(62 days)
No
The document describes a device that measures bioimpedance to determine hemodynamic parameters. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies sections.
No
The device is a monitor that measures hemodynamic parameters; it does not provide any therapy or treatment.
Yes
The device is described as a noninvasive cardiac output monitor that measures and determines hemodynamic parameters related to blood flow, contractility, and fluid status, which are used to assess a patient's physiological state for diagnosing conditions.
No
The device description explicitly states the application of "an array of adhesive ECG type surface electrode to the body" and measures "thoracic electrical bioimpedance (TEB)", indicating the use of hardware components beyond just software.
Based on the provided information, the ICON® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ICON® Function: The ICON® device measures thoracic electrical bioimpedance (TEB) through surface electrodes applied to the body. This is a non-invasive method that does not involve analyzing samples taken from the body.
- Intended Use: The intended use describes noninvasive continuous monitoring of hemodynamic parameters. This aligns with a device that interacts with the body externally, not with samples taken from it.
Therefore, the ICON® falls under the category of a medical device that performs measurements on the body, rather than an in vitro diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.
Product codes
DSB
Device Description
The ICON® is a noninvasive cardiac output monitor, also known as a hemodynamic monitor.
By application of an array of adhesive ECG type surface electrode to the body, the ICON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle.
The ICON® determines hemodynamic parameters related to blood flow, contractility and fluid status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.
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
Non-clinical Testing: Demonstration of substantial equivalence between the ICON® (new device) and the AESCULON® (predicate device) was based on an assessment of non-clinical performance data.
Clinical Testing: Clinical testing not part of this submission.
Key Metrics
Not Found
Predicate Device(s)
K081035 AESCULON® Type (Version) C2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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DSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany • San Diego, California, USA
Page 1 of 3
510(k) Summary
| Date: | 29 September 2008 |
|---|---|
| Submitter: | Osypka Medical, Inc. |
| 7855 Ivanhoe Avenue, Suite 226, La Jolla, CA 92037 | |
| Contact Person: | Markus Osypka, Ph.D., President |
| Osypka Medical, Inc. | |
| 7855 Ivanhoe Avenue, Suite 226, La Jolla, California 92037 | |
| Phone: (858) 454 0021 | |
| Fax: (858) 454 0064 | |
| Device Trade | |
| Names: | CARDIOTRONIC® ICON® |
| OSYPKA MEDICAL® ICON® | |
| All of Type (Version) C3 | |
| Common / | |
| Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, Cardiovascular Monitor |
| Classification | |
| Names: | 21 CFR 870.2770 Impedance Plethysmograph |
| Regulatory | |
| Class: | Class II |
| Product Code: | DSB |
| Predicate | |
| Device: | K081035 AESCULON® Type (Version) C2, further referred to as the AESCULON® |
| Device | |
| Description: | The ICON® is a noninvasive cardiac output monitor, also known as a |
| hemodynamic monitor. |
By application of an array of adhesive ECG type surface electrode to
the body, the ICON® measures thoracic electrical bioimpedance
(TEB) and in particular the changes of bioimpedance related to the
cardiac cycle.
The ICON® determines hemodynamic parameters related to blood
flow, contractility and fluid status. |
| Intended Use: | The ICON® is intended for noninvasive continuous monitoring of
hemodynamic parameters for adult, pediatric, and neonatal patients in
hospitals, hospital-type facilities, mobile, and home environments
under the care of a physician, nurse or medical technician. |
| Technology: | The ICON®, including the option Pacemaker Clinic®, is substantially
equivalent to the predicate device AESCULON® in terms of design,
intended use and principal of operation. Measurement of thoracic
electrical bioimpedance (TEB) and recording of the ECG is
accomplished by attaching an array of ECG type surface electrodes to
the patient. A high frequency, low amplitude patient auxiliary current is
applied via the outer electrodes and the resulting voltage and the
ECG is recorded between the inner electrodes.
For the estimation of stroke volume (SV) the ICON® (new device) and
AESCULON® (predicate device) use the general relationship
$SV=V_{EPT} \cdot \overline{V}{FT} \cdot FT$
with $V{EPT}$ being the volume of electrically participating tissue, $\overline{V}_{FT}$
being the mean blood velocity during flow time, and $FT$ being the left
ventricular flow time.
Both the ICON® (new device) and the AESCULON® (predicate device)
derive from the measurement of TEB
$ the base impedance $Z_0$ ,
$ the magnitude of the maximum rate of change of impedance
$\left \frac{dZ(t)}{dt} \right {MIN}$ and
$ the left-ventricular flow time $FT$ . |
| Theory /
SV Algorithm | The ICON® (new device) and AESCULON® (predicate device) do not
differ in the theoretical model applied to the measurement of the
magnitude of the maximum rate of change of impedance
$ \begin{pmatrix} \frac{dZ(t)}{dt} \end{pmatrix}{MIN} $ , which relates this magnitude to peak aortic blood
acceleration. The ICON® (new device) and the AESCULON®
(predicate device) derive thereof an index of contractility. |
| Options: | Unlike the AESCULON® (predicate device), the ICON® (new device)
does not provide the options incorporating a module and accessories
for measurement of noninvasive blood pressure (NIBP) and pulse
oximetry (SpO2). |
| Summary Non-
Clinical Testing: | Demonstration of substantial equivalence between the ICON® (new
device) and the AESCULON® (predicate device) was based on an
assessment of non-clinical performance data. |
| Summary
Clinical Testing: | Clinical testing not part of this submission. |
| Conclusion: | It is concluded that the ICON® is as safe, as effective, and performs
as well as the AESCULON® (predicate device). |
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K082242 中文/3
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OSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany • San Diego, California, USA
Page 2 of 3
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OSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany · San Diego, California, USA
Page 3 of 3
OSYPKA MEDICAL, CARDIOTRONIC, the company logos, AESCULON, CHF CLINIC, ELECTRICAL
CARDIOMETRY, ELECTRICAL VELOCIMETRY, EV, ICON, and PACEMAKER CLINIC are trademarks Osypka Medical GmbH (Berlin, Germany), and Osypka Medical, Inc. (La Jolla, CA, USA). MASIMO and SET are trademarks of Masimo Corporation (Irvine, CA, USA).
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osypka Medical, Inc. c/o Markus Osypka, PhD President 7855 Ivanhoe Avenue, Suite 226 La Jolla, CA 92037
Re: K082242
Trade/Device Name: ICON Model C3 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: September 19, 2008 Received: September 22, 2008
Dear Dr. Osypka
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.
4
Page 2 – Markus Osypka, PhD
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 clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number:
Device Name:
ICON®
Type C3
Indications for Use:
The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter-Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atthlse for B Zuckerman
of Cardiovascular D
510(k) Number K082242