MODIFICATION TO GALILEO GOLD

K080181 · Hamilton Medical AG · CBK · Jun 24, 2008 · Anesthesiology

Device Facts

• Record ID: K080181
• Device Name: MODIFICATION TO GALILEO GOLD
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

Device Story

GALILEO Gold is an electronically controlled pneumatic intensive care ventilator. It utilizes air and oxygen to provide positive pressure ventilation to patients ranging from neonates to adults. The system features an LCD touch screen, physical keys, and a press-and-turn knob for user interaction. It provides audible and visual alarms for patient and ventilator status. Powered by AC with battery backup, it supports intrahospital transport. Healthcare professionals use the device at the bedside to manage patient respiration; the output assists clinical decision-making by providing controlled ventilatory support. The device benefits patients by maintaining respiratory function in critical care environments.

Clinical Evidence

Bench testing only. Wave-form performance testing was conducted in accordance with standard F1100-90 to demonstrate substantial equivalence to legally marketed devices.

Technological Characteristics

Electronically controlled pneumatic system; AC power with battery backup; LCD touch screen interface; supports adult, pediatric, infant, and neonatal ventilation. Complies with ASTM F1100-90 for wave-form performance.

Indications for Use

Indicated for positive pressure ventilatory support in adult, pediatric, infant, and neonatal patients within hospital or institutional settings, including bedside and intrafacility transport.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• HAMILTON GALILEO GoldASV (K061090)
• MAQUET Servo-i (K041223)
• GE Datex-Ohmeda Engström Carestation (K062710)

Submission Summary (Full Text)

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K080181

Image /page/0/Picture/1 description: The image shows the words "HAMILTON MEDICAL" in a bold, sans-serif font. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The letter "O" in "HAMILTON" has a logo inside of it.

JUN 2 4 2008

# 510(k) Summary

:

| SUBMITTER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>7402 Bonaduz, Switzerland |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| PREPARATION DATE: | April 08, 2008 |
| TRADE NAME: | GALILEO Gold |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use<br>(21 CFR 868.5895, Product Code CBK) |
| LEGALLY MARKETED<br>DEVICES TO WHICH<br>EQUIVALENCE IS<br>BEING CLAIMED: | HAMILTON GALILEO GoldASV<br>510(k) Number: K061090 |
| | MAQUET Servo-i<br>510(k) Number: K041223 |
| | GE Datex-Ohmeda Engström Carestation<br>510(k) Number: K062710 |

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#### DEVICE DESCRIPTION

The GALILEO Gold is an electronically controlled pneumatic intensive care ventilation system. It uses oxygen and air to ventilate adult, pediatric, infant, and neonatal patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.

The GALILEO Gold's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-and-turn knob. The GALILEO Gold provides audible and visual patient- and ventilator-related alarms.

#### INTENDED USE

The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients.

The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied.

The GALILEO Gold ventilator is not intended for transportation outside the hospital or for use in the home environment.

In the USA, federal law restricts this device to sale by or on the order of a physician.

### INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE NEW DEVICE COMPARED TO THE PREDICATE DEVICES

The technological characteristics of the previous GALILEO Gold^SV ventilator have not been changed for the new device GALILEO Gold. The expanding of the intended use to neonatal patients does not result in the use of new technological characteristics.

The GALILEO Gold's indication statements and its neonate ventilation characteristics are substantially equivalent to those of the predicate devices Servo-i and Engström Carestation.

### NONCLINICAL PERFORMANCE TEST DATA SUBMITTED

The ventilator was subject to wave-form performance testing as described in the standard F1100 - 90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device.

### CONCLUSION

HAMILTON MEDICAL has demonstrated the GALILEO Gold ventilator to be safe and effective when used as labeled.

This device is considered to be substantially equivalent to currently marketed predicate devices and the expanding of the intended patient population to neonates does not raise new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2008

Mr. Joerg Schneider Quality Engineer, R&D Hamilton Medical AG Via Crusch 8 CH-7402 Bonaduz SWITZERLAND

Re: K080181

Trade/Device Name: GALILEO Gold Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 4, 2008 Received: June 9, 2008

Dear Mr. Schneider:

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 - Mr. Schneider

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 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,

Susan Gunn
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 STATEMENT

| 510(k) Number: | K080181 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GALILEO Gold |
| Indication for Use: | The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment. |

ਮ Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh Van

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

510(k) Number: K040181