(56 days)
Not Found
No
The summary describes a device that measures standard spirometry parameters using a pneumotachometer and performs calculations based on these measurements. There is no mention of AI or ML in the intended use, device description, or performance studies. The evaluation against ATS/ERS standards suggests a deterministic algorithm based on established physiological measurements.
No
The device is described as a diagnostic spirometer used for pulmonary function testing to measure gas flow, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer".
No
The device description explicitly states that the respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer), which is a hardware component. The performance studies also mention that "the hardware and software meet the ATS/ERS standards," indicating the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The Spirometry Option for Innocor measures the flow of gas moving into and out of a patient's lungs directly from the patient's breathing. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is for "diagnostic spirometry, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs." This is a direct physiological measurement, not an in vitro analysis.
- Device Description: The description confirms that it measures "respiratory flow" and "gas concentrations when breathing ambient air."
While the device is used for diagnostic purposes related to pulmonary function, the method it employs (measuring airflow directly from the patient) falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs.
In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are:
| Abbreviation | Name | Unit |
|---|---|---|
| FEV1 | Forced expiratory volume in one second | L [BTPS] |
| FVC | Forced vital capacity | L [BTPS] |
| FEV1% | FEV1/FVC | % |
| PEF | Peak expiratory flow | 1/sec [BTPS] |
| MEF 75* | Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired | 1/sec [BTPS] |
| MEF 50* | Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired | l/sec [BTPS] |
| MEF 25* | Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired | I/sec [BTPS] |
| FET | Forced expiratory time | Sec |
| MVV | Maximum voluntary ventilation | L/min [BTPS] |
- MEF 75 is equal to FEF 25 (maximal instantaneous forced expiratory flow where 25% of the FVC has been expired); MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.
Product codes (comma separated list FDA assigned to the subject device)
DQK, BZG, BZL
Device Description
Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Cardiopulmonary Exercise Testing Option to Innocor provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (Vr) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined bv simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests, providing the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.
Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. Spirometry is recognized as a valuable screening test of general respiratory health.
The Spirometry Option for Innocor measures the subset of spirometric variables of a patient during a forced expiration testing procedure. These measured variables include FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), FEV . PEF (peak expiratory flow), MEF 75 (Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired), MEF 50, MEF 25, FET (Forced expiratory time) and MVV (Maximum voluntary ventilation). These parameters are determined by measurements of the respiratory flow when breathing ambient air during a spirometry test of a patient (tidal breathing followed by a full inspiration and then finally a maximal forced expiration). The respiratory flow is measured by means of a pneumotachometer.
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
Not Found
Intended User / Care Setting
health care providers
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 Spirometry Option for Innocor has been evaluated against the "Standardisation of Spirometry" document in the series "ATS/ERS Task Force: Standardisation of Lung Function Testing," issued by The American Thoracic Society (ATS) and the European Respiratory Society (ERS). Performance data demonstrates that the hardware and software meet the ATS/ERS standards, and the Spirometry Option for Innocor is accordingly substantially equivalent to legally marketed predicate diagnostic spirometers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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
5. 510(k) Summary
Spirometry Option for Inno
| Date of Summary | 12/12/2008 |
|---|---|
| Submitter/Contact | |
| Person | H. Carl Jenkins |
| The Wood Burditt Group | |
| 1025 W. Everett Rd., Suite 100 | |
| Lake Forest, IL 60045 | |
| (ph) (847) 234-7500 x 205 | |
| (fax) (847) 574-0728 | |
| (email) hcjenkins@woodburditt.com | |
| FEB 2 3 2009 | |
| Applicant | Innovision A/S |
| Lindvedvej 75 | |
| DK-5260 Odense S | |
| Denmark | |
| Phone: +45 65 95 91 00 | |
| Fax: +45 65 95 78 00 | |
| info@innovision.dk | |
| www.innovision.dk | |
| Device Name | Spirometry Option to Innocor |
| Common Name | Diagnostic Spirometer |
| Classification | [Hemodynamic Measurements—Already Cleared K051907] |
| Computer, diagnostic, programmable | |
| Regulation Number: 21 CFR §870.1425 | |
| Product Code: DQK | |
| Panel Code: Cardiovascular | |
| Device Class: IIa | |
| [Cardiopulmonary Exercise Testing Option – Already Cleared K071911] | |
| Oxygen uptake computer | |
| Regulation Number: 21 CFR §868.1730 | |
| Product Code: BZL | |
| Panel Code: Anesthesiology | |
| Device Class: IIa |
- 510(k) Summary
Page 5.1 of 5.5
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5. 510(k) Summary
Spirometry Option for Innocor
| [Spirometry Option] | |
|---|---|
| Diagnostic spirometer | |
| Regulation Number: 21 CFR §868.1840 | |
| Product Code: BZG | |
| Panel Code: Anesthesiology | |
| Device Class: II | |
| Legally Marketed | |
| Predicate Devices | The Spirometry Option for Innocor is substantially equivalent in |
| respect to the intended use, design and method of operation to: | |
| Predicate Device No. 1 | |
| Name: Innocor | |
| 510(k) number: K051907 | |
| Manufacturer: Innovision A/S, Denmark | |
| Predicate Device No. 2 | |
| Name: Cardiopulmonary Exercise Testing Option | |
| 510(k) number: K071911 | |
| Manufacturer: Innovision A/S, Denmark | |
| Predicate Device No. 3 | |
| Name: Spirobank G | |
| 510(k) number: K072979 | |
| Manufacturer: MIR Medical International Research | |
| Device Description | Innocor is a compact point-of-care device intended to be used for |
| non-invasive measurement of a) cardiac output (CO) and other | |
| hemodynamic parameters utilizing inert gas rebreathing (IGR) | |
| technology, and b) metabolic parameters including oxygen uptake | |
| by means of a breath-by-breath gas exchange method. | |
| The Cardiopulmonary Exercise Testing Option to Innocor |
- 510(k) Summary
Page 5.2 of 5.5
K0838797 :: $2/5
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