Who is the manufacturer of ICON, MODEL C3?

Osypka Medical, Inc. filed the 510(k) submission for ICON, MODEL C3 (K082242).

What is the FDA product code for ICON, MODEL C3?

DSB. It is classified under 21 CFR 870.2770 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ICON, MODEL C3?

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

What are the predicate devices for ICON, MODEL C3?

AESCULON® Type (Version) C2 (K081035).

Who can help prepare an FDA 510(k) submission like ICON, MODEL C3?

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.

ICON, MODEL C3

K082242 · Osypka Medical, Inc. · DSB · Oct 8, 2008 · Cardiovascular

Device Facts

Record ID	K082242
Device Name	ICON, MODEL C3
Applicant	Osypka Medical, Inc.
Product Code	DSB · Cardiovascular
Decision Date	Oct 8, 2008
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2770
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

ICON is a noninvasive cardiac output monitor measuring thoracic electrical bioimpedance (TEB). Device uses an array of adhesive ECG-type surface electrodes; applies high-frequency, low-amplitude auxiliary current via outer electrodes; records resulting voltage and ECG between inner electrodes. System calculates hemodynamic parameters—blood flow, contractility, fluid status—using the relationship SV = VEPT * VFT_mean * FT. Inputs include base impedance (Z0), magnitude of maximum rate of change of impedance (dZ/dt_MIN), and left-ventricular flow time (FT). Device is used in hospitals, mobile, and home environments by physicians, nurses, or technicians. Output provides clinicians with real-time hemodynamic data to assist in clinical decision-making regarding patient fluid status and cardiac function, potentially benefiting patients through noninvasive monitoring.

Clinical Evidence

No clinical data; substantial equivalence demonstrated via non-clinical performance assessment.

Technological Characteristics

Noninvasive impedance plethysmograph (21 CFR 870.2770). Uses ECG-type surface electrodes for TEB measurement. High-frequency, low-amplitude current application. Includes Pacemaker Clinic option. Standalone device.

Indications for Use

Indicated for noninvasive continuous hemodynamic monitoring in adult, pediatric, and neonatal patients in clinical, mobile, or home settings under professional supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

AESCULON® Type (Version) C2 (K081035)

Related Devices

K081035 — AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 · Osypka Medical, Inc. · May 30, 2008
K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC · Osypka Medical, Inc. · Feb 1, 2008
K974725 — BIOZ.COM SYSTEM · Cardiodynamics International Corp. · Mar 18, 1998
K972320 — BIOZ SYSTEM & BIOZ PORTABLE · Cardiodynamics International Corp. · Sep 11, 1997
K090602 — CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS · Cardiodynamics International Corp. · May 28, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a black and white graphic. The graphic contains a square with a circle inside of it. The circle is filled with a checkered pattern. 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). | {1}------------------------------------------------ K082242 中文/3 Image /page/1/Picture/1 description: The image shows a black square with a white circle inside. The circle is filled with a checkered pattern of black and white squares. The checkered pattern gives the circle a textured appearance. The white circle is centered within the black square. OSYPKA MEDICAL 510(k) Summary K082242 Berlin, Germany • San Diego, California, USA Page 2 of 3 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a square shape with a circular pattern inside. The pattern consists of alternating black and white squares arranged in a grid-like fashion. The background of the image is black, which contrasts with the white color of the square shape and the circular pattern. ## 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: K082242 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