(277 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional electronic and pneumatic control systems.
Yes
The device is a ventilator, which provides positive pressure ventilatory support to patients. This directly treats or alleviates a condition, aligning with the definition of a therapeutic device.
No
This device is a ventilator, designed to provide ventilatory support. Its function is therapeutic, not diagnostic. While it monitors and alarms, these features support ventilation, rather than diagnose a medical condition.
No
The device description explicitly details hardware components such as pneumatics, electrical systems, an LCD display with touch screen, keys, and a press-and-turn knob, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the HAMILTON-G5 ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing positive pressure ventilatory support to patients (adults, pediatrics, and infants). This is a direct treatment or life support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering gas and controlling ventilation, monitoring alarms, and distributing power. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document 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 samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, the HAMILTON-G5 ventilator falls under the category of a therapeutic or life support medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HAMILTON-G5 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 optionally infant patients.
The device is intended for use by properly trained personnel under the direct supervision of a licensed physician.
The HAMILTON-G5 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 intended for transportation outside the hospital or for use in the home environment.
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.
Indications for Use: The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and optionally 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 HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air to ventilate adult, pediatric and optionally infant patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The HAMILTON-G5'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-andturn knob.
The HAMILTON-G5 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 and optionally infant patients
Intended User / Care Setting
properly trained personnel under the direct supervision of a licensed physician.
for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed air is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.
healthcare professionals provide patient care, including use as a patient bedside for intra-facility 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)
Performance tests were performed, and the test results indicated that the device performed as specified.
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
3 9N K070513 11
510(k) Summary
NOV 2 6 2007
| SUBMITTER: | HAMILTON MEDICAL AG
Via Crusch 8
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: | Aug 10, 2007 |
| TRADE NAME: | HAMILTON-G5 |
| 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 |
1
DEVICE DESCRIPTION
The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air to ventilate adult, pediatric and optionally infant patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport.
The HAMILTON-G5'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-andturn knob.
The HAMILTON-G5 provides audible and visual patient- and ventilator-related alarms.
INTENDED USE
The HAMILTON-G5 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 optionally infant patients.
The device is intended for use by properly trained personnel under the direct supervision of a licensed physician.
The HAMILTON-G5 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 intended for transportation outside the hospital or for use in the home environment.
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 DEVICE
The indication statements for the HAMILTON-G5 ventilator are comparable to those for the predicate device.
Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are equivalent to those of the predicate device HAMILTON GALILEO Gold*SV (K061090).
HAMILTON MEDICAL has demonstrated the HAMILTON-G5 ventilator to be safe and effective. The HAMILTON-G5 is considered to be substantial equivalent to a currently marketed predicate device which has been previously cleared by FDA.
2
PERFORMANCE TESTS
Performance tests were performed, and the test results indicated that the device performed as specified.
CONCLUSION
The HAMILTON-G5 conforms to the FDA recognized standards for safety and performance issues with lung ventilators. This assures that the performance of this device can be considered safe and effective with respect to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2007
Mr. Joerg Schneider Quality Engineer, R&D Hamilton Medical AG Via Crusch 8 CH-7402 Bonaduz SWITZERLAND
Re: K070513
Trade/Device Name: HAMILTON-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 9, 2007 Received: November 16, 2007
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.
4
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.
Syrite Y. Michael Davis.
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: K070513
Device Name: HAMILTON-G5
Indication for Use: The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and optionally 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.
X 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)
Will Maly for m. Husband
(Division Sign-Off) ( Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K070513 510(k) Number: