SMARTPILOT VIEW MODEL MK04500

K103035 · Draeger Medical GmbH · BSZ · Mar 28, 2012 · Anesthesiology

Device Facts

• Record ID: K103035
• Device Name: SMARTPILOT VIEW MODEL MK04500
• Applicant: Draeger Medical GmbH
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2

Indications for Use

The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia. The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows: Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years

Device Story

SmartPilot View is software running on a dedicated workstation (Draeger C700) that integrates data from anesthesia workstations, IV pumps, and patient monitors. It processes drug dosage data alongside patient parameters (HR, NIBP, etCO2, BIS) to visualize pharmacokinetic and pharmacodynamic effects of intravenous (hypnotics, opioids, muscle relaxants) and volatile anesthetics. The system uses PK/PD models to calculate and display synergetic/additive drug effects in a 2D diagram and computes a novel pharmacodynamic parameter (NSRI). Used by anesthesia professionals in clinical settings, the output provides theoretical modeling information to assist in anesthesia management and retrospective case analysis. It does not control drug delivery but informs clinical decision-making regarding anesthesia depth and drug titration.

Clinical Evidence

No clinical data. Bench testing only, including software validation per IEC 62304 and risk management per ISO 14971.

Technological Characteristics

Software-based PK/PD modeling system. Operates on dedicated patient vicinity workstation (Draeger C700) with Infinity Explorer. Connectivity via RS232/RJ45. Implements pharmacokinetic and pharmacodynamic models for specific intravenous and volatile anesthetics. Complies with IEC 62304 and ISO 14971.

Indications for Use

Indicated for adult patients (age 18-90, height 150-200 cm, weight 40-140 kg) undergoing general anesthesia to monitor/log drug dosage and display PK/PD modeling information.

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

• Navigator Applications Suite (K071097, K081941, K083098, K102389)
• Infinity Explorer (K013515, K022889, K030615, K040945, K060254)

Submission Summary (Full Text)

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MAR 2 8 2012

K103035 Traditional 510(k) SmartPilot View

Dräger

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# Premarket Notification 510(k) summary As required per 807.92

### General Company Information

| Submitters Name and Address: | Dräger Medical GmbH<br>Moislinger Allee 53-55,<br>D-23542 Luebeck, Germany | |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact Person: | Mr. Ulrich Schroeder<br>Moislinger Allee 53-55,<br>D-23542 Luebeck, Germany<br>Phone : [phone]<br>Fax :[phone]<br>Email: [e-mail] | |
| Alternate | Mrs. Joyce Kilroy, Draeger Medical Systems, Inc., 3135<br>Quarry Road, Telford, PA 18969-1042<br>Phone [phone],<br>Fax: [phone]<br>Email: [e-mail] | |
| Versions : | Initial Version : | 2010-10-08 |
| | Change 1 for submission: | 2012-03-28 |
| Device Name | | |
| Common Name: | Software, Information system, anaesthesia | |
| Legally Marketed Device<br>Identification (Trade name): | SmartPilot View | |
| Regulation Number | 868.5160 | |
| Regulation Description | Gas machine for anesthesia | |
| Regulation Medical Specialty | Anesthesiology | |

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### K103035 Traditional 510(k) SmartPilot View

| Product Code | BSZ |
|---------------------------|---------|
| Class | 2 |
| 510(k) Number (if known): | K103035 |

### Device description:

The current version of the SmartPilot View is receiving data from a dedicated anesthesia workstation or combination of workstation and other devices.

Image /page/1/Figure/5 description: The image shows a diagram with four boxes. The boxes on the left are labeled M, A, and IV. The box on the right is labeled C700 IT. The boxes on the left are connected to the box on the right by lines labeled RS232 and RJ45/RS232.

- র্ব Anesthesia workstation
- Monitor M
- IV IV pumps

The Software SmartPilot View runs on a dedicated patient vincinity workstation (Draeger C700 for IT) with the installed Infinity Explorer Software.

The data is taken from dedicated anesthesia workstation A (Draeger Primus US "Apollo") or combination of the workstation and other devices like IV Pumps (B.Braun Perfusor Space pump) and patient monitors M (Draeger Delta/Delta XL, Kappa, Omega S).

The software visualizes the drug effect based on pharmacokinetic models and the drug interaction based on pharmacodynamic models known from scientific literature.

The software visualizes the synergetic and additive drug effect on a screen in a specially developed 2D pharmacodynamic diagram. Furthermore a new pharmacodynamic parameter (NSRI) is calculated based on the synergetic drug effects.

The software monitors and calculates data for the use during the anesthesia case. The software also logs data during the anesthesia case for a retrospective analysis.

Supported drugs:

Intravenous hypnotics – Propofol

Volatile hypnotics

- Isoflurane
- Sevoflurane
- Desflurane
- Enflurane

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Image /page/2/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots above the letter. The text is black and appears to be slightly pixelated, suggesting it may be a scanned image or a low-resolution graphic. The background is plain white.

Intravenous opioids

### - Fentanyl

- Remifentanil
- Sufentanil
- Alfentanil

Intravenous muscle relaxants

- Pancuronium
- Rocuronium

### Parameters provided by the basic device (monitor and anaesthesia machine)

- Heart rate HR in 1/min
- Mean non-invasive blood pressure NIBP M or mean arterial pressure ART M in mmHg or kPa.
- ~ End-expiratory CO2 concentration etCO2 in mmHg, Vol.% or kPa.
- Bispectral index BIS
- BIS signal quality index SQI in % ।

### Statement of Indications / Intended Use:

The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information.

Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.

The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia.

The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows:

Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years

### Substantial Equivalence (identification of the legally marketed Predicate):

With respect to the pharmacokinetic and pharmacodynamic calculation and display of data the Smart Pilot View is equivalent to the Navigator Applications Suite (K071097, K081941, K083098, K102389) from GE Healthcare Finland Oy.

The display of the monitoring data is equivalent to the Software Infinity Explorer (K013515, K022889, K030615, K040945, K060254) from Draeger Medical Systems, Inc..

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### Assessment of non-clinical testing:

The SmartPilot View has been tested according to its specifications, including software validation.

The following standards and guidelines were used to support the safe use of the Software:

ISO 14971 :2007 Medical devices - Application of risk management to medical devices

IEC 62304 :2006 Medical device software - Software life-cycle processes

FDA CDRH Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on: May 11, 2005)

### Clinical performance data:

Not applicable

### Biocompatibility:

Not applicable

### Sterilization:

Not applicable

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

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

Draeger Medical GmbH C/O Ms. Royce Kilroy Vice President Draeger Medical System. Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

MAR 2 8 2012

Re: K103035

Trade/Device Name: SmartPilot View Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: March 22, 2012 Received: March 23, 2012

Dear Ms. Kilroy:

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. Kilroy

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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 Statement

510(k) Number (if known): K103035

Device Name: SmartPilot View

Indications for Use:

The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.

The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia.

The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows:

Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years

Schultheis

(Division Sign-Off) vision of Anesthesiology, General Hospital rection Control. Dental Devices

1103035 i10(k) Number:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)