Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard spirometry measurements and calculations based on physical signals and established formulas. There is no mention of AI, ML, or related concepts in the provided text.

Therapeutic

No
The device is used to test lung function and acquire signals related to pulmonary function, not to provide treatment.

Diagnostic

Yes

The device "test[s] lung function" and performs various tests (FVC, FEV1, etc.) and calculations to assess lung health, which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a turbine-type transducer, display, keyboard, power supply, and physical dimensions, indicating it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the SPIRO PD spirometer is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze specimens taken from the human body. The SPIRO PD spirometer measures lung function by analyzing the mechanical signals generated by a patient's breathing. It does not analyze blood, urine, tissue, or any other biological specimen.
The device description focuses on mechanical and electrical signal processing. The description details how the device converts mechanical signals from breathing into electrical signals for processing, not the analysis of biological samples.
The tests performed are related to lung mechanics. FVC, FEV1, PEF, etc., are all measures of how air moves in and out of the lungs, which is a mechanical process.
The intended use describes testing lung function directly from the patient. The device is used by the patient under instruction to test their lung function, not to analyze a sample taken from them.

Therefore, the SPIRO PD spirometer falls under the category of a medical device used for physiological measurement, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

Product codes (comma separated list FDA assigned to the subject device)

BZG

Device Description

The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbine-type transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal.

The SPIRO PD performs the following tests:

FVC
FEV1
FEV1/FVC
PEF
FEF 25-75%
Estimated Lung Age and Flow/Volume Curve

The Spiro PD performs the following calculations:

% Predicted of FVC
Severity of FVC
% Predicted of FEV1
Severity of FEV1
% Predicted of FEV1/FVC
Severity of FEV1/FVC
% Predicted of FEF 25-75%
Severity of FEF 25-75%
% Predicted of PEF, Severity of PEF

The physical configuration of the Spiro PD:

Display Color, Touch screen LCD 320 x 240 resolution
Keyboard - Touch screen
Power supply 3.7V Lithium-ion battery 650 mAh
Dimensions 200 x 96 x 40mm
Weight 256g with battery

The SPIRO PD spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses a turbine transducer that measures flow via infrared interruption. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lung function

Indicated Patient Age Range

2-12 years Child
13-21 years Adolescent
22 and over- Adult

Intended User / Care Setting

physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

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)

Human Factor Study:

Study type: Human Factor Study
Sample size: 45 participants
- 15 Participants 2-12 years of age
- 15 Participants 13-21 years of age
- 15 Participants 22+ years
Key results: Ease of Use scores for all age groups averaged greater than 92.5%. Label comprehension scores for all age groups averaged 97%.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K031643, K073155

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

K103575

NOV - 9 2011

510(k) Summary

Sponsor:

PMD Healthcare

6620 Grant Way Company Address: Allentown, PA 18106

484-664-7600 Telephone: Fax: 484-664-7500

Contact Person:

Wayne Meng

Summary Preparation Date: November 7, 2011

Device Name: Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel:

SPIRO PD Spirometer Spirometer, Diagnostic 868.1840 BZG Class 2 Anesthesiology

Predicate Device

Company Name	Product Name	510(k) Number
SDI Diagnostics	Spirotel	K031643
Vitalograph	Model 4000 Series	K073155

Device Description

The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbinetype transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal.

1

The SPIRO PD performs the following tests:

. FVC,
FEV1 .
FEV1/FVC ●
PEF
. FEF 25-75%
Estimated Lung Age and Flow/Volume Curve .

The Spiro PD performs the following calculations:

% Predicted of FVC ●
Severity of FVC .
. % Predicted of FEV1
Severity of FEV1 .
% Predicted of FEV1/FVC .
Severity of FEV1/FVC .
% Predicted of FEF 25-75% .
. Severity of FEF 25-75%
% Predicted of PEF, Severity of PEF .

The physical configuration of the Spiro PD:

Display Color, Touch screen LCD 320 x 240 resolution .
. Keyboard - Touch screen
Power supply 3.7V Lithium-ion battery 650 mAh .
Dimensions 200 x 96 x 40mm .
Weight 256g with battery .

Device Indications for Use

The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

The Spiro PD spirometer is indicated for the following age groups:

2-12 years Child ●
13-21 years Adolescent �
22 and over- Adult .

2

Predicate Product Comparison

Predicate Product Comparison Chart
Parameter	SPIRO PD	SDI Diagnostics'
Spirotel	Vitalograph
510(k) Number		K031643	K073155
Indications for Use
(IFU)	Indications For Use:
The SPIRO PD
spirometer is
intended to be used
by a patient under
the instruction of a
physician or
respiratory
therapist to test
lung function in
people of all ages. It
is also intended to
be used as a single-
patient device only
and can be used in
the home, factory,
hospital or
physician's office.
The Spiro PD
spirometer is
indicated for the
following age
groups:
• 2-12 years -
Child
• 13-21 years

Adolescent
• 22 and over-
Adult | Indications For Use:
The Spirotel
spirometer is
intended to be used
by a patient under
the instruction of a
physician or
respiratory therapist
to test lung function
in people of all ages.
It is also intended to
be used as a single-
patient device only
and can be used in
any setting - home,
factory, hospital or
physician's office. | The Vitalograph
Model 4000 is a
battery powered,
handheld electronic
spirometer used to
measure Peak Flow
(PEF) and Forced
expired volume
(FEV). |
| Device Description | The SPIRO PD
spirometer is a
hand-held portable
diagnostic
spirometer for the
measurement of
patient breath flow | The Spirotel
Spirometer is a
hand-held portable
diagnostic
spirometer for the
measurement of
patient breath flow | The Vitalograph
Model 4000 series
{ama-1 and copd-6}
are battery
powered handheld
electronic
spirometers used to |
| | and volume. The | and volume. The | measure expired |
| | device uses a | device uses a | Peak Flow and |
| | turbine transducer | turbine transducer | Forced Expired |
| | that measures flow | that measures | Volume after one |
| | via infrared | flow via infrared | second. The results |
| | interruption. | interruption. | can aid in the |
| | Algorithms are used | Algorithms are used | diagnosis of Asthma |
| | to determine values | to determine | and COPD in |
| | based on this flow | values based on this | patients. |
| | measurement. | flow measurement. | All variants {asma-1 |
| | Tabular and | Tabular and | and copd-6} within |
| | graphical data are | graphical data are | the range use the |
| | displayed on the | displayed on the | very same |
| | spirometer LCD | spirometer LCD | operating principle, |
| | display. | display | LCD, Buttons, and |
| | | | Mouldings. Items |
| | | | that may vary |
| | | | within the range are |
| | | | list of parameters
that the different |
| | | | variants display. I.e., |
| | | | Asma-1 displays |
| | | | FEV1 and PEF whilst |
| | | | the copd-6 displays |
| | | | FEV1 and FEV6 only. |
| | | | A uni-directional |
| | | | rotating vane with |
| | | | flow sensor to |
| | | | measure lung |
| | | | function is used. |
| | | | The measurements |
| | | | are taken via |
| | | | expiration into the |
| | | | unit flowhead, |
| | | | which is in-turn |
| | | | displayed onto and |
| | | | LCD. |
| Physical
Configuration | Display:
Color,
Touchscreen LCD
320 x 240
resolution
Keyboard: | Display:
STN LCD, 2 lines x
16 alphanumeric
characters

Keyboard: | Display:
Color LCD

Humidity Range:
Relative humidity
below 95%
(without
condensation)

Atmospheric
Pressure Range:
430mmHg to 800
mmHg | Temperature range:
15 °C - 50 °C

Humidity Range:
Relative humidity
below 95%
(without
condensation)

Atmospheric
Pressure Range:
430mmHg to 800
mmHg | Temperature
Range:
17-37°C

Humidity Range:
10-95% Relative
Humidity |

ﺘ

12.2 Predicate Product Comparison Chart

3

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,

·

,

:

·

4

.

:

5

:

.

:

.

6

Summary of Biocompatibility Tests

Standard	Test Description	Results
ISO 10993-5	Elution Test (ISO)	The test article's extracts
meet the requirements of
the test.
ISO 10993-10	Guinea Pig Closed Patch
Sensitization Test (ISO)
Cottonseed Oil Extract	This test article's
cottonseed oil extract
elicited a minimal
sensitization reaction in
guinea pigs under the
conditions of this test.
ISO 10993-10	Guinea Pig Closed Patch
Sensitization Test (SO)
Saline Extract	This test article's saline
extract did not elicit a
sensitization reaction in
guinea pigs under the
conditions of this test.
ISO 10993-10	Primary Dermal Irritation in
Rabbits (ISO) Cottonseed
Oil Extract	This test article's
cottonseed oil extract
elicited a negligible dermal
response in rabbits under
the conditions of this test.
ISO 10993-10	Primary Dermal Irritation in
Rabbits (ISO) Saline Extract	This test article's saline
extract elicited a negligible
dermal response in rabbits
under the conditions of this
test.

7

Electrical Testing Summary Table 3 Electrical Safety and EMC Tests and Results

Standard	Description of Test	Results
IEC 60601-1	Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance	Pass
IEC 60601-1-4	Medical electrical equipment Part 1-4 – Collateral
Standard: Programmable electrical medical systems	Pass
IEC 60601-1-6	Medical electrical equipment Part 1-6 – Collateral
Standard: Usability	Pass
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests	Pass

Human Factor Study

PMD Healthcare conducted a Human Factor Study using 45 participants.

o 15 Participants 2-12 years of age
o 15 Participants 13-21 years of age
o 15 Participants 22+ years

Summary of Results

Ease of Use scores for all age groups averaged greater than 92.5% Label comprehension scores for all age groups averaged 97%

Comparison of Spiro PD to Predicate Devices

Indications for Use

The Indications for Use of Spiro PD are identical to the Spirotel device with the addition of a clarification of the age groups of the intended users.

8

Technological Characteristics

The Spiro PD and the predicate devices are physically & technologically similar. All devices are portable, hand-held, battery powered devices for measurement of lung performance. The Spiro PD and Spirotel utilize lithium-based batteries while the Vitalograph uses AAA batteries. All3 devices are similar in size and weight.

All 3 devices adhere to the American Thoracic Society (ATS) guidelines. The Spiro PD is a single patient device; the mouthpiece is removable and can be cleaned. The Spirotel has a disposable mouthpiece. Both the Spirotel device employ digital turbine technology to measure flow. All 3 devices are calibrated at the factory.

All 3 devices employ an LCD to present information; the Spirotel is not color. All 3 devices can download to a computer. The Spiro PD and the Spirotel devices measure the most commonly used lung performance parameters and calculate the most common indices. All 3 devices use the NHANES III equations for their predictive models.

All 3 devices meet the safety requirements for medical electrical equipment.

All 3 devices provide the test date and time, plus symptom scores for each test. Both the Spiro PD and the Spirotel save a large number of test data sets. The maximum volume, flow range, flow accuracy, and volume accuracy are the same for the Spiro PD and the Spirotel; the Vitalograph has minor differences.

Both the Spiro PD and the Vitalograph devices estimates lung age; the Spirotel does not. The Vitalograph Model 4000 device is included as a Predicate Device specifically because it estimates lung age as does the Spiro PD.

The Spiro PD and Vitalograph have minimum test durations of 15 seconds per test and a minimum of 3 tests per session per the ATS guidelines. The Spirotel test duration has a maximum of 60 seconds.

All 3 devices operate in the same range of temperature, humidity, and pressure. The Vitalograph does not specify an operating range for atmospheric pressure.

The differences between the Spiro PD and the predicate devices are minor. The Spiro PD has a touch screen user interface while the Spirotel has a 5 key membrane and the Vitalograph has user buttons. All 3 means allow the user to enter information similarly.

Spirotel & Vitalograph use batteries that are not rechargeable whereas the Spiro PD can be recharged. This does not create a meaningful difference in the way in which the devices operate.

The Vitalograph device uses a rotor stator design to measure flow rather than digital turbine technology. Both methods provide sufficient accuracy.

The Vitalograph only measures FEV1, FEV6, FEV1/FEV6 and Lung Age and calculates the associated indices. Although the Vitalograph does not measure the full range of parameters as the Spiro PD and Spirotel, it is measures a subset of these parameters including lung age.

The Spirotel can use the Crapo equations in addition to the NHANES III for its predictive model. Although this provides an alternative model, the NHANES III method is employed by the Spiro PD and both predicate devices.

9

The differences in the technological characteristics between the Spiro PD and the predicate devices are minimal. All 3 devices are portable, hand-held, battery powered devices for measurement of lung performance. They employ similar means of user interaction, data presentation, and measure the same parameters adhering to the ATS guidelines.

Non-clinical data

The Spiro PD has passed all electrical safety and EMC tests that are required for medical devices. It has passed the standard tests required by IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-6, IEC 60601-1-2.

The patient contacting materials of the Spiro PD have passed biocompatibility testing in accordance with ISO-10993.

Human Factors/Usability testing was carried out across all 3 age groups to evaluate use related risks and labeling comprehension. The data generated in this study provided confidence that all the 3 age groups were able to use the device and to achieve the expected results in accordance with the intended use.

Clinical data

Clinical data was not required to determine the safety and effectiveness of the Spiro PD or to show substantial equivalence to the predicate devices. Therefore, no clinical data was collected or assessed as part of this 510(k) premarket notification.

Conclusion

Based on a comparison of the Spiro PD and the predicate devices with regard to their intended use and their technological characteristics, and based on successful completion of all device testing and thorough evaluation of use-related risks assessed during human factor studies, PMD healthcare concludes that the Spiro PD is safe and effective, and is substantially equivalent to legally marketed predicate devices.

10

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that appear to be flames or waves.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 9 2011

PMD Healthcare C/O Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K 103575

Trade/Device Name: SPIRO PD Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: November 7, 2011 Received: November 7, 2011

Dear Mr. Smith:

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. 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.

11

Page 2 - Mr. Smith

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

12

Indications for Use Form

Indications for Use

510(k) Number (if known):

Device Name: SPIRO PD

Indications for Use:

The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

The SPIRO PD spirometer is indicated for the following age groups:

2-12 years Child .
13-21 years Adolescent .
. 22 and over- Adult

Prescription Use _ _ _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulthess

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ L L 3 5 75

Page 1 of _ 1_