Predicate Devices

K02267, K984535, K001646, K010093, K010925, K022132, K970839, K980642, K992608

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the software modifications and performance studies do not mention any AI/ML techniques.

Therapeutic

Yes
The device is a ventilator, which provides ventilatory support to patients, directly impacting their physiological function to maintain life.

Diagnostic

No
The device is described as a ventilator, which provides ventilatory support, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a ventilator, which is a hardware medical device. The 510(k) describes software modifications to an existing hardware device, not a standalone software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device provides "positive pressure ventilatory support." This is a life-support function, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as an "intensive care ventilator." Ventilators are used to assist breathing, not to diagnose diseases or conditions.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening

The device's function is to provide mechanical ventilation, which is a therapeutic intervention, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

CBK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults, Pediatrics and Infants.

Intended User / Care Setting

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.

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K02267, K984535, K001646, K010093, K010925, K022132, K970839, K980642, K992608

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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
10	SUMMARY	OCT 27 2004
APPLICANTS NAME AND
ADDRESS		Hamilton Medical AG
Via Nova
CH-7403 Rhaezuens
Switzerland
APPLICANTS CONTACT PERSON		Dr. Andreas Scheibe
Phone: +41 81 660 60 10
Fax: +41 81 660 60 20
e-mail: ascheibe@hamilton-medical.ch
APPLICANTS CONTACT PERSON
IN THE USA		Hamilton Medical Inc.
Mr. David Thompson
Post Office Box 30008
Reno, NV 89520
Phone: 775-858-3200, Extension 349
Fax: 775-856-5621
e-mail: thompson@hammed1.com
Establishment Registration 2937708
DATE THE SUMMARY WAS
PREPARED
COMMON NAME		Continuous Ventilator
PROPRIETARY NAME		GALILEO Gold
PURPOSE OF SUBMISSION		New features for existing, legally marketed instrument
in the US (K982910, K001686)
CLASSIFICATION		Name: Ventilator, Continuous (per 21 CFR 868.5895)
Panel: Anesthesiology
Code: CBK
REGULATORY STATUS		1. Current Device Class: Class 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
DuoPAP and APRV modes	Manufacturer	510(k) number(s)	Classification
RAPHAEL	HAMILTON Medical
AG	K02267	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
Puritan Bennett 840	Nellcor Puritan-Bennett	K984535, K001646	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
NIV mode
Evita 4	Draeger
Medizintechnik AG	K010093	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
MMV+ mode
Siemens Servo'	Siemens-Elema AB	K010925, K022132	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
Siemens Servo 300A	Siemens-Elema AB	K970839	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
Evita 4	Draeger
Medizintechnik AG	K980642	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895
TRC feature
Evita 4	Draeger
Medizintechnik AG	K992608	Ventilator, Continuous,
Facility Use per 21
CFR 868.5895

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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
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2004-01-29 |
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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,
K993071, K001646,
K021573	K022679	---
Automatic and regular
switchover between two
pre-set pressure levels	Yes	Yes	Yes	No
difference
The ventilated patient can
breathe freely at either
pressure level	Yes	Yes	Yes	No
difference
The spontaneous breaths
may be pressure-supported
if desired	Yes	Yes	Yes	No
difference
The "control breaths" are
synchronized to the
spontaneous breaths by the
ventilated patients	Yes	Yes	Yes	No
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
differences |
|--------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------|
| Product name | Galileo Gold | Evita | --- |
| Manufacturer | Hamilton Medical | Draeger | --- |
| The 510(k) | To be assigned | K961687, K980642,
K992608, K010093 | --- |
| Underlying mode | Pressure support | Pressure support | No differences |
| How the inspiration is
triggered | Patient-triggered | Patient-triggered | No differences |
| How the inspiration is
limited | Pressure-limited | Pressure-limited | No differences |
| How the inspiration is
terminated | Flow-cycled (first)
Time-cycled (second) | Flow cycled (first)
Time-cycled (second) | No differences |
| Indicated patient population | For spontaneously
breathing patients only | For spontaneously
breathing patients only | No differences |
| Apnea ventilation possible? | Yes | Yes | No differences |

TRC (TUBUS RESISTANCE COMPENSATION):

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

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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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