AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

K070985 · Osypka Medical, Inc. · DSB · Feb 1, 2008 · Cardiovascular

Device Facts

• Record ID: K070985
• Device Name: AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
• Applicant: Osypka Medical, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 is a noninvasive hemodynamic monitor using Thoracic Electrical Bioimpedance (TEB). It measures base impedance (Z0), magnitude of maximum rate of change of impedance (dZ/dt_MIN), and left-ventricular flow time (FT). Unlike predicate devices using ZMARC/velocity index, AESCULON uses Electrical Velocimetry (EV) to interpret dZ/dt_MIN as peak aortic blood acceleration, deriving an Index of Contractility (ICON). It eliminates the need for a separate acceleration index (ACI) calculation. Used in hospitals, clinics, and home environments by clinicians to monitor hemodynamic status; output assists in clinical decision-making for cardiovascular management.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence based on technological characteristics and theoretical interpretation of impedance signals.

Technological Characteristics

Impedance plethysmograph (21 CFR 870.2770). Uses Thoracic Electrical Bioimpedance (TEB) sensing. Employs Electrical Velocimetry (EV) algorithm for hemodynamic parameter derivation. Standalone monitor form factor.

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

• Cardiodynamics BIOZ.COM® Hemodynamic Monitor (K011439)
• Masimo SET® Rad 5 Pulse Oximeter (K033296)

Submission Summary (Full Text)

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K670985

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

510(k) Summary Page 1 of 4

FEB - 1 - 1 - 2002

| Date: | 1 April 2007 | | |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 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™<br>AESCULON®<br>AESCULON®<br>AESCULON®<br>AESCULON®<br>OSYPKA MEDICAL®<br>AESCULON®<br>AESCULON®<br>AESCULON®<br>AESCULON® | AESCULON® | CHF Clinic™<br>Hypertension Clinic™<br>Pacemaker Clinic™<br>AESCULON®<br>CHF Clinic™<br>Hypertension Clinic™<br>Pacemaker Clinic™ |
| Common /<br>Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, Cardiovascular<br>Monitor | | |
| Classification<br>Names: | 21 CFR 870.2770<br>Impedance Plethysmograph | | |
| Regulatory<br>Class: | Class II | | |
| Product Code: | DSB | | |
| Predicate<br>Devices: | K011439 | Cardiodynamics BIOZ.COM® Hemodynamic Monitor | |
| | K033296 | Masimo SET® Rad 5 Pulse Oximeter | |
| Both the AESCULON® and BIOZ.COM 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 AESCULON differs from the predicate device BIOZ.COM® with respect to the theoretical interpretation of the measurements, in particular of the magnitude of the maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ : | | |
| | BIOZ.COM® (Predicate Device) | AESCULON® | |
| | ZMARC® | Electrical Velocimetry™ | |
| | The interpretation of $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is that it is related to peak blood velocity. The BioZ.COM® derives thereof a velocity index (VI). | The interpretation of $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is that it is related to peak aortic blood acceleration. The AESCULON® derives thereof an index of contractility (ICON™). | |
| | The BIOZ.COM® calculates the magnitude of the maximum of the second derivative of the change of impedance $\left(\frac{d^2Z(t)}{dt^2}\right)_{MIN}$ and derives thereof an acceleration index (ACI). | Because the magnitude of the maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is interpreted as being related to acceleration, no additional index is derived. | |

510(k) Summary

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

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

## 510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Markus J. Osypka, Ph.D. President Osypka Medical, Inc. 7855 Ivanhoe Avenue, Suite 226 La Jolla, CA 92037

Re: K070985

Trade/Device Name: CARDIOTRONICTM AESCULON® Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: January 20, 2007 Received: January 23, 2007

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.

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Page 2 – Mr. Markus J. Osypka, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 Biometric's (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Simmon Jr.

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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## Indications for Use

510(k) Number (if known):

K070985

Device Name:

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

Indications for 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.

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)

B.Zimmerman

Division of Chilovascular Devices