← Product Code [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG) · K103575 # SPIRO PD (K103575) _Pmd Healthcare · BZG · Nov 9, 2011 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K103575 ## Device Facts - **Applicant:** Pmd Healthcare - **Product Code:** [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG.md) - **Decision Date:** Nov 9, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1840 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric ## 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 ## Device Story SPIRO PD is a handheld, battery-powered diagnostic spirometer for measuring patient breath flow and volume. It uses a turbine transducer to convert mechanical rotation—caused by exhaled air—into electrical signals via infrared light interruption. The device is intended for single-patient use in homes, clinics, or hospitals. Patients operate the device under physician or respiratory therapist instruction. The device processes flow data to calculate pulmonary parameters (FVC, FEV1, FEV1/FVC, PEF, FEF 25-75%) and estimates lung age. Results, including flow/volume curves and severity indices, are displayed on a color touchscreen LCD. Data can be downloaded to a computer for review. By providing objective lung function metrics and symptom scores, the device aids healthcare providers in monitoring respiratory health and making clinical decisions regarding conditions like asthma or COPD. ## Clinical Evidence No clinical data was collected or assessed. Substantial equivalence was established through bench testing, including electrical safety (IEC 60601-1, -1-2, -1-4, -1-6), biocompatibility (ISO 10993), and a human factors study (n=45) demonstrating 92.5% ease-of-use and 97% label comprehension across all age groups. ## Technological Characteristics Handheld, battery-powered (3.7V Li-ion) diagnostic spirometer. Flow measurement via digital turbine transducer with infrared interruption. Features 320x240 color touchscreen LCD. Dimensions: 200x96x40mm; weight: 256g. Adheres to ATS guidelines. Predictive models: NHANES III. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1 series. Connectivity: data download to PC. ## Regulatory Identification A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. ## Predicate Devices - Spirotel ([K031643](/device/K031643.md)) - Vitalograph Model 4000 Series ([K073155](/device/K073155.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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

Keyboard; | | | Touchscreen | 5 keys membrane | User Buttons | | | Power supply:
3.7V Lithium-ion
battery 650 mAh
Dimensions: | Power supply:
3V Lithium battery
CR123A
Dimensions:
70 x 80 x 30mm | Power Supply:
2 x 1.5v AAA
batteries
Dimensions | | | 200 x 96 x 40mm
Weight:
256g with battery | Weight:
100g with battery | 113 x 63 x 48mm
Weight:
83g with battery | | Power Source | 3.7 V, 650 mAh
Lithium-ion Battery | 3V Lithium Battery | 2x1.5v AAA Battery | | ATS Spirometry
Performance
Recommendations | Yes | Yes | Yes | | Cross
Contamination
Control | Yes, single patient
device. | Yes | Yes | | Flow Detection
Principle | Digital Turbine | Digital Turbine | Rotor Stator Design | | Flowmeter
Calibration Method | Factory Calibration | Factory Calibration | Factory Calibration | | Display and Printer
Used | The SPIRO PD uses
a color touchscreen
LCD | STN LCD, 2 Lines x
16 alphanumeric
characters | The Vitalograph
Model 4000 uses a
color LCD Display | | Graphic Output | Graphic output can
be shown on the
LCD screen and
downloaded to a
computer | Graphic output can
be shown on the
LCD screen and
downloaded to a
computer | Graphic Output
shown on LCD
screen and
downloaded to a
computer | | Tests Performed | FVC, FEV1,
FEV1/FVC, PEF, FEF
25-75%, Estimated
Lung Age and
Flow/Volume Curve | FVC, FEV1, FEV1%,
PEF, FEF25-75%,
FET, and
Flow/Volume Curve | FEV1, FEV6,
FEV1/FEV6 and
estimated Lung Age | | Indices Calculated | % Predicted of FVC,
Severity of FVC, %
Predicted of FEV1,
Severity of FEV1, %
Predicted of
FEV1/FVC, Severity
of FEV1/FVC, %
Predicted of FEF 25- | % Predicted of FVC,
Severity of FVC, %
Predicted of FEV1,
Severity of FEV1, %
Predicted of
FEV1/FVC, Severity
of FEV1/FVC, %
Predicted of FEF 25- | FEV1 and FEV1 %
Predicted
FEV6 and FEV6 %
Predicted
FEV1/FEV6 and
FEV1/FEV6
Predicted
FEV1/FEV6 ration | | | 75%, Severity of FEF
25-75%, %
Predicted of PEF,
Severity of PEF | 75%, Severity of FEF
25-75%, % Predicted
of PEF, Severity of
PEF | 75%, Severity of FEF
25-75%, % Predicted
of PEF, Severity of
PEF | | Predictive Models
Used | NHANES III | NHANES III, Crapo,
Morris | NHANES III | | General Electrical
Safety Tests IEC
60601-1 and IEC
60601-1-2 | Yes | Yes | Yes | | Provides Test date
and time, plus
symptom scores | Yes | Yes | Yes | | Diary storage | 180 days | 100 Days | None | | Replies to simple
questions and test
quality control | Yes | Yes | No | | Maximum Volume | 0 - 10 L | 10 L | 0.99 L BTPS | | Flow Range | 0 -16 L/s | +16 L/s | 0.15 kPa/L/s at 14
L/s | | Flow Accuracy | $\u00b15%$ or 200 mL/s | $\u00b15%$ or 200 mL/s | $\u00b13%$ | | Volume Accuracy | $\u00b13%$ or 50 mL,
whichever is
greater | $\u00b13%$ or 50 mL,
whichever is greater | $\u00b13%$ | | Lung Age | Yes | NO | Yes… --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K103575](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K103575) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com