NAVIGATOR APPLICATIONS SUITE

K071097 · GE Healthcare Finland Oy · BSZ · Oct 10, 2007 · Anesthesiology

Device Facts

• Record ID: K071097
• Device Name: NAVIGATOR APPLICATIONS SUITE
• Applicant: GE Healthcare Finland Oy
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Navigator Applications Suite integrates data from anesthesia delivery systems, IV infusion pumps, and patient monitors. Operates on a medical-grade PC mounted to anesthesia machines; used by clinicians in clinical settings. Three modules: Navigator Therapy uses PK/PD models to visualize modeled effects of propofol and four analgesics, including synergistic effects; Navigator Protocol displays facility-specific care protocols; Navigator Device provides troubleshooting for anesthesia system alarms. System captures data automatically from infusion pumps to reduce manual entry. Output provides clinicians with modeled drug concentration/effect estimates to assist in anesthesia management. Models are based on published literature and assume healthy patient physiology; they do not represent real-time patient measurements.

Clinical Evidence

No clinical data. Bench testing only. Device relies on published pharmacokinetic and pharmacodynamic models for drug effect estimation.

Technological Characteristics

Medical software package running on a medical-grade PC. Interfaces with anesthesia delivery systems, patient monitors, and infusion pumps. Uses PK/PD and synergistic PD mathematical models. Connectivity via network communication similar to iCentral. No direct patient contact.

Indications for Use

Indicated for patients aged 18-90 years, weighing 40-140 kg, with heights 150-190 cm, undergoing anesthesia. Used for visualization of modeled drug effects, access to care protocols, and troubleshooting anesthesia delivery systems. Contraindicated for patients outside specified demographic ranges; models assume healthy patient physiology.

Regulatory Classification

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. 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).

Predicate Devices

• Datex-Ohmeda S/5 Anesthesio Monitor (K030812)
• Datex-Ohmeda Network and iCentral (K052972)

Submission Summary (Full Text)

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Page 1 of 4

K071097

0CT 1 0 2007

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

# 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: [phone] Fax: [phone]

# NAME OF CONTACT:

Ms. Adrienne Lenz

#### DATE:

April 13, 2007

## 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) Datex-Ohmeda S/5 Anesthesio Monitor (K030812) with L-ANE03 and L-ANE03A software and Datex-Ohmeda Network and iCentral (K052972).

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

The Navigator Applications Suite is o product that integrates information from a 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 phormacokinetic and pharmacodynamic (PK/PD) models and multi-drug models for propofol and four analgesic drugs. Novigator 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.
- . 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 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.

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

With respect to Navigator Therapy, the Navigator is similar to the Datex-Ohmeda S/5 Anesthesia Monitor (K030812). The S/5 Monitor measures the anesthetic agent level being delivered and applies a mathematical model and displays the estimated Minimum Alveolar Concentration (MAC), which is an estimate of the anesthetic effect on the patient. Similar to the PK/PD models in Navigator, the MAC models implemented in the S/5 Monitor were first published in peer-reviewed journal articles. Both devices provide clinicians with information about the anesthesia pharmaceuticals delivered to the patient.

The devices differ in their general construction. The Navigator Applications Suite is a medical software program loaded onto a medical arade PC that is physically mounted to an anesthesia machine whereas the S/5 Anesthesia Monitor includes integrated modules containing both hardware and software. The Navigator Applications Suite does not have direct contact with the patient. The S/5 Anesthesia Monitor, depending on module confiquration, can have several points of direct patient contact.

The S/5 Anesthesia Monitor displays MAC of anesthetic agents. The Navigator Applications Suite differs in that its pharmacokinetic models display effect site concentration (Ce), taking into account the temporal delay between changes in alveolor concentration and subsequent changes in the concentration at the site of drug effect. The Navigator Applications Suite also differs in that intravenous drugs can be displayed as well as inhaled agents. The Navigator Applications Suite also can display pharmacodynamic models for intravenous drugs. including synergies between some drugs.

The Navigator Applications Suite communicates with other devices using communication methods similar to the Datex-Ohmeda S/5 Network and Central (iCentral), K052972.

The protocol and device features of the Navigator Applications Suite take information that is currently available to the hospital in paper form and displays them electronically at the point of care.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.

OCT 1 0 2007

ood 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 Post Office Box 7550 Madison, Wisconsin 53707

Re: K071097

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: September 21, 2007 Received: September 24, 2007

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 (OS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sugitte y. Mickiewiczmd.

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:

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.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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| PAGE IF | |
| NEEDED). | A |

Concurrence of CDRH, Office of Dev

(Division Sign Division of Anesthesiology, General Hospital Page 1 of 1 Infection Control, Dental Devices

510(k) Number: K071097