(20 days)
Not Found
No
The summary describes a system for acquiring, displaying, storing, and analyzing physiological data using real-time software, but there is no mention of AI or ML technologies. The analysis described appears to be standard signal processing and reporting.
No
The device is described as acquiring, displaying, storing, recording, analyzing, and presenting patient data and vital signs. It is used for monitoring and diagnostic purposes, not for therapeutic intervention.
Yes
The device acquires, displays, stores, records, and analyzes essential patient data such as ECG, blood pressure, pulse oximetry, respiration, cardiac output, and body temperature, which are all used to assess a patient's health status.
No
The device description explicitly mentions hardware components such as a SUN® computer, a Physiological Front End (PFE), a Thermal Array Chart Recorder, and a Laser Printer, which are integral to the system's operation and data acquisition/output.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The description of the HORIZON 9000 WS (Cathlab) clearly states that it acquires and displays essential patient data directly from the patient (in vivo) through sensors and connections for ECG, blood pressure, pulse oximetry, respiration, cardiac output, and body temperature.
- The device focuses on monitoring and analyzing physiological signals and waveforms from within the body. It's a system for real-time patient monitoring and data management during procedures, not for analyzing samples in a laboratory setting.
The device is a physiological monitoring and data management system used in a clinical setting, likely a catheterization laboratory ("Cathlab"), to acquire and display vital signs directly from the patient. This falls under the category of medical devices used for patient monitoring and data acquisition, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXG
Device Description
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 Cathlab runs on a UNIX/Sun Solaris* operating system on a SUN® computer that utilizes spowerful, 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 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 .
- Thermodilution cardiac output
- Pulse Oximetry (SpO2)
- 24 channel thermal array chart recorder .
Horizon 9000 WS Options:
- Full Disclosure ●
- Off-line workstations ●
- Remote Interactive terminal ●
- Angiography Analysis Package ●
- Cardiology Data Base and Inventory ●
- Optomagnetic or CDR drive .
- Choice of Console Table regular, enhanced or compact .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Cathlab with the CFE has been subject to extensive safety and performance testing in order to ensure that the signals/waveforms sent by the CFE to the Cathlab have the same characteristics as those sent by the PFE to the Cathlab.
Final testing for the whole Cathlab 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.
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.
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.
Not Found
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
§ 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).
0
OCT 1 5 2003
Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for new PFE (Patient Front End) for Cathlab
Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a lowercase letter 'm' inside of a black circle. The text 'mennenmedical' is written below the logo, with 'mennen' in black and 'medical' in a lighter color.
Mennen Medical Ltd., 4 Hayarden Street, Yavne PO Box 102, Rehovot 76100 Israel
Date: 16 September 2003
Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Special 510(k): Device Modification - Horizon 9000WS 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 |
| Contact person: | Asher Kassel, Director of Regulatory Affairs |
| 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: | Asher Kassel, Director of Regulatory Affairs |
| Product Name: | |
| Proprietary: | Horizon 9000WS |
| Common: | Cathlab |
| Mennen Medical Part Number: | 960-100-020 (full system) |
| FDA Classification of Cathlab: | |
| Classification Name: | Programmable diagnostic computer |
| Classification Number: | 21 CFR 870.1425 |
| Classification: | Class II |
| Product Code: | DXG |
1
Performance Standards: None promulgated
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 60601-1-2 (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:
PFE = Patient Front End, and refers to the data acquisition module of the Horizon 9000WS, the predicate device before modification
CFE = Cathlab Front End, and refers to the data acquisition module of the Horizon 9000WS after modification, the subject of this Special 510(k).
Predicate Device:
2
General Description of the Horizon 9000WS Cathlab
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 Cathlab runs on a UNIX/Sun Solaris* operating system on a SUN® computer that utilizes spowerful, 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 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 .
- Thermodilution cardiac output
- Pulse Oximetry (SpO2)
- 24 channel thermal array chart recorder .
Horizon 9000 WS Options:
- Full Disclosure ●
- Off-line workstations ●
- Remote Interactive terminal ●
- Angiography Analysis Package ●
- Cardiology Data Base and Inventory ●
- Optomagnetic or CDR drive .
- Choice of Console Table regular, enhanced or compact .
Intended Use of the Horizon 9000WS Cathlab:
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.
3
K032997
page 4/10
Summary of the technological characteristics of the CFE of the Horizon 9000WS Cathlab
The following tables summarize data on the CFE (modified device) of the Horizon 9000WS Cathlab:
| CFE of Horizon 9000WS Cathlab | |
|---|---|
| Part/Option Number | 960-551-010 (CFE) |
| Dimensions (H x W x D) | 24 x 22 x 10 cm (9 x 11 x 4") |
| Input Circuit Parameters | CFE |
| Chassis Leakage Current | All patient signal inputs fully isolated ( |