(784 days)
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No
The description mentions "unique algorithms that reject artifacts and perform all required calculations," but does not explicitly state or imply the use of AI or ML techniques. The focus is on bioimpedance measurements and standard signal processing.
No
The device is a monitor used to assess hemodynamic and ventilatory parameters; it does not provide therapy or treatment.
Yes
The device is intended for monitoring hemodynamic and ventilatory parameters in individuals needing cardiac output assessment, specifically individuals with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients, and patients in intensive and cardiac care units and rehabilitation. Monitoring these physiological parameters aids in assessing the patient's condition and guiding further medical intervention, which falls under the definition of a diagnostic device.
No
The device description explicitly states it includes hardware components such as electrodes, a patient module, and a microprocessor, in addition to the software.
Based on the provided information, the NICaS 2001 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic 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 outside the body (in vitro).
- NICaS 2001 Function: The NICaS 2001 is a noninvasive monitor that measures bioimpedance from the patient's body using electrodes attached to the skin. It directly monitors physiological parameters in vivo (within the living body).
The device description clearly states it "unlizes bioimpedance measurements from the blood circulatory system" and uses electrodes attached to the patient. This is a direct measurement of physiological signals from the living body, not the analysis of a specimen taken from the body.
N/A
Intended Use / Indications for Use
The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
Product codes
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Device Description
The NICaS 2001 is a noninvasive cardio-respiratory monitor which unlizes bioimpedance measurements from the blood circulatory system to calculate hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index and total peripheral resistance) and ventilatory parameters (including respiratory rate). The NCaS 2001 uses 4 electrodes that pick up the signals which are amplified inside the patient module. After signal amplification and filtration, the analysis is done by a powerful microprocessor. The microprocessor-driven software includes unique algorithms that reject artifacts and perform all required calculations for stroke volume (SV) and other derived parameters. The results are displayed on a PC screen. The software allows data storage, recall/review and printout. The electrodes are nondisposable (standard electrode by Nicolet) "strap" style attached to cable leads. These electrodes consist of two 55 cm electrode strips for the leg and two 25 cm electrode strips for the arm. The electrodes are attached to the two identified input connectors of the patient module. The patient module also connects with the computer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data collected from a study conducted by Dr. H. Miller at the Ichilov Hospital, Israel, correlated cardiac output by the NICaS 2001 with the standard invasive technique of thermodilution. Data collected from a study conducted by Dr. Michael Luchansky at the Tel Aviv Medical Center correlated the respiratory rate measured with the Horizon 2000 Physiological Monitor with the NICaS 2001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
BoMed's NCCOM3-R7 Monitor
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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JUN 28 1998
510(k) Summary
Submitter's Name:
N.I. Medical, Ltd. 31 Habarzel Street Tel Aviv 69710 Israel Phone: 972-3-492124 Facsimile: 972-3-6482401
Contact Person:
June 19, 1996 510(k) Summary Date:
Device Name: NICaS 2001 Noninvasive Cardio-Respiratory System
Mr. S. Pilovski, C.E.O.
Common Name: Noninvasive Cardio-Respiratory Monitor
Classification Name: Impedance plethysmography (21 CFR 870.2770)
Predicate Device: BoMed's NCCOM3-R7 Monitor
Device Description: The NICaS 2001 is a noninvasive cardio-respiratory monitor which unlizes bioimpedance measurements from the blood circulatory system to calculate hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index and total peripheral resistance) and ventilatory parameters (including respiratory rate). The NCaS 2001 uses 4 electrodes that pick up the signals which are amplified inside the patient module. After signal amplification and filtration, the analysis is done by a powerful microprocessor. The microprocessor-driven software includes unique algorithms that reject artifacts and perform all required calculations for stroke volume (SV) and other derived parameters. The results are displayed on a PC screen. The software allows data storage, recall/review and printout. The electrodes are nondisposable (standard electrode by Nicolet) "strap" style attached to cable leads. These electrodes consist of two 55 cm electrode strips for the leg and two 25 cm electrode strips for the arm. The electrodes are attached to the two identified input connectors of the patient module. The patient module also connects with the computer.
Intended Use:
The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
1
Precaution:
The effective use of the NICaS 2001 has not been established in the following clinical conditions:
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- Severe valvular disease
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- Severe septic shock
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- Severe aortic aneurysms
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- Occlusion of the abdominal aorta or aortic bifurcation
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- Peripheral arterial disease
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- Coarctation of the aorta
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- Chaotic breathing patterns
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- Intra cardiac shunts
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- Severe arrhythmias
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- Dialysis
Comparison of Technological Characteristics:
The NICaS 2001 and the BoMed NCCOM3-R7 derive parameters such as stroke volume, cardiac output and other related cardiac parameters by analyzing the impedance changes in the body as influenced by the pumping action of the heart. A modified Kubicek algorithm is used in both devices.
Differences between the NICaS 2001 and the BoMed NCCOM3-R7:
The NICaS 2001 measures total body impedance, which includes both the peripheral and the thorax areas, while BoMed measures only thoracic impedance. This methodology is based on modification of the Kubicek algorithm, the inclusion of patient data (i.e., weight and height), so that a final analysis can provide parameters relative to total body measurement and not only thoracic parameters.
The NICaS 2001 technology allows the display of the respiratory wave as an optional reference for the clinician.
The following parameters are included in the BoMed NCCOM3-R7 but are not displayed on the NICaS 2001: dZ/dt, pre ejection time, ejection time, peak flow, ejection fraction and end diastolic volume. The thoracic fluid index (TFI) is not available by the NICaS 2001 because the device can not distinguish between the thorax and the peripheral; they are measured together in the NICaS 2001. The TFI is not needed for any other calculation.
Safety and Effectiveness Information
The NICaS 2001 was designed to meet the IEC 601-1-1 and UL 544 medical safety standards. It was tested and approved by TUV.
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Data collected from a study conducted by Dr. H. Miller at the Ichilov Hospital, Israel, correlated cardiac output by the NICaS 2001 with the standard invasive technique of thermodilution. Data collected from a study conducted by Dr. Michael Luchansky at the Tel Aviv Medical Center correlated the respiratory rate measured with the Horizon 2000 Physiological Monitor with the NICaS 2001.