Who is the manufacturer of HAMILTON-TC1?

Hamilton Medical AG filed the 510(k) submission for HAMILTON-TC1 (K112006).

What is the FDA product code for HAMILTON-TC1?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for HAMILTON-TC1?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HAMILTON-TC1?

HAMILTON-C2 (K102775); DRAEGER Oxylog 3000 (K062267).

Who can help prepare an FDA 510(k) submission like HAMILTON-TC1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HAMILTON-TC1

K112006 · Hamilton Medical AG · CBK · Feb 9, 2012 · Anesthesiology

Device Facts

Record ID	K112006
Device Name	HAMILTON-TC1
Applicant	Hamilton Medical AG
Product Code	CBK · Anesthesiology
Decision Date	Feb 9, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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 Story

HAMILTON-TC1 is a compact (6.5 kg), turbine-driven transport ventilator for adult and pediatric patients. It operates on AC/DC power without requiring external compressed air or O2. Designed for hospital and aeromedical environments (fixed-wing/helicopter), it features a ruggedized, impact-resistant case and automatic barometric altitude compensation. Operated by trained clinicians via a touchscreen 'Ventilation Cockpit' GUI, it includes the ASV (Adaptive Support Ventilation) mode to automate lung-protective strategies and weaning. A microprocessor system controls gas delivery and patient monitoring, with a cross-checking alarm controller to mitigate software failure risks. A 'lock-button' prevents inadvertent setting changes. The device provides continuous ventilatory support, with output data used by clinicians to manage patient respiratory status, potentially reducing operator error and improving weaning outcomes.

Clinical Evidence

Bench testing only. Performance evaluated via waveform analysis (ASTM F1100-90) comparing HAMILTON-TC1 to HAMILTON-C2. Environmental testing conducted per RTCA/DO-160F for shock, vibration, and high-altitude performance. Software verification and validation testing confirmed implementation of requirements.

Technological Characteristics

Turbine-driven, microprocessor-controlled ventilator. Materials: impact-resistant ruggedized enclosure. Connectivity: DC-power inlet. Standards: RTCA/DO-160F (airworthiness), IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 5356-1. Features: touchscreen GUI, ASV mode, automatic altitude compensation. Software: rule-based control with cross-checked alarm monitoring.

Indications for Use

Indicated for positive pressure ventilatory support in adult and pediatric patients. Intended for use in intensive care, recovery rooms, emergency/primary care, and during transport via rescue vehicles, jets, or helicopters. Contraindicated for neonatal patients.

Regulatory Classification

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.

Predicate Devices

HAMILTON-C2 (K102775)
DRAEGER Oxylog 3000 (K062267)

Related Devices

K120670 — HAMILTON-T1 · Hamilton Medical AG · Apr 3, 2012
K121225 — HAMILTON-C2 · Hamilton Medical AG · Nov 16, 2012
K123637 — HAMILTON-C3 · Hamilton Medical AG · Dec 21, 2012
K120574 — HAMILTON-C1 · Hamilton Medical AG · May 30, 2012
K090468 — HAMILTON-C2 · Hamilton Medical AG · Jun 15, 2009

Submission Summary (Full Text)

{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 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 | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | на на пра продательно в полности в полнеском в мог дажность по 1500 W A = ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | IN II HOR HUIN UITUR LIGH LE A S LEGILISEMENTERS METHOR | {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: - 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. | . | - | | ----------- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | ------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Change or come a parties of the a ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . No. I i marries within A BOOK CHANGE CONTRACT COLLEGIAL ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 100 con dealers | . 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 12 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ANNUAL BE E. LAND HORNER . | | {2}------------------------------------------------ | Company of Children Comments of Children Comments of Children Comments of Children Comments of Children MARK PARTY AND AND AND AND A Project-Name" | - Box 44 000 00 - 1 Canada Collection College Compression Compression Comprehensive Company of Concellente Company of HAMILTON-TC1 510(k) submission in HAMILTON 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 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | THE LANDER . LEE R BEAR & BOOK . | | {3}------------------------------------------------ | 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 13485 | Medical devices -- Quality management systems. | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | EN ISO 9001 | Quality management systems. | | EN ISO 5359 | Low-pressure hose assemblies for use with medical gases. | | EN 794-1 | Particular requirements for critical care ventilators. | | EN 794-3 | Particular requirements for emergency and transport ventilators. Equal to EN 60068-2-6; -29; -64. | | EN 1789 | Medical vehicles and their equipment - Road ambulances. | | EN 13718-1 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances | | IEC 62133 | Battery Safety. Non-Spillable. | | ASTM F1100-90 | Standard Specification for Ventilators Intended for Use in Critical Care (for waveform standard analysis between the C2 and HAMILTON-TC1). | | MIL-STD-461E | RS101, CS114 (curve #3), and RE101 (Army 7-cm limit). | | ----------------------------------------------------------------------------- LA PROD COLOR COLLECTION COLLEGION | ------------- | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------| | ------------------------------------------------------------------------------ -- A FREE HERE RE SECREED LE MERCEMENT - CONSEMBER FOR LE LEA LEGILLE & FACE AND BASED OF ------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . . - A BR LE S S S S S S S S F F C S CHILD A MINIST AND Callege Back . ------------------ | . . | : {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 continues 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 1.0 Doc .- Version: | # 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. | . | CONS LEARNER | . . . 11 1 11 11 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | BE FRE LEWING OF BARRING LEASURE LEASER CANNO . . . 196 = 54 % = 10 % . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A A M C C A R E R R M C L B R B R M B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B W B WARRE L W A FINE A MONTH A COLUMN OF . 1 A | AMARK E E E E E ERICALIBRARI | {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized 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 {7}------------------------------------------------ ### 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: _______________________________________________________________________________________________________________________________________________________________

HAMILTON-TC1

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Device Story

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