(152 days)
Not Found
No
The summary describes a standard electronically controlled pneumatic ventilator and does not mention any AI or ML capabilities.
Yes
The device is a ventilator, which provides ventilatory support to patients, directly treating a medical condition.
No
The device is described as a ventilator, providing ventilatory support. Its functions involve delivering gas, controlling pneumatics, monitoring alarms, and distributing power, but not diagnosing conditions.
No
The device description explicitly states it is an "electronically controlled pneumatic intensive care ventilation system" with physical components like pneumatics, electrical systems, a user interface with an LCD display, touch screen, keys, and a knob. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the GALILEO Gold ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "positive pressure ventilatory support" to patients. This is a direct therapeutic intervention on a living patient, not a test performed on a sample taken from a patient outside the body.
- Device Description: The description details a system that delivers gas, controls pneumatics, monitors alarms, and has a user interface for controlling ventilation. This aligns with the function of a life support device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The GALILEO Gold ventilator's function is to support respiration in patients, which is a direct medical intervention.
N/A
Intended Use / Indications for Use
The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility 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 is an electronically controlled pneumatic intensive care ventilation system. It uses oxygen and air to ventilate adult, pediatric, infant, and neonatal patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The GALILEO Gold'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-and-turn knob. The GALILEO Gold provides audible and visual patient- and ventilator-related alarms.
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
adult, pediatric, infant, and neonatal patients
Intended User / Care Setting
hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport
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 ventilator was subject to wave-form performance testing as described in the standard F1100 - 90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device.
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 words "HAMILTON MEDICAL" in a bold, sans-serif font. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The letter "O" in "HAMILTON" has a logo inside of it.
JUN 2 4 2008
510(k) Summary
:
| SUBMITTER: | HAMILTON MEDICAL AG
Via Crusch 8
7402 Bonaduz, Switzerland |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Joerg Schneider
Phone: +41 81 660 64 79
Fax: +41 81 660 60 20
e-mail: jschneider@hamilton-medical.ch |
| PREPARATION DATE: | April 08, 2008 |
| TRADE NAME: | GALILEO Gold |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | Ventilator, Continuous, Facility Use
(21 CFR 868.5895, Product Code CBK) |
| LEGALLY MARKETED
DEVICES TO WHICH
EQUIVALENCE IS
BEING CLAIMED: | HAMILTON GALILEO GoldASV
510(k) Number: K061090 |
| | MAQUET Servo-i
510(k) Number: K041223 |
| | GE Datex-Ohmeda Engström Carestation
510(k) Number: K062710 |
1
DEVICE DESCRIPTION
The GALILEO Gold is an electronically controlled pneumatic intensive care ventilation system. It uses oxygen and air to ventilate adult, pediatric, infant, and neonatal patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The GALILEO Gold'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-and-turn knob. The GALILEO Gold provides audible and visual patient- and ventilator-related alarms.
INTENDED USE
The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients.
The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied.
The GALILEO Gold ventilator 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.
INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE NEW DEVICE COMPARED TO THE PREDICATE DEVICES
The technological characteristics of the previous GALILEO Gold^SV ventilator have not been changed for the new device GALILEO Gold. The expanding of the intended use to neonatal patients does not result in the use of new technological characteristics.
The GALILEO Gold's indication statements and its neonate ventilation characteristics are substantially equivalent to those of the predicate devices Servo-i and Engström Carestation.
NONCLINICAL PERFORMANCE TEST DATA SUBMITTED
The ventilator was subject to wave-form performance testing as described in the standard F1100 - 90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device.
CONCLUSION
HAMILTON MEDICAL has demonstrated the GALILEO Gold ventilator to be safe and effective when used as labeled.
This device is considered to be substantially equivalent to currently marketed predicate devices and the expanding of the intended patient population to neonates does not raise new questions of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2008
Mr. Joerg Schneider Quality Engineer, R&D Hamilton Medical AG Via Crusch 8 CH-7402 Bonaduz SWITZERLAND
Re: K080181
Trade/Device Name: GALILEO Gold Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 4, 2008 Received: June 9, 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.
3
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 Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Susan Gunn
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
4
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K080181 |
|---|---|
| Device Name: | GALILEO Gold |
| Indication for Use: | The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment. |
ਮ 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)
Minh Van
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K040181