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.

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:

1. 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.
1. 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.
1. 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.
1. 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.
1. 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.

AI/ML Overview

Acceptance Criteria and Study for HAMILTON-T1 Ventilator

This document describes the acceptance criteria and the non-clinical study that demonstrates the HAMILTON-T1 ventilator meets these criteria, as presented in the provided 510(k) summary (K120670).

1. Table of Acceptance Criteria and Reported Device Performance

The HAMILTON-T1 is essentially a modified HAMILTON-TC1 (K112006) for use in high-altitude flight environments. Therefore, its performance is largely measured against established standards and its predicate device. The acceptance criteria are derived from these recognized standards and confirmed through a battery of non-clinical tests.

Acceptance Criteria Category	Specific Criteria (Standard/Guidance Document)	HAMILTON-T1 Performance (Reported in 510(k) Summary)
Safety - General	IEC 60601-1: General Requirements for Safety	Non-clinical test results show device is safe.
Safety - Electromagnetic Compatibility (EMI)	IEC 60601-1-2: Electromagnetic Compatibility	Increased immunity from EMI, including >30 V/m. Meets RTCA/DO-160F, Section 21, Category M (maximum level of radiated radio frequency interference).
Safety - Software	IEC 60601-1-4: Programmable electrical medical systems; IEC 62304: Software life-cycle processes	Software verification and validation testing demonstrates all specified requirements implemented correctly and completely. Hazard analysis and traceability analysis performed.
Safety - Alarms	IEC 60601-1-8: Alarm Systems	Not explicitly detailed, but implied through general safety and predicate equivalence.
Safety - Critical Care Ventilators	IEC 60601-2-12: Critical Care Ventilators	Not explicitly detailed, but implied through general safety and predicate equivalence, and its basis on HAMILTON-C2.
Usability	IEC 62366: Application of usability engineering to medical devices; AAMI/ANSI HE75: Human factors engineering. Design of medical devices	Touchscreen "Ventilation Cockpit" provides exact information, helps focus. "Lock-button" prevents inadvertent changes.
Risk Management	EN ISO 14971: Application of risk management to medical devices	Hazard analysis performed.
Airborne Environmental Conditions	RTCA/DO-160F (Environmental Conditions and Test Procedures for Airborne Equipment), specific sections: 7 (Normal surge voltage), 8 (Low/Abnormal surge voltage, Voltage spikes), 16.6 (DC input power leads), 17 (Vibration), 18.3.1 (Operational Shocks and Crash Safety), 19.3.1 (Abnormal operating conditions), 20 (Magnetic field induced into equipment), 21 (Radio Frequency Susceptibility - Radiated & Conducted), 25 (Electrostatic Discharge & Radiated Electromagnetic Field)	Tested and evaluated for flight and high-altitude environments. Meets or exceeds all specified RTCA/DO-160F sections. Automatically compensates for altitude changes.
Road Ambulances	EN 1789: Medical vehicles and their equipment - Road ambulances	Unit ruggedized to withstand shock, vibrations, water ingress, and drops.
Air Ambulances	EN 13718-1: Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances	Tested for use in fixed and rotary-wing aircraft. Automatically compensates for altitude changes.
Mechanical Performance (Waveform)	ASTM F1100-90: Standard Specification for Ventilators Intended for Use in Critical Care (for waveform standard analysis)	Ventilator subjected to waveform performance testing.
Ruggedness/Durability	EN 794-3: Particular requirements for emergency and transport ventilators (Equal to EN 60068-2-6; -29; -64)	Unit contained in impact resistant case, ruggedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
Input Power	IEC 62133: Battery Safety. Non-Spillable.	Twin hot-swappable battery supply. Runs using AC or DC power.
Software Equivalence	N/A	Software is identical to HAMILTON-C2's software, with some options unavailable.
Predicate Equivalence	N/A	Intended use, technological characteristics, and performance specifications are equivalent to HAMILTON-TC1 (K112006).

2. Sample Sizes Used for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of devices. The "test set" refers to the HAMILTON-T1 device itself being subjected to various non-clinical tests.
Data Provenance: The testing was conducted by HAMILTON MEDICAL AG, a Swiss company. The tests are non-clinical, involving the device's physical and software performance under simulated conditions as per internationally recognized standards (e.g., IEC, ISO, RTCA/DO-160, ASTM, EN, MIL-STD). This is a prospective evaluation of the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable for this submission. The "ground truth" for non-clinical performance refers to the established requirements and specifications outlined in the referenced standards (e.g., a certain level of EMI immunity, specific waveform characteristics). Compliance is measured against these objective, quantifiable standards, not against expert human interpretations of clinical data. Testing personnel performing these evaluations would be qualified engineers and technicians.

4. Adjudication Method for the Test Set

This section is not applicable for a non-clinical performance study. The adjudication method as described typically refers to how disagreements among human readers or expert reviewers are resolved in a clinical study where subjective interpretation is involved. Non-clinical tests against objective standards do not require such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance and equivalence to a predicate device, not on diagnostic or treatment efficacy evaluated through human-in-the-loop performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the device's engineering and software attributes was done through the extensive non-clinical testing described. This includes:

Software verification and validation testing: To ensure specified requirements are implemented correctly and completely.
Waveform performance testing: As described in ASTM F1100-90.
EMI/EMC testing: Against IEC 60601-1-2 and RTCA/DO-160F.
Environmental stress testing: For shock, vibration, water ingress, drops, and high-altitude/low-pressure conditions.
Safety testing: Against a range of IEC 60601-1 series standards.

These tests evaluate the device's intrinsic functional and safety characteristics without direct human intervention in its operation for a clinical outcome.

7. The Type of Ground Truth Used

The ground truth used for this submission is engineering specifications and recognized international consensus standards. These include:

Performance Specifications: Quantifiable parameters like FiO2 range, Tidal Volume, Peak Flow, which are compared against known requirements for ventilators.
Safety Standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, IEC 60601-2-12, IEC 62304, IEC 62366, EN ISO 14971.
Environmental and Transportation Standards: Such as RTCA/DO-160F, EN 794-3, EN 1789, EN 13718-1.
Waveform Standards: ASTM F1100-90.

The device's performance in designated tests is measured against the limits and criteria defined by these standards.

8. The Sample Size for the Training Set

This refers to a machine learning context. Since the HAMILTON-T1 device is not described as utilizing a machine learning algorithm that requires a "training set" of data, this section is not applicable. The device's software is based on the HAMILTON-C2's software and verified through traditional software validation methods, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, this section is not applicable as there is no "training set" in the context of this device's development or evaluation.

Summary

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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 AGVia Crusch 8Bonaduz, 7402SWITZERLAND
	CONTACT PERSON:	Ralph AguilaRegulatory Affairs / Quality EngineerPhone: +49 171 401 7192Fax: +41 81 660 60 20e-mail: raguila@hamilton-medical.ch
	ESTABLISHMENTREGISTRATIONNUMBER:	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-TC1510(k) Number: K112006

Simults builtery exchange

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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

1. 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.
1. 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.
1. 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.
1. 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.
1. 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."

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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.

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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

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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 transportventilators. 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 - Part1: 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 CriticalCare (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.

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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 MedicalHAMILTON-T1	DrägerOxylog 3000+	CareFusionEnVe
Biphasic breathing	Yes	No	Yes
Advanced biphasicventilation modesDuoPAP / APRV	Yes	No	No
Closed-Loop Ventilationwith ASV	Yes	No	No
Smart Apnea Backup	Yes	No	No
Breathing circuitcompensation	Yes	No	No
Nebulizer	Yes	No	Yes
Expiratory TriggerSensitivity	Yes	No	Yes
CO2 measurement(sidestream andmainstream)	Yes	No	No
Volumetric capnography	Yes	No	No
Dynamic Lung	Yes	No	No
VentStatus Window	Yes	No	No
Interface to monitoringsystem 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

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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.

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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:

K120670

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

Regulation Number and Section

§ 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).