Who is the manufacturer of SPIRO PD?

Pmd Healthcare filed the 510(k) submission for SPIRO PD (K103575).

What is the FDA product code for SPIRO PD?

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for SPIRO PD?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SPIRO PD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPIRO PD

Q: What are the predicate devices for SPIRO PD?

Spirotel (K031643); Vitalograph Model 4000 Series (K073155).

K103575 · Pmd Healthcare · BZG · Nov 9, 2011 · Anesthesiology

Device Facts

Record ID	K103575
Device Name	SPIRO PD
Applicant	Pmd Healthcare
Product Code	BZG · Anesthesiology
Decision Date	Nov 9, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Indications for Use

Indicated for lung function testing in children (2-12 years), adolescents (13-21 years), and adults (22+ years) under the instruction of a physician or respiratory therapist.

Regulatory Classification

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)
Vitalograph Model 4000 Series (K073155)

Related Devices

K991412 — VITALOGRAPH MICRO · Vitalograph, Inc. · Feb 4, 2000
K100928 — MICRO DIARY SPIROMETER · Viasys Respiratory Care, Inc. · Mar 7, 2011
K241843 — TD-7301 Spirometer (TD-7301) · Gostar Co., Ltd. · Nov 20, 2024
K022276 — KOKOMATE · Ferraris Respiratory, Inc. · Oct 4, 2002
K231416 — Air Next (NVD-02) · Nuvoair AB · Jan 18, 2024

Submission Summary (Full Text)

{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…