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 Description

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, 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 .

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy:

Device: Horizon Angio Cathlab (a sub-system of the Horizon 9000WS Cathlab)

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive performance specifications for the Horizon Angio, which serve as the acceptance criteria. The accompanying information (e.g., "Meets or exceeds ANSI standard") indicates that the device's performance is intended to meet these criteria.

Parameter	Acceptance Criteria (from text)	Reported Device Performance (Implied as meeting criteria)
Chassis Leakage Current	All patient signal inputs fully isolated (<50 μA). Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical Aparatus," (SCLE) Dec, 1978 item 2.1.1.	The device is stated to meet or exceed these standards.
ECG Frequency Response	Monitor Mode: 0.5 to 40 Hz; Diagnostic: 0.05 to 150 Hz; Exercise: 1 to 25 Hz, -3 dB	Performance is stated to be exactly these specifications.
ECG 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 differential at 10 Hz	Performance is stated to be exactly these specifications.
ECG Common Mode Rejection	At least 100 dB at 50/60 Hz Without lead misbalance; 86 db with lead misbalance. In accordance with ANSI/AAMI EC11(9) Para. 3.2.11.	Performance is stated to be exactly these specifications.
ECG Input Dynamic Range	±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8) Para. 3.2.9.1.	Performance is stated to be exactly these specifications.
ECG Input Offset	± 300mV, as per ANSI/AAMI EC13 Para. 3.2.9.1.	Performance is stated to be exactly these specifications.
ECG Noise	Less than 30 μV p-p referenced to input	Performance is stated to be exactly these specifications.
Pacemaker Pulse Rejection	Reject pulses from: 2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec pulse widths and ≥3.0mV for 0.1mSec pulse width	Performance is stated to be exactly these specifications.
Defibrillator Protection	Up to 5 KV. Amplifier Recovery time: < 3 seconds	Performance is stated to be exactly these specifications.
QRS Detection	0.25 to 5.0 mV, 70-120 msec width	Performance is stated to be exactly these specifications.
Heart Rate Range	20 to 350 bpm	Performance is stated to be exactly these specifications.
Heart Rate Accuracy	Within 2 bpm	Performance is stated to be exactly these specifications.
Heart Rate Response Time	Less than 7 sec for step change of 60 bpm from a base of 60 bpm	Performance is stated to be exactly these specifications.
Blood Pressure Input Sensitivity	5 μvolts/volt/mmHg	Performance is stated to be exactly these specifications.
Blood Pressure Ranges	-50 to +300 mmHg	Performance is stated to be exactly these specifications.
Blood Pressure Zero Accuracy	± 0.2 mmHg	Performance is stated to be exactly these specifications.
Blood Pressure Zero Drift	Less than +/- 0.2 mmHg in 24 hours	Performance is stated to be exactly these specifications.
Blood Pressure Linearity	Better than 1% of full scale	Performance is stated to be exactly these specifications.
Blood Pressure Common Mode Rejection	80 dB minimum (reference to chassis 50/60Hz)	Performance is stated to be exactly these specifications.
Blood Pressure Frequency Response	DC to 12 Hz (DC to 40 Hz optional)	Performance is stated to be exactly these specifications.
Temperature Range	27 °C to 45°C --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Temperature Accuracy	± 0.2°C --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Respiration Frequency Response	0.13 to 2.5 Hz., 3 dB bandwidth ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Respiration Range	8 to 150 bpm	Performance is stated to be exactly these specifications.
SpO2 Range	0% to 100% --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pulse Rate Range (SpO2)	20-250 bpm, below 20 displays zero --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pulse Rate Accuracy (SpO2)	± 3 bpm ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SpO2 Accuracy	Determined by specific sensor: Adult: ±2 digits between 70% and 100%, ±3 digits between 50% and 70%. Neonatal: ±3 digits between 70% and 95% --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP) Pressure Accuracy	Overall ± 3 mmHg, full scale ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Performance is stated to be exactly these specifications. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Defibrillation Pulse Protection	5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per IEC 60601-2-27 (12), clauses 17,101 and 102 --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The device is stated to meet these standards. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degree of protection against electrical shock	Type CF and BF (ECG, IBP and CO = CF; NIBP and SpO2 = BF) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The device is stated to meet these classifications. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electrosurgical Interference Suppression	Yes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The device is stated to have this feature. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. Sample Size Used for the Test Set and Data Provenance:

The document lacks explicit details regarding the sample size used for the test set in performance testing. It states: "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." This implies internal testing rather than a clinical study with a specific patient test set.

The data provenance is not mentioned. Given the nature of a 510(k) submission for a device modification, the testing is likely retrospective on simulated or internal test data, not prospective clinical data from specific countries of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish a "ground truth" for a test set in the context of clinical performance. The testing described focuses on engineering and performance specifications against industry standards.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the testing focuses on meeting technical specifications rather than interpreting results that would require expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. This device is a physiological data acquisition and display system, not an AI diagnostic tool that assists human readers with interpretation. Therefore, a study comparing human reader improvement with or without AI assistance is not applicable to the information provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The "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" implies standalone testing against its own specifications and relevant standards. The device is a "programmable diagnostic computer" that acquires and displays data, not an algorithm providing a diagnosis that would be independently evaluated for "algorithm-only" performance in a clinical context. Its performance is measured by the accuracy and reliability of its physiological measurements and display capabilities.

7. Type of Ground Truth Used:

The "ground truth" for the performance specifications are the defined electrical, physiological, and safety standards (e.g., ANSI/AAMI EC11, IEC 60601 series). For example, the accuracy of heart rate is measured against a known, controlled input signal, not against a clinical expert's interpretation or pathology.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as the Horizon Angio is not explicitly described as an AI/ML-driven device that learns from data. It's a system designed to acquire and display real-time physiological data based on pre-defined algorithms and hardware.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a training set or AI/ML components, the establishment of ground truth for a training set is not pertinent to this document.

Summary

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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 (240) 276-0293. 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 (800) 638-2041 or (301) 443-6597 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

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
p 1/8

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,Rehovot, 76100, Israel
Tel:	+972-8-9323333
Fax:	+972-8-9328510

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

K043564
P 2/8

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 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 .

04:3564 > 3/8

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Intended Use of the Horizon Angio

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 ElectromedicalAparatus," (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 MΩdifferential at 10 Hz
Common Mode Rejection:	At least 100 dB at 50/60 Hz Without lead misbalance86 db with lead misbalance
	The common mode rejection ratio is in accordance with ANSI/AAMI EC11(9)Para. 3.2.11.
Input Dynamic Range:	±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8) Para.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. Signalimpressed across selected lead
Noise:	Less than 30 μ V p-p referenced to input
Pacemaker PulseRejection:	Reject pulses from:2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec pulse widths and≥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 DefibrillationSignal:	Pulse Width: 100 ms.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 duringzero:	± 2 mmHg
Zero Accuracy:	± 0.2 mmHg
Zero Drift:	Less than +/- 0.2 mmHg in 24 hours
Transducer LoadImpedance:	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(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%.Neonatal: ±3 digits between 70% and 95%

Auxiliary Inputs
Input Voltage:	+/-5 Volt
Frequency Response:	DC to 120 Hz

Non-Invasive BloodPressure (NIBP)
Method:	Oscillometric
	Horizon Angio
Non-Invasive BloodPressure (NIBP)
Initial Inflation:	150 mmHg (adult)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 perIEC 60601-2-27 (12), clauses 17,101 and 102
Degree of protectionagainst electrical shock	Type CF and BF.ECG, IBP and CO = CFNIBP and SpO2 = BF
ElectrosurgicalInterference Suppression	Yes
Displayed Waveforms
ECG	Up to 12 lead
BP	2 separate or superimposed
Respiration	1
SpO2	1
Displayed NumericParameters	1
Heart Rate	Yes
Respiration Rate	Yes
SpO2	Yes
BP - Systolic, Diastolic,Mean	Yes
Temperature	2
	Horizon Angio
Alarm Indications	No

Display Functions
Change ECG LeadSelection	YES
Display of ArrhythmiaInformation	YES
Data Review: Trends	YES
Data Review: Tabular	YES
User defined ConfigurationSetup	YES
User defined DefaultSettings	YES
Accessories	Compatible with Mennen Medical Envoy patient monitor

K043564-
P4/8

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Food and Drug Administration

Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio

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{9}------------------------------------------------

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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.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).