HORIZON ANGIO CATHLAB

K043564 · Mennen Medical , Ltd. · DQK · Jan 27, 2005 · Cardiovascular

Device Facts

• Record ID: K043564
• Device Name: HORIZON ANGIO CATHLAB
• Applicant: Mennen Medical , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Horizon Angio 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 Angio is a computerized laboratory system for hemodynamic monitoring during vascular catheterization. Inputs include multi-lead ECG, invasive/non-invasive blood pressure, pulse oximetry (SpO2), respiration, cardiac output, and body temperature sensors. The system uses a Sun Blade 150 workstation running a UNIX-based Cathlab program to digitize, process, and display real-time vital signs and waveforms. It provides graphical presentations of abdominal, cranial, and peripheral vascular systems to support catheterization reporting. Output includes real-time waveform/numeric displays on local LCDs and printed textual/graphical case history reports via laser printer. Used in clinical settings by healthcare professionals to document procedures and monitor patient status. Benefits include continuous hemodynamic oversight and automated case documentation.

Clinical Evidence

Bench testing only. Performance testing verified functional requirements and specifications. Electrical safety and EMC testing conducted by an independent laboratory to ensure compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, and IEC 60601-2-49 standards.

Technological Characteristics

Workstation-based system (Sun Blade 150, UNIX OS). Inputs: 7/12-lead ECG, 2x IBP, NIBP (oscillometric), SpO2, Temp, Respiration. Connectivity: Ethernet hub. Electrical safety: Type CF (ECG, IBP, CO) and BF (NIBP, SpO2) isolation. Standards: IEC 60601 series, ANSI/AAMI EC11/EC13. Dimensions: 24x22x10 cm. Signal processing: QRS detection (0.25-5.0 mV), pacemaker pulse rejection, defibrillator protection (5kV).

Indications for Use

Indicated for patients requiring continuous monitoring of vital signs including ECG, heart rate, invasive/non-invasive blood pressure, pulse oximetry, respiration, cardiac output, and body temperature 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 9000WS Cathlab (K032997)

Reference Devices

• Horizon 9000WS Cathlab (K940415)
• Horizon 9000WS Cathlab (K991775)
• Mennen Medical Envoy patient monitor

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.

Public Health Service

FEB 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mennen Medical Ltd. c/o Ms. Micha Oestereich Regulatory Affairs 4 Ha-Yarden Street, Yavne P.O. Box 102, Rehovot 76100 ISRAEL

Re: K043564

Trade Name: Horizon Angio Cathlab Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: December 20, 2005 Received: December 27, 2005

Dear Ms. Oestereich:

This letter corrects our substantially equivalent letter of January 27, 2005 regarding the trade name.

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 (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 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 - Ms. Micha Oestereich

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 continue 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/dsma/dsmamain.html

Sincerely yours,

Brimmimer for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# 043564

Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio

#### INDICATIONS FOR USE

The Horizon Angio 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

Blanuma

Slan-Om (Divis Cardlovascylar Devic 510(k) Number

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Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio

K043564
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JAN 2 7 2005

Image /page/3/Picture/3 description: The image shows the logo for Mennen Medical. The logo consists of a lowercase letter 'm' inside of a black circle. The words 'mennen medical' are written in lowercase letters to the right of the circle.

Partners in Patient Care

Date: December 14, 2004

# Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Special 510(k): Device Modification - Horizon Angio Cathlab

#### Establishment Name, Registration Number and Address:

| Name: | Mennen Medical Ltd. |
|----------------------|-----------------------------------------|
| Registration Number: | 9611022 |
| Operator Number: | 9011766 |
| Address: | 4 Hayarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102,<br>Rehovot, 76100, Israel |
| Tel: | [phone] |
| Fax: | [phone] |

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

Attn .: Document Control Clerk From: Micha Oestereich, Regulatory Affairs

#### Product Name:

Horizon Angio Proprietary: Horizon Angio Common: Mennen Medical Part Number:

960-100-410 (115V) 960-100-420 (230V)

#### FDA Classification of Cathlab:

| Classification Name: | Programmable diagnostic computer |
|------------------------|----------------------------------|
| Classification Number: | 21 CFR 870.1425 |
| Classification: | Class II |
| Product Code: | DXG |

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Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio

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#### None promulgated Performance Standards:

# Voluntary Standards:

IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11 Amendment 2 - 1995-03

# IEC 60601-1-1 (2000)

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

# IEC 60601-1-2 (2001):

Medical electrical equipment. General requirements for Safety. Electromagnetic Compatibility Requirements and Tests.

# IEC 60602-2-27 (1994):

Medical electrical equipment, Part 2, Requirements for safety of electrocardiograph monitoring equipment.

# IEC 60601-2-30 (1995):

Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment

# IEC 60601-2-34 (1994):

Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment

# IEC 60601-2-49 (2001):

Particular Requirements for the safety of multifunction patient monitoring equipment

# Terminology:

Horizon 9000WS Cathlab = The predicate device The Horizon 9000WS Cathlab was approved for marketing by the FDA (K940415 and K991775 and K032997)

Horizon Angio Cathlab = Subject of this Special 510(k). The Horizon Angio is a modified device, a sub-system of the Horizon 9000WS Cathlab

# Predicate Device:

- · Horizon 9000WS Cathlab (K032997)

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The Horizon Angio 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, analyzed and presented in a variety of report formats.

The Horizon Angio software includes graphic presentation of the abdominal, cranial and peripheral vascular system, to support reporting of vascular catheterization.

The Sun Blade 150 workstation is a uni-processor system that runs the Cathlab program on a UNIX operating system. The workstation receives the digitized signals from the CFE via the Ethernet hub, displays real-time vital signs, analyzes, processes, and calculates the vital sign data and waveforms, cardiac status in real time during the catheterization process, creating a fully documented case history. The workstation continuously displays the vital signs waveforms and data on the local LCD displays.

The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

A Laser Printer is provided in the system. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

#### Base Configuration: Cathlab parameters

- . 2 Invasive Blood Pressure channels
- . Diagnostic 7 or 12 Lead ECG
- . Non-invasive Blood Pressure
- Pulse Oximetry (SpO2) .

#### Horizon Angio Options:

- Full Disclosure .
- Off-line workstations ●
- Remote Interactive terminal .
- . Angiography Analysis Package
- CDR, DVD or Optomagnetic drive .
- Choice of Console Table regular, enhanced, compact or without consol .

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# Intended Use of the Horizon Angio

The Horizon Angio 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 continuous/v 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.

# Summary of the technological characteristics of the Horizon Angio

The following tables summarize data on the Horizon Angio (modified device) of the Horizon 9000WS Cathlab:

| | Horizon Angio |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Part/Option Number | 960-100-410 (115V) |
| Dimensions (H x W x D) | 24 x 22 x 10 cm (9 x 11 x 4") |
| Input Circuit Parameters | |
| Chassis Leakage Current | All patient signal inputs fully isolated (<50 μA). |
| | Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical<br>Aparatus," (SCLE) Dec, 1978 item 2.1.1. |
| ECG | 7 or 12 leads |
| Frequency Response | Monitor Mode: 0.5 to 40 Hz |
| | Diagnostic: 0.05 to 150 Hz, |
| | Exercise: 1 to 25 Hz, -3 dB |
| Input Impedance: | Typical 20 MΩ |
| | Minimum greater than: |
| | 5 MΩ differential, DC to 10 Hz; 2.5 MΩ differential 10 to 100 Hz. 3 MΩ<br>differential at 10 Hz |
| Common Mode Rejection: | At least 100 dB at 50/60 Hz Without lead misbalance<br>86 db with lead misbalance |
| | The common mode rejection ratio is in accordance with ANSI/AAMI EC11(9)<br>Para. 3.2.11. |
| Input Dynamic Range: | ±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8) Para.<br>3.2.9.1. |
| Input offset | ± 300mV, as per ANSI/AAMI |
| | EC13 Para. 3.2.9.1. |
| | Horizon Angio |
| ECG | |
| Gain: | Manual selection of 250, 500, 1000, 2000, 4000 and 8000 x ECG. Signal<br>impressed across selected lead |
| Noise: | Less than 30 μ V p-p referenced to input |
| Pacemaker Pulse<br>Rejection: | Reject pulses from:<br>2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec pulse widths and<br>≥3.0mV for 0.1mSec pulse width |
| Defibrillator Protection: | Up to 5 KV. Amplifier |
| | Recovery time: < 3 seconds |
| Lead Fault Sense: | On any ECG electrode |
| QRS Detection: | 0.25 to 5.0 mV, 70-120 msec width |
| Synchronous Defibrillation<br>Signal: | Pulse Width: 100 ms.<br>Amplitude: 5 Vdc amplitude into 500Ω, short-circuit proof |
| ECG Analog Output: | 1 Volt / mVolt |
| Heart Rate | |
| Range: | 20 to 350 bpm |
| Accuracy: | Within 2 bpm. |
| Response Time: | Less than 7 sec for step change of 60 bpm from a base of 60 bpm |
| Blood Pressure | |
| Input Sensitivity: | 5 μvolts/volt/mmHg |
| Transducer Excitation: | 5 Volt |
| Ranges: | -50 to +300 mmHg |
| Maximum variation during<br>zero: | ± 2 mmHg |
| Zero Accuracy: | ± 0.2 mmHg |
| Zero Drift: | Less than +/- 0.2 mmHg in 24 hours |
| Transducer Load<br>Impedance: | 300 – 600Ω |
| Linearity: | Better than 1% of full scale |
| Common Mode Rejection: | 80 dB minimum (reference to chassis 50/60Hz) |
| | Horizon Angio |
| Blood Pressure | |
| Frequency Response: | DC to 12 Hz<br>(DC to 40 Hz optional) |
| | |
| Temperature | |
| Range: | 27 °C to 45°C. |
| Accuracy: | ± 0.2°C. |
| | |
| Respiration | |
| Frequency Response: | 0.13 to 2.5 Hz., 3 dB bandwidth. |
| Range: | 8 to 150 bpm. |
| Excitation: | 65 kHz |
| | |
| Pulse Oximetry (SpO2) | |
| Probe Type: | Masimo™ reusable or disposable |
| Range: | 0% to 100% |
| Pulse Rate Range: | 20-250 bpm, below 20 displays zero |
| Rate Accuracy: | ± 3 bpm |
| SpO2 Accuracy: | Determined by specific sensor: |
| | Adult: ±2 digits between 70% and 100% |
| | ±3 digits between 50% and 70%.<br>Neonatal: ±3 digits between 70% and 95% |
| | |
| Auxiliary Inputs | |
| Input Voltage: | +/-5 Volt |
| Frequency Response: | DC to 120 Hz |
| | |
| Non-Invasive Blood<br>Pressure (NIBP) | |
| Method: | Oscillometric |
| | Horizon Angio |
| Non-Invasive Blood<br>Pressure (NIBP) | |
| Initial Inflation: | 150 mmHg (adult)<br>120 mmHg (pediatric). |
| Pressure Accuracy: | Overall ± 3 mmHg, full scale. |
| Defib. Pulse Protection | 5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per<br>IEC 60601-2-27 (12), clauses 17,101 and 102 |
| Degree of protection<br>against electrical shock | Type CF and BF.<br>ECG, IBP and CO = CF<br>NIBP and SpO2 = BF |
| Electrosurgical<br>Interference Suppression | Yes |
| Displayed Waveforms | |
| ECG | Up to 12 lead |
| BP | 2 separate or superimposed |
| Respiration | 1 |
| SpO2 | 1 |
| Displayed Numeric<br>Parameters | 1 |
| Heart Rate | Yes |
| Respiration Rate | Yes |
| SpO2 | Yes |
| BP - Systolic, Diastolic,<br>Mean | Yes |
| Temperature | 2 |
| | Horizon Angio |
| Alarm Indications | No |
| | |
| Display Functions | |
| Change ECG Lead<br>Selection | YES |
| Display of Arrhythmia<br>Information | YES |
| Data Review: Trends | YES |
| Data Review: Tabular | YES |
| User defined Configuration<br>Setup | YES |
| User defined Default<br>Settings | YES |
| Accessories | Compatible with Mennen Medical Envoy patient monitor |

K043564-
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# Food and Drug Administration
Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio

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#### Conclusion of technological characteristics:

We consider the Horizon Angio to be substantially equivalent to the Horizon 9000WS Cathlab. We submit that any differences between the two modules:

- fall within the scope of a Special 510(k) Device Modification and .
- do not raise any new issues of safety and effectiveness .

#### Testing

Final testing for the whole Horizon Angio system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Electrical Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards.

#### Indications for Use

There is no change to the Indications for Use for the Horizon Angio. Mennen intends to use the Horizon Angio for "acquiring and displaying essential patient data" according to the approved "Indications for Use" in K032997. The full "Indications for Usc" appear on page 9 below.