(145 days)
942227
No
The description mentions "mathematical algorithms" for analysis, but there is no mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets for model development. The performance studies focus on comparison to a predicate device and a simulator, not on validating an AI/ML model.
No
The device is described as a diagnostic tool for monitoring hemodynamic parameters, not for treating conditions.
Yes
The device description explicitly states, "It is used for noninvasive cardiac diagnostic purposes." Additionally, the intended use describes monitoring hemodynamic parameters and assessing cardiac output in patients with various cardiac conditions, which falls under diagnostic activities.
No
The device description explicitly states it is a "CD-ROM shaped device" and an "impedance device" that uses electrodes and an alternating current. It receives analog signals, amplifies and filters them, and then transmits them to a microprocessor for digitization and analysis. This clearly indicates the presence of hardware components beyond just software.
Based on the provided information, the NICaS 2004 Slim is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- NICaS 2004 Slim Function: The NICaS 2004 Slim is a device that measures hemodynamic parameters (like cardiac output, heart rate, etc.) non-invasively by applying electrical currents to the body and measuring the impedance changes. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use is to monitor hemodynamic parameters in patients, which is a direct measurement of physiological function within the body, not an analysis of a sample outside the body.
Therefore, the NICaS 2004 Slim falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
Product codes
DSB
Device Description
The NICaS (non-invasive cardiac system) is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes.
The NICaS (non-invasive cardiac system) SLIM 2004 is an impedance device which is unique in its use of a laptop computer as part of a technology for non-invasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC.
The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ.
The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0).
The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor. where they are digitized and analyzed via mathematical algorithms.
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
Non-clinical Testing:
The NICaS 2004 Slim has been tested and found to comply with the requirements of IEC 60601-1-1.
The NICaS 2001 and the NICaS 2004 were attached to a simulator and fifty readings were taken. In all cases, the the NICaS 2004 exhibited significantly improved readings when compared to the NICaS 2001.
Clinical Testing:
The NICaS 2004 Slim was used on one hundred sixty three patients and the readings were compared to thermodilution on the same patients.
Key Metrics
Not Found
Predicate Device(s)
NICaS 2001 Noninvasive Cardio-Respiratory System (510(k) number 942227)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) Summary
JUL 16 2007
| Submitter: | N. I. Medical, Ltd.
3 Ein Chay Street
Kfar Malal 45920
Israel |
|-----------------------|----------------------------------------------------------------------------------------|
| Contact Person: | James Collie
Phone: 215-491-5245
Or
Igor Granov
Phone: 011-972-9-746696213 |
| Date Prepared: | February 19, 2007 |
| Device Trade Name: | NICaS 2004 Slim Bioimpedance Cardiac
Analyzing Measuring System |
| Common/Usual
name: | Bioimpedance Cardiac Analyzing measuring
System |
| Classification name: | Impedance Plethysmograph |
| Predicate Devices: | NICaS 2001 Noninvasive Cardio-Respiratory
System (510(k) number 942227) |
Device Description:
The NICaS (non-invasive cardiac system) is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes.
The NICaS (non-invasive cardiac system) SLIM 2004 is an impedance device which is unique in its use of a laptop computer as part of a technology for non-invasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC.
The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ.
K070500 p:113
1
The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0).
The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor. where they are digitized and analyzed via mathematical algorithms.
Indications for Use:
The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
Statement of Technical Comparison:
The NICaS 2004 Slim bioimpedance cardiac analyzing measuring system is substantially equivalent to the NICaS 2001 non-invasive cardio-respitory system which was cleared under 510(k) number K942227. Both of these devices were developed by and are manufactured for N. 1. Medical, Ltd., Israel. Both are also used for used for noninvasive cardiac diagnostic purposes.
The principle of the technology used by both devices is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0).
The analog resistance signals are received by the devices, where they are amplified and filtered. These signals are then transmitted to a microprocessor, where they are digitized and analyzed via mathematical algorithms. The data are portrayed on the computers screen
The following table lists the differences between the devices:
2
| Attribute | Predicate Device | |
|---|---|---|
| NICaS 2001 | NICaS 2004 Slim | |
| 1. Computer Connection | Outside computer- | |
| connected via cable | Fits into the computer | |
| CD-ROM area | ||
| 2. Leads | Bipolar (2 leads) with | |
| clips | Tetrapolar (4 leads) with | |
| snaps | ||
| 3. Body connection | Straps | ECG snap electrodes |
| 4. Mathematical data | ||
| analysis | Algorithm | Improved algorithm |
| providing greater | ||
| mathematical precision |
NON-clinical Testing:
The NICaS 2004 Slim has been tested and found to comply with the requirements of IEC 60601-1-1.
The NICaS 2001 and the NICaS 2004 were attached to a simulator and fifty readings were taken. In all cases, the the NICaS 2004 exhibited significantly improved readings when compared to the NICaS 2001.
Clinical Testing:
The NICaS 2004 Slim was used on one hundred sixty three patients and the readings were compared to thermodilution on the same patients.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 2007
NI Medical, Inc. c/o Mr. James Collie Consultant J. R. Collie Associates, Inc. 414 Maryjoe Way Warrington, PA 18976
Re: K070500
Trade Name: Bioimpedance Cardiac Analyzing Measuring System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: June 11, 2007 Received: June 13, 2007
Dear Mr. Collie:
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 may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. James Collie
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 begin 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 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,
Bfimmuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K070500
Device Name: NICaS 2004 SLIM
Indications for Use:
The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bommina
(Division Sign-Off) (Division of Cardlovascular Devices 510(k) Number
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