(330 days)
Not Found
No
The summary describes a traditional electronically controlled pneumatic ventilator with new features like nebulization, cuff pressure control, and new ventilation modes. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes.
The device is a ventilator, which is used to provide positive pressure ventilatory support, indicating it is directly involved in treating a patient's medical condition.
No
The device is described as a ventilator, providing ventilatory support and delivering gas. While it monitors and controls certain physiological parameters (like cuff pressure), its primary function is therapeutic (ventilatory support), not diagnostic. It does not identify or diagnose a condition.
No
The device description clearly outlines hardware components such as pneumatics, electrical systems, LCD-display with touch screen, keys, and a press-and-turn knob, indicating it is not software-only.
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 provides "positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients." This describes a life support device that directly interacts with the patient's respiratory system.
- Device Description: The description details a system that "delivers gas," "controls pneumatics," "monitor alarms," and includes features like nebulization and cuff pressure control. These are all functions related to mechanical ventilation and patient support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. IVD devices are typically used in laboratories or at the point of care for analyzing biological samples.
Therefore, the HAMILTON-G5 ventilator is a therapeutic and monitoring 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 to adult and pediatric patients, and optionally to infant and neonatal patients. 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 or heliox to ventilate adults, pediatrics, infants, and neonates. 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-and-turn knob. The new nebulization function with AERONEB nebulizers is for use with mechanically ventilated patients to aerosolize physician prescribed medications for inhalation. The new cuff pressure controller implemented in the HAMILTON-G5 is for continuous monitoring and adjustment of the cuff pressure of a tracheal or tracheostomy tube. nCPAP-PS is a new ventilation mode which applies nCPAP with additional pressure support by nasal interfaces with reduced dead space on neonates. NIV-ST is a new mode available for adult and pediatric patients. It delivers pressure-controlled, time-cycled mandatory breaths and pressure-supported, flow-cycled spontaneous breaths by a mask or other noninvasive patient interface.
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, by properly trained personnel under the direct supervision of a licensed physician.
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)
No clinical testing was conducted or required in support of this premarket clearance notification.
Safety testing of the HAMILTON-G5 with the new options was conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards. The test results show that the device is safe and effective for its intended use.
The ventilator was further subject to wave-form performance testing as described in the standard ASTM F1100-90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device.
The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092148, K080181, K072412, K983219, K092733, K081842
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/0 description: The image shows a handwritten string of characters. The characters appear to be "K1038803". The characters are written in a cursive style, with some of the numbers being connected. The image is in black and white.
510(k) Summary
| Submitter: | HAMILTON MEDICAL AG |
|---|---|
| Via Crusch 8 | |
| 7402 Bonaduz, Switzerland | |
| Contact Person: | Name: Frederike Brühschwein |
| Phone: +41 81 660 6568 | |
| Fax: +41 81 660 6020 | |
| Preparation Date: | 2011-11-02 |
| 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 | HAMILTON-C2 (K092148) |
| HAMILTON-GALILEO (K080181) | |
| which equivalence is being | Dräger EvitaXL with NeoFlow and SpO2 |
| claimed: | options (K072412, K983219) |
| ARM PYTON ETT Cuff Pressure Regulator | |
| (K092733) | |
| GE Datex-Ohmeda Engström Carestation | |
| (K081842) |
Device Description
The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system.
It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. 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-and-turn knob. The new nebulization function with AERONEB nebulizers is for use with mechanically ventilated patients to aerosolize physician prescribed medications for inhalation. The new cuff pressure controller implemented in the HAMILTON-G5 is for continuous monitoring and adjustment of the cuff pressure of a tracheal or tracheostomy tube. nCPAP-PS is a new ventilation mode which applies nCPAP with additional pressure support by nasal interfaces with reduced dead space on neonates. NIV-ST is a new mode available for adult and pediatric patients. It delivers
1
pressure-controlled, time-cycled mandatory breaths and pressure-supported, flow-cycled spontaneous breaths by a mask or other noninvasive patient interface.
Intended use
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas 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.
The device 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.
SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES
The indication statements for the HAMILTON-G5 ventilator are comparable to those for the predicate devices.
Technological characteristics and performance specifications of the HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices.
The new nebulization function is comparable to the nebulization function in the predicate device Engström Carestation.
The new cuff pressure controller is considered to be substantial equivalent to the PYTON ETT Cuff Pressure Regulator.
The new NIV-ST mode is equivalent to the NIV-ST mode in the HAMILTON-C2 and the new nCPAP-PS mode can be compared with the PCV+/Assist, mask ventilation mode of the Evita XL.
HAMILTON MEDICAL has demonstrated the modified HAMILTON-G5 ventilator to be safe and effective.
The ventilator is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTS
Safety testing of the HAMILTON-G5 with the new options was conducted according to IEC60601-1, IEC60601-1-2, IEC 60601-2-12 and other applicable standards. The test results show that the device is safe and effective for its intended use.
The ventilator was further subject to wave-form performance testing as described in the standard ASTM F1100-90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device.
2
The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted or required in support of this premarket clearance notification.
SUMMARY OF OTHER INFORMATION
This submission included comparison of intended use statements, proposed product labeling and summary information and labeling on predicate devices.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The results of verification, validation, and testing activities demonstrate that the modified HAMLTON-G5 ventilator is as safe, as effective, and performs as well as or better than the legally marketed devices identified above.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HAMILTON MEDICAL AG C/O Mr. Brain Edwards Senior Consultants, Regulatory Services MDGI 49 Plain Street North Attleboro, Massachusetts 02764
Re: K103803
Trade/Device Name: HAMILTON-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 21, 2011 Received: November 22, 2011
Dear Mr. Edwards:
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, subiect 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
NOV 2 3 2011
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Page 2 - Mr. Edwards
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. nut
Anthony D. Watson, B.S., M.S., M.B.A. 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: | HAMILTON-G5 |
| Indication for Use: | The HAMILTON-G5 ventilator is intended to provide positive |
| pressure ventilatory support to adult and pediatric patients, and | |
| optionally to infant and neonatal patients. | |
| 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 _ X (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)
Susan Penn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
103803 510(k) Number: _______________________________________________________________________________________________________________________________________________________________