HAMILTON-C3
Device Facts
| Record ID | K123637 |
|---|---|
| Device Name | HAMILTON-C3 |
| Applicant | Hamilton Medical AG |
| Product Code | CBK · Anesthesiology |
| Decision Date | Dec 21, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates. Intended areas of use: · In the intensive care ward or in the recovery room. · During transfer of ventilated patients within the hospital. The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Device Story
HAMILTON-C3 is a continuous ventilator for adult, pediatric, infant, and neonatal patients in critical care or during hospital transport. Device features a turbine and internal batteries for mobility. Input data includes respiratory parameters and patient signals; system processes these via a touchscreen 'Ventilation Cockpit' GUI. Device provides invasive and non-invasive ventilation modes, including ASV (Adaptive Support Ventilation) and IntelliSync, to automate lung-protective strategies and weaning. Output includes real-time waveforms, trended monitoring parameters (up to 72 hours), and alarm notifications. Clinicians use the 12.1" display to monitor patient status and adjust ventilation settings. Device benefits include reduced operator error, early weaning, and continuous support during patient movement.
Clinical Evidence
Bench testing only. No clinical data presented. Safety and effectiveness established through software verification, validation, and adherence to recognized standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, and ISO 14971.
Technological Characteristics
Continuous ventilator with turbine and battery power. Features 12.1" touchscreen display. Supports invasive/non-invasive modes (ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, PSIMV+ with IntelliSync). Connectivity includes sidestream CO2 monitoring. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-12, IEC 62304, IEC 62366, ISO 5356-1, AAMI/ANSI HE75, and ISO 14971.
Indications for Use
Indicated for positive pressure ventilatory support for adult, pediatric, infant, and neonatal patients in intensive care, recovery rooms, or during intra-hospital transport. Must be used by qualified personnel under physician direction.
Regulatory Classification
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.
Predicate Devices
- HAMILTON-C2 (K121225)
Reference Devices
- Draeger Evita XL (K083050)
- Maquet Servo-i (K073179)
- CareFusion Avea (K103211)
- GE Carestation (K111116)
- HAMILTON-G5 (K103803)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is composed of two lines of text, with "HAMILTON" on the top line and "MEDICAL" on the bottom line. To the right of the word "HAMILTON" is a circular logo with a stylized "H" inside. The text is in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the text "HAMILTON-C3" in a bold, sans-serif font. The text is all uppercase, with a hyphen separating "HAMILTON" and "C3". The letters are solid black against a white background, creating a high-contrast image.
# 510(k) SUMMARY
K123637
| SUBMITTER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>Bonaduz, Grisons 7402<br>SWITZERLAND | DEC 2 1 2012 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Ralph Aguila<br>Regulatory Affairs / Quality Engineer<br>Phone: +41 81 660 6845<br>Fax: +41 81 660 6020<br>e-mail: raaguila@hamilton-medical.ch | |
| ESTABLISHMENT<br>REGISTRATION #: | 3001421318 | |
| PREPARATION DATE: | December 19th, 2012 | |
| TRADE NAME: | HAMILTON-C3 | |
| COMMON NAME: | Continuous Ventilator | |
| CLASSIFICATION NAME: | Class II Ventilator, Continuous | |
| REGULATION NUMBER: | 21 CFR 868.5895 | |
| PRODUCT CODE: | CBK | |
| PREDICATE DEVICE: | HAMILTON-C2 (K121225) | |
Image /page/0/Picture/9 description: The image shows the "Swiss Quality" logo. The logo consists of a white cross inside of a black circle on the left. To the right of the symbol, the words "Swiss Quality" are written in black.
Image /page/0/Picture/6 description: The image shows the logo for IntelliSync NEO. The logo consists of a stylized "S" inside a circle, followed by the word "INTELLISYNC" in bold, sans-serif font. To the right of "INTELLISYNC" is the word "NEO", also in bold, sans-serif font.
・
:
Image /page/0/Picture/7 description: The image shows a recycling symbol with the letters "ASV" in the center. The symbol consists of three arrows forming a triangle, which is a common representation of recycling. The letters "ASV" are placed within the triangle, possibly indicating a specific recycling program or company.
INTELLITRIQ
{1}------------------------------------------------
# DEVICE DESCRIPTION
- The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.
- 1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
- 2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
- 3. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
- 4. The HAMILTON-C3 includes a 12.1" wide-screen monitor.
# INTENDED USE
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.
Intended areas of use:
- · In the intensive care ward or in the recovery room.
- · During transfer of ventilated patients within the hospital.
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
# SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATE DEVICES
The intended use statement for the modified HAMILTON-C3 ventilator is substantially equivalent to that of the predicate device. The technological characteristics (i.e., design, material, energy source) and performance specifications of the proposed HAMILTON-C3 ventilator are substantially equivalent to those of the predicate device. The only difference between the predicate HAMILTON-C2 and the HAMILTON-C3 is the screen size. The HAMILTON-C2 has a 10.4" screen size. Alternatively, the HAMILTON-C3 has a 12.1" screen size. Additionally, because of the extra space from the larger and wider screen, the HAMILTON-C3 displays up to 4 waveforms simultaneously, as well as all the 7 different alarm-limitation parameters, while the HAMILTON-C2 can only display 2 waveforms and the alarm-limitation parameters are divided in two different windows. In addition, the I:E values are now shown on the main screen of the HAMILTON-C3 on the lower left-hand corner.
Image /page/1/Picture/17 description: The image contains a logo with a white cross inside of a black circle. To the right of the logo, the words "Swiss Quality" are written in black font. The text is stacked vertically, with "Swiss" on top of "Quality". The image appears to be a close-up of a product label or advertisement.
{2}------------------------------------------------
# HAMIL
Image /page/2/Figure/2 description: The image shows a screen display from a medical device, likely a ventilator, displaying various parameters and waveforms. Numerical values such as '26', '3.1', '507', '16', and '1:1' are visible on the left side, possibly representing respiratory measurements. The right side of the screen displays 'ASV Adult/Ped', '155% MinVol', '10 cmH2O PEEP/CPAP', and '50% Oxygen', along with buttons labeled 'Controls' and 'Alarms'.
# COMPARISON TABLE BETWEEN PROPOSED AND PREDICATE DEVICE
The following table compares the HAMILTON-C3 with its predicate device, the HAMILTON-C2. In addition, a further comparison is made with other FDA-cleared ventilators with similar features.
| | Proposed<br>device:<br>HAMILTON-<br>C3 | Predicate<br>device:<br>HAMILTON-<br>C2<br>(K102775) | Draeger<br>Evita XL<br>(K083050) | Maquet<br>Servo-i<br>(K073179) | CareFusion<br>Avea<br>(K103211) | GE<br>Carestation<br>(K111116) | HAMILTON-<br>G5<br>(K103803) |
|-------------------------------|----------------------------------------|------------------------------------------------------|----------------------------------|--------------------------------|---------------------------------|--------------------------------|------------------------------|
| Screen size | 12.1" | 10.4" | 15" | 12" | 12" | 12" | 15" |
| # of Waveforms | 4 | 2 | 3 | 3 | 3 | 3 | 4 |
| Minimal Tidal<br>Volume | 2 mL | 2mL | 3 mL | 2mL | 2 mL | 2 mL | 2 mL |
| Maximum In-<br>spiratory Flow | 240<br>L/min | 240<br>L/min | 120<br>L/min | 180<br>L/min | 150<br>L/min | 160<br>L/min | 180<br>L/min |
| Monitoring | Ti, Te, PTP,<br>RCexp | Ti, Te, PTP,<br>RCexp | No Ti / Te | N/A | No Te /<br>PTP | No PTP /<br>RCexp | Ti, Te, PTP,<br>RCexp |
| Battery time | 390 min. | 390 min. | 120 min. | 180 min. | 60 min. | 120 min. | 120 min. |
| Sidestream CO2 | Yes | Yes | No | No | No | Yes | Yes |
Image /page/2/Picture/6 description: The image shows a logo with the words "Swiss Quality" next to a white cross inside of a gray circle. The cross is a symbol often associated with Switzerland. The text is in a simple, sans-serif font and is aligned to the right of the cross.
{3}------------------------------------------------
# HAMILTON.C3
# DISCUSSION ON THE NON-CLINICAL PERFORMANCE TESTS
The non-clinical test results show that the HAMILTON-C3 is safe and effective for its intended use. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.
Below is a list of standards and guidance documents recognized by FDA to establish the basis of safety and effectiveness for the HAMILTON-C3:
| | Draft Reviewer Guidance for Ventilators.1995. | |
|----------------|----------------------------------------------------------|--|
| IEC 60601-1 | General Requirements for Safety. | |
| IEC 60601-1-2 | Electromagnetic Compatibility. | |
| IEC 60601-1-4 | Programmable electrical medical systems. | |
| IEC 60601-1-8 | Alarm Systems | |
| IEC 60601-2-12 | Critical Care Ventilators. | |
| IEC 62304 | Software life-cycle processes. | |
| IEC 62366 | Application of usability engineering to medical devices. | |
| ISO 5356-1 | Conical connectors: Part 1: Cones and sockets. | |
| AAMI/ANSI HE75 | Human factors engineering. Design of medical devices. | |
| ISO 14971 | Application of risk management to medical devices. | |
## CONCLUSION
A complete revision level history, hazard analysis, and a traceability analysis linking requirements to validation were done. The results of foregoing tests, along with the necessary verification and validation tests, demonstrate that the modified HAMILTON-C3 ventilator is as safe, as effective, and performs just as well as the HAMILTON-C2. HAMILTON MEDICAL has demonstrated the proposed HAMILTON-C3 ventilator to be as safe and effective as the predicate device.
Image /page/3/Picture/8 description: The image contains a logo with a white cross inside a black circle on the left. To the right of the logo, the words "Swiss Quality" are written in a simple, sans-serif font. The text is stacked vertically, with "Swiss" on top of "Quality". The overall design is clean and professional, suggesting a focus on quality and Swiss origin.
Image /page/3/Picture/10 description: The image shows a logo with the letters "ASV" inside a circle. The letters are in bold, and the circle has a thick border. There are some other markings around the logo, but they are not clear enough to identify.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2012
Mr. Ralph Aguila Regulatory Affairs / Quality Engineer Hamilton Medical AG Via Crusch 8 Bonaduz, Grisons Switzerland 7402
Re: K123637
Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 21, 2012 Received: November 26, 2012
## Dear Mr. Aguila:
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. 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.
{5}------------------------------------------------
Page 2 - Mr. Aguila
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/CDRH0ffices/ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
**Kwame** O. **Ulmer**
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
# INDICATIONS FOR USE STATEMENT
510(k) Number:
K123637
Device Name:
HAMILTON-C3
Indication for Use:
The HAMILTON-C3 ventilator is intended to provide positive pres-I ne NAMETOR Sport to adults, pediatrics, infants and neonates.
Intended areas of use:
· In the intensive care ward or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
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)
Albert E. Moyal Albert E. 2012.12.19 Moyal 22:18:25 -05'00' · for LS
(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division of Ancol. Dental Devices
510(k) Number,
