(31 days)
Not Found
No
The summary describes a computerized laboratory system for acquiring, displaying, storing, and analyzing physiological data. It mentions standard signal processing and data analysis but does not include any terms or descriptions indicative of AI or ML technologies.
No
The device is described as a computerized laboratory for acquiring, displaying, storing, and analyzing physiological patient data, not for providing therapy.
Yes
The device acquires, displays, stores, and analyzes essential patient data such as ECG, blood pressure, pulse oximetry, respiration, and cardiac output. This data is used to monitor and assess a patient's physiological status, which is a core function of a diagnostic device. The analysis and reporting features further support its diagnostic capabilities by providing structured information for clinical evaluation.
No
The device description explicitly mentions hardware components such as a Sun Blade 150 workstation, Ethernet hub, LCD displays, and a Laser Printer, in addition to the software.
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 Horizon Angio acquires and displays physiological data from the patient's body (in vivo), such as ECG, blood pressure, and temperature.
- The intended use and device description focus on monitoring and analyzing real-time physiological signals and hemodynamic data. This is characteristic of patient monitoring and diagnostic systems used in clinical settings, not laboratory analysis of samples.
- There is no mention of analyzing biological samples or performing tests on specimens.
The Horizon Angio is a system for physiological monitoring and data management during procedures like vascular catheterization.
N/A
Intended Use / Indications for Use
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, recorded, analyzed and presented in a variety of report formats.
Product codes
DQK, DXG
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 .
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
043564
Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for Horizon Angio
INDICATIONS FOR USE
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, recorded, analyzed and presented in a variety of report formats.
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
3
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 |
4
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)
5
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 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 .
04:3564 > 3/8
6
Intended Use of the Horizon Angio
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 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 ( |