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. 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 for propofol and four analgesic drugs. Navigator also supports automatic data capture from supported intravenous drug infusion pumps to minimize manual data entry.
Navigator Protocol: Framework to enable access to facility-selected care protocols at the . point of care.
t Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

The Navigator Applications Suite has been modified to work in a network environment.

AI/ML Overview

This document (K081941) is a 510(k) Premarket Notification for the Navigator Applications Suite, a software package that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. The notification focuses on modifications to the device to work in a network environment, with no changes to the intended use or fundamental scientific technology. Therefore, the information provided primarily concerns non-clinical testing for safety and compliance with standards, rather than clinical performance or AI-specific validation.

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

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because the submission is for a modification that doesn't alter core functionality or intended use. Instead, the acceptance criteria are implicitly tied to compliance with relevant medical device standards and software validation.

Acceptance Criteria Type	Acceptance Criteria (Implicit from Standards)	Reported Device Performance
Software Validation	Thorough software validation completed.	Verified and completed.
Safety Standards	Compliance with IEC 60601-1, IEC 60601-1-1, EN 60601-1-2, EN 60601-1-4.	Compliance verified.
Labeling/Risk Mgmt.	Compliance with EN 980, EN 1041, EN ISO 14971.	Compliance verified.
Network Functionality	Ability to operate in a network environment with connectivity to an iCentral Network and Central Station.	New configuration allows 16 Navigators to be used via iCentral Network.
Intended Use	No changes to intended use.	Confirmed as unchanged from predicate.
Fundamental Technology	No changes to fundamental scientific technology.	Confirmed as unchanged from predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of clinical data for performance evaluation. The testing described is primarily non-clinical, focusing on software verification and validation, and compliance with standards. Therefore, information on sample size, data provenance, or retrospective/prospective studies is not applicable or provided.

3. 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)

This information is not provided as the submission concerns non-clinical testing and regulatory compliance for a software modification, not a clinical performance study requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication is described.

5. 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

Not applicable. This submission is for a medical device software that provides information and tools (PK/PD modeling, protocols, troubleshooting) for anesthesia management, not an AI-based diagnostic or assistive tool that would typically involve a multi-reader multi-case study to evaluate human reader improvement. The "AI" aspect here (PK/PD modeling) is based on published models, not machine learning trained on images or diagnostic data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Navigator Applications Suite, particularly the Navigator Therapy component, contains algorithms (pharmacokinetic and pharmacodynamic models). The document states: "Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient." and "Drug models are calculated and displayed assuming a healthy patient." This indicates that the algorithms operate in a "standalone" computational manner based on pre-defined models. However, the output is "displayed" to a healthcare provider, implying a human-in-the-loop for interpretation and clinical decision-making. The "standalone performance" in this context would refer to the accuracy of the model calculations based on inputs, which is implicitly validated by the software testing and reliance on "published models." Specific metrics for this standalone performance are not provided beyond the general statement of "thoroughly tested through verification of specifications and validation."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the PK/PD models, the "ground truth" is implied to be published pharmacokinetic and pharmacodynamic models. The software's validation would focus on correctly implementing these models and calculations. For the other functionalities (Protocol and Device), the "ground truth" would relate to the correct display of protocols and troubleshooting information, which is validated through software testing against design specifications.

8. The sample size for the training set

Not applicable. The device's "AI" component (PK/PD modeling) is based on published mathematical models, not on a machine learning approach requiring a training set of data.

9. How the ground truth for the training set was established

Not applicable, as no training set (in the machine learning sense) is mentioned. The ground truth for the underlying PK/PD models would have been established through extensive prior research, clinical trials, and scientific consensus leading to their publication. The device uses these established models rather than training its own.

Summary

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K0819411

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

AUG - 7 2008

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:

June 25, 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).

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

. 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 for propofol and four analgesic drugs. Navigator also supports automatic data capture from supported intravenous drug infusion pumps to minimize manual data entry.
Navigator Protocol: Framework to enable access to facility-selected care protocols at the . point of care.
t Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

The Navigator Applications Suite has been modified to work in a network environment.

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.

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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 (K071097). The Therapy. 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 or fundamental scientific technology.

The versions differ in that the new version can now operate in a network environment. The previously cleared Navigator Applications Suite had direct connections to a single S/5 Anesthesia Monitor and Infusion pumps. In this configuration, the S/5 Anesthesia Monitor could not be connected to a central station. The new configuration allows 16 Navigator's to be used by connection to an iCentral Network and Central Station, which in turn connects to the $/5 Anesthesia Monitors.

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	Medical Electrical Equipment, Part 1:General Requirements for Safety
IEC 60601-1-1:2000	Medical Electrical Equipment, Safetyrequirements for medical electrical systems
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 Medical Systems
EN 980;2003	Graphical Symbols for Use in LabelingMedical Devices
EN 1041: 1998	Information Supplied By the Manufacturer
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)

The modifications made to the Navigator Applications Suite did not require clinical testing.

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.

1 1988 plus Amendment 1: 1991 and Amendment 2: 1995

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like emblem with three stylized lines representing feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Healthcare Finland Oy C/O Ms. Adrienne Lenz Senior Regulatory Affairs Specialist Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707-7550

AUG - 7 2008

Re: K081941

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: June 25, 2008 Received: July 8, 2008

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 yours,

Chiu-Ling, Ph.D.

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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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 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.

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)

Nut D. Rabel for MH

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K081944

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).