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 Intended Use of the Horizon XVU is same as the Indications For Use as indicated above.

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, 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 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 Sun Ultra 25 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Horizon XVu device:

Important Note: The provided document is a 510(k) premarket notification for a device modification. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel clinical study with detailed acceptance criteria and performance metrics for an entirely new device. As such, the document primarily describes the device and its intended use, and explains why the modification does not alter its fundamental safety or effectiveness.

Therefore, the information you've requested regarding specific acceptance criteria, comprehensive study designs, sample sizes, expert qualifications, and detailed performance metrics is largely absent from this particular 510(k) document. The device is being cleared based on its similarity to a previously cleared device (Horizon SE) and the limited nature of the modification (primarily a GUI change).

Despite this, I will attempt to extract and infer what I can from the provided text to address your points, acknowledging where information is not present.

Acceptance Criteria and Device Performance

Due to the nature of this 510(k) (device modification, specifically a GUI change), the document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new device's clinical trial results. The "performance" being validated here is primarily that the new GUI does not negatively impact the existing functionalities and performance of the predicate device.

The implicit acceptance criteria for this modification are:

Functional Equivalence: The Horizon XVu performs all the functions of the Horizon SE.
Safety Equivalence: The GUI change does not introduce new safety risks.
Effectiveness Equivalence: The GUI change does not negatively impact the device's ability to acquire, display, store, and analyze patient data effectively for its intended use.
User Interface Improvement: The new GUI is "more user-friendly" and has a "modern look" with "better contrast and easier user interface."

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Document)
Functional Equivalence to Predicate Device (Horizon SE): The Horizon XVu retains all previous functionalities for acquiring, displaying, storing, and analyzing vital sign data (ECG/HR, invasive BP, SpO2, respiration, cardiac output, body temp, EtCO2).	"The Horizon XVu is a system identical to the Horizon SE Cathlab but with different graphic user interface." "The Horizon XVu uses the same CFE front end electronics and the same hardware platform as the Horizon SE." "The list of functions and protocols was not changed." "The control panels and information lists where not modified, but the GUI view and colors, were modified to use new colors with better contrast and easier user interface." "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." (This implies that the core functional performance matches the predicate, K032997, which was already cleared.)
Safety Equivalence: No new safety hazards introduced by the GUI change.	Not explicitly stated as a tested outcome in the provided text, but implied by the 510(k) process for device modification, which assesses if the changes raise new questions of safety or effectiveness. The fundamental hardware and signal acquisition remain the same.
User Interface Improvement: Modern look, user-friendly, better contrast, easier interaction.	"This new GUI is more users friendly and will give the system a more modern look without changing the signal acquisition, storage and report capabilities." "The advantages of the Horizon XVu on the Horizon SE Cathlab are: User friendly Modern look." "The GUI... were modified to use new colors with better contrast and easier user interface."

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly mentioned. Given this is a GUI change to an existing device, a formal "test set" in the sense of a new clinical study with patient data is unlikely to have been conducted for this 510(k). The focus would be on internal verification and validation of the software change.
- Data Provenance: Not applicable in the context of a new clinical study. The device itself is manufactured in Israel ("Mennen Medical Ltd., 4 Hayarden Street, Yavne, 81228, Israel").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "ground truth" derived by experts for a test set in this document, as it's a device modification focused on the user interface and functional equivalence, not a new diagnostic or prognostic tool requiring clinical adjudication.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a physiological monitoring system and is not described as having AI capabilities or undergoing an MRMC study for diagnostic effectiveness. It's an information display and management system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device; it's a integrated system for acquiring and displaying physiological data for human interpretation and use in medical procedures.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth is described in this context. The "ground truth" for the device's accuracy in measuring ECG, BP, etc., would have been established during the original predicate device clearance (K032997) through calibration and performance testing against reference standards, not through expert consensus on patient data for this GUI update.
The sample size for the training set:
- Not applicable. This document describes a traditional medical device (physiological monitor with a specific GUI), not a machine learning or AI algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable, as no training set is described.

Summary of the 510(k) Scope:

This 510(k) (K081484) is a "Special 510(k)" for a "Device Modification - Horizon XVu." The core premise is that the Horizon XVu is "identical to the Horizon SE Cathlab but with different graphic user interface." The key justification for substantial equivalence lies in the fact that the underlying hardware, signal acquisition electronics (CFE), functions, and protocols were not changed. Only the "GUI view and colors" were modified to improve user-friendliness and provide a modern look. Therefore, the detailed studies and performance metrics typically expected for an entirely new device, or a device with new clinical claims, are not required or presented in this type of submission. The FDA's clearance (JUN 20 2008 letter) confirms that the device is "substantially equivalent" to its predicate, based on this scope.

Summary

{0}------------------------------------------------

Name:	Mennen Medical Ltd.
Registration Number:	9611022	JUN 20 2008
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

Traditional 510(k): Device Modification - Horizon XVu

Terminology

Horizon XVu = Subject of this 510(k). The Horizon XVu is a modified device, a system identical to the Horizon SE Cathlab but with different graphic user interface.

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

Intended Use of the Horizon SE/Horizon XVu:

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

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.

Functional Description of the Horizon XVu

{1}------------------------------------------------

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

4 Invasive Blood Pressure channels .
Diagnostic 7 or 12 Lead ECG .
Non-invasive Blood Pressure .
Pulse Oximetry (SpO2) .
. EtCO2 (optional)

Horizon XVu 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 .

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

{2}------------------------------------------------

· 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
(B) The Central System contains the following main devices:
- · A SUN® OEM Workstation (computer) see details on the Sun workstation below
- · Two local LCD displays
- · Video line driver
- · AC Power Unit
- · Laser printer
- Hub
- Modem
- · Opto-magnetic disk (optional)

Reasons for replacing the graphic user interface of the Horizon SE:

The Horizon SE used a GUI -- Graphic User Interface with a stile that was useful at the time of the original release of the Horizon SE (Horizon 9000) release.

During the years, with the movement of computers toward Windows platform there was a need and client request to change the GUI to a more modern look.

This new GUI is more users friendly and will give the system a more modern look without changing the signal acquisition, storage and report capabilities.

The advantages of the Horizon XVu on the Horizon SE Cathlab are: User friendly Modern look

Description of the design of the Horizon XVu

The Horizon XVu uses the same CFE front end electronics and the same hardware platform as the Horizon SE.

The list of functions and protocols was not changed.

The control panels and information lists where not modified, but the GUI view and colors, were modified to use new colors with better contrast and easier user interface.

{3}------------------------------------------------

Image /page/3/Figure/2 description: The image shows a screenshot of a medical software interface. The interface includes various panels and sections, such as patient information, display settings, and procedure documentation. There are also controls for navigation and data input, as well as a diagram of a heart.

Horizon SE Technician screen

Horizon XVu Technician Screen

{4}------------------------------------------------

Food and Drug Administration
Special 510K - Device Modification -- Horizon XVu

Image /page/4/Figure/1 description: The image shows a screenshot of a software interface, possibly for medical imaging or diagnostics. The interface includes various panels and tools, such as a diagram of a heart (5), toolbars (1), and a timeline or data log (7). The interface also displays patient information (4) and time stamps (9), suggesting it is used for real-time monitoring or recording of medical data. The numbers 2, 3, 6, 8, and 10 are also labeled on the image.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 2008

Mennen Medical Ltd. c/o Mr. Ifat Oren QA and Regulatory Affairs 4 Ha-Yarden Street, PO Box 102 Rehovot Yavne 76100 ISRAEL

Re: K081484

Trade Name: Horizon XVU Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: May 21, 2008 Received: May 28, 2008

Dear Mr. Oren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav 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

{6}------------------------------------------------

Page 2 - Mr. Ifat Oren

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Horizon XVU

Indications For Use:

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

Prescription Use YES (Part 21 CFR 801 Subpart 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)
--------------------------------------------------------

econo

liovascular Devices

Page 1 of 1

KDBI484 510(k) Number

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).