Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical grade PC physically mounted to the Anesthesia Delivery System and receives data from supported Anesthesia Delivery Systems, Anesthesia Patient Monitors and Intravenous Drug Infusion Pumps.

Navigator Therapy displays pharmacokinetic, pharmacodynamic (PK/PD) and synergistic PD modeling information. Navigator Therapy provides the heath care provider with information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.

Models only apply to the following patient populations:

Age:	18 – 90 years old
Weight:	40Kg - 140 Kg
Height:	150cm - 190cm

Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient.

Navigator Protocol allows facilities to load electronic versions of care protocols. This feature can be configured with selected patient monitoring parameters available for viewing in conjunction with the care protocol.

Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information.

The system is designed for facility use and should only be used under the orders of a clinician.

Device Description

The Navigator Applications Suite is a product that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. It works in a standalone or networked environment. The three main functions of the Navigator are:

. Navigator Therapy: Visualization of the modeled effect of the anesthesia drugs on the patient displayed on a point-of-care Navigator computer. The visualization is based on pharmacokinetic and pharmacodynamic (PK/PD) models and multi-drug models. Navigator also supports automatic data capture from supported intravenous drug infusion pumos and patient monitors to minimize manual data entry
- Navigator Protocol: Framework to enable access to facility-selected care protocols at the point of care.
. Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

AI/ML Overview

This is a 510(k) premarket notification for the Navigator Applications Suite. The device is a software package that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. It has three main functions: Navigator Therapy, Navigator Protocol, and Navigator Device. The submission is for an updated version of the Navigator Applications Suite, which includes new multi-drug models for inhaled agents and expands the number of multi-drug models available in the system.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) and corresponding reported performance metrics directly related to the new features (inhaled anesthetic models, expanded multi-drug models).

The "acceptance criteria" appear to be compliance with established medical device standards and demonstrating usability in a clinical setting, rather than specific performance metrics for the predictive models themselves.

Acceptance Criteria Category	Reported Device Performance/Conclusion
Software Validation	Thoroughly tested through verification of specifications and validation, including software validation.
Compliance with Standards	Verification of compliance with IEC 60601-1, EN 60601-1-2, EN 60601-1-4, EN 980, EN 1041, EN ISO14971.
Clinical Usability	Demonstrated usability of the device in a clinical setting. Does not introduce any hazards into the environment of use.
Safety and Effectiveness (Overall Conclusion)	No new questions of safety and effectiveness as compared to the predicate device. Substantially equivalent to legally marketed predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Additional testing of the Navigator Applications Suite was performed in a clinical setting to demonstrate the usability of the device."

Sample Size for Test Set: The exact sample size for this clinical usability testing is not specified in the document.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "a clinical setting," which implies prospective data collection during the usability study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document focuses on "usability" in a clinical setting. It does not mention the use of experts to establish a "ground truth" in the context of the predictive models for the test set. For a usability study, the "experts" would typically be the clinicians using the device, and their feedback on usability would be the "ground truth." However, no specific details on the number or qualifications of these clinicians are provided.

4. Adjudication Method for the Test Set

As the document describes clinical usability testing and not a performance study requiring ground truth for predictive model accuracy, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study to measure reader improvement with AI assistance was not done or mentioned in this submission. The focus was on demonstrating usability and compliance with standards for a device that provides predictive model information, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The core functionality of the Navigator Applications Suite, specifically Navigator Therapy, is a standalone algorithm that displays pharmacokinetic and pharmacodynamic modeling information. The models themselves calculate and predict values. The document states, "Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient." This indicates that the algorithm's predictions are a standalone output.

However, the "clinical testing" described was for "usability" of the device in a clinical environment, meaning it involved human interaction, but not a standalone performance study in the sense of validating the algorithm's predictive accuracy against measured patient outcomes. The foundational models are "published models," implying their standalone performance was established prior to their integration into this device.

7. The Type of Ground Truth Used

For the predictive models: The document states, "Calculated drug concentrations and effects are based on published models." This implies that the ground truth for these models is derived from established scientific literature and research.

For the usability study: The "ground truth" would be the observed user interactions, feedback, and assessment of whether the device was usable and did not introduce hazards, rather than a specific medical "ground truth" (like pathology or outcomes data).

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The predictive models are based on "published models," which means they were developed using existing data sets (pharmacokinetic and pharmacodynamic studies) that are not detailed in this submission. This is not a de novo AI model trained from scratch with new data for this submission.

9. How the Ground Truth for the Training Set Was Established

Since the models are based on "published models," the ground truth for their original development would have been established through extensive pharmacokinetic and pharmacodynamic research, including clinical trials and observational studies that measured drug concentrations, physiological effects, and patient responses. These methods are not detailed in this 510(k) submission, as the models themselves are externally sourced and established.

Summary

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083098

Premarket Notification 510(k) Summary As required by section 807.92 Navigator Applications Suite

APR - 1 2009

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare Finland OY C/O Datex-Ohmeda PO Box 7550 Madison, WI 53707 USA Tel: 608-221-1551 Fax: 608-223-2496

NAME OF CONTACT:

Ms. Adrienne Lenz, RAC Ms. Karla Krause (alternate)

DATE:

October 14, 2008

DEVICE NAME as required by 807.92(a)(2)

· TRADE NAME:
Navigator Applications Suite

COMMON NAME:

Navigator Applications Suite

CLASSIFICATION NAME:

BSZ, Accessory to gas machine for anesthesia or analgesia

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Navigator Applications Suite is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Navigator Applications Suite (K071097, K081941).

DEVICE DESCRIPTION as required by 807.92(a)(4)

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. Navigator Therapy: Visualization of the modeled effect of the anesthesia drugs on the patient displayed on a point-of-care Navigator computer. The visualization is based on pharmacokinetic and pharmacodynamic (PK/PD) models and multi-drug models. Navigator also supports automatic data capture from supported intravenous drug infusion pumos and patient monitors to minimize manual data entry
- Navigator Protocol: Framework to enable access to facility-selected care protocols at the point of care.
. Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

INTENDED USE as required by 807.92(a)(5)

Models only apply to the following patient populations:

Age:	18 – 90 years old
Weight:	40Kg - 140 Kg
Height:	150cm - 190cm

Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient.

Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information.

The system is designed for facility use and should only be used under the orders of a clinician.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Navigator Applications Suite has been updated from the predicate version (K081941. K071097). The Protocol and Device functionality is the same in the modified version as in the predicate version. There have been no changes to the intended use of the device.

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The Therapy function of the Navigator Applications Suite has been modified to display predicted behavior of inhaled anesthetic agents based on the existing pharmacokinetic and pharmacodynamic models with predicted end-tidal anesthetic agent concentration values. The previously cleared Navigator Applications Suite displayed predictive models for intravenous drugs only.

The predicate version displayed multi-drug models for propofol and four analgesic drugs. This new software version is expanding the number of multi-drug models available in the system. There are new models for synergistic effects of six inhaled agents and four analgesics.

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

Navigator Applications Suite has been thoroughly tested through verification of specifications and validation, including software validation. Verification of compliance with the following standards has also been made to support safe use of the device in its intended environment.

IEC 60601-1: 1988A1: 1991, A2: 1995	Medical Electrical Equipment, Part 1:General Requirements for Safety
EN 60601-1-2:2001	Medical Electrical Equipment, Part 2:Electromagnetic Compatibility-Requirements and Tests
EN 60601-1-4:2000	Medical Electrical Equipment, Part 4Programmable Electrical MedicalSystems
EN 980;2003	Graphical Symbols for Use in LabelingMedical Devices
EN 1041:1998	Information Supplied By theManufacturer
EN ISO14971:2000	Medical devices-Application of riskmanagement to medical devices

SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)

Additional testing of the Navigator Applications Suite was performed in a clinical setting to demonstrate the usability of the device. The results demonstrate that the device is usable in a clinical environment and does not introduce any hazards into the environment of use.

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Navigator Applications Suite as compared to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR -1 2009

GE Healthcare Finland OY C/O Ms. Adrienne Lenz Regulatory Affairs Manager Datex-Ohmeda, Incorporated PO Box 7550 Madison, Wisconsin 53707-7550

Re: K083098

Trade/Device Name: Navigator Applications Suite Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: March 4, 2009 Received: March 5, 2009

Dear Ms. Lenz:

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 - Ms. Lenz

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 vours.

Snite y. Michauoms.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K

Device Name: Navigator Applications Suite

Indications For Use:

Models only apply to the following patient populations:

Age:	18 – 90 years old
Weight:	40Kg - 140 Kg
Height:	150cm - 190cm

Calculated druq concentrations and effects are based on published models, and do not represent actual measurements from a patient. Druq models are calculated and displayed assuming a healthy patient.

Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information.

The system is designed for facility use and should only be used under the orders of a clinician.

Prescription Use XXX (Part 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)

Susan Kunst (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).