K Number

Device Name

HORIZON XVU (FFR)

Manufacturer

MENNEN MEDICAL LTD.

Date Cleared

2013-08-30

(263 days)

Product Code

DQX

Regulation Number

870.1330

Intended Use

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

Device Description

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display. The Central System contains the following main devices: Computer, Two local LCD displays, Video line driver, AC Power Unit, Laser printer, Hub, Modem. FFR is a mode that uses two invasive pressure inputs. Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K041134

Reference Devices

K091165

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on real-time data acquisition, processing, and display of physiological signals and calculations like FFR, without mentioning any AI/ML techniques for analysis or interpretation. The "computerized laboratory" aspect refers to standard digital processing and control.

Therapeutic

No
The device is described as acquiring and displaying patient data and waveforms for diagnostic and monitoring purposes during catheterization, not for providing direct therapy.

Diagnostic

Yes
The device acquires, displays, stores, records, and analyzes essential patient data and hemodynamic data, including FFR, for diagnosis and patient care during catheterization.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of both a "Front End unit" (CFE) which acquires and processes vital signs, and a "Central system" which includes hardware components like a computer, displays, power unit, printer, hub, and modem. This indicates it is a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Horizon XVu is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (in glass or outside the body).
Horizon XVu Function: The Horizon XVu acquires and displays physiological data directly from the patient in real-time during a catheterization procedure. It measures vital signs like ECG, blood pressure, pulse oximetry, etc., and calculates values like FFR based on these direct measurements.
Lack of Specimen Testing: There is no mention of the Horizon XVu analyzing any biological specimens taken from the patient. Its function is focused on monitoring and processing real-time physiological signals.

Therefore, the Horizon XVu falls under the category of a physiological monitoring and data acquisition system used in a clinical setting, not an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and FFR, can be stored, recorded, analyzed and presented in a variety of report formats.

Product codes (comma separated list FDA assigned to the subject device)

DQK, DQX

Device Description

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history.

The Horizon XVu is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, ICECG, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature. Heart rate, multi-lead ECG, EtCO2 and BP waveforms from different heart and vascular 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 XVu software includes graphic presentation of the Heart and abdominal, cranial and peripheral vascular system, to support reporting of heart and vascular catheterization.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart and vascular sites, coronary arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Horizon XVu has been subject to extensive performance testing to ensure that: 1. The acquisition and display of the patient data and waveforms by the Horizon XVu with 960-OPT-580/585 remain the same for the predicate device Horizon XVu.

At the system level, SW Validation of the performance of the Horizon XVu with 9600PT580/585 as compared to the Horizon XVu Cathlab system, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Horizon XVu.

The SW Test Description for the Horizon XVu with 9600PT580/585 was derived from the SW Test Description for the Horizon XVu Cathlab system, with the necessary addition of the FFR measurements

Final testing for the Horizon XVu system included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Horizon XVu system.

Electrical Safety testing and EMC testing were performed by an independent testing laboratory (Standard Institute of Israel SII) to ensure that the device complicable industry and safety standards (attached in Part 17)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041134

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K091165

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

Image /page/0/Picture/1 description: The image contains the logo for Mennen Medical. The logo consists of a stylized letter "m" enclosed in a circle on the left, followed by the words "mennen" stacked on top of "medical" on the right. The text is in a simple, sans-serif font.

Topic: Traditional 510K for Horizon XVu-addition of FFR Programmable diagnostic computer

Establishment Name, Registration Number and Address:

510K number:	K123792
Name:	Mennen Medical Ltd.
Registration Number:	9611022
Operator Number:	9069173
Address:	4 Hayarden Street, Yavne, 81228, Israel
Postal Address:	PO Box 102,
Rehovot, 76100, Israel
Tel:	+972-8-9323333

Fax: +972-8-9328510 Contact person: Ifat Oren, Regulatory Affairs

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

AUG 30 2013

Attn.: Document Control Clerk From: Ifat Shwarts, Regulatory Affairs

The following information is being submitted in conformance with 21 CFR 807.87:

1. Classification Name	Programmable diagnostic computer
2. Classification Number:	21 CFR 870.1425
3. Common/Usual Name	Programmable diagnostic computer
4. Trade/Proprietary Name	Horizon XVu
5. Part Number of Horizon SE	960-100-310 (115V)
960-100-320 (230V)
6. Establishment Registration Number	9611022
7. FDA Classification	Class II
8. Product Code	DQK
9. Reviewing Panel	Cardiovascular
10. Performance Standards	page 12
11. 510(k) Marketing clearance for Horizon XVu	K091165 – August 7, 2009

Image /page/1/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter "m" inside of a circle on the left, with the words "mennen medical" to the right of the circle. The word "mennen" is on top of the word "medical".

ComboMap

Traditional 510(k): Device Modification - Horizon XVu K123792

Terminology

Subject of this 510(k) = Horizon XVu with FFR

The Horizon XVu is a modified device, a system identical to the Horizon XVu Cathlab with the addition of Fractional Flow Ratio (FFR) measurement.

This submission is for a modification of the Horizon XVu that Mennen Medical has received 510K clearance for marketing by the FDA (K091165) August 7, 2009 (enclosed in part 21)

We intend to add to the Horizon XVu Computerized Catheterization Laboratory, FFR measurement option using as a predicated device the:

Volcano ComboMap = The predicated device for FFR measurement. The COMMBOMAP was cleared for marketing by FDA (K041134) June 2, 2004 (see attached FDA letter - part 21)

Intended Use of the Horizon XVu with FFR

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

Image /page/2/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a circle with the letter "m" inside of it, followed by the words "mennen" in bold black letters and "medical" in light gray letters. The logo is simple and modern, and it is likely used to represent the company's brand.

1. Device Description: Horizon XVu

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history.

Image /page/2/Picture/4 description: This image shows a Horizon XVu Cathlab System, including the console option and a general view of the system. The image also shows the physician's remote, the CFE (presumably an electronic component), and the CFE mounting location. The Horizon XVu Cathlab System is labeled at the bottom of the image.

Page 3 of 12

Image /page/3/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a circular graphic on the left and the words "mennen medical" on the right. The word "mennen" is on top of the word "medical". The circular graphic contains a stylized letter "m".

2. Functional Description of the Horizon XVu

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

Catheterization procedure

During a typical catheterization procedure, the physician guides a catheter to the site of interest by observing an X-ray display and the Horizon XVu Patient Data Display, and then instructs the catheterization technician at the on-line workstation to acquire pressure waveform(s) data for that site. With a single keystroke, the technician labels the site and initiates waveform/data sample acquisition.

The waveform of interest changes to a pre-defined color at the Patient Data Display during acquisition for ease of identification. Another keystroke signals the Horizon XVu to stop the acquisition and begin analysis of the newly acquired pressure information via the dedicated Workstation Horizon XVu Computer, at which time the waveform for the corresponding pressure channel will change back to one of the default colors for non-defined pressures.

The Patient Data Procedure Display provides a view of the acquired ECG and heartbeats sampled for review, editing, and acceptance via the Horizon XVu Interface. The numerical results of calculations are based on the average of the accepted beats. These results will include such items as (for example) Systolic, Diastolic, and Mean pressure values.

The technician may at this point use the Interface to accept the displayed pressure information; doing so will store the values to the patient's on-line Procedure File.

The Horizon XVu is used for activities such as coronary and peripheral endovascular procedures and Angioplasty. The basic steps described above (catheter positioning, site definition/acquisition, analysis and acceptance) are performed as an integral part of these procedures.

The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard.

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

・

Image /page/4/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a circular graphic on the left and the words "mennen medical" on the right. The circular graphic appears to have the letter "m" inside of it. The words "mennen medical" are stacked on top of each other.

Base Configuration: Cathlab parameters

ECG/Heart Rate/Respiration .
4 Invasive Blood Pressure channels .
Non-invasive Blood Pressure .
Pulse Oximetry (SpO2) .
. EtCO2 (optional)
. respiration
temperature .
ICECG Intra-Cardiac ECG .

Horizon XVu Options:

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

Main components of the Horizon XVu:

The Horizon XVu system consists of:

(A) a Front End unit and

(B) a Central system

The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs (A) from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display.

The CFE can acquire the following physiological signals of the patient:

· ECG the CFE acquires an ECG waveform and measures Heart Rate
· ICECG the CFE measures 6 channels of differential intra-cardiac ECG
· Blood Pressure the CFE acquires a BP waveform and measures Systole, Diastole and Mean Pressure
· Temperature the CFE measures Temperature by means of a numeric value in Co or Fo
· SpO2 the CFE acquires and measures oxygen saturation and creates a photoplethysmographic waveform and numeric value of the oxygen saturation
· EtCO2 the CFE measures CO2 during the respiration cycle and present the end tidal (end expiratory) CO2 and the inspired CO2 - inCO2 and the respiration rate - RR

Image /page/5/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter "m" inside of a circle on the left, with the words "mennen" and "medical" stacked on top of each other to the right of the circle. The text and the letter "m" are in a simple, sans-serif font.

The Central System contains the following main devices: (B)
- · Computer- see details below
- · Two local LCD displays
- Video line driver
- · AC Power Unit
- · Laser printer
- Hub
- Modem

FFR - Fractional Flow Reserve

FFR is a mode that uses two invasive pressure inputs.

Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed. The value of Pd/Pa is calculated continuously during intracoronary or venous pharmacological Hyperemic stimulus. The pressure gradient across lesion is measured and the pressure ration is calculated. Providing the FFR parameter that is used to evaluate the importance of the lesion in limiting blood flow to the distal coronary.

Computer Workstation

The computer workstation is a uni-processor system that runs the Horizon XVu 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. ECG and FFR waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

3. Horizon XVu 960-OPT-580/585 - similarity and Differences in Design:

Horizon XVu with FFR 960-OPT-580/585 vs. Horizon XVu

The following technological and other characteristics/features apply to both the Horizon XVu and to the Horizon XVu with FFR 960-OPT-580/585

. Intended for use in hospitals
. Do not change the functionality of the Cathlab system
. Isolated inputs for vital signs sensors

Image /page/6/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter "m" inside of a circle on the left, followed by the words "mennen" and "medical" stacked on top of each other on the right. The text is in a simple, sans-serif font.

ECG amplifier front end with defibrillator protection .
Invasive BP input circuit .
Non Invasive BP measurement .
. SpO2 measurement
. Selectable filters for ECG and BP
. Analog output for ECG and BP
. Doctor's display of vital signs and physiological waveforms
. Show doctor feature for diagrams from the technician screen

The main difference between the Horizon XVu and the Horizon XVu with FFR 960-OPT-580/585 .:

On the Horizon XVu with FFR 960-OPT-580/585 it is possible to display the FFR waveform and value.

The SW changes of the Horizon XVu with FFR 960-OPT-580/585 vs. the Horizon XVu are not related to the type, size, method of integration, and assembly of the HW components.

The following table compares the major software element and/or changes done in the Horizon XVu vs. the Horizon XVu with FFR 960-OPT-580/585, Cathlab:

| SW Component | Horizon XVu
960-800-XXX | Horizon XVu with
9600OPT580/585
FFR |
|----------------------------------------------------------------|------------------------------------------|-------------------------------------------|
| Doctors display | All waveforms and numeric vital
sings | Same |
| Display of leads and
waveforms on Cathlab
display screen | Yes | Yes |
| Solaris Operating
System for Cathlab | Yes | Yes |
| Technician Screen | Controls only | Same |
| GUI | Same | Same |
| Menus | Full set | Same |
| Vital Signs | Full set | Full set + FFR |

	Horizon XVu	Horizon XVu- FFR
Part/Option Number	960-800-XXX	960-OPT-580 for use of RADI
wire
960-OPT-585 for Volcano wire
Input Circuit Parameters
Surface ECG	Yes	Yes

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ICECG
NIBP	Yes	Yes
Invasive BP	4 channels	4 channels – 2 used for FFR
Respiration	Yes	Yes
SpO2	Yes	Yes
EtCO2	Yes	Yes

Menu Details

Technician Display

The technician display of the Horizon XVu FFR 960-OPT-580/585 is identical to the Horizon XVu with the addition of control of the FFR procedure.

The GUI control keys of the Horizon XVu 960-OPT-580/585 are same as to the Horizon XVu, with the addition of FFR procedure

We submit that the addition of the FFR 960-OPT-580/585 option to the Horizon XVu is limited to the addition of a new parameter - FFR. This change does not amount to a change in the "fundamental scientific technology" of the Cathlab and does not disqualify the Horizon XV u from being the subject of a 510(k).

Comparison to the predicate device

The Horizon XVu with FFR 960-OPT-580/585 option is comparable to the FFR mode of the predicated device Volcano - ComboMap (see also part 12- Substantial equivalence) The functional menus of Horizon XVu were modified by adding the option to measure and calculate the FFR vital sign and waveform, without any change to the other vital sign monitoring capabilities

| Subject | Volcano - ComboMap
Predicated Device | FFR mode on Horizon
XVu |
|--------------------|-----------------------------------------|------------------------------------------------------|
| FDA 510 K | K 041134 | K 091165 prior to change |
| Features | FFR + Flow velocity | FFR |
| Pressure wire | Volcano | Volcano or Radi |
| Transducer input | 5μV/V/mmHg | 5μV/V/mmHg |
| Pressure range | -30 to +330 mmHg | -50 to +300 mmHg |
| Pressure bandwidth | DC to 25 Hz | DC to 6 Hz, DC to 12 Hz,
DC to 24 Hz, DC to 40 Hz |

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| Measurement accuracy | ± 3 mmHg (-30 to +100 mmHg)
± 3% (> 100 mmHg) | +/- 2 mmHg, or +/- 2%,
whichever is greater,
exclusive of transducer |
|------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------|
| # pressure channels | 2 | 4 (2 used for FFR) |
| Analog Pressure output | 1V/100 mmHg. | same |
| Pa | Mean Arterial Pressure | Same |
| Pd | Mean Distal Pressure at
the tip of the pressure
wire | Same |
| FFR = Pd/Pa | Ratio | Same |
| Tracing | ECG,
Pa dynamic , Pa mean,
Pd dynamic, Pd mean
FFR | Same |

Explanation of differences

The basic amplifier specifications are the same for the Horizon XVu (FDA approved) and the Horizon XVu with FFR

The number of pressure channels of the Horizon XVu is four (4). Two (2) of these channels are used for the FFR calculation. Same as in the predicated Volcano ComboMap. The FFR option of the Horizon XVu is comparable only to the pressure measurement of the COMBOMAP, and not to the ComboMap capabilities to measure flow.

4. Reasons to the change

FFR

Mennen Medical has added to the FFR capability, for the following reasons

. Users request to add to the Horizon XVu the FFR software capability to enable use of the pressure measurements that are performed in any case of hemodynamic catheterization.
. Use of FFR feature on the Horizon XVu provides an important measurement without the need for an addition device.
. The Horizon XVu is used for coronary diagnosis and implantation of stents and FFR is a diagnostic tool in the decision if and where to implant a stent.

We submit that no changes were made:

· to the control mechanism of the Horizon XVu.
· to the operating principle of the Horizon XVu.
· to the energy type of the Horizon XVu

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The FFR option is a software option , thus sterilization is not an issue.

FFR capability uses single use pressure wire sensors not manufactured by Mennen Medical which are supplied sterile. Thus sterilization is not an issue.

5. Conclusion of comparison of technological characteristics:

We consider the FFR option of the Horizon XVu to be substantially Equivalent to the FFR in the Volcano ComboMap

We submit that any difference between the FFR measurement of the Horizon XVu and the FFR measurement of the ComboMap.

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

6. Verification, Validation and Testing

The SW Test Description for the Horizon XVu with 9600PT580/585 was derived from the SW Test Description for the Horizon XVu Cathlab system, with the necessary addition of the FFR measurements

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7. Proposed Labeling

The system will be called Horizon XVu with FFR 960OPT580/585

Page IV of the introduction to the Horizon XVu User Guide contains the following

Prescription Notice: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only." The following symbols appear on page IX of the Horizon XVu User's Guides under the section entitled "Label Locations & Symbol Descriptions," and on the front panel of the CFE. See the image of the front panel of the CFE on page 11 below.

Image /page/10/Figure/6 description: This image shows a table with different medical symbols and their descriptions. The first row shows an exclamation point inside of a triangle, with the text "Attention - see Accompanying Instructions for Use". The second row shows a stick figure inside of a square, with the text "Type BF Applied part (next to NIBP, EtCO2 and SpO2 connectors)". The third row shows a heart inside of a square, with the text "Type CF Applied Part (next to IBP, Temperature and CO connectors)". The fourth row shows a heart inside of a square with two symbols on either side of the heart, with the text "Type CF Applied Part - Defibrillation Proof (next to ECG connector)".

Image /page/10/Picture/7 description: The image shows a medical device with several labeled sections. The sections include ECG/RESP, SpO2, CO/2 Temp, NIBP, Temp 1, and Temp 2/EtCO2. On the right side of the device, there are four IBP sections labeled 1 through 4, each with a 'Zero' button.

Symbols and labeling on the front panel of the CFE

Image /page/11/Picture/1 description: The image shows the logo for Mennen Medical. The logo consists of a stylized letter 'm' enclosed in a circle on the left, followed by the word 'mennen' in a simple, sans-serif font on the top line. Below 'mennen', the word 'medical' is written in the same font, completing the logo.

8. Voluntary Standards

Appropriate voluntary standards for this device, to which conformance have been demonstrated:

- IEC 60601-1: (2005) Medical Electrical Equipment Part:1 General Requirements for Safety
- 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 (2007): Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
☆ IEC 60601-2-27 (2005): Medical electrical equipment, Part 2, Requirements for safety of electrocardiograph monitoring equipment.
今 IEC 60601-2-30 (1999): Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment
☆ IEC 60601-2-34 (2005): Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment
や IEC 60601-2-49 (2006): Particular Requirements for the safety of multifunction patient monitoring equipment

9. Indications for Use

Attachment:

Horizon XVu User Manual - part 13 FTP for FFR option in Horizon XVu - Part 16 j Horizon XVu, Risk Analysis - part 16 d

Public Health Service

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center . WO66-G60 Silver Spring, MD 20993-002

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August 30, 2013

Mennen Medical Ltd. c/o: Ifat Shwarts Regulatory Affairs 4 Hayarden st., Yavne P.O. Box 102 Rehovot, IS 76100

K123792 Re:

Trade Name: Horizon XVu (FFR) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQX Dated: August 2, 2013 Received: August 5, 2013

Dear Ifat Shwarts:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

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

Enclosure

K123792

Indications for Use

510(k) Number (if known):

Device Name: Horizon XVu

Indications For Use:

*The Intended Use of the Horizon XVu as indicated above is same as the Indications For Use.

Prescription Use_YES (Part 21 CFR 801 Subpan D) AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Com
Digitally signed by
:Owen P. Faris -S
Date: 2013.08.30
15:27:18-04'00'

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