GALILEO GOLD ASV

K061090 · Hamilton Medical AG · CBK · Jul 17, 2006 · Anesthesiology

Device Facts

• Record ID: K061090
• Device Name: GALILEO GOLD ASV
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GALILEO Gold ASV ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility 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 ASV is a software-modified intensive care ventilator for adult, pediatric, and infant patients. It provides conventional ventilation and Adaptive Support Ventilation (ASV). ASV maintains clinician-set minute ventilation without exceeding preset plateau pressures; it provides full support during apnea/low-drive and transitions to spontaneous ventilation. Operation involves a 3-step closed-loop cycle: breath-by-breath patient assessment; calculation of optimal breath pattern using Otis's minimal work of breathing method; and automatic adjustment of mandatory rate and inspiratory pressure. Used in hospital ICUs and for intra-facility transport by trained personnel under physician supervision. Clinicians monitor output to guide respiratory management. Benefits include automated, optimized ventilatory support tailored to patient respiratory mechanics.

Clinical Evidence

Clinical performance data from patients with normal lungs and diverse respiratory failures demonstrated that ASV technology is safe and effective. No adverse effects, complications, or reintubations were reported. User assessments indicate the extended ASV mode performs clinically as well as predicate devices.

Technological Characteristics

Continuous ventilator; software-modified version of K040574. Features closed-loop controller using physiological feedback signal (RCero). Performance evaluated per ASTM F1100-93. Operates on microcomputer system. Intended for hospital/institutional use with compressed gas supply.

Indications for Use

Indicated for positive pressure ventilatory support in adult, pediatric, and infant patients requiring intensive care. Contraindicated for use in the presence of flammable anesthetic agents, ignition sources, or MRI environments.

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 Gold (K040574)
• Dräger EvitaXL with option SmartCare (K051263)

Submission Summary (Full Text)

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K061090

Image /page/0/Picture/1 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a stylized "H" inside a circle. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in a smaller, sans-serif font.

# 510(k) Summary

JUL 1 7 2006

| 510(k) OWNER: | Hamilton Medical AG<br>Via Crusch 8<br>CH-7402 Bonaduz<br>Switzerland |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| PREPARATION DATE: | April 11, 2006 |
| TRADE NAME: | GALILEO GoldASV |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use<br>(21 CFR 868.5895, Product Code CBK) |
| REASON FOR THIS 510(K) SUBMISSION: | The GALILEO GoldASV is a software<br>modified version of the legally marketed<br>device GALILEO Gold (K040574) |
| LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED: | HAMILTON GALILEO Gold<br>510(k) Number: K040574<br>Dr\u00e4ger EvitaXL with option SmartCare<br>510(k) Number: K051263 |

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Image /page/1/Picture/0 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H" inside of a circle. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in a smaller font.

#### DEVICE DESCRIPTION

The GALILEO Gold N is a software modified version of the legally marketed device GALILEO Gold (K040574). The GALILEO Gold SV is a full-functioned intensive care ventilator. It can ventilate adult, pediatric and infant patients. The GALILEO Gold*ASV offers a full spectrum of modalities, from the conventional to the new included Adaptive Support Ventilation, ASV.

ASV is designed to maintain at least the minute ventilation set by the clinician. ASV does this without exceeding a preset plateau pressure. ASV provides full ventilation in apnea or low-drive conditions, then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps:

- 1. Assess the patient breath-by-breath.
- 2. Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607).
- 3. Approach the target by automatically adjusting mandatory rate and inspiratory pressure.

#### INTENDED USE

The GALILEO Gold®56 ventilator is intended to provide positive pressure ventilatory support in intensive care units.

The ventilator is intended for intensive care ventilation of adult, pediatric and infant patients.

The device is intended for use by properly trained personnel under the direct supervision of a licensed physician.

The GALILEO Gold®V ventilator is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed air is supplied.

The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment.

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

### SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES

The indication statements for the GALILEO Gold SV ventilator are comparable to those for the predicate devices.

All technological characteristics and performance specifications of the GALILEO Gold4SV ventilator, are equivalent to those of the predicate device GALILEO Gold (K040574), except for the use of a closed-loop controller in the new added ASV mode.

The closed-loop controller using a physiological feedback signal is comparable with the closed-loop controller used in the SmartCare mode of the predicate device Dräger EvitaXL (K051263).

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Image /page/2/Picture/0 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, sans-serif font. To the right of the word "HAMILTON" is a symbol that appears to be a stylized "H" inside a circle. Below the word "MEDICAL" is the tagline "MAKING TECHNOLOGY SERVE MANKIND" in a smaller font.

Assessment and clinical performance data affirm that the ASV mode using RCero as feedback signal for the closed-loop control is safe and effective.

#### SUMMARY OF NON-CLINICAL PERFORMANCE TESTS

The performance/qualification testing of the new added GALILEO Gold feature ASV has been done on modular, integration and system level. There were no performance deviations observed or documented during testing.

The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. No new question raised regarding safety and effectiveness of the complete instrument and its new feature.

As the implementation of the new software feature does not include any new hardware, certain tests could be omitted. However, the impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing.

### SUMMARY OF CLINICAL PERFORMANCE DATA

Performance data of patients with normal lungs and diverse respiratory failures, ventilated with the ASV technology are on hand with no adverse effects, complications or required reintubation reported.

User assessments show that the extended ASV mode is as safe, as effective, and performs clinically as well as the predicate devices.

#### CONCLUSION

The ventilator GALILEO GoldASV is except for the use of a closed-loop controller in the new added ASV mode substantially equivalent in safety and effectiveness to the HAMILTON GALILEO Gold ventilator (K040574).

The closed-loop controller using a physiological feedback signal is comparable with the closed-loop controller used in the SmartCare mode of the predicate device Dräger EvitaXL (K051263).

Assessment and clinical performance data affirm that the ASV mode using RCern as feedback signal for the closed-loop control is safe and effective.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 1 7 2006

Re: K061090

Trade/Device Name: Galileo Gold ASV Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 11, 2006 Received: April 18, 2006

Dear Ms. 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 - Ms. 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,

Squire J. Michie Dmd.

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: | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GALILEO Gold ^ASV ventilator |
| Indication for Use: | The GALILEO Gold ^ASV ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Juven

a of Anesthesiology, General Hospital,
.....un Control, Dental Devices

K061090