The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

Device Description

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, whose prime function is the acquisition and display of vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Cathlab is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats. The system has a UNIX Sun Solaris 2 (Ultra 5 computer) that utilizes powerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides print-outs of textual and graphical summaries of all patient data and catheterization procedures.

AI/ML Overview

This document is a 510(k) summary for the Mennen Medical LTD. Horizon 9000 WS Computerized Catheterization Laboratory. It describes the device's function and its substantial equivalence to a previously cleared device. However, this document does not contain information about specific acceptance criteria or study results demonstrating that the device meets such criteria.

Here's why and what information is missing:

No Acceptance Criteria or Performance Data: The provided text is a regulatory submission for premarket notification (510(k)). Its primary purpose is to establish substantial equivalence to a predicate device, not to detail specific performance studies with acceptance criteria. It states that "None promulgated" for Performance Standards, indicating that the FDA had not issued specific performance standards for this type of device at that time.
Focus on Substantial Equivalence: The document highlights the device's capabilities and compares them to a predicate device (Horizon 9000 WS - K 940415) cleared in 1995. The FDA's letter (Page 6) confirms that they "reviewed your Section 510(k) notification... and have determined the device is substantially equivalent." This means the device is considered as safe and effective as a legally marketed predicate device, primarily based on its specifications and intended use, not necessarily independent performance studies against defined acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details because that information is not present within the provided text.

To answer your questions, the following information would typically be found in a detailed device validation study report, which is usually part of a more extensive submission, but not always summarized in the publicly available 510(k) summary:

A table of acceptance criteria and the reported device performance: Would need specific performance claims (e.g., accuracy of heart rate measurement within X BPM, blood pressure measurement within Y mmHg) and the results of tests demonstrating these.
Sample size used for the test set and the data provenance: Would need details on how many patients or data points were used for testing, and if the data was collected prospectively, retrospectively, or from specific geographies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a device primarily measuring physiological parameters. Ground truth for parameters like heart rate or blood pressure would come from other validated measurement devices, not expert consensus interpretation.
Adjudication method: Not applicable for this type of device.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Highly unlikely for a a data acquisition and display system. MRMC studies are typical for image interpretation devices where human readers interpret medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone system for data acquisition and display. Its performance would be evaluated on its ability to accurately acquire and display physiological data.
The type of ground truth used: For physiological measurements, ground truth would typically be established by simultaneously using a highly accurate, reference standard measurement device (e.g., highly calibrated pressure transducers for blood pressure, gold-standard ECG machines for heart rate).
The sample size for the training set: Not applicable for this type of device. Training sets are relevant for AI/ML algorithms that learn from data. This device is described as a "computerized laboratory" using "real-time software to control the system operation and to process the vital patient sign data measurements," implying programmed functionality, not machine learning.
How the ground truth for the training set was established: Not applicable for this type of device.

Summary

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JUN 24 1999

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

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

MENNEN MEDICAL LTD. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: 972-8-938-3030 Fax: 972-8-940-6519

Page 1 of 4

Date: June 23, 1999

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

Establishment Name, Registration Number and Address

Name:	Mennen Medical Ltd
Registration Number:	9611022
Operator Number:	9011766
Address:	Kiryat Weizmann Science ParkRehovot 76100 IsraelTel: 972-8-938-3030Fax: 972-8-940-6519

Contact person:

Ken Raichman, Director of Regulatory Affairs

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

Ms. Marian Kroen Attn.:

From: Kenneth Raichman Director of Regulatory Affairs

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Food and Drug Administration

Special 510(k) Summary, Horizon 9000 WS

Product Name

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

FDA Classification

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

Performance Standards

None promulgated

Predicate Devices

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

Date of preparation of Summary

June 10, 1999

Device Description

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

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

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Food and Drug Administration

Special 510(k) Summary, Horizon 9000 WS

summaries of all patient data and catheterization procedures.

Base Configuration:

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

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

Horizon 9000 WS Options:

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

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

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

MENNEN MEDICAL LTD. Kiryat Weizmann Science Park Rehovot 76100 Israel Tel: 972-8-9383030 Fax: 972-8-9406519

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

Computerized Catheterization Laboratory - Horizon 9000 WS

Indications for Use:

Kenneth Raichman

(Signature)

Kenneth Raichman

Director of Regulatory Affairs Mennen Medical Ltd.

Date: June 23, 1999

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

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

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

Dear Mr. Raichman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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Paqe 2 - Mr. Kenneth Raichman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours,

sincerely yours,

Thomas J. Callahan

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

Enclosure

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Page 1 of 1

510(k) Number: K991775

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

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

VCalla Miller

ascular. Respiratory.

Regulation Number and Section

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).