HORIZON SE

K070254 · Mennen Medical , Ltd. · DQK · Apr 19, 2007 · Cardiovascular

Device Facts

• Record ID: K070254
• Device Name: HORIZON SE
• Applicant: Mennen Medical , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output and body temperatures. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

Device Story

Horizon SE is a computerized laboratory system for monitoring patient physiological data. Inputs include ECG signals, invasive blood pressure, pulse oximetry, EtCO2, respiration, cardiac output, and body temperature. The device processes these inputs to display real-time waveforms and numerical hemodynamic data on a Physiological Waveform Display. It supports storage, recording, and analysis of data for report generation. Used in clinical settings (Cathlab) by healthcare professionals. The system provides continuous monitoring to assist clinicians in hemodynamic assessment and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Computerized diagnostic system for physiological monitoring. Features multi-lead ECG, invasive BP, pulse oximetry, EtCO2, respiration, cardiac output, and temperature sensors. Waveform display and data analysis software. Class II device (21 CFR 870.1425).

Indications for Use

Indicated for acquisition and display of patient physiological data including ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output, and body temperatures in a clinical laboratory setting.

Regulatory Classification

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.

Predicate Devices

• Horizon SE Cathlab (K032997)
• VitaLogik 5000 (K052288)

Submission Summary (Full Text)

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| Name: | Mennen Medical Ltd. |
|----------------------|-----------------------------------------|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| Address: | 4 Hayarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102,<br>Rehovot, 76100, Israel |
| Tel: | [phone] |
| Fax: | [phone] |
| Contact person: | Micha Oestereich, Regulatory Affairs |
| | APR 19 2007 |

## Traditional 510(k): Device Modification - Horizon SE

## Terminology

Horizon SE = Subject of this 510(k). The Horizon SE is a modified device, a system identical to of the Horizon SE Cathlab with the addition of EtCO2 measurement.

Horizon SE = The predicate device. The Horizon SE Cathlab was cleared for marketing by the FDA (K032997)

VitaLogik 5000 = The predicated device for EtCO2 measurement. The VitaLogik 5000 was cleared for marketing by FDA (K052288)

## Intended Use of the Horizon SE

The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2007

Mennen Medical Ltd. c/o Mr. Micha Oestereich Regulatory Affairs 4 Hayarden Street, Yavne, 81228, Israel PO Box 102 Rehovot, 76100, Israel

Re: K070254

Trade Name: Horizon SE Cathlab with etCO2 Option Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: January 6, 2007 Received: January 26, 2007

Dear Mr. Oestereich:

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.

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

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Page 2 – Mr. Micha Oestereich

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,

B. Himmer for

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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510(k) Number : K070254

Device Name: Horizon SE

## INDICATIONS FOR USE

The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output and body temperatures.

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

Prescription Use (Part 21 CFR 801 Subpart D)

B.Bimmma
(Division Sign-Off)