GALILEO GOLD

K040574 · Hamilton Medical, Inc. · CBK · Oct 27, 2004 · Anesthesiology

Device Facts

• Record ID: K040574
• Device Name: GALILEO GOLD
• Applicant: Hamilton Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 27, 2004
• 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 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 or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.

Device Story

GALILEO Gold is an intensive care ventilator providing positive pressure ventilatory support. Modifications add four software-based modes: DuoPAP/APRV (alternating pressure levels with synchronized spontaneous breathing); NIV (non-invasive ventilation via mask/mouthpiece); MMV+ (pressure-controlled, minute volume-constant ventilation); and TRC (tube resistance compensation to offset ET/tracheostomy tube resistance). Device operates at bedside or during intra-facility transport; requires compressed gas. Operated by trained personnel under physician supervision. Output includes pressure-controlled ventilation and calculated intra-tracheal pressure curves. Benefits include optimized work of breathing and synchronized ventilatory support. No hardware changes; modifications are purely software-based.

Clinical Evidence

Bench testing only. Performance/qualification testing performed at modular, integration, and system levels. Evaluated per ASTM F1100-93; waveform analysis showed no safety/effectiveness concerns. Software impact on microcomputer system (execution times, reaction times, load) verified. No performance deviations observed.

Technological Characteristics

Software-based modifications to existing intensive care ventilator. Features: DuoPAP/APRV, NIV, TRC, MMV+. Connectivity: Standalone/hospital-integrated. Energy: Compressed gas required. Standards: ASTM F1100-93. Software: Embedded firmware, no hardware changes.

Indications for Use

Indicated for positive pressure ventilatory support in adults, pediatric, and infant patients in hospital/institutional settings. Contraindicated for home use or transport outside the hospital.

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

• RAPHAEL (K022679)
• Puritan Bennett 840 (K984535, K001646)
• Evita 4 (K010093, K980642, K992608)
• Siemens Servo 300A (K970839)
• Siemens Servo' (K010925, K022132)

Submission Summary (Full Text)

{0}------------------------------------------------

| Project-Name : GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | | Doc.-No.: E35103_Part: | |
|-------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | | Doc.-Version : 1.1 |
| <b>10</b> | <b>SUMMARY</b> | <b>OCT 27 2004</b> | |
| APPLICANTS NAME AND<br>ADDRESS | | Hamilton Medical AG<br>Via Nova<br>CH-7403 Rhaezuens<br>Switzerland | |
| APPLICANTS CONTACT PERSON | | Dr. Andreas Scheibe<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| APPLICANTS CONTACT PERSON<br>IN THE USA | | Hamilton Medical Inc.<br>Mr. David Thompson<br>Post Office Box 30008<br>Reno, NV 89520<br>Phone: [phone], Extension 349<br>Fax: [phone]<br>e-mail: [e-mail]<br>Establishment Registration 2937708 | |
| DATE THE SUMMARY WAS<br>PREPARED | | | |
| COMMON NAME | | Continuous Ventilator | |
| PROPRIETARY NAME | | GALILEO Gold | |
| PURPOSE OF SUBMISSION | | New features for existing, legally marketed instrument<br>in the US (K982910, K001686) | |
| CLASSIFICATION | | Name: Ventilator, Continuous (per 21 CFR 868.5895)<br>Panel: Anesthesiology<br>Code: CBK | |
| REGULATORY STATUS | | 1. Current Device Class: Class 2<br>2. Performance Standards & Special Controls: None | |

{1}------------------------------------------------

| Кчиф574 | | | |
|----------------|---------------------------------------------------------------|--|-------------------------|
| Project-Name : | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | | Doc.-No.: E35103 Part 2 |
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | | Doc.-Version : 1.1 |

# PREDICATE DEVICE IDENTIFICATION

| | Legally marketed devices to which equivalence is being claimed | | | |
|-------------------------------------------|----------------------------------------------------------------|------------------|----------------------------------------------------------------|--|
| Predicate Device<br>DuoPAP and APRV modes | Manufacturer | 510(k) number(s) | Classification | |
| RAPHAEL | HAMILTON Medical<br>AG | K02267 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| Puritan Bennett 840 | Nellcor Puritan-Bennett | K984535, K001646 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| NIV mode<br>Evita 4 | Draeger<br>Medizintechnik AG | K010093 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| MMV+ mode<br>Siemens Servo' | Siemens-Elema AB | K010925, K022132 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| Siemens Servo 300A | Siemens-Elema AB | K970839 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| Evita 4 | Draeger<br>Medizintechnik AG | K980642 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |
| TRC feature<br>Evita 4 | Draeger<br>Medizintechnik AG | K992608 | Ventilator, Continuous,<br>Facility Use per 21<br>CFR 868.5895 | |

| announce and states of the contrôleant of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of | Separate of the country of consisted on the consideration of | Property and Personal Property of |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| A . S<br>.<br>100<br>1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br><br>.<br><br><br><br>Now and was a second and a not a may<br>Call State Charles Children Children Comment Com-<br><br><br><br><br>Canada Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Ca<br>.<br><br><br><br>. | I I see to real a management come an<br>:<br>4. 17 - 51.5 ----------------------------------------------------------------------------<br>.<br><br><br><br><br> |
| .<br>Section of the station of the collection of | of contract from to the partment<br>of the count of the children and the collection of the comments of | |

{2}------------------------------------------------

| Project-Name : | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc .- No. : | E35103 Part 2 |
|----------------|---------------------------------------------------------------|-----------------|---------------|
| Doc .- Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc .-Version : | 1.1 |

### DEVICE DESCRIPTION

The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator.

This application is for the following options to the Galileo Gold ventilator:

- . The DuoPAP (Duo Positive Airway Pressure ventilation) and APRV (Airway Pressure Release Ventilation) ventilation modes technically almost identical. In both modes, the ventilator alternates the airway pressure between two positive levels according to the preset controls. The ventilated patient can breathe at either pressure level. The spontaneous breaths are synchronized with the automatic switchover between the two pressure levels.
- . The NIV (Non-Invasive Ventilation) mode is designed to facilitate ventilation assistance in a noninvasive way (e.g. a facial, a nasal mask or a mouth piece) between the ventilator and the patient's airway.
- The MMV* (Mandatory Minute Ventilation with Advanced Performance) mode is a pressure-controlled, . minute volume-constant ventilation with controlled P & and ventilation rate. The patient pressure is controlled to PEEP + Psp during the insufflation and to PEEP during the expiration. The patient target pressure is identical for the mandatory and for the spontaneous breaths. The mandatory ventilation rate and the inspiration time are set by the clinician. Depending on the patient's spontaneous breath rate, some mechanical breaths are added to achieve the mandatory rate.
- TRC (Tube Resistance Compensation) is a feature to minimize the patient's work of breathing to . overcome the additional airway resistance due to the presence of an ET-tube or a tracheotomy tube.

#### INTENDED USE

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

#### INTENDED OPERATOR

The GALILEO Gold is intended for use by properly trained personnel under the direct supervision of a licensed physician. In the US, federal laws restricts this device to sale by or on the order of a physician.

#### INTENDED PATIENT POPULATIONS

The GALILEO Gold is intended for intensive care ventilation of adults, pediatric and infant patients.

#### INTENDED USE ENVIRONMENT

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

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

#### SUBSTANTIAL EQUIVALENCE

The DuoPAP and the APRV mode of the GALILEO Gold is substantially equivalent to the DuoPAP and APRV modes of the RAPHAEL ventilator and to the BiLevel mode of the Puritan-Bennett 840 ventilator system. The NIV mode of the GALILEO Gold is substantially equivalent to NIV option of the Evita 4 ventilator. The TRC feature of the GALILEO Gold is substantially equivalent to the ATC option of the Evita 4 ventilator. The MMV+ mode of the GALILEO Gold is substantially equivalent to the Evita 4 ventilator and to the Automode of the Servo 300A and Servo' ventilators.

| C. Danuser | 1 18 800<br>Page 4 of | 90<br>2004-01-29 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Copyright by<br>・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・<br><br>0) 0. | <br>----------------------------------------------------------------------<br><br>.<br><br>Comments of the program and the comments of the country<br>22 11 11 11 11 11 11 11 11 11<br>.<br>Carlos Controller Comments of<br><br>- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -<br><br>consistential consideration of the comments of the com-<br><br><br>Carlos Concession Comers<br>March Market Children Street we well was and the was and<br>200 "print<br>and the contribution of the count<br>the was an a superior of the control of<br>and the state of the county of<br><br><br><br>and the contract and the problem of the promotive of the country<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> | .<br>1 - 3 - 5 - 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -<br>Comments of the Research and Children<br><br><br>11 11 2 111 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2<br>CONFIDENTIAL .<br><br> |

{3}------------------------------------------------

| K444571 | | | |
|----------------|---------------------------------------------------------------|---------------------|--------------------------|
| Project-Name : | GALILEO Gold 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No. : E35103 Part 2 |
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | | Doc.-Version : 1.1 |

#### SUMMARY OF PERFORMANCE TESTS

The performance/qualification testing of the new added Galileo Gold features (DuoPAP/APRV, NIV, TRC and MMV') has been done on modular, integration and system level. The modular and integration testing of the new software based features have been successfully performed for each individual new mode. System tests were executed with a complete instrument, i.e. the new software together with the existing Galileo Gold hardware. As presented within the accompanying documentation, there were no performance deviations observed or documented during modular, integration and system testing.

The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. The graphical analyses of the waveforms shows that there is no new question raised regarding safety and effectiveness of the complete instrument and its new features.

As the implementation of the new software features in the Galileo Gold instrument did not include any new hardware, certain tests could be omitted (e.g. the ASTM F-1100 endurance testing, the EMC testing and the EN-60601-1 and EN 60601-1-2). However, the impact of the new software on the microcomputer system (execution times of the different communication processes, reaction times and the overal load) were tested and documented. As presented within the accompanying documentation, there were no performance deviations observed or documented during the testing.

#### COMPARISON OF GALILEO GOLD NEW FEATURES TO PREDICATE DEVICES

The four following tables compare the major technological performance characteristics of the new Galleo Gold features to its predicate devices. There are no significant differences between the new Galileo Gold features and its predicates.

#### MAJOR FEATURE COMPARISON

#### DUOPAP & APRV (DUAL PRESSURE VENTJLATION MODE)

| Function | DuoPAP & APRV | BiLevel | DuoPAP & APRV | Discussion of the differences |
|-------------------------------------------------------------------------------------------------------|------------------|---------------------------------------------------|------------------|-------------------------------|
| Product name | Galileo Gold | PB 840 | Raphael | --- |
| Manufacturer | Hamilton Medical | Nellcor Puritan-Bennett | Hamilton Medical | --- |
| The 510(K) number | To be assigned | K970460, K984535,<br>K993071, K001646,<br>K021573 | K022679 | --- |
| Automatic and regular<br>switchover between two<br>pre-set pressure levels | Yes | Yes | Yes | No<br>difference |
| The ventilated patient can<br>breathe freely at either<br>pressure level | Yes | Yes | Yes | No<br>difference |
| The spontaneous breaths<br>may be pressure-supported<br>if desired | Yes | Yes | Yes | No<br>difference |
| The "control breaths" are<br>synchronized to the<br>spontaneous breaths by the<br>ventilated patients | Yes | Yes | Yes | No<br>difference |

| C. Danuser | Page 5 of 7 | 2004-01-29 |
|------------|------------------------------------|--------------|
| | © Copyright by HAMILTON MEDICAL AG | CONFIDENTIAL |

{4}------------------------------------------------

| Project-Name : | GALILEO Gold 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No. : | E35103_Part 2 |
|----------------|---------------------------------------------------------------|---------------------|----------------|---------------|
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | | Doc.-Version : | 1.1 |

## NIV MODE (NON INVASIVE VENTILATION MODE)

| Function | NIV | NIV option | Discussion of the<br>differences |
|--------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------|
| Product name | Galileo Gold | Evita | --- |
| Manufacturer | Hamilton Medical | Draeger | --- |
| The 510(k) | To be assigned | K961687, K980642,<br>K992608, K010093 | --- |
| Underlying mode | Pressure support | Pressure support | No differences |
| How the inspiration is<br>triggered | Patient-triggered | Patient-triggered | No differences |
| How the inspiration is<br>limited | Pressure-limited | Pressure-limited | No differences |
| How the inspiration is<br>terminated | Flow-cycled (first)<br>Time-cycled (second) | Flow cycled (first)<br>Time-cycled (second) | No differences |
| Indicated patient population | For spontaneously<br>breathing patients only | For spontaneously<br>breathing patients only | No differences |
| Apnea ventilation possible? | Yes | Yes | No differences |

# TRC (TUBUS RESISTANCE COMPENSATION):

| | TRC | ATC option | Discussion of<br>differences |
|-------------------------------------------------------------------------|------------------|---------------------------------------------|------------------------------|
| Function | | | |
| Product name | Galileo Gold | Evita 4 | --- |
| Manufacturer | Hamilton Medical | Draeger | --- |
| 510(k) number | To be assigned | K961687,<br>K980642,<br>K992608,<br>K010093 | --- |
| To minimize additional WoBpt caused by ET-<br>tube or tracheostomy tube | Yes | Yes | No difference |
| Compensate the resistance from an ET-tube<br>or a tracheostomy tube | Yes | Yes | No difference |
| Apply instantaneous opposite counter-force<br>to offset the resistance | Yes | Yes | No difference |
| Compensation works in both inspiration and<br>expiration phases | Yes | Yes | No difference |
| Users must set up the tube type, size and<br>compensation intensity | Yes | Yes | No difference |
| Display on-line a calculated intra-tracheal<br>pressure curve | Yes | Yes | No difference |

| C. Danuser | Page 6 of 7 | 2004-01-29 |
|------------------------------------|-------------|--------------|
| © Copyright by HAMILTON MEDICAL AG | | CONFIDENTIAL |

{5}------------------------------------------------

| Project-Name: | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc.-No.: | E35103 Part 2 |
|---------------|---------------------------------------------------------------|---------------|---------------|
| Doc.-Title: | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version: | 1.1 |

# MMV* (MANDATORY MINUTE VENTILATION WITH ADVANCED PERFORMANCE)

| Major feature of ventilation | MMV+ | MMV | Automode | |
|-----------------------------------------------------|---------------------|---------------------------------------------------|------------------------|-----|
| Product name | Galileo Gold | Evita 4 | Servo1 and Servo 300 A | |
| Manufacturer | Hamilton<br>Medical | Draeger | Siemens | |
| | | | PRVC | VS |
| User sets target minute ventilation | Yes | Yes | Yes | No |
| User sets target tidal volume | Yes | Yes | Yes | No |
| User sets target rate | Yes | Yes<br>(only the<br>minimum<br>mandatory<br>rate) | Yes | No |
| Regulated inspiratory pressure | Yes | No | Yes | Yes |
| Regulated respiratory rate | Yes | Yes | No | No |
| Assured minimum target minute<br>ventilation | Yes | Yes | Yes | No |
| Switch between mandatory and<br>spontaneous breaths | Yes | No | Yes | |

| t the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first for the first<br>Januser | aloe | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CALLA<br>10. 14. 11<br>As a version of " " " "<br>:<br><br>.<br><br>Property and an an and the province<br>© GT<br>- CODVI-<br>- ANDRECHOAL - | <br>August 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -<br><br>.<br>.<br>. .<br>. SALE FER<br>And Include and<br> | 2004-01-<br>Company Comments of Children<br>Call And Childer Species Children March 19 to Children<br><br>C = = = = = = = = = = = = = = = = = = = = = = =<br><br><br>.<br> |
| <br><br>AND AUGUALL LA-LA-LA-LA-<br>. MILE E E MILLE B LE BELL B LE LEBERT . BE COLLECT . CONTRACT . CONTRACT . CONTRACT . CONTRACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTAC | <br><br><br>MARKA ARRENA ARABARA AND AND AND AND AND<br>Station Andrews Children Arts Children Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company<br>State and the designed and second consideration of the commender of the commended to the commend | ARTHER<br>Comments of the consisted to the |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

OCT 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. J. David Thompson General Manager Hamilton Medical, Incorporated P.O. Box 30008 Reno. Nevada 89520

Re: K040574

Trade/Device Name: Galileo Gold Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 30, 2004 Received: October 1, 2004

Dear Mr. Thompson:

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.

{7}------------------------------------------------

#### Page 2 -- Mr. Thompson

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/dsma/dsmamain.html

Sincerely yours,

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

{8}------------------------------------------------

#### INDICATIONS FOR USE

510(k) Number: K 040574

#### Device Name: Galileo Gold ventilator

- The Galileo Gold ventilator is intended to provide positive pressure ventilatory Indication for Use: 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 or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.
Prescription Use X (Per 21 CFR 801 Subpart D)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Century O, on for AAC

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

510(k) Number: kφ4φS74

Page 1 of _1