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 mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems.

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

The theoretical models are for the following patient populations:

Age	18 - 90 years old
Weight 4	0 - 140 kg / 88.2 to 308.6 pounds
Height	150 - 190cm / 59.1 to 74.8 inches

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 is not intended to be the sole source for patient specific guidance on clinical decisions, including dosing decisions for anesthetic drugs. Always refer to the appropriate drug labeling for dosing information and quidance.

Navigator Protocol allows hospitals 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 providing access to certain anesthesia delivery system alarm information.

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

Device Description

The Navigator Applications Suite is a software product that runs on a medical grade computer and 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 medical grade 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 pumps and patient monitors to minimize manual data entry.
Naviaator 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

Here's an analysis of the provided text regarding the Navigator Applications Suite, structured to address your specific points.

Acceptance Criteria and Device Performance Study

The provided document (510(k) summary K102389 for the Navigator Applications Suite) does not contain explicit acceptance criteria or a dedicated study proving performance against them in the traditional sense of a clinical or analytical performance study of an AI/ML device.

This submission is a 510(k) for a software update (Version 3) of an existing device. The core argument for substantial equivalence relies on:

No significant changes to intended use or fundamental scientific technology.
Software re-write for performance and UI improvements.
Compatibility with additional patient monitors and IV pumps.
Minor wording clarifications to the intended use and emphasis on the theoretical/advisory nature of the device.
Previous versions (K071097, K081941, K083098) serving as predicates.

Therefore, instead of a table of acceptance criteria and reported device performance through a new clinical study, the document emphasizes nonclinical testing for verification of specifications and validation, including software validation, and compliance with standards. The key conclusion is that "The modifications made to the Navigator Applications Suite did not require clinical testing to demonstrate the safety and effectiveness of the updated device."

Given this, I will answer the questions based on the information provided, highlighting what is (and isn't) present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit acceptance criteria and corresponding reported device performance from a new study are not detailed in this 510(k) summary. The document states that the device was updated from a predicate and underwent nonclinical testing.

The "performance" described is largely about the software's functionality and compatibility, rather than a clinical performance metric against a gold standard.

Acceptance Criteria Category	Reported Device "Performance" / Evidence
Functional Verification	"thoroughly tested through verification of specifications and validation, including software validation."
Standard Compliance	"Verification of compliance with... IEC 60601-1-4:2000"
Improved Performance	"new architecture to improve performance and user interface workflows."
Expanded Compatibility	"updated to be compatible with additional patient monitors and IV pumps."
No Safety/Effectiveness Issues	"no new questions of safety and effectiveness for the Navigator Applications Suite Version 3 as compared to the predicate device."

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

Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a "test set" of patient data for the updated device in the context of AI/ML evaluation. The assessment of the device's efficacy relies on its substantial equivalence to previously cleared predicates and non-clinical software validation.

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

Not applicable/Not provided. Since there was no clinical "test set" requiring ground truth establishment, this information is not relevant to this submission. The device provides "theoretical information about the modeled effect" and "is not intended to be the sole source for patient specific guidance on clinical decisions."

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set with an adjudication method is described.

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

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) submission. The device is not positioned as an AI-assisted diagnostic or decision support tool that co-interprets with human readers in a way that typically necessitates an MRMC study to measure improved reader performance. It provides "theoretical information" and "advisory" data.

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

Partially Yes, in a limited context. The device is an "algorithm" (using PK/PD models) that provides information. However, the performance validation described is "software validation" and "verification of specifications," rather than a standalone clinical performance study comparing the algorithm's output to a clinical ground truth. The device's output (calculated concentrations and effects) is always theoretical and stated to not be the "sole source for patient specific guidance." Its standalone performance is thus evaluated in terms of its computational accuracy based on published models and software integrity, not an independent assessment of clinical utility (which is explicitly disclaimed).

7. The Type of Ground Truth Used

Mathematical Models/Published Data. For the core function of Navigator Therapy (PK/PD modeling), the "ground truth" for the calculations is based on "published models." The document explicitly 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 software's accuracy is validated against the proper implementation and output consistency with these established mathematical models.

For Navigator Protocol and Navigator Device features, the "ground truth" would relate to the correct display of facility-selected care protocols and accurate troubleshooting information for anesthesia delivery systems, likely validated through functional testing against source documents.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device utilizes pharmacokinetic and pharmacodynamic models, which are generally based on physiological research and mathematical derivations, not typically "trained" on large datasets in the way modern machine learning models are. The models themselves are "published models." Therefore, a "training set" in the AI/ML sense is not relevant for this device.

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

Not applicable/Not provided. As explained above, a "training set" is not applicable in the context of this device's technological basis. The models used are established scientific models from published literature.

Summary

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

K102389

JUN 1 0 2011

GENERAL COMPANY INFORMATION as reguired 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. Monica Morrison Ms. Karla Krause (alternate)

DATE: June 7, 2011

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

TRADE NAME:

Navigator Applications Suite

· COMMON NAME:

Navigator Applications Suite

CLASSIFICATION NAME:

BSZ. Accessory to aas machine for anesthesia or analgesia 21 CFR 868.5160

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as reguired 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, K083098),

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 medical grade 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 pumps and patient monitors to minimize manual data entry.
Naviaator 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)

Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical-arade PC mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems.

The theoretical models are for the following patient populations:

Age	18 - 90 years old
Weight	40 - 140 kg / 88.2 to 308.6 pounds
Height	150 - 190cm / 59.1 to 74.8 inches

Calculated drug concentrations and effects are based on published models, and do not represent actual meosurements from a patient. Drug models are calculated and displayed assuming a healthy patient. Navigator is not intended to be the sole source for patient specific quidance on clinical decisions, including dosing decisions for anesthetic drugs. Always refer to the appropriate drug labeling for dosing information and guidance.

Navigator Device is a troubleshooting aid providing access to certain anesthesia delivery system alarm information.

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

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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 (K083098, K081941. K071097). There have been no significant changes to the intended use or fundamental scientific technology.

The Navigator Applications Suite software code has been rewritten (Version 3) with a new architecture to improve performance and user interface workflows. The Navigator Applications Suite (Version 3) is also released as a software-only product, which can be installed on any hardware (medical grade computer) meeting the minimum requirements. The previously cleared Navigator Applications Suite was shipped with mandatory hardware that was used to run the program.

Additionally, the Navigator Applications Suite Version 3 has been updated to be compatible with additional patient monitors and IV pumps.

The intended use was updated for only minor wording clarifications. The clarifications include accommodating alternate locations for the user's own medical grade computer: "…PC mounted on or near the anesthesia delivery system." Additional statements have been added to the indications for use to emphasize the theoretical and advisory nature of the device. As stated above, Navigator Version 3 software is now provided as a stand-alone product that can be ordered separately from a computer. Other minor modifications include the option for Navigator to receive data from electronic record keeping systems. In addition, imperial units (pounds and inches) were added next to the metric units for patient weight and height ranges.

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 60601-1-4:	Medical Electrical Equipment, Part 4
2000	Programmable Electrical MedicalSystems

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

The modifications made to the Navigator Applications Suite did not require clinical testing to demonstrate the safety and effectiveness of the updated device.

CONCLUSION:

The summary above demonstrates that there are no new questions of safety and effectiveness for the Navigator Applications Suite Version 3 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 & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GE Healthcare Finland OY C/O Ms. Monica Morrison Regulatory Affairs Leader Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707-7550

JUN 1 0 2011

Re: K102389

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: May 31, 2011 Received: June 1, 2011

Dear Ms. Morrison:

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. Please note: CDRH does not.evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Morrison

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K102389

Device Name: Navigator Applications Suite

Indications For Use:

The theoretical models are for the following patient populations:

Age	18 - 90 years old
Weight 4	0 - 140 kg / 88.2 to 308.6 pounds
Height	150 - 190cm / 59.1 to 74.8 inches

Navigator Device is a troubleshooting aid providing access to certain anesthesia delivery system alarm information.

The system is designed for hospital 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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division Sign (tf)Division Sign-Off) )ivision of Anesthesiology, General Hospital ് fection Control, Dental Devices

:10(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).