(90 days)
No
The description of the Adaptive Support Ventilation (ASV) mode details a rule-based, algorithmic approach to adjusting ventilation parameters based on patient assessment and a calculation method (Otis's minimal work of breathing). While it's a closed-loop system and adapts, it doesn't describe learning from data or using complex models typically associated with AI/ML. The "Assess," "Calculate," and "Approach" steps are deterministic and based on a defined physiological model, not a learned pattern.
Yes
The device is a ventilator intended to provide ventilatory support to patients, which is a therapeutic function.
No
Explanation: The device is described as a ventilator, which provides ventilatory support. While it assesses patient breath-by-breath to adjust ventilation, its primary function is therapeutic (providing breathing support), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "software modified version of the legally marketed device GALILEO Gold (K040574)" and refers to it as a "full-functioned intensive care ventilator." The performance studies also mention testing the "complete instrument" and the impact of the software on the "microcomputer system," indicating the presence of hardware components beyond just software.
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 description details a ventilator and its ventilation modes, including Adaptive Support Ventilation (ASV). This is consistent with a respiratory support device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on such analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This ventilator does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
CBK
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:
-
- Assess the patient breath-by-breath.
-
- Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607).
-
- Approach the target by automatically adjusting mandatory rate and inspiratory pressure.
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
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.
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 AG
Via Crusch 8
CH-7402 Bonaduz
Switzerland |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider
Phone: +41 81 660 6479
Fax: +41 81 660 60 20
e-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 software
modified version of the legally marketed
device GALILEO Gold (K040574) |
| LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED: | HAMILTON GALILEO Gold
510(k) Number: K040574
Dr\u00e4ger EvitaXL with option SmartCare
510(k) Number: K051263 |
1
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
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:
-
- Assess the patient breath-by-breath.
-
- Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607).
-
- 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).
2
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.
3
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.
4
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
5
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