HAMILTON-G5

K070513 · Hamilton Medical AG · CBK · Nov 26, 2007 · Anesthesiology

Device Facts

• Record ID: K070513
• Device Name: HAMILTON-G5
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HAMILTON-G5 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 optionally infant patients. The device is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 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 intended for transportation outside the hospital or for use in the home environment. 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.

Device Story

HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator; provides positive pressure ventilatory support. Inputs: oxygen and air. Operation: electrical systems control pneumatics to deliver gas; monitors patient/ventilator alarms. Output: mechanical ventilation; audible/visual alarms. Used in ICUs and for intra-hospital transport; operated by trained personnel under physician supervision. User interface: LCD touch screen, keys, press-and-turn knob. Power: AC with battery backup. Benefits: provides respiratory support for critically ill patients; facilitates transport within hospital facilities.

Clinical Evidence

Bench testing only. Performance tests confirmed the device performed as specified and conformed to FDA-recognized standards for safety and performance of lung ventilators.

Technological Characteristics

Electronically controlled pneumatic ventilator. Powered by AC with battery backup. Features LCD touch screen, keys, and press-and-turn knob interface. Provides positive pressure ventilation for adult, pediatric, and infant patients. Designed for bedside use and intra-hospital transport.

Indications for Use

Indicated for positive pressure ventilatory support for adult, pediatric, and optionally infant patients in hospital/institutional settings. Contraindicated for use outside the hospital, in home environments, in the presence of flammable anesthetic agents, or near MRI equipment.

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)

Submission Summary (Full Text)

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# 3 9N K070513 11

## 510(k) Summary

NOV 2 6 2007

| SUBMITTER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>7402 Bonaduz<br>Switzerland |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| PREPARATION DATE: | Aug 10, 2007 |
| TRADE NAME: | HAMILTON-G5 |
| 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 |

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#### DEVICE DESCRIPTION

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air to ventilate adult, pediatric and optionally infant patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.

The HAMILTON-G5'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-andturn knob.

The HAMILTON-G5 provides audible and visual patient- and ventilator-related alarms.

#### INTENDED USE

The HAMILTON-G5 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 optionally infant patients.

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

The HAMILTON-G5 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 intended for transportation outside the hospital or for use in the home environment.

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 DEVICE

The indication statements for the HAMILTON-G5 ventilator are comparable to those for the predicate device.

Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are equivalent to those of the predicate device HAMILTON GALILEO Gold*SV (K061090).

HAMILTON MEDICAL has demonstrated the HAMILTON-G5 ventilator to be safe and effective. The HAMILTON-G5 is considered to be substantial equivalent to a currently marketed predicate device which has been previously cleared by FDA.

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### PERFORMANCE TESTS

Performance tests were performed, and the test results indicated that the device performed as specified.

#### CONCLUSION

The HAMILTON-G5 conforms to the FDA recognized standards for safety and performance issues with lung ventilators. This assures that the performance of this device can be considered safe and effective with respect to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2007

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

Re: K070513

Trade/Device Name: HAMILTON-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 9, 2007 Received: November 16, 2007

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.

Syrite Y. Michael Davis.

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: K070513

Device Name: HAMILTON-G5

Indication for Use: The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and optionally 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.

X 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)

Will Maly for m. Husband

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

K070513 510(k) Number: