HAMILTON-C2

{0}------------------------------------------------ Image /page/0/Picture/0 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. To the right of the word "HAMILTON" is a logo that appears to be a stylized letter "H" inside of a circle. The text is black and the background is white. ## 11-121-222-11 · HAMILTON. ## 510(k) SUMMARY : NOV 1 6 2012 | SUBMITTER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>Bonaduz, Grisons 7402<br>SWITZERLAND | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | 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: | 2012-10-23 | | TRADE NAME: | HAMILTON-C2 | | COMMON NAME: | Continuous Ventilator | | CLASSIFICATION NAME: | Class II Ventilator, Continuous | | REGULATION NUMBER: | 21 CFR 868.5895 | | PRODUCT CODE: | CBK | | PREDICATE DEVICE:<br>(PRIMARY) | HAMILTON-C2 (K102775) | | PREDICATE DEVICES:<br>(SECONDARY) | HAMILTON-G5 (K103803),<br>HAMILTON-T1 (K120670),<br>Draeger's Infinity Acute Care System<br>Workstation - Neonatal Care (K093632). | STITUELLI SYNC NEO Image /page/0/Picture/5 description: The image shows a logo with the words "Swiss Quality" to the right of a symbol. The symbol is a white cross inside of a circle. The cross has thick lines and rounded edges. Image /page/0/Picture/6 description: The image contains two logos. The first logo is for Intellitrig, and the second logo is a recycling symbol with the letters ASV inside. The Intellitrig logo is a stylized wordmark with a unique font. The ASV logo is a circular recycling symbol with arrows pointing in a clockwise direction. {1}------------------------------------------------ Image /page/1/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 symbol that appears to be a stylized "H" inside of a circle. The text is in a bold, sans-serif font. #### DEVICE DESCRIPTION The HAMILTON-C2 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C2 is also able to ventilate infants and neonates. The HAMILTON-C2 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, HAMILTON-G5, and HAMILTON-T1, 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-C2 includes the ASV ventilationmode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning. The HAMILTON-C2 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAML-TON-C2 offers ventilation modes that provide full and partial ventilatory support. - 1. The HAMILTON-C2 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+ with IntelliSync, and PSIMV+ without IntelliSync. - 2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours. - 3. The new HAMILTON-C2 offers the mode option of both "PSIMV+ with IntelliSync" and "PSIMV+ without IntelliSync". In the previously cleared version of the HAMILTON-C2, the only version of PSIMV+ that was included had IntelliSync. - 4. The ability to turn off the Apnea alarm in the nCPAP-PS mode. - 5. Because some clinicians prefer to set the rate and the inspiration time Ti and other clinicians prefer to set the rate and the inspiration-expiration ratio I:E to define the timing of mandatory breaths in controlled modes. Therefore, both options are available in the proposed HAMILTON-C2 #### INTENDED USE The HAMILTON-C2 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-C2 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. Image /page/1/Picture/16 description: The image shows a logo with the words "Swiss Quality" next to a symbol. The symbol is a white cross inside of a circle. The cross is similar to the Swiss flag. The logo is likely used to indicate that a product or service is of Swiss origin or meets Swiss quality standards. Image /page/1/Picture/17 description: The image contains a recycling symbol with the letters "ASV" inside. To the right of the symbol is the word "Part". The image is black and white. {2}------------------------------------------------ # HAMIL #### SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COM-PARISON WITH THE PREDICATE DEVICES The intended use statement for the modified HAMILTON-C2 ventilator is substantially equivalent to that of the primary predicate device. The technological characteristics (i.e., design, material, energy source) and performance specifications of the proposed HAMILTON-C2 ventilator are substantially equivalent to those of the predicate devices. HAMILTON MEDICAL has demonstrated the proposed HAMILTON-C2 ventilator to be as safe and effective as the predicate devices. PSIMV+ with IntelliSync is a mode that delivers pressure-controlled, time-cycled mandatory breaths and pressure supported, flow-cycled spontaneous breaths. As with the PCV+ mode, PSIMV+ with IntelliSync delivers a preset pressure, but does not guarantee a fixed tidal volume, especially during changes in respiratory system compliance, airway resistance, Auto-PEEP, or the patient's respiratory activity. The graphic below illustrates this principle: Image /page/2/Figure/5 description: This image shows a graph of pressure (P) over time (t) during mechanical ventilation. The graph illustrates both machine-triggered mandatory breaths and patient-triggered spontaneous breaths. The pressure limit, Pinsp, is the same for both machine and patient-triggered breaths during the inspiratory phase. For PSIMV+ without IntelliSync, the mandatory breaths are PCV+ breaths which can be alternated with SPONT breaths. PSIMV+ without IntelliSync does not guarantee the delivery of an adequate tidal volume at all times. Therefore, when using this mode, the operator must carefully monitor changes in the patient's status. The following graphic illustrates the previous points: Image /page/2/Figure/7 description: This image shows a graph of pressure (P) over time (t) during mechanical ventilation. The graph shows two types of breaths: machine-triggered mandatory breaths and patient-triggered spontaneous breaths. The machine-triggered breaths reach a higher pressure, labeled as "Pcontrol", while the patient-triggered breaths reach a lower pressure, labeled as "Psupport". Image /page/2/Picture/8 description: The image shows a logo with the words "Swiss Quality" to the right of a symbol. The symbol is a white cross inside of a circle. The cross is similar to the Swiss flag. Image /page/2/Picture/9 description: The image contains two logos. The first logo is for "TELLTRIG" and the second logo is a recycling symbol with the letters "ASV" in the center. The recycling symbol is made up of three arrows pointing in a circular motion. The image is in black and white. {3}------------------------------------------------ # HAMILTON.C Lastly, nCPAP-PS is designed to apply nasal continuous positive airway pressure with additional pressure support to infants and neonates. With the new version of the HAMILTON-C2, the operator has the ability of turning off the apnea alarm in the nCPAP-PS mode. However, the minimum respiratory rate for patients in this mode remains 15 b/min to 150 b/min. ### DISCUSSION ON THE NON-CLINICAL PERFORMANCE TESTS The non-clinical test results show that the HAMILTON-C2 is safe and effective for its intended use. The HAMILTON-C2 was further subjected to waveform performance testing as described in the standard ASTM F1100-90. 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-C2: | | 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-C2 ventilator is as safe, as effective, and performs just as well as the other legally marketed predicate devices identified above. INTELLIS Image /page/3/Picture/9 description: The image shows a logo with the words "Swiss Quality" to the right of a symbol. The symbol is a white cross inside of a circle. The cross is similar to the Red Cross symbol, but it is white instead of red. The words "Swiss Quality" are written in a simple, sans-serif font. Image /page/3/Picture/10 description: The image contains two logos. The first logo on the left says "INTELLITRIG" in a stylized font with a cross-like symbol above it and two curved lines below. The second logo on the right is a circular symbol with the letters "ASV" inside, surrounded by arrows indicating a recycling or circular process. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract image of an eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Mr. Ralph Aguila Regulatory Affairs / Quality Engineer Hamilton Medical AG Via Crusch 8 Bonaduz, Grisons Switzerland 7402 Re: K121225 Trade/Device Name: Hamilton-C2 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 23, 2012 Received: October 31, 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 approvisions of the Act. The general controls provisions of the Act include ventrements 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 Eederal Register. {5}------------------------------------------------ #### Page 2 - Mr. Aguila I age 2 = Mr. Againa 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 mount that I Bringederal statutes and regulations administered by other Federal agencies. or mo recor any 1 oustal the Act's requirements, including, but not limited to: registration 1 ou intine (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (roporting of invents as set forth in the quality systems (QS) regulation (21 CFR Part 820); production one 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/ucml ! 5809.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 1 ou may 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, DN: c=US, o=U.S. Govemment, ou=HHS Du=FDA ou=People cn=Anthony D 0.9.2342.19200300.100.1.1=1300092402 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: #### K121225 Device Name: #### HAMILTON-C2 Indication for Use: The HAMILTON-C2 ventilator is intended to provide positive The FrAmEPOW 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-C2 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a of its stated technical physician and within the limits 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) ## Lester W. Schultheis Jr 2012.11.16 10:54:50 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospitci Division Control. Dental Devices (Division of Anesthesiology, Contail Devicess Infection of Anesthology, Dental Devicess Infection Control, Dental Devices . K121225 510(k) Number:_