The function of the NICaS™ electrode is unchanged from that of the Nicolet Biomedical Instruments Velcro ground strap in the original NICaS™ 2001 cardio-respiratory system,(510(k)K942227) submission, namely, to transmit electrical signals to and from the skin and the NICaS™ 2001 cardiorespiratory system.

The indications for use of the NICaS™ 2001 cardio-respiratory system remain unchanged from those included in the original NICaS™ 2001 cardio-respiratory system, (510(k) K942227), namely, monitoring hemodynamic parameters including stroke volume, stroke index. heart rate, cardiac index, cardiac output, and total peripheral resistance; and the ventilatory parameter, respiratory rate. The device is intended for use in male and female patients with cardiovascular disorders including:

patients undergoing cardiac catheterization
cardiac surgery patients
patients in intensive and cardiac care units
patients in rehabilitation centers

Device Description

The NICaS™ Electrodes are fixed to intact skin of the arms and legs of a patient that is to be monitored for cardiac output. The electrodes employ a biocompatable conductive adhesive to maintain their position for up to 24 hours of continuous monitoring. As stated in the original submission, the electrodes conduct a 1.4 mA, 32.5 KHz current to the skin from the NICaS™ 2001 Noninvasive Cardio-Respiratory System (K942227) which uses the principle of bioimpedance to determine various cardiac parameters including cardiac output. The change from the strap type electrodes included in the original submission will permit longer term patient monitoring. The change in electrodes does not require any changes to the NICAS™ 2001 Noninvasive Cardio-Respiratory System itself. The electrodes continue to be attached to the two identified input connectors of the patient module. The patient module also connects with the computer.

The electrode design is similar to the Katecho, Inc. K-Defib/Pace Pediatric Electrode (K954505). The materials and manufacturing methods are the same, therefore no new biocompatability issues are raised. The only change is that the size and shape of the electrode has been modified for ease of use in the clinical setting.

AI/ML Overview

Here's a summary of the acceptance criteria and the studies performed for the NICaS™ Electrode, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	The electrode design, materials, and manufacturing methods are identical to the predicate device (Katecho, Inc. K-Defib/Pace Pediatric Electrode, K954505), indicating no new biocompatibility issues are raised. Specific standards met: ANSI/AAMI EC12-1991 paragraph 3.2.2.1 and ANSVAAMI EC12-1991 paragraph 3.2.1.
Electrical Safety	The NICaS™ 2001 cardio-respiratory system (with which the electrode is used) was designed to meet IEC 601-1-1 and UL 544 medical safety standards and was tested and approved by TÜV.
Functionality (Signal Transmission)	The function of the NICaS™ Electrode is unchanged from the Nicolet Biomedical Instruments Velcro ground strap, which is to transmit electrical signals to and from the skin and the NICaS™ cardio-respiratory system.
Stability of Cardiac Output Data over 24 hours	Cardiac output data gathered at several points during a 24-hour period using the NICaS™ Electrode were stable throughout the observation period.
Correlation of Cardiac Output Data with Predicate Electrode	Cardiac output data gathered using the new NICaS™ Electrodes closely correlated with data obtained using the Nicolet Biomedical electrodes.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Two studies were conducted. The first study on stability involved "volunteers." The second study on correlation involved "normal volunteers." Specific numbers are not provided.
- Data Provenance: Both studies were "performed by N.I. Medical." The country of origin for the data is not explicitly stated but can be inferred to be Israel, where N.I. Medical, Ltd. is located. Both studies appear to be prospective as they were specifically performed to evaluate the new electrodes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies focused on objective measurements of cardiac output stability and correlation, rather than subjective expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- An adjudication method is not applicable and not described. The studies involve direct measurements of cardiac output and comparison, not interpretation that requires adjudication among experts.
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 performed, nor is it applicable. This device is an electrode for bioimpedance measurement, not an AI-assisted diagnostic tool requiring human reader interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable as the device is an electrode, a hardware component for signal transmission. Its performance is evaluated in conjunction with the NICaS™ 2001 system. The studies described are evaluations of the electrode's physical and electrical properties, and its impact on the system's cardiac output measurements. The "standalone" performance here relates to its ability to maintain stable and comparable electrical signals for the system to process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the studies was based on the measurement of cardiac output data.
  - For the stability study: Consistency of cardiac output measurements over time within the same subject.
  - For the correlation study: Comparison of cardiac output measurements obtained using the new electrodes against those obtained using the established predicate electrodes (Nicolet Biomedical electrodes). The predicate device's measurements serve as the reference or "ground truth" for comparison.
The sample size for the training set:
- Not applicable. This device is an electrode; there is no machine learning model or algorithm that requires a "training set" in the context of its function.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this device.

Summary

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1972001

510(k) Summarv

Submitter's Name:	N.I. Medical, Ltd.22 Maskit StreetHerzliya Pituach 46733IsraelPhone: 011 972 9 9513868 (voice)011 972 9 9513866 (FAX)	JUL - 8 1997
Contact Person:	Alexander TsoglinDirector of Research and Development
510(k) Summary Date:	March 28, 1997
Device Name:	NICaS™ Electrode
Common Name:	Electrode for bipolar method of bioimpedance measurement
Classification Name:
Predicate Devices:	With respect to indication for use:Nicolet Biomedical Instruments Velcro ground strap included in theNICaS™ 2001 510(k), (K942227)With respect to materials and biocompatability:Katecho, Inc. K-Defib/Pace Pediatric Electrode (K954505)

Device Description:

The electrode design is similar to the Katecho, Inc. K-Defib/Pace Pediatric Electrode (K954505). The materials and manufacturing methods are the same, therefore no new biocompatability issues

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are raised. The only change is that the size and shape of the electrode has been modified for ease of use in the clinical setting.

Intended Use:

The NICaS™ Electrode is used only in conjunction with the NICaS™ 2001 and all other NICAS™ devices .

The function of the NICaS™ Electrode is unchanged from that of the Nicolet Biomedical Instruments Velcro ground strap in the original NICaS™ 2001 cardio-respiratory system, (510(k) K942227) submission, namely, to transmit electrical signals to and from the skin and the NICAS™ cardio-respiratory system.

Comparison of Technological Characteristics:

Both the NICaS™ Electrode and the Katecho, Inc. K-Defib/Pace Pediatric Electrode are constructed from identical foam base, tin laminate conductor and a biocompatable conductive gel materials. The NICaS™ Electrode is a different shape and smaller size than the Katecho, Inc. K-Defib/Pace Pediatric Electrode. The principles of operation of the NICaS™ 2001 cardiorespiratory system remain unchanged and the electrical current carried by the NICaS™ Electrode is identical to that carried by the Nicolet Biomedical Instruments Velcro ground strap.

Safety and Effectiveness Information:

The NICaS™ 2001 cardio-respiratory system was designed to meet the IEC 601-1-1 and UL 544 medical safety standards. It was tested and approved by TÜV. In addition, the electrodes conform to ANSI/AAMI EC12-1991 paragraph 3.2.2.1 and ANSVAAMI EC12-1991 paragraph 3.2.1 standards.

Data:

The performance characteristics of the NICaS™ Electrode have been measured over the full 24 hour recommended period of use in a study employing volunteers. This study was performed by N.I. Medical. It demonstrated that cardiac output data gathered at several points during the 24 hour period are stable throughout the observation period. A second study performed by N.I. Medical on normal volunteers confirmed that cardiac output data gathered using the new electrodes closely correlated with data obtained using the Nicolet Biomedical electrodes.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUM SERVICES • USA" is arranged around the eagle in a circular fashion. The seal is black and white.

Food and Drug Administration 9200 Corporate Eoulevard Rockville MD 20850

... ......

Mr. Barry Sall, R.A.C. PAREXEL International Corporation 1601 Trapelo Road Waltham, Massachusetts 02154

Re: K972001 NICaS™ 2001 Cardio-Respiratory System JUL - 8 1997 Regulatory Class: II (two) Product Code: 74 DRX Dated: May 29, 1997 Received: May 30, 1997

Dear Mr. Sall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic (95) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act " for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Barry Sall, R.A.C.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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4

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510(k) Number (if known): -

Device Name: NICaS™ 2001 cardio-respiratory, system

K972001

Indications For Use ... ... . .

The NICas™ electrode is used only in conjunction with the NICaS™ 2001 and all other NICaS™ devices.

The function of the NICas™ electrode is unchanged from that of the Nicolet Biomedical Instruments Velcro ground strap in the original NICas™ 2001 cardio-respiratory system,(510(k)K942227) submission, namely, to transmit electrical signals to and from the skin and the NICaS™ 2001 cardiorespiratory system.

The indications for use of the NICas™ 2001 cardio-respiratory system remain unchanged from those included in the original NICaS™ 2001 cardio-respiratory system, (510(k) K942227), namely, monitoring hemodynamic parameters including stroke volume, stroke index. heart rate, cardiac index, cardiac output, and total peripheral resistance; and the ventilatory parameter, respiratory rate. The device is intended for use in male and female patients with cardiovascular disorders including:

. patients undergoing cardiac catheterization
. cardiac surgery patients
. patients in intensive and cardiac care units
. patients in rehabilitation centers

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

N-Pugi-

(Division Sign-Off)
Division of Cardiovascular, Respiratory,

and Neurological Devices

510(k) Number [K972001](https://510k.innolitics.com/device/K972001)

:云

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional format 1-2-96)

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.