(58 days)
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: Oxygen uptake, Carbon dioxide excretion, Expiratory minute ventilation. Calculated/derived parameters: Oxygen uptake per kg, Respiratory exchange ratio, Alveolar ventilation, Anatomical dead space (Fowler dead space), Tidal volume, Respiratory rate, End-tidal concentration of oxygen, End-tidal concentration of carbon dioxide, Expiratory quotient / ventilatory equivalent for oxygen, Expiratory quotient / ventilatory equivalent for carbon dioxide. And the following calculated parameters after an incremental exercise test: Anaerobic threshold, Respiratory compensation, Rest values, Values at AT point, Values at max exercise.
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 Breath-by-Breath option provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (VE) 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. This gives 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.
The provided text describes the Cardiopulmonary Exercise Testing Option to Innocor. Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device has been shown through bench testing to be substantially equivalent to the predicate device. However, specific numerical acceptance criteria for performance metrics (such as accuracy, precision, or deviation) and the exact reported device performance metrics are not detailed in the provided text. The statement is a general claim of equivalence.
| Parameter/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measurement of metabolic parameters on a breath-by-breath basis | Substantially equivalent to Medical Graphics Ultima System, K061731 | Shown to be substantially equivalent to Medical Graphics Ultima System, K061731 through bench testing |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" but does not specify a sample size for the test set. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts or provide details about their number or qualifications in establishing ground truth for the bench testing. The comparison is made against a legally marketed predicate device.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
An MRMC comparative effectiveness study was not conducted as per the provided information. The study described is a bench test for device equivalence, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The study was described as "bench testing" to demonstrate substantial equivalence to a predicate device. This implies a standalone (algorithm/device only) performance evaluation against the predicate, rather than an evaluation with human interaction.
7. The Type of Ground Truth Used
The ground truth for the bench testing appears to be the measurements provided by the legally marketed predicate device, the Medical Graphics Ultima System (K061731). The new device's performance was compared to this established device.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This submission focuses on the performance of a medical device rather than an AI/machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, no information is provided on how its ground truth was established.
Summary of Study Information:
The study described is a bench testing comparison of the Cardiopulmonary Exercise Testing Option to Innocor against a legally marketed predicate device (Medical Graphics Ultima System, K061731). The primary goal was to demonstrate substantial equivalence in the measurement of metabolic parameters on a breath-by-breath basis. The document lacks specific details regarding quantitative performance metrics, sample sizes, data provenance, expert involvement, or adjudication methods typically associated with clinical or AI algorithm validation studies. The ground truth for this comparison was established by the measurements of the predicate device.
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5. 510(k) Summary
SEP - 7 2007
| Date of Summary | 9 July 2007 | |
|---|---|---|
| Submitter/Contact | Richard O. Wood | |
| Person | The Wood Burditt Group | |
| FDA Regulatory Counseling | ||
| 1025 W. Everett Rd., Suite 100 | ||
| Lake Forest, IL 60045 | ||
| (ph) (847) 234-7500 x 203 | ||
| (fax) (847) 574-0728 | ||
| (email) rowood@woodburditt.com | ||
| Applicant | Innovision A/S | Phone: +45 65 95 91 00 |
| Lindvedvej 75 | Fax: +45 65 95 78 00 | |
| DK-5260 Odense S | info@innovision.dk | |
| Denmark | www.innovision.dk | |
| Device Name | Cardiopulmonary Exercise Testing Option to | Innocor |
| (referred to in this submission as "Cardiopulmonary Exercise | ||
| Testing Option to Innocor," "Breath-by-Breath System," and | ||
| "BbB System") | ||
| Common Name | Cardiopulmonary Exercise Testing System | |
| 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] | ||
| Oxygen uptake computer | ||
| Regulation Number: 21 CFR §868.1730 | ||
| Product Code: BZL | ||
| Panel Code: Anesthesiology | ||
| Device Class: IIa |
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| Legally Marketed | The Cardiopulmonary Exercise Testing Option to Innocor is |
|---|---|
| Predicate Devices | 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: Ultima System | |
| 510(k) number: K061731 | |
| Manufacturer: Medical Graphics Corporation, MN | |
| 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 Breath-by-Breath option provides measurements of gas | |
| exchange parameters including oxygen uptake (VO2), carbon | |
| dioxide excretion (VCO2), ventilation (VE) 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. This gives 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. | |
| Intended Use and | A cardiopulmonary exercise testing option is available for |
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.
| Indications | Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: |
|---|---|
| Main metabolic parameters: | |
| Oxygen uptake | |
| Carbon dioxide excretion | |
| Expiratory minute ventilation | |
| Calculated/derived parameters: | |
| Oxygen uptake per kg | |
| Respiratory exchange ratio | |
| Alveolar ventilation | |
| Anatomical dead space (Fowler dead space) | |
| Tidal volume | |
| Respiratory rate | |
| End-tidal concentration of oxygen | |
| End-tidal concentration of carbon dioxide | |
| Expiratory quotient / ventilatory equivalent for oxygen | |
| Expiratory quotient / ventilatory equivalent for carbon dioxide | |
| And the following calculated parameters after an incremental exercise test: | |
| Anaerobic threshold | |
| Respiratory compensation | |
| Rest values |
:
.
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| Values at AT point | |
|---|---|
| Values at max exercise | |
| Performance Testing | The Cardiopulmonary Exercise Testing Option to Innocorhas been shown by bench testing to be substantiallyequivalent in respect to its intended use to measure metabolicparameters on a breath-by-breath basis to the legallymarketed predicate device Medical Graphics Ultima System,K061731. |
:
:
1
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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2007
Innovision A/S c/o Mr. Richard O. Wood Sponsor Representative The Wood Burditt Group LLC 1025 Everett Road, Suite 100 Lake Forest, IL 60045
Re: K071911
Trade Name: Innocor, Models INN00400 and INN00500 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: August 29, 2007 Received: September 5, 2007
Dear Mr. Wood:
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. Richard O. Wood
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 (QS) 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,
Bhimimao for
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
510(k) Number (if known): __ K ( 7/ 9/1
Device Name: Cardiopulmonary Exercise Testing Option to Innocor
Indications for Use:
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-bybreath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for:
Main metabolic parameters:
-
- Oxygen uptake
- Carbon dioxide excretion
- · Expiratory minute ventilation
Calculated/derived parameters:
- Oxygen uptake per kg
- · Respiratory exchange ratio
- Alveolar ventilation
- · Anatomical dead space (Fowler dead space)
- · Tidal volume
- · Respiratory rate
- · End-tidal concentration of oxygen
- · End-tidal concentration of carbon dioxide
- · Expiratory quotient / ventilatory equivalent for oxygen
- · Expiratory quotient / ventilatory equivalent for carbon dioxide
And the following calculated parameters after an incremental exercise test:
- · Anaerobic threshold
- · Respiratory compensation
- " Rest values
- · Values at AT point
- · Values at max exercise
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)
B. Rammima
lylslon Sign-Off) Division of Cardlovascular Devices 510(k) Number
- Indications for Use Statement
Page 4-1 of 4-1
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).