AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2

K081035 · Osypka Medical, Inc. · DSB · May 30, 2008 · Cardiovascular

Device Facts

• Record ID: K081035
• Device Name: AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
• Applicant: Osypka Medical, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic® are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

AESCULON® Version C2 is a noninvasive hemodynamic monitor; measures thoracic electrical bioimpedance (TEB) and ECG via surface electrodes. Applies high-frequency, low-amplitude auxiliary current to outer electrodes; records voltage and ECG between inner electrodes. Calculates hemodynamic parameters including stroke volume (SV), blood flow, contractility (ICON™), and fluid status. Optional modules for NIBP (SunTech Advantage) and SpO2 (Masimo MS-11) integration. Used in hospitals, mobile, and home environments by clinicians. Output provides real-time hemodynamic data to assist in clinical decision-making regarding patient cardiovascular status and fluid management.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via non-clinical performance data.

Technological Characteristics

Noninvasive impedance plethysmograph; uses surface ECG-type electrodes for TEB and ECG recording. High-frequency, low-amplitude current application. Includes optional NIBP and SpO2 modules. Software-based processing of impedance signals (Z0, dZ/dt_min) and flow time (FT).

Indications for Use

Indicated for noninvasive continuous hemodynamic monitoring in adult, pediatric, and neonatal patients in hospital, mobile, and home settings.

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® Version C1.1 (K070895)

Submission Summary (Full Text)

{0}------------------------------------------------

K081035/S1
P1/3

Image /page/0/Picture/1 description: The image shows the logo for OSYPKA MEDICAL. The logo consists of a black square with a white checkered circle inside, followed by the text "OSYPKA MEDICAL" in a large, sans-serif font. Below the company name is the text "Berlin, Germany • San Diego, California, USA" in a smaller font, indicating the company's locations.

510(k) Summary

Page 1 of 3

## 510(k) Summary

MAY 3 0 2008

| Date: | 8 April 2008 | | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------|--|
| Submitter: | Osypka Medical, Inc.<br>7855 Ivanhoe Avenue, Suite 226, La Jolla, CA 92037 | | | |
| Contact Person: | Markus Osypka, Ph.D., President<br>Osypka Medical, Inc.<br>7855 Ivanhoe Avenue, Suite 226, La Jolla, California 92037<br>Phone: [phone] Fax: [phone] | | | |
| Device Trade<br>Names: | CARDIOTRONIC™ | AESCULON® | CHF Clinic™ | |
| | | AESCULON® | Hypertension Clinic™ | |
| | | AESCULON® | Pacemaker Clinic™ | |
| | OSYPKA MEDICAL® | AESCULON® | | |
| | | AESCULON® | CHF Clinic™ | |
| | | AESCULON® | Hypertension Clinic™ | |
| | | AESCULON® | Pacemaker Clinic™ | |
| | All of Version C2 | | | |
| Common /<br>Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, Cardiovascular<br>Monitor | | | |
| Classification<br>Names: | 21 CFR 870.2770 | Impedance Plethysmograph | | |
| Regulatory<br>Class: | Class II | | | |
| Product Code: | DSB | | | |
| Predicate<br>Device: | K070895 | AESCULON® Version C1.1 | | |

7855 Ivanhoe Avenue, Suite 226 • La Jolla, CA 92037
Phone [phone] • Fax [phone]
www.osypkamed.com Osypka Medical, Inc.

{1}------------------------------------------------

# 510(k) Summary

Page 2 of 3

T

<081035151

| Device<br>Description: | The AESCULON® Version C2, including the models CHF Clinic™,<br>Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasive<br>comprehensive cardiovascular monitor, also known as a<br>hemodynamic monitor. | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | By application of an array of adhesive ECG type surface electrode to<br>the body, the AESCULON® measures thoracic electrical<br>bioimpedance (TEB) and in particular the changes of bioimpedance<br>related to the cardiac cycle. | |
| | The AESCULON® determines hemodynamic parameters with respect<br>to blood flow, vascular system (if the NIBP option is incorporated),<br>contractility and fluid status. | |
| Intended Use: | The AESCULON®, AESCULON® CHF Clinic™, AESCULON®<br>Hypertension Clinic® and AESCULON® Pacemaker Clinic® are<br>intended for noninvasive continuous monitoring of hemodynamic<br>parameters for adult, pediatric, and neonatal patients in hospitals,<br>hospital-type facilities, mobile, and home environments. | |
| Technology: | The AESCULON® Version C2, including the models CHF Clinic™,<br>Hypertension Clinic™ and Pacemaker Clinic™, is substantially<br>equivalent to the predicate device AESCULON® Version C1.1 in terms<br>of design, intended use and principal of operation. Measurement of<br>thoracic electrical bioimpedance (TEB) and recording of the ECG is<br>accomplished by attaching an array of ECG type surface electrodes to<br>the patient. A high frequency, low amplitude patient auxiliary current is<br>applied via the outer electrodes and the resulting voltage and the<br>ECG is recorded between the inner electrodes. | |
| | For the estimation of stroke volume (SV) the AESCULON® Version C2<br>(new device) and Version C1.1 (predicate device) use the general<br>relationship | |
| | $SV = V_{EPT} · \bar{V}_{FT} · FT$ | |
| | with $V_{EPT}$ being the volume of electrically participating tissue, $\bar{V}_{FT}$<br>being the mean blood velocity during flow time, and FT being the left<br>ventricular flow time. | |

Image /page/1/Picture/4 description: The image shows a black square with a white circle inside. The circle is filled with a checkerboard pattern of alternating black and white squares. The checkerboard pattern is slightly distorted, as if it were wrapped around a sphere.

OSYPKA MEDICAL

Berlin, Germany • San Diego, California, USA

{2}------------------------------------------------

OSYPKA MEDICAL
Berlin, Germany • San Diego, California, USA
510(k) Summary
Page 3 of 3

Both the AESCULON® Version C2 (new device) and Version C1.1
(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 / The AESCULON® Version C2 (new device) and Version C1.1
SV Algorithm (predicate device) do not differ in the theoretical model applied to the
measurement of the magnitude of the maximum rate of change of

impedance
$$\left| \frac{dZ(t)}{dt} \right|_{MIN}$$
, which relates this magnitude to peak aortic
blood acceleration. The AESCULON® Version C2 (new device) and
Version C1.1 derive thereof an index of contractility (ICON™).

Options: The AESCULON® Version C2 (new device) and Version C1.1
(predicate device) may incorporate a module and accessories for
measurement of noninvasive blood pressure (NIBP) manufactured or
supplied by SunTech Medical Instruments, Raleigh, NC (model
'Advantage').

The AESCULON® Version C2 (new device) and Version C1.1
(predicate device) may incorporate a module and accessories for
pulse oximetry (SpO2) manufactured or supplied by Masimo, Irvine,
CA (Model 'MS-11').

Summary Non- Demonstration of substantial equivalence between the AESCULON®
Clinical Testing: Version C2 (new device) and the Version C1.1 (predicate device) was
based on an assessment of non-clinical performance data.

Summary Clinical testing not part of this submission.
Clinical Testing:

Conclusion: It is concluded that the AESCULON® Version C2 is as safe, as
effective, and performs as well as the predicate device Version C1.1.

08/035/51

OSYPKA MEDICAL, CARDIOTRONIC, the company logos, AESCULON, CHF CLINIC, ELECTRICAL OSTPRA MEDICAL, CARDIOTHONG, the Company logo, HEBO SEVY ON. SELVE, ICON, CANDIOMETIT, ELEOTHIONE VEEGEMENT DAY DAY CORER and WINDOW TO THE CIRCULATION are r Hociminer - Oeline, "Total" (Berlin, Germany), and Osypka Medical, Inc. (La Jolla, CA, USA). trademarks of Coyparks of Masimo Corporation (Irvine, CA, USA).

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the department's name encircling it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

Osypka Medical, Inc. c/o Mr. Markus Osypka, Ph.D. President 7855 Ivanhoe Ave., Suite 226 La Jolla, CA 92037

Re: K081035

Aesculon®, Aesculon® CHF Clinic™, Aesculon® Hypertension Clinic and Aesculon® Pacemaker Clinic® Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: May 7, 2008 Received: May 12, 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 - Mr. Markus Osypka, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blommor for

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:

K081035

Device Name:

AESCULON® AESCULON® CHF Clinic ™ AESCULON® Hypertension Clinic® AESCULON® Pacemaker Clinic®

Version C2

Indications for Use:

The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and
AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use X (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)

B.Brammer
(Division Sign Off)

on of Cardio 510fk) Nu