MODIFICATION TO NICO WITH MARS, MODEL 7300 by RESPIRONICS NOVAMETRIX, INC.

cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.

Device Description

The NICO with MARS, Model 7300, is a patient monitor capable of monitoring a patient's cardiac output, spirometry, carbon dioxide, and functional oxygen saturation and pulse rate. In addition, the Model 7300 is capable of communicating with a variety of patient information systems, including the Respironics Esprit ventilator.

AI/ML Overview

The provided text describes a special 510(k) submission for a device modification, specifically an interface for the NICO with MARS, Model 7300 monitor to communicate with the Respironics Esprit ventilator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance in the same way a new device might.

Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth are not present or not directly applicable in this specific regulatory submission. The document mainly outlines the device's intended use, technological characteristics, and compares it to a predicate device (K030886 - NICO with MARS, Model 7300).

However, I can extract the information that is present and indicate where the requested information is not available from the provided text.

Acceptance Criteria and Device Performance:

The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) for the communication interface. Instead, the "acceptance" is based on the demonstration of substantial equivalence to a predicate device, meaning the modified device performs as intended without raising new questions of safety or effectiveness.

The "reported device performance" in this context refers to the inherent performance of the NICO with MARS, Model 7300, for which the communication interface is being added. The document reiterates its original intended uses and technological characteristics.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (NICO with MARS, Model 7300)
Communication Interface Functions as Intended (with Respironics Esprit ventilator) and does not compromise the safety or effectiveness of the NICO with MARS, Model 7300.	The NICO with MARS, Model 7300, is a patient monitor capable of monitoring: - Cardiac output via partial rebreathing in adult patients mechanically ventilated during general anesthesia and in ICU. - Spirometric and CO2 monitoring in neonatal, pediatric, and adult patients during general anesthesia, ICU, and ED. - Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric, and adult patients during no motion and motion conditions, and for well or poorly perfused patients during general anesthesia, ICU, and ED. The monitor uses: - Flow sensors and pneumatics for flow measurement (proportional to pressure drop). - Infrared absorption (IR) technique for CO2 monitoring. - Red and infrared light sources in sensors for oxygen saturation and pulse rate (plethysmogram and MARS technology's frequency-based algorithm). - Non-invasive differential Fick partial re-breathing technique for cardiac output. - Bidirectional serial communications (ASCII/scaled binary digits) and analog outputs for external devices, including Respironics Esprit Ventilator.
No new questions of safety or effectiveness are raised.	The submission states: "The NICO with MARS, Model 7300, monitor with NICO to Esprit Communications Interface has the same intended use as the predicate monitor [K030886]." This implies that the safety and effectiveness profile is maintained.

Acceptance Criteria (Implicit for Substantial Equivalence)

Reported Device Performance (NICO with MARS, Model 7300)

Communication Interface Functions as Intended (with Respironics Esprit ventilator) and does not compromise the safety or effectiveness of the NICO with MARS, Model 7300.

The NICO with MARS, Model 7300, is a patient monitor capable of monitoring: - Cardiac output via partial rebreathing in adult patients mechanically ventilated during general anesthesia and in ICU. - Spirometric and CO2 monitoring in neonatal, pediatric, and adult patients during general anesthesia, ICU, and ED. - Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric, and adult patients during no motion and motion conditions, and for well or poorly perfused patients during general anesthesia, ICU, and ED. The monitor uses: - Flow sensors and pneumatics for flow measurement (proportional to pressure drop). - Infrared absorption (IR) technique for CO2 monitoring. - Red and infrared light sources in sensors for oxygen saturation and pulse rate (plethysmogram and MARS technology's frequency-based algorithm). - Non-invasive differential Fick partial re-breathing technique for cardiac output. - Bidirectional serial communications (ASCII/scaled binary digits) and analog outputs for external devices, including Respironics Esprit Ventilator.

No new questions of safety or effectiveness are raised.

The submission states: "The NICO with MARS, Model 7300, monitor with NICO to Esprit Communications Interface has the same intended use as the predicate monitor [K030886]." This implies that the safety and effectiveness profile is maintained.

Here's a breakdown of the other requested information based on the provided document:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This document describes a 510(k) for a device modification, specifically a communication interface. It does not mention a clinical test set or data from a study to establish performance for this particular modification. The focus is on demonstrating substantial equivalence to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. Since no specific test set or clinical study data is presented for this modification, there's no mention of experts establishing a ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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. This is a medical monitoring device, not an AI-assisted diagnostic tool. No MRMC study or AI components are mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device integrates with human operation as a monitor. The "standalone" performance would refer to the device's function in monitoring, which is described in its technological characteristics, but not as an "algorithm only" in the context of AI. The communication interface itself is a technical component, not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided for this modification. For the original device, performance would likely have been validated against established reference methods for cardiac output, CO2, spirometry, and pulse oximetry, but this detail is not in the provided modification summary.
The sample size for the training set:
- Not applicable / Not provided. The device does not appear to use machine learning in a way that would require a "training set" in the context of AI development.
How the ground truth for the training set was established:
- Not applicable / Not provided.

Summary

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Respironics Novametrix LLC NICO with MARS, Model 7300: NICO to Esprit Communications Interface Special 510(k) - Device Modification

K041450

Section iv - 510 (k) Summary

[ Refer to 21 C.F.R § 807.92 ]

Respironics Novametrix, LLC Submitted by: 5 Technology Drive Wallingford, CT 06492
Contact Person: Kevin Mader Q.A. and Requlatory Manager Phone: 203-697-6466

5/28/2004 Date Prepared:

NICO with MARS, Model 7300, monitor with NICO to Esprit Communications Proprietary Name: Interface

multiparameter monitor (monitoring spirometer, CO2 monitor, pulse oximeter and Common Name: cardiac output monitor with partial rebreathing valve).

Class II, 21 C.F.R. 868.1850, 868.1400, 870.2700, 868.5675 Classification Name:
NICO with MARS, Model 7300 [510(k) K030886] Predicate Device:

The NICO with MARS, Model 7300, is a patient monitor capable of monitoring a Description of Device: patient's cardiac output, spirometry, carbon dioxide, and functional oxygen saturation and pulse rate. In addition, the Model 7300 is capable of communicating with a variety of patient information systems, including the Respironics Esprit ventilator.

Intended Use of the Device: This monitor has the same intended use as the predicate monitor. For reference, the intended use of the NICO with MARS, Model 7300, monitor is to provide:

cardiac output monitoring via the method of partial rebreathing in adult ◆ patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
spirometric and carbon dioxide monitoring in neonatal, pediatric and . adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
continuous, non-invasive monitoring of functional arterial oxygen ◆ saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

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Respironics Novametrix LLC Respironics Novalnetix EEO
NICO with MARS, Model 7300: NICO to Esprit Communications Interface Special 510(k) - Device Modification

Technological Characteristics: The NICO with MARS monitor, Model 7300, uses flow seller ansocration and listics. The NICO with MARO monitor, filoseners and as such the pressure drop considered to be a fixed only of the flow. Combination CO./flow sensors are is proportional to the oqual o that are tailored for neonates, pediatric patients and adults.

The NICO with MARS monitor, Model 7300, uses an infrared absorption (IR) technique for monitoring CO2. The principle is based on the fact that CO2 technique for monitoring oo in energy of specific wavelengths, with the amount molecules absorb infrared light the CO2 concentration Solid state or energy absorbed boing an Soundstat) use a beam splitter to simultaneously CO2 sensors (such as the Ouphociaches) one which is absorbed by CO2 and one measure the in the wavelength which is not absorbed by CO2 is related to the which is not. "The wavelengan which is not to her light source is electronically pulsed intensity of the IR light 50aroot. Theo, with a chopper wheel) in order to eliminate effects of changes in electronic components.

The NICO with MARS monitor, Model 7300, measures oxygen saturation and The NOO with sensors that contain red and infrared light sources. Since oxygen pulse fate with sensors that containts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at infrarca) as compared while and pulse can be used to calculate oxygen each wavelength by the blood from red (660 nm) and infrared (940 nm) LEDs is beamed through a pulsating vascular bed - the patient's finger, ear or toe, for example. The remaining light energy not absorbed by the sample cell reaches a example. The remaining light one of the sensor. The signal received by the photodiode is split into its red and infrared components, sampled, software photode to bplit into tea roumerical value for oxygen saturation and pulse rate and as a waveform, the plethysmogram.

Functional saturation represents the amount of oxyhemoglobin as a percentage r unctional Saturation reprobe sygenated. Dysfunctional hemoglobin (COHb and METHb) are not included in the measurement of functional saturation. Pulse rate is calculated by measuring the time interval between the peaks of the infrared light waveform. The NICO with MARS must be used in conjunction with the Novametrix SuperBright™ series of oxygen saturation sensors. MARS technology uses the computational power of digital signal processing to replace the pulse rate interval and rate-based decision tree algorithm of prior devices with a more robust frequency-based algorithm.

A variation on the traditional rebreathing methods, the non-invasive differential Fick partial re-breathing technique is used in the NICO with MARS monitor. The change in VCO2 and the change in end-tidal CO2 in response to a change in ventilation is used to determine pulmonary capillary blood flow. This value is then corrected for the effect of shunt to determine cardiac output.

The NICO with MARS monitor communicates with external devices via bidirectional serial communications. Essentially the serial port communicates diroundly bendrums of flow, pressure and CO2 and error message strings comprised of a mix of ASCII characters and scaled binary digits. Analog outputs are also provided for connections to chart recorders and other equipment. Supported communication interfaces include ASC11 character output, equipmont. Oopinion, Philips VueLink/Viridia, Spacelabs Flexport, Nellcor Model N-395, and the Respironics Esprit Ventilator. The monitor is also capable of printing trend graphs to an H.P .- compatible printer.

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Public Health Service

Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a symbol consisting of three stylized, curved shapes that resemble a person. The symbol is black and the background is white.

JUN 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Mader QA and Regulatory Manager Respironics Novametrix, LLC 5 Technology Drive Wallingford, CT 06492

Re: K041450

Trade/Device Name: NICO with MARS, Model 7300 Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: May 28, 2004 Received: June 1, 2004

Dear Mr. Mader:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your soccion or career is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreativent of the enactment date of the Medical Device Amendments, or to Conimeres proc to May 20, 1978, are eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alla Costietic 7ter (71ct) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, manel as tees, as tees, and include requirements for annual registration, listing of general controls pro resuring 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 If your device is classified (600 a0070) in. 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 be found in the Code of Fouctal oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must

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Page 2 – Mr. Kevin Mader

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 Office of Compliance at (301) 594-4646. 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.

Sincercly vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Respironics Novametrix LLC Respironics Novament LLC
NICO with MARS, Model 7300: NICO to Esprit Communications Interface Special 510(k) - Device Modification

Section ii Indications for Use

K 041450 510(k) Number (if known):

Device Name: NICO with MARS, Model 7300 with NICO to Esprit Communications Interface

Indications for Use:

The intended use of the NICO with MARS, Model 7300, monitor is to provide:

cardiac output monitoring via the method of partial rebreathing in adult patients receiving . cardiac output monitoring wa the methou of partial robreaking
mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
spirometric and carbon dioxide monitoring in neonatal, pediatic and addit patients during general . spirometric and carbort dioxide montoning in noonatel, penergency department (ED). Separate arresthesia and in the intensive oans are provided for adult, pediatric and neonatal use.
continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in . continuous, flon-invasive monitoring of function and motion and motion conditions and for neonatal, pediathic and adult patients during both he motion the intensive care unit (ICU) and the emergency department (ED).

The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in The Use of the NICO will MARO, Model 1 000, monten as a last al pressure of CO2 level cannot be tolerated.

Prescription Use X (Per 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)

toa G. Harris

thesiology, General Hospital,

510(k) Number. 501457

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).