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K Number
K112006
Device Name
HAMILTON-TC1
Manufacturer
HAMILTON MEDICAL AG
Date Cleared
2012-02-09

(211 days)

Product Code
CBK
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HAMILTON-TC1 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-TC1 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-TC1 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-battery supply, and a built-in turbine; the HAMILTON-TC1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-TC1 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-TC1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixedwing aircraft, or helicopter. This makes the HAMILTON-TC1 especially relevant for Aeromedical Evacuations and Medevac operations. The HAMILTON-TC1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, 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-TC1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning. The HAMILTON-TC1's microprocessor system controls gas delivery and monitors the patient. The qas delivery and monitoring functions are cross-checked by an alarm controller. This crosschecking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure. The HAMILTON-TC1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-TC1 capable of being used in high-altitude flight environments. The HAMILTON-TC1's changes include the following: - 1. The HAMILTON-TC1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-TC1, (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-TC1. The software is also different since the HAMILTON-TC1 includes a DC-power inlet. - 2. The HAMILTON-TC1 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. - 3. The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-TC1 has been ruqgedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights. - 4. The HAMILTON-TC1 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-TC1 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. This feature is similar to the Oxylog 3000. - 5. The HAMILTON-TC1 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-tum 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.
More Information

HAMILTON-C2 K102775, DRAEGER Oxylog 3000 K062267

HAMILTON-C2 K102775, DRAEGER Oxylog 3000 K062267

Unknown
The description mentions an "ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning." While this suggests some level of automated decision-making, the summary does not explicitly state that this mode utilizes AI or ML. It could be based on pre-programmed algorithms or rule-based logic. Without further information, it's impossible to definitively confirm the presence of AI/ML.

Yes.

The HAMILTON-TC1 ventilator is intended to provide positive pressure ventilatory support, which is a therapeutic intervention for patients requiring breathing assistance, and it includes features like the ASV ventilation-mode that applies lung-protective strategies.

No

Explanation: The HAMILTON-TC1 is described as a ventilator that provides positive pressure ventilatory support and automatically compensates for altitude changes. Its primary function is to deliver gas and monitor the patient for ventilatory support, not to diagnose a condition.

No

The device description clearly indicates that the HAMILTON-TC1 is a physical ventilator with hardware components such as a turbine, batteries, a microprocessor system, and an impact-resistant case. While it includes software, it is not solely software.

Based on the provided text, the HAMILTON-TC1 ventilator is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the device provides "positive pressure ventilatory support to adults and pediatrics." This is a life-support function directly applied to a patient, not a test performed on a sample taken from a patient.
  • Device Description: The description focuses on the mechanical and software aspects of delivering ventilation, monitoring patient parameters (like gas delivery), and adapting to different environments (transport, altitude). There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
  • Lack of IVD Characteristics: The text does not describe any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.

The HAMILTON-TC1 is a therapeutic medical device used to support a patient's breathing.

N/A

Intended Use / Indications for Use

The HAMILTON-TC1 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-TC1 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-TC1 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-battery supply, and a built-in turbine; the HAMILTON-TC1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-TC1 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-TC1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixedwing aircraft, or helicopter. This makes the HAMILTON-TC1 especially relevant for Aeromedical Evacuations and Medevac operations.

The HAMILTON-TC1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, 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-TC1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.

The HAMILTON-TC1's microprocessor system controls gas delivery and monitors the patient. The qas delivery and monitoring functions are cross-checked by an alarm controller. This crosschecking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.

The HAMILTON-TC1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-TC1 capable of being used in high-altitude flight environments. The HAMILTON-TC1's changes include the following:

  1. The HAMILTON-TC1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-TC1, (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-TC1. The software is also different since the HAMILTON-TC1 includes a DC-power inlet.
  2. The HAMILTON-TC1 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.
  3. The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-TC1 has been ruqgedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
  4. The HAMILTON-TC1 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-TC1 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. This feature is similar to the Oxylog 3000.
  5. The HAMILTON-TC1 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-tum 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.
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.

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)

Non-clinical tests were performed. The ventilator was subjected to waveform performance testing as described in the standard ASTM F1100-90. The data provided from these tests were shown to be substantially equivalent to the HAMILTON-C2. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely. For airworthiness and transport aspects, the HAMILTON-TC1 is substantially equivalent to the Oxylog 3000. One of the tests used to evaluate the HAMILTON-TC1 in a high-altitude, low-pressure environment, was to place the HAMILTON-TC1 inside an altitude chamber to test the effects on the sensors and the ventilator measurements & readings. The detailed protocol and successful results for this test have been included with the submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

HAMILTON-C2 K102775, DRAEGER Oxylog 3000 K062267

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

Project-Name:HAMILTON-TC1 510(k) submissionHAMILTON MEDICAL AGDoc.-No.: 2. Al
Doc.-Title:510(k) SummaryDoc.-Version: 1.0

510(k) SUMMARY

FEB - 9 2012 ( "

(

| 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: raquila@hamilton-medical.ch |
| ESTABLISHMENT
REGISTRATION NUMBER: | 3001421318 |
| PREPARATION DATE: | 2011-06-30 |
| TRADE NAME: | HAMILTON-TC1, model T1. |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | CLASS II Ventilator, Continuous |
| REGULATION NUMBER: | 21 CFR 868.5895 |
| PRODUCT CODE: | CBK |
| PREDICATE DEVICE:
(PRIMARY) | HAMILTON-C2
510(k) Number: K102775 |
| PREDICATE DEVICE:
(SECONDARY)
For airworthiness aspects | DRAEGER Oxylog 3000
510(k) Number: K062267 |

| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Project-Name:HAMILTON-TC1 510(k) submissionHAMILTON MEDICAL AGDoc. No.: 2. Al
Doc.-Title:510(k) SummaryDoc.-Version: 1.0

DEVICE DESCRIPTION

The HAMILTON-TC1 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-battery supply, and a built-in turbine; the HAMILTON-TC1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-TC1 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-TC1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixedwing aircraft, or helicopter. This makes the HAMILTON-TC1 especially relevant for Aeromedical Evacuations and Medevac operations.

The HAMILTON-TC1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, 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-TC1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.

The HAMILTON-TC1's microprocessor system controls gas delivery and monitors the patient. The qas delivery and monitoring functions are cross-checked by an alarm controller. This crosschecking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.

The HAMILTON-TC1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-TC1 capable of being used in high-altitude flight environments. The HAMILTON-TC1's changes include the following:

    1. The HAMILTON-TC1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-TC1, (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-TC1. The software is also different since the HAMILTON-TC1 includes a DC-power inlet.
    1. The HAMILTON-TC1 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-TC1 has been ruqgedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
    1. The HAMILTON-TC1 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-TC1 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. This feature is similar to the Oxylog 3000.
    1. The HAMILTON-TC1 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-tum 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.

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INTENDED USE

The HAMILTON-TC1 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-TC1 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.

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-TC1 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-TC1 is safe and effective for its intended use. The ventilator was further subjected to wave-form performance testing as described in the standard ASTM F1100-90. The data provided from these tests, were shown to be substantially equivalent to the HAMILTON-C2. 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 quidance documents recognized by FDA to establish the basis of safety and effectiveness for the HAMILTON-TC1:

Draft Reviewer Guidance for Ventilators. 1995.
IEC 60601-1General Requirements for Safety.
IEC 60601-1-2Electromagnetic Compatibility.
IEC 60601-1-4Programmable electrical medical systems.
IEC 60601-1-8Alarm Systems
IEC 60601-2-12Critical Care Ventilators.
IEC 62304Software life-cycle processes.
IEC 62366Application of usability engineering to medical devices.
ISO 5356-1Conical connectors: Part 1: Cones and sockets.
AAMI/ANSI HE75Human factors engineering. Design of medical devices.
EN ISO 14971Application of risk management to medical devices.

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| Project-Name: 1 | · HAMILT
TON-TC1 510(k) submission | MANAGER AND AND AND AND A FRIEND ALL PLACE ALL BELLE ALL BE RESEL
TON MEDICAT
HAMIL | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AG . I Koc -No. |
|-----------------|---------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IDoc .- Title: | 510(k) Summarv | | Joc .- Version |

Other internationally recognized standards which the HAMILTON-TC1 meets or exceeds:

| RTCA/DO-160F: 2007 | Environmental Conditions and Test Procedures for Airborne
Equipment. Equivalent to EUROCAE/ED-14F. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Section 7 | Operational Shocks and Crash Safety |
| Section 8 | Vibration |
| Section 16.6 | Normal surge voltage (DC).
Abnormal operating conditions (DC).
Low voltage conditions (DC).
Abnormal surge voltage (DC). |
| Section 17 | Voltage spikes, 28 VDC |
| Section 18.3.1 | DC input power leads |
| Section 19.3.1 | Magnetic field induced into equipment by the aircraft 400 Hz
power systems in vicinity of the device |
| Section 20 | Radio Frequency Susceptibility (Radiated and Conducted) |
| Section 21 | Maximum level of conducted RF interface - Power line.
Maximum level of radiated RF interface. Category M. |
| Section 25 | Electrostatic Discharge & Radiated Electromagnetic Field |

EN ISO 13485Medical devices -- Quality management systems.
EN ISO 9001Quality management systems.
EN ISO 5359Low-pressure hose assemblies for use with medical gases.
EN 794-1Particular requirements for critical care ventilators.
EN 794-3Particular requirements for emergency and transport ventilators.
Equal to EN 60068-2-6; -29; -64.
EN 1789Medical vehicles and their equipment - Road ambulances.
EN 13718-1Medical vehicles and their equipment - Air ambulances - Part 1:
Requirements for medical devices used in air ambulances
IEC 62133Battery Safety. Non-Spillable.
ASTM F1100-90Standard Specification for Ventilators Intended for Use in Critical
Care (for waveform standard analysis between the C2 and
HAMILTON-TC1).
MIL-STD-461ERS101, CS114 (curve #3), and RE101 (Army 7-cm limit).

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COMPARISON WITH THE PREDICATE DEVICES

| | Draeger
Oxylog 3000
Predicate device:
K062267 | HAMILTON-C2
Predicate device:
K102775 | HAMILTON-TC1
(Proposed device) | COMMENTS |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Oxylog 3000 is a
time-cycled, volume
constant and
pressure controlled
emergency and
transport ventilator
for patients with a
tidal volume from 50
mL upwards.
The device is
intended for use by
trained healthcare
professionals, i.e.
doctors, nurses,
technicians, respira-
tory therapists,
paramedics.
The device is
intended for mobile
use for emergency
medical care or
primary care of
emergency patients:

  • During transport
    in emergency
    rescue vehicles or
    aircrafts including
    helicopters
  • In accident and
    emergency dept., in
    the recovery room.
    Mobile use for
    secondary transfers:
  • During transfer | The HAMILTON-C2
    ventilator is intended
    to provide positive
    pressure ventilatory
    support to adults,
    pediatrics, infants,
    and neonates.
    Intended areas of
    use:
    In the intensive
    care ward or in
    the recovery
    room.During transfer of
    ventilated
    patients within the
    hospital.During secondary
    transport from
    one hospital to
    another.
    The HAMILTON-C2
    ventilator is a medical
    device intended for
    use by qualified,
    trained personnel
    under the direction of
    a physician and
    within the limits of its
    stated technical
    specifications. | The HAMILTON-
    TC1 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-
    TC1 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. | The only major
    difference between
    the C2 and the
    HAMILTON-TC1 is
    the air-worthiness
    aspect. Because of
    the different
    environment of use
    the HAMILTON-TC1
    has an impact
    resistant case which
    protects the controls
    from damage and
    inadvertent
    manipulation.
    The HAMILTON-TC1
    automatically
    compensates for
    barometric altitude)
    changes. This feature
    is also found with the
    Oxylog 3000.
    The enclosure for the
    HAMILTON-TC1 has
    been ruggedized in
    accordance to the
    RTCA/DO 160F to
    withstand shock,
    vibrations, water
    ingress, and drops
    from >1 meter
    heights. The
    HAMILTON-TC1 also
    has a DC-power inlet.
    The HAMILTON-TC1 |
    | | by road or air
  • When moving | | | has extra safety
    features for the EMD, |
    | | ventilated patients | | | ESD, and RFI |
    | | around in the | | | environments found |
    | | hospital | | | on aircraft. |
    | | R. Aguila | 2-6 | | 1/20/2012 |
    | | Copyright by HAMILTON MEDICAL AG | | | |

5

Project-Name: HAMILTON-TC1 510(k) submission . . " HAMILTON MEDICAL AG Doc. No.: 2. A1" Doc .- Version: 1.0 Doc .- Title: 510(k) Summary

| Intended
Patient
Popula-
tion | Patients with a tidal
volume from 50 to
2,000 mL. | Patients include
adults, pediatrics,
infants, and
neonates. | Patients include
adults and
pediatrics. | The HAMILTON-TC1
is not intended for
neonatal patients. |
|----------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Maximum
Inspira-
tory Flow | 100 l/min | 240 l/min | 210 l/min | The maximum
inspiratory flow for
the HAMILTON-TC1
and the C2 are
substantially
equivalent. |

The intended use statement for the HAMILTON-TC1 ventilator is comparable to both predicate devices. Technological characteristics (i.e., design, material, energy source) and performance specifications of the HAMILTON-TC1 ventilator are substantially equivalent to those of the predicate devices. The HAMILTON-C2 and the HAMILTON-TC1 have been tested for volume, flow, and pressure waveforms. A baseline waveform analysis using the specific ventilation modes was done in order to evaluate the substantial equivalence of the HAMLTON-TC1 with the HAMILTON-C2. For airworthiness and transport aspects, the HAMILTON-TC1 is substantially equivalent to the Oxylog 3000. One of the tests used to evaluate the HAMLTON-TC1 in a high-altitude, low-pressure environment, was to place the HAMILTON-TC1 inside an altitude chamber to test the effects on the sensors and the ventilator measurements & readings. The detailed protocol and successful results for this test have been included with the submission.

The intended use of the HAMILTON-TC1 is covered by the referenced predicate devices. The materials and design are also similar to the predicate devices. The technical characteristics of the HAMILTON-TC1 do not raise any new questions regarding the safety or effectiveness of ventilators. The HAMILTON-TC1'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-TC1 is as safe, as effective, and performs as well as, or better than, the legally marketed devices. The HAMILTON-TC1 is, therefore, considered to be substantially equivalent to the currently marketed predicate devices which have been previously cleared by FDA.

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. 196 = 54 % = 10 %

.

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A FINE A MONTH A COLUMN OF
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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 eagle or bird-like symbol, with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Public Health Service

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 SWITZERLAND

Re: K112006

Trade/Device Name: HAMILTON-TC1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 31, 2012 Received: February 3, 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 111 (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.

FEB - 9 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.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jh 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-TC1

Indication for Use: The HAMILTON-TC1 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-TC1 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 (Part 21 CFR 801 Subpart D)XAND/OROver-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Scheelthesa

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________