MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS

K991775 · Mennen Medical, Inc. · DXG · Jun 24, 1999 · Cardiovascular

Device Facts

• Record ID: K991775
• Device Name: MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
• Applicant: Mennen Medical, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Jun 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. 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 9000 WS is a computerized catheterization laboratory system; acquires/displays vital-sign data and waveforms in real-time during catheterization; inputs include ECG, invasive blood pressure, pulse oximetry, respiration, cardiac output, and body temperature; system utilizes Sun Solaris 2 (Ultra 5 computer) to process physiological data; outputs include real-time waveform displays, thermal array chart recordings, and laser-printed textual/graphical reports; used in clinical catheterization labs by medical professionals; provides hemodynamic data for clinical decision-making and case history documentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes Sun Solaris 2 (Ultra 5 computer) for data processing; physiological front-end for signal acquisition; thermal array chart recorder and laser printer for output; 4 invasive BP channels, 7-lead ECG (expandable to 12-lead), thermodilution cardiac output, pulse oximetry; connectivity includes off-line workstations and remote interactive terminals.

Indications for Use

Indicated for patients undergoing catheterization procedures requiring real-time monitoring and documentation of vital signs, including ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output, and body temperature.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

• Horizon 9000 WS (K940415)

Submission Summary (Full Text)

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JUN 24 1999

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K991775" with a horizontal line above the last digit. The characters are written in a dark ink on a white background. The handwriting is somewhat uneven, but the characters are generally legible.

Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical LTD. The word "MENNEN" is in large, bold, black letters. Below it, in smaller letters, are the words "MEDICAL LTD."

MENNEN MEDICAL LTD. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: [phone] Fax: [phone]

Page 1 of 4

Date: June 23, 1999

#### Special 510(k) - K 991775 - Statement of Summary Topic: Computerized Catheterization Laboratory

## Establishment Name, Registration Number and Address

| Name: | Mennen Medical Ltd |
|----------------------|----------------------------------------------------------------------------------------------------|
| Registration Number: | 9611022 |
| Operator Number: | 9011766 |
| Address: | Kiryat Weizmann Science Park<br>Rehovot 76100 Israel<br>Tel: [phone]<br>Fax: [phone] |

Contact person:

Ken Raichman, Director of Regulatory Affairs

To: Food and Drug Administration Center for Devices and Radiological Health Document Control Center (HFZ-401) 9200 Corporate Boulevard Rockville MD 20850

Ms. Marian Kroen Attn.:

- From: Kenneth Raichman Director of Regulatory Affairs

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Food and Drug Administration

Special 510(k) Summary, Horizon 9000 WS

#### Product Name

Horizon 9000 WS Proprietary: Computerized Catheterization Laboratory (Cathlab) Common: Mennen Medical part number: 960-100-020

# FDA Classification

| Classification Name: | Programmable diagnostic computer |
|------------------------|----------------------------------|
| Classification number: | 870.1425 (21 CFR) |
| Classification: | Class II |
| Product code: | 74 DXG |

## Performance Standards

None promulgated

## Predicate Devices

Horizon 9000 WS - cleared for market by FDA on January 6, 1995 - K 940415

# Date of preparation of Summary

June 10, 1999

#### Device Description

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, whose prime function is the acquisition and display of vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Cathlab is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. 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.

The system has a UNIX Sun Solaris 2 (Ultra 5 computer) that utilizes powerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard.

The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides print-outs of textual and graphical

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Food and Drug Administration

Special 510(k) Summary, Horizon 9000 WS

summaries of all patient data and catheterization procedures.

# Base Configuration:

- 4 invasive blood pressure channels
- Diagnostic 7 lead ECG
- 1 Thermodilution cardiac output
- 24 channel thermal array chart recorder
- Pulse Oximetry

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Food and Drug Administration Special 510(k) Summary, Horizon 9000 WS

# Horizon 9000 WS Options:

- 12 lead ECG
- SpO2 monitoring
- Non-invasive Blood Pressure
- Full disclosure
- Off-line workstations
- Remote Interactive terminal
- Angiography Analysis Package
- · Cardiology Data Base and Inventory

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Food and Drug Administration Special 510(k) Summary, Horizon 9000 WS

Image /page/4/Picture/1 description: The image shows the logo for Mennen Medical. The logo includes a stylized letter 'm' in a black circle, followed by the text 'mennenmedical'. Below the logo, there is a box that says 'Partners in Patient Care'. To the right of the logo, there is contact information including an address of Kiryat Weiz, P.O.B. 102, Rehovot 76, and telephone and fax numbers of 972-8-.

MENNEN MEDICAL LTD. Kiryat Weizmann Science Park Rehovot 76100 Israel Tel: [phone] Fax: [phone]

# Special 510(K) application - K 991775 - Device Modification

Computerized Catheterization Laboratory - Horizon 9000 WS

Indications for Use:

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. 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.

Kenneth Raichman

(Signature)

Kenneth Raichman

Director of Regulatory Affairs Mennen Medical Ltd.

Date: June 23, 1999

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus symbol with three wavy lines representing health and human services. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

Mr. Kenneth Raichman Mennen Medical Ltd. Kiryat Weizmann Science Park P.O. Box 102 Rehovot 76100 ISRAEL

Re: K991775 Horizon 9000WS Computerized Catheterization Laboratory Regulatory Class: II (two) Product Code: 74 DXG Dated: May 6, 1999 Received: May 25, 1999

Dear Mr. Raichman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Kenneth Raichman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page 1 of 1

510(k) Number: K991775

Device Name: MENNEN MEDICAL LTD. HORIZON 9000 WS Computerized Catherization Labotatory

Indications For Use:

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature.

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

VCalla Miller

ascular. Respiratory.