INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)

Q: Who is the manufacturer of INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)?

Innovision A/S filed the 510(k) submission for INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) (K083879).

Q: What is the FDA product code for INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)?

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

Q: What is the regulatory pathway for INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)?

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

Q: What are the predicate devices for INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)?

Innocor (K051907); Cardiopulmonary Exercise Testing Option (K071911); Spirobank G (K072979).

Q: Who can help prepare an FDA 510(k) submission like INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)?

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.

K083879 · Innovision A/S · BZG · Feb 23, 2009 · Anesthesiology

Device Facts

Record ID	K083879
Device Name	INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
Applicant	Innovision A/S
Product Code	BZG · Anesthesiology
Decision Date	Feb 23, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

Intended 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: 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), and MVV (Maximum voluntary ventilation).

Device Story

The Spirometry Option for Innocor is an add-on module for the existing Innocor system, a point-of-care device. It utilizes a differential pressure pneumotachometer placed between the respiratory valve unit and the patient to measure respiratory flow during forced expiration maneuvers. The system processes these flow measurements to calculate spirometric variables: FEV1, FVC, FEV1%, PEF, MEF 75, MEF 50, MEF 25, FET, and MVV. Healthcare providers use these outputs to assess general respiratory health and pulmonary function. The device is intended for clinical use, allowing providers to evaluate patient lung performance through standardized testing procedures.

Clinical Evidence

Bench testing only. The device was evaluated against the 'Standardisation of Spirometry' document by the ATS/ERS Task Force. Performance data demonstrates that the hardware and software meet these international standards for lung function testing.

Technological Characteristics

Differential pressure type flowmeter (pneumotachometer) for respiratory flow measurement. Operates as an add-on module to the Innocor system. Software-based calculation of spirometric parameters from flow data. Complies with ATS/ERS standards for lung function testing.

Indications for Use

Indicated for use as a diagnostic spirometer in pulmonary function testing to measure gas flow in and out of the lungs for patients requiring assessment of respiratory health, including tidal volume and ventilation performance.

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

Innocor (K051907)
Cardiopulmonary Exercise Testing Option (K071911)
Spirobank G (K072979)

Related Devices

K042595 — SPIRO'AIR · Morgan Scientific, Inc. · May 4, 2005
K093174 — SPIROPALM · Cosmed Srl · Feb 26, 2010
K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO · Medikro OY · May 21, 2014
K991412 — VITALOGRAPH MICRO · Vitalograph, Inc. · Feb 4, 2000
K982956 — FLOWMATE II PLUS, MODEL #4000 · Spirometrics Medical Equipment Co. · Nov 24, 1998

Submission Summary (Full Text)

{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 | 5. 510(k) Summary Page 5.1 of 5.5 {1}------------------------------------------------ # 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 | 5. 510(k) Summary Page 5.2 of 5.5 K0838797 :: \$2/5 {2}------------------------------------------------ ## 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. 5. 510(k) Summary Page 5.3 of 5.5 {3}------------------------------------------------ ・ : . : ## 5. 510(k) Summary Spirometry Option for Innocor | | The Spirometry Option for Innocor, used in conjunction with the entire Innocor system, provides health care providers with a set of valuable diagnostic tools. | | | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------| | Intended Use and Indications | 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 in 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 | l/sec [BTPS] | | | MEF 75* | Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired | l/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 | l/sec [BTPS] | | | FET | Forced expiratory time | Sec | | | MVV | Maximum voluntary ventilation | L/min [BTPS] | 5. 510(k) !Summary · Page 5.4 of 5.5 : : {4}------------------------------------------------ K083879 175/5 | | *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 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 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. | . the contraction of the country of : . . : . {5}------------------------------------------------ #### 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. {6}------------------------------------------------ #### 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 {7}------------------------------------------------ ## 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% 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. 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 4. Indications for Use Statement (Division Sign-Off) Division of Cardiovascular Devices Page 4.1 of 4.1 510(k) Number_k083879