MODIFICATION TO HAMILTON-G5

K081521 · Hamilton Medical AG · CBK · Sep 25, 2008 · Anesthesiology

Device Facts

• Record ID: K081521
• Device Name: MODIFICATION TO HAMILTON-G5
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 25, 2008
• 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 to adult and pediatric patients, and optionally to infant and neonatal patients. 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

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator. It delivers gas (air/oxygen or optional heliox) to patients; electrical systems control pneumatics, monitor alarms, and manage power. Operated by trained personnel under physician supervision in hospital settings; used for bedside care and intrahospital transport. User interface includes LCD touchscreen, keys, and press-and-turn knob. Optional mainstream CO2 monitoring available. Device provides ventilatory support to assist patient breathing; output affects clinical management of respiratory failure. Benefits include life support and respiratory stabilization in critical care environments.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including safety testing per IEC60601-1, IEC60601-1-2, and IEC 60601-2-12, and waveform performance testing per ASTM F1100-90. Software verification and validation testing confirmed implementation of requirements.

Technological Characteristics

Electronically controlled pneumatic ventilator; AC power with battery backup. Features LCD touchscreen interface. Supports air/oxygen and optional heliox. Includes optional mainstream CO2 gas analyzer. Complies with IEC60601-1, IEC60601-1-2, IEC 60601-2-12, and ASTM F1100-90. Software-controlled pneumatic delivery.

Indications for Use

Indicated for positive pressure ventilatory support in adult, pediatric, and optionally infant and neonatal patients within hospital/institutional settings. 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-G5 (K070513)
• MAQUET Servo-i (K041223)
• Viasys AVEA ventilator (K062093)
• Datex-Ohmeda Engström Carestation (K062710)
• Dräger EvitaXL with NeoFlow Option (K051263, K983219)

Submission Summary (Full Text)

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Image /page/0/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. To the right of the word "HAMILTON" is a circle with the letter "H" inside.

Koris21

SEP 2 5 2008

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# 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: | May 21, 2008 |
| 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-G5<br>510(k) Number: K070513 |
| | MAQUET Servo-i<br>510(k) Number: K041223 |
| | Viasys AVEA ventilator<br>510(k) Number: K062093 |
| | Datex-Ohmeda Engström Carestation<br>510(k) Number: K062710 |
| | Dräger EvitaXL with NeoFlow Option<br>510(k) Numbers: K051263, K983219 |

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Image /page/1/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is composed of two lines of text, with "HAMILTON" on the top line and "MEDICAL" on the bottom line. To the right of the word "HAMILTON" is a circle with the letter "H" inside of it.

#### DEVICE DESCRIPTION

The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system.

It uses oxygen and air or (optionally) heliox to ventilate adults, pediatrics, and optionally infants and neonates. 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 CO2 option allows continuous mainstream monitoring of carbon dioxide.

### INTENDED USE

The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients.

The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care.

The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.

The HAMILTON-G5 ventilator may be used for transport within a hospital or hospitaltype facility provided compressed gas 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. The device 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.

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

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

Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices.

The Carbon dioxide gas analyzer is considered to be substantial equivalent to the CO2 gas analyzer of the currently marketed predicate device Servo-i.

The heliox option is comparable with the substantial equivalent option of the predicate device AVEA ventilator.

The neonate ventilation characteristics are substantially equivalent to those of the predicate devices Servo-i, Engström Carestation, and Evita XL.

HAMILTON MEDICAL has demonstrated the HAMILTON-G5 ventilator including the new options to be safe and effective.

The HAMILTON-G5 is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA.

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Image /page/2/Picture/0 description: The image shows the words "HAMILTON" and "MEDICAL" stacked on top of each other. The word "HAMILTON" is in a bold, sans-serif font, and the word "MEDICAL" is in a similar font but slightly smaller. To the right of the word "HAMILTON" is a logo that appears to be a stylized "H" inside a circle. The text and logo are all in black, and the background is white.

#### NON-CLINICAL PERFORMANCE TESTS

Safety testing of the HAMILTON-G5 with the new options was conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards. The test results show that the device is safe and effective for its intended use.

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

The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.

#### CONCLUSION

The results of verification, validation, and testing activities demonstrate that the HAMILTON-G5 ventilator including the new options is as safe, as effective, and performs as well as or better than the legally marketed devices identified above.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.

SEP 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081521

Trade/Device Name: HAMILTON-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 12, 2008 Received: September 17, 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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ﻧﻪ ..

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Thlmulrfled mrs frey

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: | HAMILTON-G5 |
| Indication for Use: | The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. 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)

MHh

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

K081521

510(k) Number: _