(29 days)
HAMILTON-C2, HAMILTON-G5
Unknown
The description mentions a "microprocessor system" and an "ASV ventilation-mode which automatically applies lung-protective strategies," but it does not explicitly state that these functions utilize AI or ML. The term "automatically" could refer to rule-based algorithms rather than learning systems.
Yes
The device is a ventilator, which provides ventilatory support to patients. This directly addresses medical conditions by assisting or replacing the natural breathing function, thereby serving a therapeutic purpose.
No
The HAMILTON-T1 is a ventilator that provides ventilatory support and monitors the patient's gas delivery, but it does not perform diagnostic functions. It is designed for therapeutic use (ventilation) rather than for identifying diseases or conditions.
No
The device description clearly details hardware components such as a built-in turbine, twin hot-swappable battery supply, impact resistant case, and a microprocessor system controlling gas delivery and monitoring. While it mentions software, it is an integral part of a physical medical device.
Based on the provided text, the HAMILTON-T1 ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- HAMILTON-T1 Function: The HAMILTON-T1 is a ventilator, a device that provides mechanical assistance to a patient's breathing. It directly interacts with the patient's respiratory system.
- Intended Use: The intended use clearly states it provides "positive pressure ventilatory support to adults and pediatrics." This is a life-support function, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on its mechanical and electronic components for delivering air and monitoring patient parameters related to breathing. There is no mention of analyzing biological samples.
Therefore, the HAMILTON-T1 falls under the category of a life-support or therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- In the intensive care ward or in the recovery room.
- For emergency medical care or primary care.
- During transport within and outside the hospital.
- During transfer by rescue vehicles, jet or helicopter.
The HAMILTON-T1 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.
Product codes
CBK
Device Description
The HAMILTON-T1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. Due to its compact design, a fully-loaded weight of only 6.5 kg (14.3 lbs), a twin hot-swappable battery supply, and a built-in turbine; the HAMILTON-T1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-T1 can run using AC or DC power. It does not need compressed air or O2 to drive the pneumatics, which reduces the weight load in the aircraft needed to operate the ventilator.
Since the HAMILTON-T1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixed-wing aircraft, or helicopter. This makes the HAMILTON-T1 especially relevant for Aeromedical Evacuations and Medevac operations.
The HAMILTON-T1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2 and HAMILTON-G5, featuring a touchscreen "Ventilation Cockpit", this provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-T1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-T1's microprocessor system controls gas delivery and monitors the patient. The gas delivery and monitoring functions are cross-checked by an alarm controller. This cross-checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.
The HAMILTON-T1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-T1 capable of being used in highaltitude flight environments. The HAMILTON-T1's changes include the following:
-
- The HAMILTON-T1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-T1, (e.g. Neonatal Ventilation & nCPAP-PS). Other features like Trends & Loops, NIV, NIV-ST, APRV, and DuoPAP are standard with the C2, but are only optional with the HAMILTON-T1.
-
- The HAMILTON-T1 has increased immunity from EMI, including >30 V/m. It also has extra safety features for the EMD, ESD, and RFI environments found on aircraft.
-
- The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-T1 has been ruggedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
-
- The HAMILTON-T1 was tested for use in fixed and rotary-wing aircraft.. Because mechanical ventilation can be challenging during air-medical transport, particularly due to the impact of changing barometric pressure with different altitude levels, the HAMILTON-T1 automatically compensates for altitude changes. Adjusting provided- and measured-patient volumes accordingly, thereby eliminating the need for manual calculation and reducing the risk of error.
-
- The HAMILTON-T1 has a "lock-button" which prevents an inadvertent change of settings. If screen lock is active, the following items are inactive: Touchscreen. Power/Standby switch, Print-screen key, Press-and-turn knob. Active are Alarm Silence, Manual Breath, O2 enrichment, Nebulizer. To switch off power, the user must press the On/Off button for > 3 s.
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
adults and pediatrics
Intended User / Care Setting
qualified, trained personnel under the direction of a physician
- In the intensive care ward or in the recovery room.
- For emergency medical care or primary care.
- During transport within and outside the hospital.
- During transfer by rescue vehicles, jet or helicopter.
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)
The non-clinical test results show that the HAMILTON-T1 is safe and effective for its intended use. The ventilator 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.
One of the tests used to evaluate the HAMILTON-T1 in a high-altitude, low-pressure environment, was to place the HAMILTON-T1 inside an altitude chamber to test the effects on the sensors and the ventilator measurements & readings.
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
APR - 3 2012 -
Image /page/0/Picture/1 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.
Image /page/0/Picture/2 description: The image shows the text "HAMILTON.T1" in a bold, sans-serif font. The word "HAMILTON" is outlined in black, with a white fill and a textured interior. The ".T1" portion of the text is solid black. The text is horizontally oriented and appears to be a logo or brand name.
SPECIAL 510(k) SUMMARY
| | SUBMITTER: | HAMILTON MEDICAL AG
Via Crusch 8
Bonaduz, 7402
SWITZERLAND |
|--|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | CONTACT PERSON: | Ralph Aguila
Regulatory Affairs / Quality Engineer
Phone: +49 171 401 7192
Fax: +41 81 660 60 20
e-mail: raguila@hamilton-medical.ch |
| | ESTABLISHMENT
REGISTRATION
NUMBER: | 3001421318 |
| | PREPARATION DATE: | 2012-02-23 |
| | TRADE NAME: | HAMILTON-T1 |
| | COMMON NAME: | Continuous Ventilator |
| | CLASSIFICATION NAME: | CLASS II Ventilator, Continuous |
| | REGULATION NUMBER: | 21 CFR 868.5895 |
| | PRODUCT CODE: | CBK |
| | PREDICATE DEVICE: | HAMILTON-TC1
510(k) Number: K112006 |
Simults builtery exchange
1
Image /page/1/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.
Image /page/1/Picture/1 description: The image shows the word "HAMILTON" in a stylized font with a black outline and a white fill. To the right of the word "HAMILTON" is a period followed by the letters "TI" in a bold, sans-serif font. The letters "TI" are solid black.
DEVICE DESCRIPTION
The HAMILTON-T1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. Due to its compact design, a fully-loaded weight of only 6.5 kg (14.3 lbs), a twin hot-swappable battery supply, and a built-in turbine; the HAMILTON-T1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-T1 can run using AC or DC power. It does not need compressed air or O2 to drive the pneumatics, which reduces the weight load in the aircraft needed to operate the ventilator.
..
Since the HAMILTON-T1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixed-wing aircraft, or helicopter. This makes the HAMILTON-T1 especially relevant for Aeromedical Evacuations and Medevac operations.
The HAMILTON-T1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2 and HAMILTON-G5, featuring a touchscreen "Ventilation Cockpit", this provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-T1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-T1's microprocessor system controls gas delivery and monitors the patient. The gas delivery and monitoring functions are cross-checked by an alarm controller. This cross-checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.
The HAMILTON-T1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-T1 capable of being used in highaltitude flight environments. The HAMILTON-T1's changes include the following:
-
- The HAMILTON-T1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-T1, (e.g. Neonatal Ventilation & nCPAP-PS). Other features like Trends & Loops, NIV, NIV-ST, APRV, and DuoPAP are standard with the C2, but are only optional with the HAMILTON-T1.
-
- The HAMILTON-T1 has increased immunity from EMI, including >30 V/m. It also has extra safety features for the EMD, ESD, and RFI environments found on aircraft.
-
- The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-T1 has been ruggedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
-
- The HAMILTON-T1 was tested for use in fixed and rotary-wing aircraft.. Because mechanical ventilation can be challenging during air-medical transport, particularly due to the impact of changing barometric pressure with different altitude levels, the HAMILTON-T1 automatically compensates for altitude changes. Adjusting provided- and measured-patient volumes accordingly, thereby eliminating the need for manual calculation and reducing the risk of error.
-
- The HAMILTON-T1 has a "lock-button" which prevents an inadvertent change of settings. If screen lock is active, the following items are inactive: Touchscreen. Power/Standby switch, Print-screen key, Press-and-turn knob. Active are Alarm Silence, Manual Breath, O2 enrichment, Nebulizer. To switch off power, the user must press the On/Off button for > 3 s.
Image /page/1/Picture/13 description: The image shows a square icon with rounded corners. The icon is black with a white image of a helicopter in the center. The helicopter has a white cross on its side, indicating that it is a medical helicopter.
Image /page/1/Picture/14 description: The image shows a black square with rounded corners. Inside the square is a white airplane icon. The airplane is facing upwards and slightly to the left. The background of the square is black.
Image /page/1/Picture/15 description: The image shows a black and white icon of an ambulance. The ambulance is depicted in a simple, cartoonish style with a boxy shape and rounded wheels. A prominent cross is visible on the side of the vehicle, indicating its medical purpose. The icon has a slightly distressed or textured appearance, giving it a vintage or worn look.
Image /page/1/Picture/16 description: The image is a black and white icon that depicts a hospital bed with a patient lying on it. The bed is on wheels and has a white sheet covering the patient. The icon is likely used to represent a hospital or medical facility. The icon is simple and easy to understand.
Image /page/1/Picture/17 description: The image is a black and white sign for a hospital. The sign is square with rounded corners and has the word "HOSPITAL" written at the top. Below the word is a large letter "H" in white. The background of the sign is black, and the text and letter are white.
Image /page/1/Picture/18 description: The image is a square icon with rounded corners. The icon is black with a white flower in the center. The flower has six petals that are arranged in a circular pattern.
NoCompAir
Independency
with turbine.
Image /page/1/Picture/20 description: The image is a graphic that shows a feature called "HotSwap". The graphic shows a battery being exchanged. The text below the graphic says "Smooth battery exchange."
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. The letters are bold and sans-serif. To the right of the word "HAMILTON" is the GE logo.
Image /page/2/Picture/1 description: The image shows the text "HAMILTON-T1" in a bold, sans-serif font. The word "HAMILTON" is outlined in black with a white fill, while the "T1" is solid black. A dot separates the two words. The text appears to be slightly distressed, with some rough edges and imperfections.
INTENDED USE
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- · In the intensive care ward or in the recovery room.
- · For emergency medical care or primary care.
- · During transport within and outside the hospital.
- · During transfer by rescue vehicles, jet or helicopter.
The HAMILTON-T1 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/2/Picture/10 description: The image shows a square icon with rounded corners. The icon is divided into two sections. The top section is a cloudy sky, and the bottom section is a solid dark color. A white airplane is in the center of the icon, with its wings and tail visible.
FAA REGULATIONS
In accordance with the US Department of Transportation (DOT) and the Federal Aviation Administration (FAA), along with their rules on the "Use of Respiratory Assistive Devices on Aircraft", the HAMILTON-T1 meets the applicable safety requirements for Medical Portable Electronic Devices (M-PED) by not exceeding the maximum level of radiated radio frequency interference as described in the RTCA/DO 160F, Section 21, Category M.
DISCUSSION ON THE NON-CLINICAL TESTS
The non-clinical test results show that the HAMILTON-T1 is safe and effective for its intended use. The ventilator 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-T1:
Image /page/2/Picture/16 description: The image shows a logo for an application called NoCompAir. The logo features a black square with rounded corners, inside of which is a white flower-like design with six petals. Below the square, the text "NoCompAir" is written in a sans-serif font.
oth turbly
| 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. |
| EN ISO 14971 | Application of risk management to medical devices. |
Image /page/2/Picture/18 description: The image shows a logo for a "HotSwap" battery exchange. The logo features a stylized image of a battery being swapped, with the words "HotSwap" printed in a bold font above the phrase "Smooth battery exchange." The logo is contained within a rounded rectangle.
3
Image /page/3/Picture/0 description: The image shows the words "HAMILTON MEDICAL" in bold, black letters. 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 circle with some design inside. The text is clear and easy to read.
RTCA/DO-160F: 2007
Section 7 Section 8
Section 16.6
Section 17
Section 20
Section 21
Section 25
Section 18.3.1
Section 19.3.1
Hamilton.T1
Other internationally recognized standards which the HAMILTON-T1 meets or exceeds:
Normal surge voltage (DC).
Low voltage conditions (DC). Abnormal surge voltage (DC).
Voltage spikes, 28 VDC
DC input power leads
Vibration
Environmental Conditions and Test Procedures for Airborne
Magnetic field induced into equipment by the aircraft 400 Hz
Radio Frequency Susceptibility (Radiated and Conducted) Maximum level of conducted RF interface - Power line.
Maximum level of radiated RF interface. Category M. Electrostatic Discharge & Radiated Electromagnetic Field
Equipment. Equivalent to EUROCAE/ED-14F
Operational Shocks and Crash Safety
Abnormal operating conditions (DC).
power systems in vicinity of the device
Image /page/3/Picture/3 description: The image is a black square with rounded corners. Inside the square is a white silhouette of a helicopter with a medical cross on its side. The helicopter is facing to the right and has a white circle on top.
Image /page/3/Picture/4 description: The image is a black square with rounded corners. Inside the square is a white silhouette of an airplane. The airplane is facing upwards and slightly to the left. The image appears to be a symbol or icon representing air travel or an airport.
Image /page/3/Picture/5 description: The image is a black and white sign with a picture of an ambulance on it. The ambulance is white and has a red cross on the side. The background of the sign is black. The sign is likely used to indicate the location of an ambulance service or emergency medical facility.
Image /page/3/Picture/6 description: The image shows a black and white icon of a person lying on a hospital bed. The bed has wheels on the bottom. The icon is enclosed in a square with rounded corners.
Image /page/3/Picture/7 description: The image shows a black and white logo for a hospital. The logo is a rounded square with the letter "H" in the center. Above the "H" is the word "HOSPITAL" in a sans-serif font. The logo is simple and easy to recognize.
| EN ISO 13485 | Medical devices -- Quality management systems.. | ||
|---|---|---|---|
| EN ISO 9001 | Quality management systems. | ||
| EN ISO 5359 | Low-pressure hose assemblies for use with medical gases. | ||
| EN 794-1 | Particular requirements for critical care ventilators. | ||
| EN 794-3 | Particular requirements for emergency and transport | ||
| ventilators. Equal to EN 60068-2-6; -29; -64. | |||
| EN 1789 | Medical vehicles and their equipment - Road ambulances. | ||
| EN 13718-1 | Medical vehicles and their equipment - Air ambulances - Part | ||
| 1: Requirements for medical devices used in air ambulances | |||
| IEC 62133 | Battery Safety. Non-Spillable. | ||
| ASTM F1100-90 | Standard Specification for Ventilators Intended for Use in Critical | ||
| Care (for waveform standard analysis) | |||
| MIL-STD-461F | RS101 CS114 (curve #3) and RF101 (Army 7 cm limit) |
Image /page/3/Picture/9 description: The image shows a logo for a company called "NoCompAir". The logo features a stylized flower or turbine design in white against a black square background. Below the logo, the text "Independency with turbine." is displayed in a smaller font, suggesting the company's focus on turbine technology and independence.
Image /page/3/Picture/10 description: The image is a white square with rounded corners, and it contains a black square at the top. Inside the black square, there is a white battery with a handle on the right side. Above the battery, there are three vertical white bars of varying heights. Below the black square, the word "HotSwap" is written in a bold, sans-serif font. Underneath "HotSwap", the phrase "Smooth battery exchange." is written in a smaller, less bold font.
4
Image /page/4/Picture/2 description: The image shows a black and white icon of a medical helicopter. The helicopter is white and has a plus sign on its side, indicating that it is used for medical purposes. The background of the icon is black, and the icon itself is in the shape of a rounded square. The image is simple and easy to understand, making it suitable for use in a variety of contexts.
Image /page/4/Picture/3 description: The image shows a square icon with a white airplane in the center. The background is divided into two sections: the top half is white, and the bottom half is black. The airplane is oriented diagonally, with its nose pointing towards the lower right corner of the icon.
Image /page/4/Picture/4 description: The image is a black and white icon of an ambulance. The ambulance is facing left and has a cross on the side. The icon is in a rounded square shape. The image is simple and easy to understand.
Image /page/4/Picture/5 description: The image is a black and white drawing of a person lying on a gurney. The gurney has four wheels and a handle. The person is lying on their back with their head resting on a pillow. The drawing is simple and easy to understand. The image is likely used to represent medical care or transportation of patients.
Image /page/4/Picture/6 description: The image shows a black and white logo for a hospital. The logo is a square with rounded corners, and the word "HOSPITAL" is written at the top of the square. Inside the square is a large letter "H". The letter "H" is white, and the rest of the square is black.
Image /page/4/Picture/7 description: The image shows a logo for a company called NoCompAir. The logo features a stylized flower with six petals in a square frame. Below the flower is the company name, "NoCompAir", and the word "Independency" is written below the company name.
with turbine
Volumetric capnography
Dynamic Lung
VentStatus Window
Interface to monitoring system or PDMS
Image /page/4/Picture/9 description: The image shows a logo for a "HotSwap" feature. The logo is a white square on a black background, with a white line running through the middle. There is a white object on top of the square, and a white handle on the right side of the square. Below the logo, the text reads "Smooth battery exchange".
| | Hamilton Medical
HAMILTON-T1 | Dräger
Oxylog 3000+ | CareFusion
EnVe |
|---------------------------------------------------------|---------------------------------|------------------------|--------------------|
| Biphasic breathing | Yes | No | Yes |
| Advanced biphasic
ventilation modes
DuoPAP / APRV | Yes | No | No |
| Closed-Loop Ventilation
with ASV | Yes | No | No |
| Smart Apnea Backup | Yes | No | No |
| Breathing circuit
compensation | Yes | No | No |
| Nebulizer | Yes | No | Yes |
| Expiratory Trigger
Sensitivity | Yes | No | Yes |
| CO2 measurement
(sidestream and
mainstream) | Yes | No | No |
| Volumetric capnography | Yes | No | No |
| Dynamic Lung | Yes | No | No |
| VentStatus Window | Yes | No | No |
| Interface to monitoring
system or PDMS | Yes | No | Yes |
| FiO2 Range | 21% - 100% | 40% - 100% | 21% - 100% |
| Tidal Volume | 20 - 2,000 mL | 50 - 2,000 mL | 50 - 2,000 mL |
| Peak Flow | 210 L/min | 100 L/min | 180 L/min |
Comparison table between two transport ventilators and the proposed device: the HAMILTON-T1, Dräger 3000+, and CareFusion EnVe.
.
:
. . . .
.
.
21 C.F.R. §807 Subpart E
5
The intended use statement for the HAMILTON-T1 ventilator is equivalent to the predicate device. The technological characteristics (i.e., design, material, energy source) and performance specifications of the HAMILTON-T1 ventilator are equivalent to those of the predicate device. One of the tests used to evaluate the HAMILTON-T1 in a high-altitude, low-pressure environment, was to place the HAMILTON-T1 inside an altitude chamber to test the effects on the sensors and the ventilator measurements & readings.
The intended use of the HAMILTON-T1 is covered by the referenced predicate device. The technical characteristics of the HAMILTON-T1 do not raise any new questions regarding the
Homillon
Image /page/5/Picture/1 description: The image is a square icon with rounded corners. The icon has a black background and a white image of a helicopter with a medical cross on its side. The helicopter is facing left and has a tail rotor and a main rotor.
Image /page/5/Picture/2 description: The image is a square icon with rounded corners. The background is black, and there is a white airplane in the center. The airplane is facing to the left and is in a flying position. The top left corner of the icon has a cloudy texture.
safety or effectiveness of ventilators. The HAMILTON-T1's software has gone through verification/validation tests. A complete revision level history, hazard analysis, and a traceability analysis linking requirements to validation were done. The conclusions drawn from the non-clinical tests demonstrate that the HAMILTON-T1 is as safe, as effective, and performs as well as the legally marketed device. The HAMILTON-T1 is, therefore, considered to be substantially equivalent to the currently marketed predicate device which has been previously cleared by FDA.
The only reason for this Special 510(k) submission is due to a name change from the HAMILTON-TC1 (K112006) to the HAMILTON-T1 (proposed device).
Image /page/5/Picture/5 description: The image is a logo with a white flower-like design on a black background. Below the design, the text "NoCompAir" is written in a sans-serif font. Underneath "NoCompAir", the text "Independency with turbine." is written in a smaller font size. The logo is contained within a rounded rectangular shape.
Image /page/5/Picture/6 description: The image is a graphic with the words "HotSwap" and "Smooth battery exchange." The graphic shows a battery being exchanged. The background is white, and the text and graphic are black.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by a serpent and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ralph Aguila Regulatory Affairs / Quality Engineer HAMILTON MEDICAL AG Via Crusch 8 Bonaduz, 7402 SWITZWERLAND
Re: K120670
Trade/Device Name: HAMILTON-T1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: February 28, 2012 Received: March 5, 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.
APR - 3 2012
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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/CDRH/CDRHOffices /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.goy/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,
for
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-T1
Indication for Use:
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- · In the intensive care ward or in the recovery room.
- · For emergency medical care or primary care.
- · During transport within and outside the hospital.
- · During transfer by rescue vehicles, jet or helicopter.
The HAMILTON-T1 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)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: R120676