(56 days)
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:
FEV1: Forced expiratory volume in one second
FVC: Forced vital capacity
FEV1%: FEV1/FVC
PEF: Peak expiratory flow
MEF 75*: Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired
MEF 50*: Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired
MEF 25*: Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired
FET: Forced expiratory time
MVV: Maximum voluntary ventilation
- 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.
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 by 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.
The Spirometry Option for Innocor device was 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). The performance data demonstrates that its hardware and software meet the ATS/ERS standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Abbreviation | Name | Unit | Acceptance Criteria (ATS/ERS Standards) | Reported Device Performance |
|---|---|---|---|---|
| FEV1 | Forced expiratory volume in one second | L [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FVC | Forced vital capacity | L [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FEV1% | FEV1/FVC | % | Meets ATS/ERS standards | Meets ATS/ERS standards |
| PEF | Peak expiratory flow | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 75* | Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 50* | Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 25* | Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FET | Forced expiratory time | Sec | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MVV | Maximum voluntary ventilation | L/min [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
*Note: MEF 75 is equal to FEF 25; MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the test set or the data provenance (country of origin, retrospective or prospective nature). It generally states that "Performance data demonstrates that the hardware and software meet the ATS/ERS standards."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
4. Adjudication method for the test set:
- This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document does not mention an MRMC comparative effectiveness study. This device is a diagnostic spirometer for measuring pulmonary function, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study described is a standalone performance evaluation of the Spirometry Option for Innocor against established spirometry standards (ATS/ERS), without involving human-in-the-loop performance testing.
7. The type of ground truth used:
- The ground truth used is the ATS/ERS Standards for spirometry. These standards define the accepted physiological measurements for various spirometric parameters.
8. The sample size for the training set:
- The document does not specify a training set sample size, as the evaluation focuses on comparing the device's measurements to established standards rather than a machine learning model's training.
9. How the ground truth for the training set was established:
- The concept of a "training set" and associated ground truth establishment is not applicable in the context described. The device's performance is validated against pre-existing, widely accepted ATS/ERS Standards, which serve as the reference for accuracy and reliability in spirometry. These standards are established by expert medical societies (American Thoracic Society and European Respiratory Society) based on scientific consensus and extensive research in pulmonary function testing.
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5. 510(k) Summary
Spirometry Option for Inno
| Date of Summary | 12/12/2008 |
|---|---|
| Submitter/ContactPerson | H. Carl JenkinsThe Wood Burditt Group1025 W. Everett Rd., Suite 100Lake Forest, IL 60045(ph) (847) 234-7500 x 205(fax) (847) 574-0728(email) hcjenkins@woodburditt.comFEB 2 3 2009 |
| Applicant | Innovision A/SLindvedvej 75DK-5260 Odense SDenmarkPhone: +45 65 95 91 00Fax: +45 65 95 78 00info@innovision.dkwww.innovision.dk |
| Device Name | Spirometry Option to Innocor |
| Common Name | Diagnostic Spirometer |
| Classification | [Hemodynamic Measurements—Already Cleared K051907]Computer, diagnostic, programmableRegulation Number: 21 CFR §870.1425Product Code: DQKPanel Code: CardiovascularDevice Class: IIa[Cardiopulmonary Exercise Testing Option – Already Cleared K071911]Oxygen uptake computerRegulation Number: 21 CFR §868.1730Product Code: BZLPanel Code: AnesthesiologyDevice 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 MarketedPredicate Devices | The Spirometry Option for Innocor is substantially equivalent inrespect 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 fornon-invasive measurement of a) cardiac output (CO) and otherhemodynamic parameters utilizing inert gas rebreathing (IGR)technology, and b) metabolic parameters including oxygen uptakeby 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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5. 510(k) Summary
<083879 $3/5 Spirometry Option for 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.
- 510(k) Summary
Page 5.3 of 5.5
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・ : .
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5. 510(k) Summary
Spirometry Option for Innocor
| The Spirometry Option for Innocor, used in conjunction with theentire Innocor system, provides health care providers with a set ofvaluable diagnostic tools. | |||
|---|---|---|---|
| Intended Use andIndications | The Spirometry Option for Innocor is intended to be used as adiagnostic spirometer, used in pulmonary function testing, tomeasure the flow of gas moving in and out of a patient's lungs. | ||
| In order to produce data regarding the maximum performance withrespect to tidal volume and ventilation, the specific parametersmeasured by the Innocor Spirometry Option are: | |||
| Abbreviation | Name | Unit | |
| FEV₁ | Forced expiratory volume in onesecond | L[BTPS] | |
| FVC | Forced vital capacity | L[BTPS] | |
| FEV₁% | FEV₁ / FVC | % | |
| PEF | Peak expiratory flow | l/sec[BTPS] | |
| MEF 75* | Maximum instantaneous forcedexpiratory flow where 75% ofthe FVC remains to be expired | l/sec[BTPS] | |
| MEF 50* | Maximum instantaneous forcedexpiratory flow where 50% ofthe FVC remains to be expired | l/sec[BTPS] | |
| MEF 25* | Maximum instantaneous forcedexpiratory flow where 25% ofthe FVC remains to be expired | l/sec[BTPS] | |
| FET | Forced expiratory time | Sec | |
| MVV | Maximum voluntary ventilation | L/min[BTPS] |
- 510(k) !Summary
·
Page 5.4 of 5.5
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K083879 175/5
| *MEF 75 is equal to FEF 25 (maximal instantaneous forcedexpiratory flow where 25% of the FVC has been expired); MEF 50is equal to FEF 50; MEF 25is equal to FEF 75. | |
|---|---|
| Performance Testing | The Spirometry Option for Innocor has been evaluated against the"Standardisation of Spirometry" document in the series"ATS/ERS Task Force: Standardisation of Lung FunctionTesting," issued by The American Thoracic Society (ATS) and theEuropean Respiratory Society (ERS). Performance datademonstrates that the hardware and software meet the ATS/ERSstandards, and the Spirometry Option for Innocor is accordinglysubstantially equivalent to legally marketed predicate diagnosticspirometers. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and conveys a sense of official authority.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Wood Burditt Group LLC. c/o Mr. H. Carl Jenkins Regulatory Affairs Counsel 10 E. Scranton Ave., Suite 201 Lake Bluff, IL 60044
FEB 2 3 2009
Re: K083879
Spirometry Option for Innocor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK, BZG and BZL Dated: December 12, 2008 Received: December 29, 2008
Dear Mr. Jenkins:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. H. Carl Jenkins
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
er R. Volmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Spirometry Option for Innocor
Indications for Use
510(k) Number (if known): Ko 8 38 2 9
Device Name: Spirometry Option for Innocor
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% ofthe FVC remains to be expired | 1/sec [BTPS] |
| MEF 50* | Maximum instantaneous forced expiratory flow where 50% ofthe FVC remains to be expired | l/sec [BTPS] |
| MEF 25* | Maximum instantaneous forced expiratory flow where 25% ofthe 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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ourna R.Values
- Indications for Use Statement
(Division Sign-Off) Division of Cardiovascular Devices
Page 4.1 of 4.1
510(k) Number_k083879
§ 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).