(231 days)
Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, troke Index, Blood Pressures (Systolic, Diastolic, Mean Arterial), ystemic Vascular Resistance, Systemic Vascular Resistance Index.
Innocor is a compact point-of-care device intended to be used for measurement of a) cardiac output (CO) utilizing inert gas rebreathing (IGR) technology and b) other hemodynamic parameters. Two Models will be made available initially in the U.S: Innocor, Innocor with NIBP option. With the NIBP module option, the device will provide values for the hemodynamic parameters included in the Indications for Use below.
The provided text for K051907 describes the Innocor device and its substantial equivalence to predicate devices, focusing on its ability to measure cardiac output and other hemodynamic parameters. However, it does not contain the detailed information required to fill out the table and answer the study-related questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study for the Innocor device itself.
The document primarily focuses on establishing substantial equivalence for regulatory purposes by comparing the Innocor's intended use and components (inert gas rebreathing for cardiac output, pulse oximeter, NIBP) to already cleared predicate devices. It lists the predicate devices and the parameters Innocor measures but does not include a specific study design with acceptance criteria and performance metrics for the Innocor.
Therefore, I cannot provide the requested table and detailed study information based solely on the provided text. The output below reflects the information that is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not specified in the provided text | Not specified in the provided text | Not specified in the provided text |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth Establishment
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication Method for Test Set
- Adjudication Method: Not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not specified in the provided text. The document focuses on device equivalence, not human reader performance with or without AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? The document describes the device's functionality for measuring various parameters. While it performs these measurements, a formal "standalone study" with specific performance metrics against an established ground truth (as typically reported for AI/algorithm performance) is not detailed. The text implies a comparison to methods like Thermodilution and Direct Fick for cardiac output, but not in the format of a standalone performance study with defined criteria and results.
7. Type of Ground Truth Used
- Type of Ground Truth: For the cardiac output measurement, the document mentions substantial equivalence to "Thermodilution Cardiac Output Computers" and the "Direct Fick Method preamendment calculation method." These predicate methods serve as a comparative basis for the Innocor's measurements, implying they represent the "truth" against which the new device is compared. However, a specific ground truth dataset and its source (e.g., pathology, outcomes data, expert consensus on a test set) for Innocor's own validation is not described.
8. Sample Size for Training Set
- Sample Size: Not applicable. The Innocor is described as a device utilizing inert gas rebreathing technology and other measurement components, not an AI/machine learning algorithm that requires a training set in the conventional sense.
9. How Ground Truth for Training Set Was Established
- How Established: Not applicable, as there is no mention of a training set for an AI/machine learning component.
{0}------------------------------------------------
K051907 1/2
510(k) Summary
| Applicant | Innovision A/SLindvedvej 75DK-5260 Odense SDenmark |
|---|---|
| Manufacturer | Same |
| Device Name | Innocor™ |
| Common Name | Computer, diagnostic, programmable |
| Classification | Relevant Device Information: Class IIPanel Code: CardiovascularProduct Code(s): DQKRegulation: §870.1425 |
| Innocor has been shown by clinical testing to be substantiallyequivalent in respect to its intended use to measure cardiacoutput to two predicate technologies: 1) Thermodilution CardiacOutput Computers (American Edwards Laboratories) K872529and K830892 and 2) the Direct Fick Method preamendmentcalculation method. | |
| Summary of SubstantialEquivalence | The pulse oximeter component in the Innocor has been shown tobe substantially equivalent to theK970763 MTS Option for the ESCORT II Monitor(Attachment 10A) K982776 Model 9303 Neonatal/Adult Vital SignsMonitor (See Attachment 2D) K021138 SleepScreen and ApnoeScreen Cardio(Attachment 10B) |
| The NIBP component option in the Innocor has been shown tobe substantially equivalent to the K032363 Zoll M-Series (NIBP Option) K051703 Clever TD-3018ATM Blood Pressure Monitor | |
| Innocor is a compact point-of-care device intended to be usedfor measurement of a) cardiac output (CO) utilizing inert gasrebreathing (IGR) technology and b) other hemodynamicparameters. | |
| Device Description | Two Models will be made available initially in the U.S:Innocor Innocor with NIBP option With the NIBP module option, the device will provide values forthe hemodynamic parameters included in the Indications for Usebelow. |
| Intended Use and Indications | Innocor is indicated for the determination of a number ofhemodynamic parameters.Cardiac Output (CO) is the principal measured parameter.Utilizing inert gas rebreathing, Innocor measures the relativelevels of two inhaled gases of differing blood solubility overapproximately 3-4 respirations and calculates pulmonary bloodflow (PBF). In the absence of a significant intrapulmonary shunt(arterial oxygen saturation ≤ 95% as measured by a pulseoximeter incorporated in the Innocor), PBF is equal to CO.As an optional accessory, Innocor includes a noninvasive BloodPressure (NIBP) monitoring system. This option providessystolic, diastolic and mean arterial pressures.With the NIBP option, Innocor provides values for the followingmeasured and calculated hemodynamic parameters:Cardiac Output Arterial Oxygen Saturation Heart Rate Stroke Volume Lung Volume Cardiac Index Stroke Index Blood Pressures (Systolic, Diastolic, Mean Arterial) Systemic Vascular Resistance |
{1}------------------------------------------------
K051907 2/2
:
:
:
{2}------------------------------------------------
Food and Drug Administration
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.
9200 Corporate Boulevard Rockville MD 20850
MAR 2 2006
Innovision A/S c/o Mr. Richard O. Wood The Wood Burditt Group 1025 W. Everett Rd, Suite 100 Lake Forest, IL 60045
Re: K051907
Trade Name: Innocor Regulation Number: 21 CFR 870.1425 Regulation Name: Diagnostic Programmable Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 13, 2005 Received: July 14, 2005
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.
{3}------------------------------------------------
Page 2 - Mr. Richard O. Wood
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that i Dri biboadse or our device complies with other requirements of the Act that I DA has made a decormination and Jointinistered by other Federal agencies. You must or any it catal statutes and regulations and limited to: registration and listing (21 Comply with an the Not 81equirements)(1); good manufacturing practice requirements as set CFN Fart 607), labeling (21 CFR Part 800); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Declients on a sectibed in your Section 510(k) I mis icter will anow you to organ manxoning of substantial equivalence of your device to a legally prematication. The PDA mining of casification 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 If you desire specific advice 10. 900 (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Oomphaller as (21 (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K051907
Device Name: Innocor
Indications For Use: Innocor is indicated for the determination of a number of hemodynamic parameters.
Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC.
As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures.
With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters:
- Cardiac Output
- Arterial Oxygen Saturation
- Heart Rate
- Stroke Volume
- Lung Volume
- Cardiac Index
- troke Index
- Blood Pressures (Systolic, Diastolic, Mean Arterial)
- ystemic Vascular Resistance
- Systemic Vascular Resistance Index
Prescription Use ਮ (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051907
Page 1 of 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).