(152 days)
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.
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.
The provided text describes the HAMILTON MEDICAL GALILEO Gold ventilator, but it does not contain the detailed information necessary to complete a table of acceptance criteria and the study that proves the device meets those criteria, as typically required for AI/machine learning device submissions.
The document is a 510(k) summary for a continuous ventilator, which is a hardware medical device rather than an AI/ML-driven software device. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and nonclinical performance (waveform testing), rather than on specific acceptance criteria and detailed study results for an AI algorithm's performance.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
- Acceptance Criteria and Device Performance: The document states "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." It does not list specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) or the quantitative reported performance of the device against such criteria.
- Sample Size for Test Set and Data Provenance: No information on a "test set" in the context of AI/ML performance evaluation is provided. The testing mentioned is "wave-form performance testing," which likely involves engineering tests rather than patient studies for algorithm validation.
- Number of Experts and Qualifications: Not applicable to this type of device submission.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable, as this is a hardware ventilator, not an AI-assisted diagnostic tool.
- Standalone Performance: While the device has standalone performance in terms of its ventilation capabilities, it's not a standalone algorithm in the AI/ML sense.
- Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for a ventilator would be its physical performance against engineering standards.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device.
In summary, the provided 510(k) for the GALILEO Gold ventilator is for a traditional medical device and does not include the type of AI/ML performance acceptance criteria, study details, or ground truth methodologies that your request anticipates. The approval is based on substantial equivalence to predicate devices and nonclinical performance testing against industrial standards (like F1100-90) for its ventilation functions and safety.
{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 AGVia Crusch 87402 Bonaduz, Switzerland |
|---|---|
| CONTACT PERSON: | Joerg SchneiderPhone: +41 81 660 64 79Fax: +41 81 660 60 20e-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 MARKETEDDEVICES TO WHICHEQUIVALENCE ISBEING CLAIMED: | HAMILTON GALILEO GoldASV510(k) Number: K061090 |
| MAQUET Servo-i510(k) Number: K041223 | |
| GE Datex-Ohmeda Engström Carestation510(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
§ 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).