HAMILTON-C3

K161450 · Hamilton Medical AG · CBK · Apr 27, 2017 · Anesthesiology

Device Facts

• Record ID: K161450
• Device Name: HAMILTON-C3
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use: In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room During transfer of ventilated patients within the hospital The HAMILTON-C3 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-C3 is a continuous ventilator providing invasive/noninvasive positive pressure support; inputs include patient respiratory signals and optional SpO2 monitoring; device uses internal turbine for air and external compressed O2; operates via qualified personnel in clinical settings (ICU, ER, recovery, transport); provides automated ventilation (ASV) and manual modes; output includes real-time ventilation parameters and alarms; assists clinical decision-making by maintaining respiratory support; benefits patients by providing tailored ventilation support.

Clinical Evidence

Bench testing only. Software verification and validation performed per FDA guidance. Waveform performance testing conducted for new ventilation modes. Compliance with IEC 60601-1, ISO 80601-2-12, ISO 80601-2-55, and ISO 80601-2-61 confirmed. No new biocompatibility testing required as materials are unchanged from previous clearances.

Technological Characteristics

Continuous ventilator; internal turbine for air, compressed source for O2; active pneumatic exhalation valve; SpO2 and CO2 monitoring options; embedded system EM10A; IEC 60601-1 (2005) compliant; software level of concern: major.

Indications for Use

Indicated for positive pressure ventilatory support in adults, pediatrics, and optionally infants and neonates. Used in intensive care, intermediate care, emergency wards, long-term acute care, recovery rooms, and during in-hospital patient transfer. Contraindications: Not for use in presence of flammable anesthetic agents or MRI equipment.

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-C3 (K123637)
• HAMILTON-G5 (K131774)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 27, 2017

Hamilton Medical AG Annemarie Höft Quality Engineer Via Crusch 8 Bonaduz, 7402 SWITZERLAND

Re: K161450

Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: March 20, 2017 Received: March 23, 2017

Dear Ms. Höft:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161450

Device Name HAMILTON-C3

Indications for Use (Describe)

The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C3 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" in large, bold letters, with a stylized "H" symbol to the right. Below "HAMILTON" is the word "MEDICAL" in a similar font but slightly smaller. Underneath the two words is the phrase "Intelligent Ventilation since 1983" in a smaller, lighter font.

Image /page/3/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a soft appearance. The word "HAMILTON" is followed by a dot and then "C3".

# 510(k) SUMMARY

l. SUBMITTER

Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland

Phone: [phone] [phone] Fax:

Contact Person: Annemarie Höft, Quality Engineer Frederike Brühschwein, Senior Manager Regulatory Affairs Date Prepared: 2017-04-24

- II. DEVICE
Name of Devices: HAMILTON-C3 Common or Usual Name: Continuous ventilator Regulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA)

- III. PREDICATE DEVICES HAMILTON-C3 (K123637) HAMILTON-G5 (K131774)
#### IV. DEVICE DESCRIPTION

The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.

The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:

- The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
- SpO2 monitoring option

#### V. INDICATIONS FOR USE

The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use:

- In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- During transfer of ventilated patients within the hospital

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Image /page/4/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".

Image /page/4/Picture/1 description: The image shows the word "HAMILTON-C3" in a stylized, sans-serif font. The letters are all in blue. The letters are rounded and have a playful appearance.

The HAMILTON-C3 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.

#### COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES VI.

A comparative summary of the technological characteristics of the HAMILTON-C3 with the primary predicate and reference devices is presented below.

| Parameters | Application device:<br>HAMILTON-C3 | Predicate device:<br>Currently<br>marketed<br>HAMILTON-C3 | Predicate device:<br>Currently<br>marketed<br>HAMILTON-G5 | Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended use | The HAMILTON-C3<br>ventilator is<br>intended to<br>provide positive<br>pressure<br>ventilatory support<br>to adults and<br>pediatrics and<br>optionally infants<br>and neonates.<br>Intended areas of<br>use:<br>In the<br>intensive care<br>ward,<br>intermediate<br>care ward,<br>emergency<br>ward, long<br>term acute<br>care hospital<br>or in the<br>recovery<br>roomDuring<br>transfer of<br>ventilated<br>patients<br>within the<br>hospitalThe HAMILTON-C3<br>ventilator is a<br>medical device<br>intended for use by<br>qualified, trained<br>personnel under<br>the direction of a<br>physician and<br>within the limits of<br>its stated technical | The HAMILTON-C3<br>ventilator is<br>intended to<br>provide positive<br>pressure<br>ventilatory support<br>to adults,<br>paediatrics,<br>infants, and<br>neonates.<br>Intended areas of<br>use:<br>In the<br>intensive care<br>ward or in the<br>recovery<br>room.During<br>transfer of<br>ventilated<br>patients<br>within the<br>hospital.The HAMILTON-C3<br>ventilator is a<br>medical device<br>intended for use by<br>qualified, trained<br>personnel under<br>the direction of a<br>physician and<br>within the limits of<br>its stated technical<br>specifications. | The HAMILTON-G5<br>ventilator is<br>designed for<br>intensive care<br>ventilation of adult<br>and paediatric<br>patients, and<br>optionally infant<br>and neonatal<br>patients. The<br>device is intended<br>for use in the<br>hospital and<br>institutional<br>environment<br>where healthcare<br>professionals<br>provide patient<br>care. The<br>HAMILTON-G5<br>ventilator is<br>intended for use by<br>properly trained<br>personnel under<br>the direct<br>supervision of a<br>licensed physician.<br>The HAMILTON-G5<br>ventilator may be<br>used for transport<br>within a hospital or<br>hospital-type<br>facility -- provided<br>compressed gas is<br>supplied.<br>The device is not to<br>be used in the<br>presence of<br>flammable<br>anesthetic agents | Substantially<br>equivalent |
| | specifications. | | or other ignition<br>sources. The<br>ventilator is not to<br>be used in an<br>environment with<br>magnetic<br>resonance imaging<br>(MRI) equipment.<br>The device is not<br>intended for<br>transportation<br>outside the<br>hospital or for use<br>in the home<br>environment. | |
| Product<br>classification<br>code | CBK (subsequent:<br>DQA) | CBK | CBK (subsequent:<br>DQA) | Substantially<br>Equivalent |
| CFR citation | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5895 | Substantially<br>Equivalent |
| Principal<br>operator | Qualified, trained<br>personnel under<br>the direction of a<br>physician | Qualified, trained<br>personnel under<br>the direction of a<br>physician | Qualified, trained<br>personnel under<br>the direction of a<br>physician | Substantially<br>Equivalent<br>Same principal<br>operator as on<br>HAMILTON-C3 and<br>HAMILTON-G5 |
| Environment<br>of use | Intended areas of<br>use:<br>●<br>In the<br>intensive care<br>ward,<br>intermediate<br>care ward,<br>emergency<br>ward, long<br>term acute<br>care hospital<br>or in the<br>recovery<br>room<br>●<br>During<br>transfer of<br>ventilated<br>patients<br>within the<br>hospital | Intended areas of<br>use:<br>●<br>In the<br>intensive care<br>ward or in the<br>recovery<br>room.<br>●<br>During<br>transfer of<br>ventilated<br>patients<br>within the<br>hospital. | Intended areas of<br>use:<br>●<br>In the<br>intensive care<br>ward,<br>intermediate<br>care ward,<br>emergency<br>ward, long<br>term acute<br>care hospital<br>or in the<br>recovery<br>room<br>●<br>During<br>transfer of<br>ventilated<br>patients<br>within the<br>hospital | Substantially<br>Equivalent<br>Same environment<br>of us as on<br>HAMILTON-C3 and<br>HAMILTON-G5 |
| Intended<br>patient<br>population | Adults, pediatrics,<br>infants and<br>neonates | Adults, pediatrics,<br>infants and<br>neonates | Adults, pediatrics,<br>infants and<br>neonates | Substantially<br>Equivalent<br>Same Intended<br>patient population<br>as on HAMILTON-<br>C3 and HAMILTON-<br>G5 |
| Patient<br>interface | Delivered<br>invasively (via ET<br>tube) or<br>noninvasively (via<br>mask) | Delivered<br>invasively (via ET<br>tube) or<br>noninvasively (via<br>mask) | Delivered<br>invasively (via ET<br>tube) or<br>noninvasively (via<br>mask) | Substantially<br>Equivalent<br>Same patient<br>interface as on<br>HAMILTON-C3 and<br>HAMILTON-G5 |
| Power source | AC, DC, Battery | AC, DC, Battery | AC, Battery | Substantially<br>Equivalent<br>Power source is<br>unchanged. |
| Operational<br>modes | PCV+ SPONT APVcmv /<br>(S)CMV+ APVsimv /<br>SIMV+ ASV (only for<br>adult/pediatric patients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS<br>(only for<br>neonatal<br>patients) (S)CMV (only<br>for<br>adult/pediatric<br>patients) SIMV (only<br>for<br>adult/pediatric<br>patients) | PCV+ SPONT (S)CMV+<br>SIMV+ ASV (only for<br>adult/pediatric<br>patients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS<br>(only for<br>neonatal<br>patients) | (S)CMV (only<br>for adult and<br>pediatric<br>patients) P-CMV SIMV (only for<br>adult and<br>pediatric<br>patients) P-SIMV SPONT APVcmv<br>APVsimv ASV (only for<br>adult and<br>pediatric<br>patients) DuoPAP APRV NIV (only for<br>adult and<br>pediatric<br>patients) NIV-ST (only<br>for adult and<br>pediatric<br>patients) nCPAP-PS<br>(only for<br>neonatal<br>patients) VS | Substantially<br>Equivalent |
| Electrical<br>safety | IEC 60601-1: 2005<br>(3rd Edition): all<br>applicable<br>requirements met. | IEC 60601-1:1988<br>(A1:1991 +<br>A2:1995): all<br>applicable<br>requirements met. | IEC 60601-1: 2005<br>(3rd Edition): all<br>applicable<br>requirements met. | Substantially<br>Equivalent |
| Emergency air<br>intake | In case of a power<br>supply, technical,<br>or pneumatics<br>failure the ambient<br>valve allows<br>spontaneous | In case of a power<br>supply, technical,<br>or pneumatics<br>failure the ambient<br>valve allows<br>spontaneous | In case of a power<br>supply, technical,<br>or pneumatics<br>failure the ambient<br>valve allows<br>spontaneous | Substantially<br>Equivalent<br>Same emergency<br>air intake as on<br>HAMILTON-C3 and<br>HAMILTON-G5 |
| Active<br>exhalation<br>valve? | Yes, pneumatic | Yes, pneumatic | Yes, pneumatic | Substantially<br>Equivalent<br>Active exhalation is<br>unchanged. |
| Alarms and<br>monitoring | Yes | Yes | Yes | Substantially<br>Equivalent |
| Supply gas | Oxygen, ambient<br>air | Oxygen, ambient<br>air | Oxygen, Air, Heliox | Substantially<br>Equivalent |
| Method of<br>supply gas<br>pressurization | Internal turbine for<br>air, compressed<br>source for 02 | Internal turbine for<br>air, compressed<br>source for 02 | Compressed<br>source for Air, 02,<br>Heliox | Substantially<br>Equivalent |
| CO2<br>monitoring<br>option | Yes | Yes | Yes | Substantially<br>Equivalent<br>CO2 monitoring is<br>unchanged. |
| SpO2<br>monitoring<br>option | Yes | No | Yes | Substantially<br>Equivalent |
| Differences in<br>technological<br>characteristics | Embedded<br>-<br>system type:<br>EM10A<br>Internal flow<br>sensor with<br>the ability to<br>detect reflow<br>Flashing<br>-<br>alarm lamp | Embedded<br>-<br>system type:<br>EM10A<br>Internal flow<br>sensor<br>without the<br>ability to<br>detect reflow<br>Alarm lamp<br>not flashing,<br>only<br>illuminated | Embedded<br>-<br>system type:<br>EM01A<br>Internal flow<br>valve without<br>the ability to<br>detect reflow<br>Flashing<br>-<br>alarm lamp | Substantially<br>Equivalent |

Table 1: Comparison of HAMILTON-C3 with predicate device

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Image /page/5/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".

Image /page/5/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is a bright blue color. The letters are bold and easy to read.

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Image /page/6/Picture/0 description: The image contains the logo for Hamilton Medical. The logo has the word "HAMILTON" on the top line with a symbol to the right of the word. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line. All of the text and the symbol are in blue.

Image /page/6/Picture/1 description: The image shows the word "HAMILTON.C3" in blue font. The letters are bold and rounded. The word is written in all capital letters.

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Image /page/7/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" stacked on top of the word "MEDICAL". To the right of the word "HAMILTON" is a blue circle with a white "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".

Image /page/7/Picture/1 description: The image shows the text "HAMILTON-C3" in a bold, sans-serif font. The text is a solid blue color. The letters are rounded and have a slightly cartoonish appearance. The word "HAMILTON" is followed by a dot and then the letter "C" and the number "3".

As can be seen in the table above, the application device HAMILTON-C3 has the same technological characteristics as the predicate HAMILTON-C3, with the exception of its internal flow sensor. The applicant device HAMILTON-C3 add new (S)CMV and SIMV ventilation mode which have same algorithms for delivering breaths as the predicate device HAMILTON-G5.

Altogether, the technological characteristics of the application device HAMILTON-C3 are substantially equivalent to the predicate devices. Thus, the comparison of the HAMILTON-C3 to its predicate devices does not raise new safety and effectiveness concerns.

#### VII. PERFORMANCE DATA

The following performance and nonclinical data are provided in support of the substantial equivalence determination.

The Software Design and Validation process, together with the bench testing of the device, demonstrated that the HAMILTON-C3 operates as intended.

In particular, testing demonstrated that the HAMILTON-C3 is compliant with the following guidelines and standards:

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Image /page/8/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circular symbol. Below the logo is the text "Intelligent Ventilation since 1983".

Image /page/8/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a playful appearance. The word "HAMILTON" is followed by a dot and then the number "C3".

- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General -Requirements for Safety
- -IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- -ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- -IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
- IEC 62304 (2006): Medical device software Software life-cycle processes -
- -ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Additional software verification and validation testing were conducted and documentation was provided as recommended by the FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Testing of the modified HAMILTON-C3, with the new features, was conducted. The new ventilation modes were subjected to waveform performance testing. The data provided from these tests was shown to be substantially equivalent to the legally marketed devices.

Since only materials already used in earlier 510(k)s are introduced with this 510(k), Hamilton Medical did not conduct any additional biocompatibility testing.

#### VIII. CONCLUSION

The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-C3 ventilator is as safe and as effective as the legally marketed devices identified herein.