(211 days)
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 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:
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
The HAMILTON-TC1 is a continuous ventilator intended to provide positive pressure ventilatory support to adults and pediatrics in various medical settings, including intensive care, emergency care, and during transport. The device's substantial equivalence to predicate devices (HAMILTON-C2 and DRAEGER Oxylog 3000) was established through non-clinical performance testing and compliance with recognized standards.
Here's a breakdown of the acceptance criteria and study aspects based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in a direct side-by-side comparison. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through compliance with a broad set of recognized standards and successful completion of non-clinical tests.
The document highlights the following general performance discussions:
- Waveform Performance: The HAMILTON-TC1 was subjected to waveform performance testing as described in Aston F1100-90. The data from these tests were shown to be substantially equivalent to the HAMILTON-C2.
- Airworthiness and Transport Aspects: For airworthiness and transport, the HAMILTON-TC1 is considered substantially equivalent to the Oxylog 3000. It compensates for altitude changes and has increased immunity to EMI.
- Altitude Testing: The HAMILTON-TC1 was placed inside an altitude chamber to test the effects on sensors and ventilator measurements/readings in a high-altitude, low-pressure environment. The detailed protocol and successful results were included in the submission.
- Software Verification and Validation: This testing demonstrated that all specified requirements have been implemented correctly and completely.
- Intended Use Compatibility: The intended use of the HAMILTON-TC1 is explicitly stated to be comparable to both predicate devices.
- Technological Characteristics: Design, material, and energy source are described as substantially equivalent to predicate devices.
- Max Inspiratory Flow:
- HAMILTON-C2 (Predicate): 240 l/min
- HAMILTON-TC1 (Proposed): 210 l/min
- Comparison: Deemed "substantially equivalent."
The primary acceptance criteria are met through adherence to the following standards, ensuring safety and effectiveness:
| Standard/Guidance Document | Aspect Covered |
|---|---|
| Draft Reviewer Guidance for Ventilators (1995) | General guidance for ventilators |
| 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 |
| RTCA/DO-160F: 2007 | Environmental Conditions and Test Procedures for Airborne Equipment (e.g., shocks, vibration, voltage spikes, RF susceptibility, ESD, REI) |
| 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 |
| EN 1789 | Medical vehicles and their equipment – Road ambulances |
| EN 13718-1 | Medical vehicles and their equipment – Air ambulances - Part 1 |
| IEC 62133 | Battery Safety. Non-Spillable |
| ASTM F1100-90 | Standard Specification for Ventilators Intended for Use in Critical Care (waveform analysis) |
| MIL-STD-461E | RS101, CS114 (curve #3), and RE101 (EMI/EMC testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" for a test set in the context of a clinical study or a data set for an AI model.
The tests described are primarily engineering and bench testing for compliance with standards (e.g., ASTM F1100-90 for waveform testing, RTCA/DO-160F for environmental conditions, IEC standards for safety/EMC). For these types of tests, a single device or a small number of devices manufactured according to specifications are typically tested to ensure design compliance.
Data provenance is not applicable in the sense of patient data origin, as this is a device engineering and performance evaluation, not a clinical data analysis study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This document pertains to the regulatory submission of a medical device (ventilator), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" here is adherence to engineering standards and functional specifications.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where discrepancies in expert diagnoses or annotations need to be resolved. This is not relevant for the type of device performance testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The HARTILTON-TC1 is a standalone ventilator device and not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone in the sense that they evaluate the device itself (HAMILTON-TC1) without explicitly measuring human-in-the-loop performance with an AI component. The ventilator's performance is tested against established engineering and safety standards. While the device has a "microprocessor system" and "alarm controller" with software, its overall functioning is as a medical device in itself, not an algorithm providing diagnostic or treatment recommendations that would typically be evaluated for standalone AI performance.
7. Type of Ground Truth Used
The "ground truth" in this context is based on:
- Engineering Standards and Specifications: The device's performance is compared against the requirements and methodologies outlined in various international and national standards (e.g., IEC 60601 series, ISO standards, ASTM F1100-90, RTCA/DO-160F).
- Performance of Predicate Devices: The HAMILTON-TC1's performance characteristics (e.g., waveform data, intended use, technological characteristics) are demonstrated to be "substantially equivalent" to legally marketed predicate devices (HAMILTON-C2 and DRAEGER Oxylog 3000), which serve as a benchmark for acceptable performance.
- Successful Completion of Non-Clinical Tests: This includes tests for safety, electromagnetic compatibility, environmental conditions (shock, vibration, altitude), software verification/validation, and specific functional tests like waveform analysis.
8. Sample Size for the Training Set
N/A. The HAMILTON-TC1 is a hardware-based medical device with integrated software, not a machine learning model that requires a distinct "training set" of data for learning or optimization in the typical AI sense. Software verification and validation are performed against defined requirements, not statistical training data.
9. How the Ground Truth for the Training Set Was Established
N/A, for the reasons stated in point 8.
{0}------------------------------------------------
| Project-Name: | HAMILTON-TC1 510(k) submission | HAMILTON MEDICAL AG | Doc.-No.: 2. Al |
|---|---|---|---|
| Doc.-Title: | 510(k) Summary | Doc.-Version: 1.0 |
510(k) SUMMARY
FEB - 9 2012 ( "
(
| SUBMITTER: | HAMILTON MEDICAL AGVia Crusch 8Bonaduz, 7402SWITZERLAND |
|---|---|
| CONTACT PERSON: | Ralph AguilaRegulatory Affairs / Quality EngineerPhone: +49 171 401 7192Fax: +41 81 660 60 20e-mail: raquila@hamilton-medical.ch |
| ESTABLISHMENTREGISTRATION 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-C2510(k) Number: K102775 |
| PREDICATE DEVICE:(SECONDARY)For airworthiness aspects | DRAEGER Oxylog 3000510(k) Number: K062267 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. | ||
|---|---|---|
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{1}------------------------------------------------
| Project-Name: | HAMILTON-TC1 510(k) submission | HAMILTON MEDICAL AG | Doc. No.: 2. Al |
|---|---|---|---|
| Doc.-Title: | 510(k) Summary | Doc.-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:
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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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{2}------------------------------------------------
| Company of Children Comments of Children Comments of Children Comments of Children Comments of ChildrenMARK PARTY AND AND AND AND AProject-Name" | - Box 44 000 00 - 1Canada Collection College Compression Compression Comprehensive Company of Concellente Company ofHAMILTON-TC1 510(k) submission inHAMILTON MEDICAL .a G | Doc -No. | |
|---|---|---|---|
| Ooc .- Title: | 510(k) Summary | Doc .- Version |
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 60601-1 | 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. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Acres of the Real Property of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the |
|---|---|
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{3}------------------------------------------------
| Project-Name: 1 | · HAMILTTON-TC1 510(k) submission | MANAGER AND AND AND AND A FRIEND ALL PLACE ALL BELLE ALL BE RESELTON MEDICATHAMIL | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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 AirborneEquipment. 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 Hzpower 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 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 CriticalCare (for waveform standard analysis between the C2 andHAMILTON-TC1). |
| MIL-STD-461E | RS101, CS114 (curve #3), and RE101 (Army 7-cm limit). |
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|---|---|---|
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{4}------------------------------------------------
| Call of Allier of State Are Are Charles Are of Artists Ancessarial of | Project-Name: HAMILTON-TC1 510(k) submission | HAMILTON MEDICAL AG * | Doc .- No .: 2. Al |
|---|---|---|---|
| Doc .- Title: | Acres of the confident of the first of the continues510(k) Summary------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1.0Doc .- Version: |
COMPARISON WITH THE PREDICATE DEVICES
| DraegerOxylog 3000Predicate device:K062267 | HAMILTON-C2Predicate device:K102775 | HAMILTON-TC1(Proposed device) | COMMENTS | |
|---|---|---|---|---|
| IntendedUse | Oxylog 3000 is atime-cycled, volumeconstant andpressure controlledemergency andtransport ventilatorfor patients with atidal volume from 50mL upwards.The device isintended for use bytrained healthcareprofessionals, i.e.doctors, nurses,technicians, respira-tory therapists,paramedics.The device isintended for mobileuse for emergencymedical care orprimary care ofemergency patients:* During transportin emergencyrescue vehicles oraircrafts includinghelicopters* In accident andemergency dept., inthe recovery room.Mobile use forsecondary transfers:* During transfer | The HAMILTON-C2ventilator is intendedto provide positivepressure ventilatorysupport to adults,pediatrics, infants,and neonates.Intended areas ofuse:In the intensivecare ward or inthe recoveryroom.During transfer ofventilatedpatients within thehospital.During secondarytransport fromone hospital toanother.The HAMILTON-C2ventilator is a medicaldevice intended foruse by qualified,trained personnelunder the direction ofa physician andwithin the limits of itsstated technicalspecifications. | The HAMILTON-TC1 ventilator isintended to providepositive pressureventilatory supportto adults andpediatrics.Intended areas ofuse:In the intensivecare ward or inthe recoveryroom.For emergencymedical care orprimary care.During transportwithin andoutside thehospital.During transferby rescuevehicles, jet orhelicopter.The HAMILTON-TC1 ventilator is amedical deviceintended for use byqualified, trainedpersonnel underthe direction of aphysician andwithin the limits ofits stated technicalspecifications. | The only majordifference betweenthe C2 and theHAMILTON-TC1 isthe air-worthinessaspect. Because ofthe differentenvironment of usethe HAMILTON-TC1has an impactresistant case whichprotects the controlsfrom damage andinadvertentmanipulation.The HAMILTON-TC1automaticallycompensates forbarometric altitude)changes. This featureis also found with theOxylog 3000.The enclosure for theHAMILTON-TC1 hasbeen ruggedized inaccordance to theRTCA/DO 160F towithstand shock,vibrations, wateringress, and dropsfrom >1 meterheights. TheHAMILTON-TC1 alsohas a DC-power inlet.The HAMILTON-TC1 |
| by road or air* When moving | has extra safetyfeatures 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
| IntendedPatientPopula-tion | Patients with a tidalvolume from 50 to2,000 mL. | Patients includeadults, pediatrics,infants, andneonates. | Patients includeadults andpediatrics. | The HAMILTON-TC1is not intended forneonatal patients. |
|---|---|---|---|---|
| MaximumInspira-tory Flow | 100 l/min | 240 l/min | 210 l/min | The maximuminspiratory flow forthe HAMILTON-TC1and the C2 aresubstantiallyequivalent. |
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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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
{8}------------------------------------------------
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) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
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: _______________________________________________________________________________________________________________________________________________________________
§ 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).