HAMILTON-MR1

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Hamilton Medical. The logo consists of the word "HAMILTON" in bold, sans-serif font, with a stylized "H" symbol to the right. Below the word "HAMILTON" is the word "MEDICAL" in a similar bold, sans-serif font. The logo is simple and modern, and the use of bold fonts gives it a strong and professional look. ST ILTON "T TRI # 510(k) SUMMARY Image /page/0/Picture/3 description: The image is a black square with a white icon in the center. The icon depicts a radar-like symbol with concentric circles emanating from a central point, with the number "1m" above the circles. There are also left and right arrowheads on either side of the circles, suggesting a range or distance measurement. MRIcompliant Compatibility up to 1 n Image /page/0/Picture/5 description: The image is of an app icon. The icon is a black square with rounded corners. Inside the square is a flower-like design with six petals. The petals are different shades of white, gray, and black. NoCompA Image /page/0/Picture/7 description: The image shows a gray square with rounded corners. Inside the square is a gray triangle with the letters "MR" in bold, yellow font. The letters are stacked on top of each other, with "M" on top and "R" on the bottom. Image /page/0/Picture/8 description: The image is a square icon with rounded corners. The icon is gray and features a simple line drawing of a person lying on a gurney. The gurney has wheels and a handle, suggesting it is a medical stretcher. Image /page/0/Picture/9 description: The image is a square sign with rounded corners. The sign is gray with the word "HOSPITAL" at the top. Below the word is a large letter "H" in black. | SUBMITTER: | HAMILTON MEDICAL AG<br>Via Crusch 8<br>Bonaduz, 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<br>NUMBER: | 3001421318 | | PREPARATION DATE: | November 8th, 2013 | | TRADE NAME: | HAMILTON-MR1 | | CLASSIFICATION NAME: | CLASS II Ventilator, Continuous | | REGULATION NUMBER: | 21 CFR 868.5895 | | PRODUCT CODE: | CBK | | PREDICATE DEVICE:<br>(PRIMARY) | HAMILTON-C1<br>510(k) Number: K120574 | | PREDICATE DEVICE:<br>(SECONDARY) | UNI-VENT Eagle II MR ventilator<br>510(k) Number: K111473<br><br>AESTIVA/5 MRI anesthesia system<br>510(k) Number: K050055 | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" stacked on top of "MEDICAL". The "O" in Hamilton is replaced with a symbol that looks like a stylized "H" inside a circle. #### DEVICE DESCRIPTION Image /page/1/Picture/3 description: The image shows a black square button with a white icon on it. The icon depicts a person standing within a circular radar-like display, with the number "1m" at the top. There are left and right arrowheads on either side of the circle. Image /page/1/Picture/5 description: The image is of a logo. The logo is a black square with rounded corners. Inside the square is a flower-like design with six petals. The petals are different shades of gray, ranging from light gray to dark gray. Image /page/1/Picture/7 description: The image is a gray square with rounded corners. Inside the square is a gray triangle with the letters "MR" in bold, dark gray font. The letters are centered within the triangle. Image /page/1/Picture/8 description: The image is a gray square containing a black icon. The icon depicts a person lying on a gurney or hospital bed, which is supported by a wheeled frame. The person is shown in profile, lying flat on their back. The gurney has an X-shaped support structure with wheels at each of the four corners. Image /page/1/Picture/17 description: The image is a square icon for a hospital. The icon is gray with rounded corners. The letter "H" is in the center of the icon in a dark gray color. The word "HOSPITAL" is written in a smaller font above the "H". The HAMILTON-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It covers a full range of clinical requirements such as: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive Ventilation (NIV). It can be used at the 500 gauss line, in the presence of either 1.5T or 3T magnets. In the MRI environment, where strong magnetic fields pose a danger for both the patient and the operator, safety is the highest priority. With the effectively shielded, MRI-compatible HAMILTON-MR1 ventilator, ventilation performance and MR image quality is guaranteed throughout the procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less. The HAMILTON-MR1 can be used in ICU special care areas, cardiac surgery recovery rooms. step-down or sub-acute care units, and when transporting patients to the MRIdepartment. In these cases, the HAMILTON-MR1 guarantees uncompromised continuous ventilation care from the ICU to the MRI and back with its 6-hour long batteries. Alternatively, the HAMILTON-MR1 can be used as an MRI-proprietary ventilator, waiting in the MRI department for the patient. In the MR environment -- when the clinician is unable to stay close to the patient for routine adjustments -- the ASV mode adapts to the patient's lung condition. Positioning a medical device too close to the MRI can have fatal consequences and cause serious injury to the patient or clinician. In addition, significant financial losses can occur if an MRI shutdown is required. The HAMILTON-MR1's integrated gaussmeter continuously monitors the magnetic field and gives the clinician both an audible and a visual signal if the HAMILTON-MR1 is getting too close to the MRI magnet. For increased MRI safety and ease of use in the MR environment, the integrated gaussmeter continues monitoring -- even when the ventilator is not in use. Close proximity of the ventilator to the MRI machine is crucial. The HAMILTON-MR1 is a ventilator able to be used at a magnetic field strength of 500 gauss, without creating any MR image artifacts. Both the HAMILTON-MR1's software and ventilation modes are identical to the HAMILTON-C1. One can operate the HAMILTON-MR1 with the touch-screen or with a single-turn wheel. Hard keys give direct access to the most important functions. The two devices are identical with the exception of modifications related to the MR environment (e.g. integrated gaussmeter, special alarm indicators, MR-specific labeling, the reduction in ferromagnetic materials, the removal of the options board, and increased safety measures for battery removal or replacement). Due to these modifications, the HAMILTON-MR1 is able to withstand the challenging conditions found in the MR environment. With the large alarm lamp, a clinician can immediately identify an alarming HAMILTON-MR1 ventilator because the alarm lamp is located at the top of the device, even if the clinician is a long distance away or when several different devices are operating simultaneously in the same room. The high-performance turbine can deliver up to 210 L/min flow, which is potentially helpful when using NIV modes of ventilation. The HAMILTON-MR1 includes a trolley made out of nonferrous materials, which will not be attracted to the powerful electromagnetic forces emanating from the MRI's magnet. The trolley also has a "fail-safe" braking system (i.e., Dead man's brake). {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that appears to be a stylized letter "H" inside of a circle. The logo is simple and modern, and it is likely used to represent the company's brand. ## INTENDED USE Image /page/2/Picture/3 description: The image is a square icon with rounded corners, set against a dark background. The icon features a stylized representation of a surveillance camera or sensor, with concentric circles emanating from it, suggesting a range or field of view. Above the camera, the text '1m' indicates a distance, possibly the range of the sensor. Arrows pointing left and right are positioned on either side of the camera, implying a scanning or detection capability in both directions. # # - Image /page/2/Picture/6 description: The image is a square icon with rounded corners. The background of the icon is dark gray. In the center of the icon is a stylized flower or star shape composed of six petals or points. The petals are colored in a gradient from white to dark gray, creating a sense of depth and dimension. NoCompAir Independency with turbine. Image /page/2/Picture/8 description: The image shows a gray square with rounded corners. Inside the square is a triangle, also gray, with the letters "MR" in black inside the triangle. The letters are in a sans-serif font and are slightly overlapping. Image /page/2/Picture/9 description: The image shows a symbol that is commonly used to represent medical assistance or emergency services. The symbol features a person lying on a gurney or stretcher, which is a wheeled platform used to transport patients. The gurney is depicted with its wheels visible, and there is a person standing next to it, possibly a medical professional or caregiver. The symbol is often used in hospitals, ambulances, and other healthcare settings to indicate the availability of medical assistance or emergency services. Image /page/2/Picture/10 description: The image shows a square sign for a hospital. The sign is gray with rounded corners. The letter "H" is in the center of the sign, and the word "HOSPITAL" is at the top. The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use: - · In the MRI department - · In the intensive care ward or in the recovery room - · During transfer of ventilated patients within the hospital The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5T and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications. ## DISCUSSION OF THE NON-CLINICAL TESTS | IEC 60601-1 | FDA Draft Reviewer Guidance for Ventilators (1995) | |----------------|----------------------------------------------------------| | IEC 60601-1-2 | General Requirements for Safety | | IEC 60601-1-4 | Electromagnetic Compatibility | | IEC 60601-1-8 | Programmable electrical medical systems | | IEC 60601-2-12 | Alarm Systems | | IEC 62304 | Critical Care Ventilators | | IEC 62366 | Software life-cycle processes | | ISO 5356-1 | Application of usability engineering to medical devices. | | ISO 5367 | Conical connectors: Part 1: Cones and sockets | | AAMI/ANSI HE75 | Breathing tubes intended for use with ventilators | | ISO 14971 | Human factors engineering. Design of medical devices | | ISO 21647 | Application of risk management to medical devices | | | Basic safety and performance of respiratory gas monitors | Other internationally recognized standards which the HAMILTON-MR1 meets or exceeds: | ASTM F2213-06 | Standard Test Method for Measurement of Magnetically<br>Induced Torque on Medical Devices in the MR Environment | |---------------|-----------------------------------------------------------------------------------------------------------------| | ASTM F2052-06 | Measurement of Magnetically Induced Displacement Force<br>on Medical Devices in the MR Environment | | ASTM F2119-07 | Evaluation of MR Image Artifacts from Passive Implants | | ASTM F2503-08 | Marking medical devices for safety in the MR environment | | IEC 62133 | Battery safety standard. Non-spillable. | | IEC 60601-1-6 | Usability engineering process | | ASTM F1100-90 | Waveform performance and volume comparison testing | | MIL-STD-461F | Immunity to conducted electromagnetic energy | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" in a bold, sans-serif font, with the letter "O" replaced by a stylized "H" symbol. Below "HAMILTON" is the word "MEDICAL" in a similar bold font, creating a stacked logo design. # AT ILTON "T TRI # COMPARISON WITH THE PRIMARY PREDICATE DEVICE | | | PARAMETERS | HAMILTON-MR1<br>(Proposed device) | HAMILTON-C1<br>Predicate device: K120574 | COMMENTS | |--|--------------------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Image: MRicompliant Compatibility for up to 1 m. | Intended Use | The HAMILTON-MR1<br>ventilator is intended to<br>provide positive pressure<br>ventilatory support to adults<br>and pediatrics.<br>Intended areas of use:<br>• In the MRI department<br>• In the intensive care ward<br>or in the recovery room<br>• During transfer of<br>ventilated patients within<br>the hospital<br>The HAMILTON-MR1<br>ventilator is classified as<br>MR Conditional with the<br>use of 1.5 T and 3.0 Tesla<br>static magnetic field<br>scanners.<br>The HAMILTON-MR1<br>ventilator is a restricted<br>medical device intended for<br>use by qualified, trained<br>personnel under the<br>direction of a physician and<br>within the limits of its stated<br>technical specifications. | The HAMILTON-C1<br>ventilator is intended to<br>provide positive pressure<br>ventilatory support to<br>adults and pediatrics.<br>Intended areas of use:<br>• In the intensive care<br>ward or in the recovery<br>room<br>• During transfer of<br>ventilated patients within<br>the hospital<br>The HAMILTON-C1<br>ventilator is a medical<br>device intended for use by<br>qualified, trained<br>personnel under the<br>direction of a physician<br>and within the limits of its<br>stated technical<br>specifications. | Substantially equivalent.<br>The differences in the<br>intended use of the<br>HAMILTON-MR1 are<br>highlighted in <b>bold</b> .<br>The only major difference<br>between the HAMILTON-<br>C1 and the HAMILTON-<br>MR1 has to do with the<br>additional protections<br>which the HAMILTON-<br>MR1 has, in order to<br>withstand the high<br>electromagnetic fields<br>present near an MRI<br>scanner.<br>The HAMILTON-MR1 has<br>passed rigorous testing to<br>make sure that it will<br>function properly in the<br>MRI environment. Testing<br>included: magnetic field<br>interactions, heating,<br>induced electrical fields,<br>and artifacts. | | | Image: NoCompAir Independency with turbine. | Intended patient<br>population | Patients include adults and<br>pediatrics. | Patients include adults and<br>pediatrics. | Equivalent | | | Image: MR | Maximum<br>inspiratory flow | 210 L/min | 210 L/min | Equivalent | | | Image: HOSPITAL H | MRI-room<br>compatible | Yes | No | Not equivalent | | | | Temperature<br>Range | 5 to 40° C (operating),<br>-20 to 60° C (storage) | 5 to 40° C (operating),<br>-20 to 60° C (storage) | Equivalent | | | | Software<br>version | Version 1.2.0 | Version 1.1.2 | Substantially equivalent | | | | Number of<br>batteries | 2 | 1 | Substantially equivalent | | | | Weight | 6.8 kg (15 lb), or<br>21 kg (46 lb) w/ trolley | 4.9 kg (10.8 lb) | Substantially equivalent | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Hamilton Medical. The text "HAMILTON" is in bold, black letters, with a stylized "G" symbol next to it. Below "HAMILTON" is the word "MEDICAL", also in bold, black letters. # Host JILTO. ". 151 | PARAMETERS | HAMILTON-MR1<br>(Proposed device) | HAMILTON-C1<br>Predicate device: K120574 | COMMENTS | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Operation<br>environmental<br>requirements | •5 to 40 °C (41 to 104 °F)<br>•10 to 95%, non-condensing<br>•1100 to 700 hPa | •5 to 40 °C (41 to 104 °F)<br>•10 to 95%, non-condensing<br>•1100 to 600 hPa | Substantially<br>Equivalent | | Input Power | AC: 100 to 240 V, 50/60 Hz | AC: 100 to 240 V, 50/60 Hz | Equivalent | | Power<br>Consumption | 50 VA typical | 50 VA typical | Equivalent | | Battery | Two batteries, Li-ion, sealed,<br>maintenance-free | One battery, Li-ion, sealed,<br>maintenance-free | Substantially<br>Equivalent | | Battery operating<br>time (typical) | 5.5 hours | 2 hours | Substantially<br>Equivalent | | Safety features | • Apnea backup ventilation<br>• Automatic self-tests<br>• Alarms (operator-<br>adjustable / non-adjustable)<br>• Alarm backup buzzer<br>• External flow sensor failure<br>mode<br>• Safety mode in case of<br>technical failures<br>• Air inlet HEPA filter<br>monitoring<br>• Monitored fan<br>• Event log | • Apnea backup ventilation<br>• Automatic self-tests<br>• Alarms (operator-<br>adjustable / non-adjustable)<br>• Alarm backup buzzer<br>• External flow sensor<br>failure mode<br>• Safety mode in case of<br>technical failures<br>• Air inlet HEPA filter<br>monitoring<br>• Monitored fan<br>• Event log | Equivalent | | Emergency air<br>intake | In case of a power supply,<br>technical, or pneumatics<br>failure the ambient valve<br>allows spontaneous<br>breathing. | In case of a power supply,<br>technical, or pneumatics<br>failure the ambient valve<br>allows spontaneous<br>breathing. | Equivalent | | Maximum working<br>pressure limit | 60 cmH20 | 60 cmH20 | Equivalent | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" stacked on top of "MEDICAL". To the right of the word "HAMILTON" is a stylized "H" inside of a circle. Image /page/5/Picture/1 description: The image shows the word "HAMILTON.MR1" in a bold, sans-serif font. The letters are black, and the background is white. The letters are evenly spaced and easy to read. The word appears to be a brand name or product name. 1m **MRIcompliant** Compatibility for up to 1 m. Image /page/5/Picture/4 description: The image is a square icon with rounded corners. The background of the icon is dark gray. In the center of the icon is a six-petal flower design. The petals are colored in shades of gray, ranging from light gray to dark gray, creating a gradient effect. NoCompAir independency with turbine. Image /page/5/Picture/6 description: The image shows a gray square with a triangle inside. The triangle is also gray and has the letters "MR" in bold, yellow font inside. The letters are centered within the triangle. Image /page/5/Picture/7 description: The image is a gray square with rounded corners. Inside the square is a black icon of a person lying on a gurney. To the right of the gurney is a person standing with a cane. Image /page/5/Picture/8 description: The image is a gray square with rounded corners. Inside the square is a large, dark gray letter "H". Above the "H" is the word "HOSPITAL" in smaller, dark gray letters. The image likely represents a hospital sign or symbol. ## MAGNETIC FIELD THRESHOLDS | Alarm/action | Magnetic<br>field range | Accuracy | |---------------------------------------------|-------------------------|-----------| | Green light - acceptable | $\leq$ 50mT | $\pm$ 10% | | Yellow light - too close, alarm sounds | 50 - 80mT | | | Red light - too close, alarm sounds | > 80mT | | | Red X light - technical fault, alarm sounds | -- | | The intended-use statement for the HAMILTON-MR1 ventilator is comparable to the primary predicate device. The only difference is that the HAMILTON-MR1 can also be used in the MR-environment. However, the technological characteristics (i.e., design and energy source) and the performance specifications of the HAMILTON-MR1 ventilator are equivalent to those of the HAMILTON-C1 predicate device. The HAMILTON-MR1 has not been tested for the inclusion of wireless connections into its USB-port, e.g. plug-in "dongles", as The AESTIVA/5 MRI anesthesia system (K050055) is referred to as a predicate device since it also has an integrated gaussmeter, which notifies the user when the device is in excess of its labeled operating parameters. This is comparable to the integrated gaussmeter found on the HAMILTON-MR1, which notifies the user when the device is in excess of its labeled operating parameters (i.e. 50mT / 500 gauss). Non-clinical performance testing has shown that the HAMILTON-MR1's integrated gaussmeter has an accuracy level of ± 10%. described in the FDA guidance on RF Wireless Technology in Medical Devices. #### Note: These values are based on a comparison with a commercially available, calibrated thirdparty gaussmeter. The HAMILTON-MR1's integrated gaussmeter's magnetic sensors are located at the center of the HAMILTON-MR1's enclosure; it consequently measures the gauss levels at the center of device. Furthermore, performance bench-testing has shown that gauss levels of 29mT in the center of the HAMILTON-MR1, correspond to ≤ 50mT on the outside of the HAMILTON-MR1's enclosure. Nevertheless, the HAMILTON-MR1 can function in accordance to its "essential performance criteria" at qauss levels of more than 100mT (1,000 gauss), although this is not recommended by HAMILTON MEDICAL. These performance tests were conducted using both the Philips Achieva 3.0T and 1.5T MRI scanners. For the dynamic field testing, HAMILTON MEDICAL used the compatibility protocols for third-party equipment validation recommended by Philips (e.g. MaxGrad. MaxB1+SAR, MaxGrad+RF). In non-clinical testing, the device was found to be MRI safe to operate at (or less than) a fringe magnetic of 50mT. This testing was based on both ASTM F2213-06 (Magnetically Induced Torque) and ASTM F2052-06 (Magnetically Induced Displacement Force), which showed that the HAMILTON-MR1 with its brake activated, will only be pulled towards the MRI magnet at gauss levels of ≥ 445mT (4,450 gauss) with a magnetically induced force of 64.2 newtons. This test was conducted using a Philips Achieva 3.0 MRI scanner. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a stylized "H" inside of a circle. ### INTEGRATED GAUSSMETER Image /page/6/Picture/3 description: The image shows a black button with a white icon. The icon depicts a person standing within a circular range, labeled "1m" at the top. There are left and right arrows on either side of the circle, suggesting a range or distance adjustment feature. The button appears to be part of a device or interface related to distance measurement or proximity detection. **MRIcompliant** Compatibility for up to 1 m. Image /page/6/Picture/5 description: The image is a square icon with a dark background. In the center of the icon is a stylized flower or star shape composed of six petals or leaves. The petals are arranged in a circular pattern, radiating outward from the center. The petals are colored in varying shades, creating a sense of depth and visual interest. NoCompAir Independency with turbine Image /page/6/Picture/7 description: The image is a gray square button with rounded corners. Inside the square is a triangle, and inside the triangle are the letters "MR" in bold, sans-serif font. The letters are also gray, but slightly lighter than the background of the triangle. Image /page/6/Picture/8 description: The image describes the gauss levels and LED indicators for the HAMILTON-MR1 ventilator in relation to MRI scanner proximity. A green LED indicates safe distance at 290 gauss (29mT) or less. A yellow LED indicates a range of 300 gauss (30mT) to 690 gauss (69mT), triggering a warning alarm to move the ventilator away from the MRI scanner. A red LED indicates at least 700 gauss (70mT), causing continuous flashing and an audible alarm, requiring servicing by a HAMILTON-MEDICAL specialist. The HAMILTON-MR1 includes similar LED indicators to that of the AESTIVA/5 (K050055). The purpose for the three LED indicators on the integrated gaussmeter is to provide a visual representation of a range of gauss levels. For example, in the HAMILTON-MR1, the green LED shows that the integrated gaussmeter at the center of the ventilator is measuring gauss ### COMPARISON WITH OTHER MR-COMPATIBLE VENTILATORS | | Proposed<br>device:<br>HAMILTON-MR1 | Maquet<br>Servo-i<br>(K063404) | CareFusion<br>LTV 1200 MR<br>(K083688) | GE Versamed<br>iVent 201 MRI<br>(K073694) | Impact<br>Eagle II MR<br>(K111473) | |-----------------------------------------------------|-------------------------------------|--------------------------------|----------------------------------------|-------------------------------------------|------------------------------------| | Maximum<br>recommended<br>magnetic<br>induction | 50mT<br>(500 gauss) | ∼20mT<br>(∼200 gauss) | ∼10mT<br>(∼100 gauss) | ∼10mT<br>(∼100 gauss) | ∼20mT<br>(∼200 gauss) | | Nearest<br>distance to<br>the MRI's bore<br>opening | ∼1 m<br>(3.25 ft) | ∼2.25 m<br>(7.5 ft) | ∼2.75 m<br>(9 ft) | ∼2.75 m<br>(9 ft) | ∼2 m<br>(6.5 ft) | | Minimal Tidal<br>Volume (VT) | ≥ 20 mL | ≥ 100 mL | ≥ 50 mL | ≥ 100 mL | ≥ 50 mL | | Integrated<br>Gaussmeter | Yes | No | No | No | No | #### CONCLUSION The intended use of the HAMILTON-MR1 is substantially equivalent to the predicate devices. The HAMILTON-MR1's software has passed through verification/validation tests. A complete revision level history, hazard analysis, and a traceability analysis linking requirements to validation were done. The HAMILTON-MR1 includes a risk management report, system-level validation, verification testing according to the applicable standards, and testing in an MR environment. The conclusions drawn from the non-clinical tests demonstrate that the HAMILTON-MR1 is substantially equivalent to the legally marketed devices cited above. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white. #### 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 · November 20, 2013 Hamilton Medical AG Mr. Ralph Aguila Regulatory Affairs/Quality Engineer Via Crusch 8 BONADUZ. GRISONS 7402 SWITZERLAND Rc: KI22438 Trade/Device Name: HAMILTON-MR1 Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, Continuous Regulatory Class: II Product Code: CBK Dated: November 8, 2013 Received: November 12, 2013 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. Iisting 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 nay 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. 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 {8}------------------------------------------------ #### Page 2 - Mr. Aguila or any Federal statuies 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address Intp://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum. 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. Image /page/8/Picture/8 description: The image contains a combination of text and decorative elements. The text includes "Tejashri Purohit-Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". There is also a decorative flourish on the left side of the image, and the word "FOR" is visible in the bottom right corner. Erin Keith, M.S. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT ### K122438 510(k) Number: Device Name: HAMILTON-MR1 Indication for Use: The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use: - · In the MRI department - · In the intensive care ward or in the recovery room - · During transfer of ventilated patients within the hospital The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 T and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 ventilator is a restricted 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 (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) Anya C. Harı Digitally signed by Anya C. Hany -S DN: colls, DaU.S. Government, ouatHHS, ou=FDA Poorta, consinva C Harry -S. 0.9.2342.19200300.100.1.3 =0011315590 Date: 2013.11.19 15:21:16 -05 00