, VC, VCex,
VCin, VCmax, VT | of the subject
device. |
| Power | 2 x AAA Alkaline and
Rechargeable
Batteries | Rechargeable lithium-
ion batteries | Rechargeable battery
pack | The difference in
power sources
between devices
does not raise
concerns of safety
or effectiveness of
the subject device
as validated by the
electrical safety,
performance, and
EMC testing. |
| Air Resistance | 48.54 Pas/L
(Highest Expiratory
Impedance) | 137 Pa*s/L | *0.3 cm H2O/L/s at 16
L/s | Differences in
dynamic air
resistance
between devices
based on design |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| Volume Range & Accuracy | 0-10 L,
± 2.5% or ± 0.050 L | 0-8 L,
± 3% or ± 0.050 L | *±12 L,
*±2% or 0.050 L | Difference
between volume
range and
accuracy
between devices
are minor, the
subject device
meets permissible
margins given in
ATS guidelines
and ISO 286782. |
| Flow Range & Accuracy | 0 - 14 L/s,
±10% or ± 170 mL/s | 0 - 14 L/s,
±5% or 200 mL/s | *±16 L/s
*±2% or 0.020 L/s
(except PEF)
*±5% or 0.200 L/s PEF
accuracy | Difference
between flow
range and
accuracy
between devices
are minor, the
subject device
conforms to
permissible
margins given in
ISO 286782. |
| Display
Type/Size | Mobile app | Mobile app | Touch-enabled display
on device | Identical for
subject and
predicate devices. |
| Flow-Volume Loop | During test and test
review | During test and test
review | *During test and test
review | Identical |
| Volume-Time Curve | During test and test
review | During test and test
review | *During test and test
review | Identical |
| Dimensions W x D x H | 110mm x 40.8m x
63.3mm | 88.9mm x 114.3mm x
50mm | *87mm x 155mm x
36mm | Subject device is
smaller in overall
volume than both |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| | | | | predicate and
reference devices.
Difference in size
does not raise
concerns for
subject device
safety and
effectiveness as
demonstrated in
usability and
performance tests. |
| Weight | 90g (with batteries) | 300g (with batteries) | *356 g (with batteries) | Subject device
weighs less than
both predicate and
reference devices.
Difference in
weight does not
raise concerns for
subject device
safety and
effectiveness as
demonstrated in
usability and
performance tests. |
| Connection to patient | Mouthpiece | Mouthpiece | Mouthpiece | Identical |
| Storage
Temperature | -20°C to 60°C | *-20°C to 70°C | *-20°C to 50°C | Minor differences.
Differences do not
affect the safety
and effectiveness
of the subject
device as
demonstrated in
product testing. |
| Storage
Humidity (RH) | 5% to 85% | 15% to 95% | *5% to 90% | Minor differences.
Differences do not
affect the safety
and effectiveness |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| Operational
Temperature | 15°C to 35°C | 17°C to 35°C | *0°C to 40°C | of the subject
device as
demonstrated in
product testing.
Minor differences.
Differences do not
affect the safety
and effectiveness
of the subject
device as
demonstrated in
product testing. |
| Operational
Humidity (RH) | 30% to 85% | 30% to 75% | *5% to 90% | Minor differences.
Differences do not
affect the safety
and effectiveness
of the subject
device as
demonstrated in
product testing. |
| Expected
Service Life | 5 years | Not Provided | *7 years | Similar for subject
and reference
device, difference
does not affect the
safety or
effectiveness of
the subject
device. |
| Water Ingress
Protection | IP22 | IP22 | Not Provided | Identical for
subject and
predicate. |
| Electrical safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Meets IEC 60601-1 | Identical |
| EMC safety | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Identical |
| Home use | Meets IEC 60601-1-11 | Meets IEC 60601-1-11 | Not Provided | Identical for
subject and
predicate device. |
| Biocompatibility | Meets ISO 10993-1,
ISO 10993-5, ISO | Meets ISO 10993-1,
ISO 10993-5 | ISO 10993-1, ISO
10993-5, ISO 10993-10 | Subject, predicate
and reference |
| Attribute | Subject Device
Spirohome | Predicate Device
GoSpiro (K163249) | Reference Device
(K161536) | Similarities /
Differences |
| | 10993-10, ISO 10993-
11, ISO 18562- 1, ISO
18562-2, ISO 18562-3,
USP 43-NF 38 (2020)
and EP
2.6.14 (EP 10.3) | ISO 10993-10, Volatile
Organic
Compounds (VOC),
CO, CO2, Ozone, and
PM2.5 testing | ISO 10993-18,
ISO/FDIS 18562-2,
ISO/FDIS 18562-3 | devices meet
requirements of
ISO 10993-1 and
ISO 18562-1.
Subject device
also meets
pyrogen and LAL
testing
requirements. |
İnofab Sağlık Teknolojileri A.Ş. Üniversiteler Mah. İhsan Doğramacı Blv. No:17/115 ODTÜ Teknokent Silikon Blok Çankaya / ANKARA +90 312 988 0 308 · info@inofab.health · wwwinofab.health F-129 R.00 / 2022.08.25
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7
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10
11
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VII. PERFORMANCE DATA
The SpiroHome Ultrasonic Spirometer was tested against criteria for:
- · Functional Requirements
- ATS 2019 / ERS waveform simulator testing o
- ISO 26782:2009 o
- ISO 23747:2015 O
- High Altitude Performance O
- O Flow Resistance
- · Electrical Requirements
- o AAMI ANSI ES 60601-1
- O IEC 60601-1-11
- IEC 60601-1-2 o
- Biocompatibility
Contact Type and Duration: Surface Contact, Mucosa, Externally Communicating, Tissue; permanent (>30 days)
- ISO 10993-1 O
- ISO 10993-3 o
- ISO 10993-5 O
- O ISO 10993-10
- ISO 10993-11 O
- ISO/FDIS 18562-1 O
- ISO/FDIS 18562-2 o
- ISO/FDIS 18562-3 ೧
- · Shipping Requirements, Packaging and Distribution
- ASTM D4332 o
- ASTM D7386 O
- ASTM F1886/F1886M O
- ISO 17664 O
- ISO 11737-1 o
- · Cleaning
- ISO 17664 O
- AAMI TIR30 O
- AAMI TIR12 o
- ASTM E2314 O
- ISO 15883-1 O
- O ISO 11737-1
- ISO/TS 15883-5 O
- Software and System Verification and Validation
- Guidance for the Content of Premarket Submissions for Software Contained in o Medical Devices
- IEC 62304 o
- Human Factors Study
- Guidance for Applying Human Factors and Usability Engineering to Medical Devices o
- AAMI/ANSI HE75:2009 O
15
ANSI/AAMI/IEC 62366-1:2015 O
VIII. CONCLUSIONS
Based upon the foregoing performance testing and comparison to the legally marketed predicate device, and reference device, for indications for use, technology, and performance, we believe we have demonstrated that the Spirometer is substantially equivalent to the predicate device.