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

AI/ML Overview

The provided document focuses on the Hamilton Medical GALILEO GoldASV ventilator and its substantial equivalence to predicate devices, rather than an AI-powered diagnostic device. Therefore, a direct application of the requested acceptance criteria and study details for an AI-powered device is not fully applicable.

However, I can extract the relevant information regarding the performance and safety assessment of the GALILEO GoldASV ventilator, specifically its new ASV mode, and structure it as closely as possible to your request for an AI device, by interpreting "acceptance criteria" as the demonstration of safety and effectiveness.

Here's an analysis based on the provided text:

Device: GALILEO GoldASV Ventilator (specifically the new ASV mode)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Interpreted)	Reported Device Performance (Summary)
Safety and Effectiveness of the ASV mode with closed-loop control	"Assessment and clinical performance data affirm that the ASV mode using RCero as feedback signal for the closed-loop control is safe and effective." "User assessments show that the extended ASV mode is as safe, as effective, and performs clinically as well as the predicate devices."
No performance deviations during testing (modular, integration, system level)	"There were no performance deviations observed or documented during testing."
Compliance with ASTM Standard F1100-93	"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."
Absence of adverse effects, complications, or required reintubation in clinical use of ASV	"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."
Impact of new software on microcomputer system	"The impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing."
Substantial equivalence to predicate devices (GALILEO Gold K040574 and Dräger EvitaXL K051263)	"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)."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of an AI study. The document refers to "Performance data of patients with normal lungs and diverse respiratory failures, ventilated with the ASV technology."
Data Provenance: Not specified, but likely from clinical settings where the ASV technology was used. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable here as the device is a ventilator, not an AI diagnostic system requiring expert-established ground truth for a test set. The efficacy and safety are assessed through engineering tests and clinical observations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The assessment involves performance testing and clinical observation, not expert adjudication of diagnostic outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a ventilator, not an AI-assisted diagnostic tool for human readers. The document highlights "User assessments show that the extended ASV mode is as safe, as effective, and performs clinically as well as the predicate devices," suggesting a comparison of the device's performance to existing ones, but not an MRMC study with human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone ventilator with an automated ASV mode (a closed-loop controller). Its performance was evaluated on its own ("The performance/qualification testing of the new added GALILEO Gold feature ASV has been done on modular, integration and system level"). The ASV mode operates automatically by continuous repetition of steps, implying an algorithm-only function once set up by the clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for a ventilator's performance is typically established through:

Engineering specifications and testing (e.g., meeting flow and pressure targets).
Physiological outcomes data (e.g., maintained minute ventilation, not exceeding plateau pressure, automatic control return as spontaneous ventilation begins).
Clinical observations and "no adverse effects, complications or required reintubation" as reported from patient data.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model trained on a specific dataset. The "training" for the ventilator's algorithm is embedded in its design based on physiological principles (e.g., minimal work of breathing method by Otis).

9. How the ground truth for the training set was established

Not applicable, as it's not an AI training set in the conventional sense. The "ground truth" for the ASV algorithm's behavior is rooted in established physiological models and engineering principles to achieve desired ventilatory support.

Summary

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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 AGVia Crusch 8CH-7402 BonaduzSwitzerland
CONTACT PERSON:	Joerg SchneiderPhone: +41 81 660 6479Fax: +41 81 660 60 20e-mail: jschneider@hamilton-medical.ch
PREPARATION DATE:	April 11, 2006
TRADE NAME:	GALILEO GoldASV
COMMON NAME:	Continuous Ventilator
CLASSIFICATION NAME:	Ventilator, Continuous, Facility Use(21 CFR 868.5895, Product Code CBK)
REASON FOR THIS 510(K) SUBMISSION:	The GALILEO GoldASV is a softwaremodified version of the legally marketeddevice GALILEO Gold (K040574)
LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED:	HAMILTON GALILEO Gold510(k) Number: K040574Dr\u00e4ger EvitaXL with option SmartCare510(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

1. Assess the patient breath-by-breath.
1. Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607).
1. 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 (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 (240) 276-3150 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(Part 21 CFR 801 Subpart D)	X
	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Juven

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

K061090

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).