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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NICaS 2004 Slim Bioimpedance Cardiac Analyzing Measuring System, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the NICaS 2004 Slim. Instead, it describes a non-clinical and clinical testing approach to demonstrate substantial equivalence to its predicate device, the NICaS 2001, and to illustrate its improved performance. The core "acceptance" appears to be based on demonstrating superior or at least equivalent performance to the predicate device in relevant measurements.

However, based on the provided text, we can infer a form of acceptance criteria related to its improved readings.

Acceptance Criteria (Inferred from study outcomes)	Reported Device Performance (NICaS 2004 Slim)
Non-Clinical: Improved readings compared to NICaS 2001 on a simulator	Non-Clinical: Exhibited significantly improved readings when compared to the NICaS 2001 (50 readings taken on a simulator).
Clinical: Agreement with thermodilution (gold standard for cardiac output)	Clinical: Readings were compared to thermodilution on 163 patients. (The degree of agreement/correlation is not explicitly stated in this summary, but the comparison itself served as the basis for clinical assessment.)
Compliance with IEC 60601-1-1 requirements	Found to comply with the requirements of IEC 60601-1-1.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 163 patients for the clinical study. Additionally, 50 readings were taken on a simulator for non-clinical testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the device manufacturer is N. I. Medical, Ltd. in Israel, suggesting the study may have been conducted there or internationally. Given a 510(k) summary, it's typically a summary of completed studies rather than a prospective study design being presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Ground Truth: The ground truth for the clinical test set was established by thermodilution. This is an invasive, established method for measuring cardiac output, often considered a gold standard. No "experts" in the human sense were explicitly mentioned for interpreting the thermodilution data, as the method itself directly provides the reference measurement.
- Non-Clinical Ground Truth: For the non-clinical testing, a "simulator" was used. The ground truth would be the known, controlled parameters set by the simulator itself.
Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1) is mentioned in the provided text, as the comparison was made against objective measurements (thermodilution for clinical, simulator output for non-clinical).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted or described. The NICaS 2004 Slim is a device that directly measures parameters (though using sophisticated algorithms), not one that assists human readers in interpreting complex images or data in a diagnostic context that would typically require MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is primarily a standalone algorithm-only performance. The device takes measurements, processes them with its "improved algorithm," and provides hemodynamic parameters. While a human clinician interprets these parameters, the measurement and calculation process itself is automated.
The type of ground truth used:
- Clinical: Thermodilution (a recognized clinical standard/gold standard for cardiac output measurement).
- Non-Clinical: Simulator output (controlled, known values).
The sample size for the training set:
- The document does not specify a separate "training set" sample size. The focus is on the performance of the device and its algorithm rather than the development of a trained AI model in the modern sense. The "improved algorithm" is mentioned as providing greater mathematical precision, implying refinement, but no details on training data are provided.
How the ground truth for the training set was established:
- Not applicable, as a distinct training set and its ground truth establishment are not discussed in the summary. The "improved algorithm" development process, which might be analogous to training, is not detailed in terms of specific data provenance or ground truth methods.

Summary

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510(K) Summary

JUL 16 2007

Submitter:	N. I. Medical, Ltd.3 Ein Chay StreetKfar Malal 45920Israel
Contact Person:	James ColliePhone: 215-491-5245OrIgor GranovPhone: 011-972-9-746696213
Date Prepared:	February 19, 2007
Device Trade Name:	NICaS 2004 Slim Bioimpedance CardiacAnalyzing Measuring System
Common/Usualname:	Bioimpedance Cardiac Analyzing measuringSystem
Classification name:	Impedance Plethysmograph
Predicate Devices:	NICaS 2001 Noninvasive Cardio-RespiratorySystem (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 is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ.

K070500 p:113

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Indications for Use:

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:

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Attribute	Predicate Device
	NICaS 2001	NICaS 2004 Slim
1. Computer Connection	Outside computer-connected via cable	Fits into the computerCD-ROM area
2. Leads	Bipolar (2 leads) withclips	Tetrapolar (4 leads) withsnaps
3. Body connection	Straps	ECG snap electrodes
4. Mathematical dataanalysis	Algorithm	Improved algorithmproviding greatermathematical 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.

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.