HAMILTON-C3

K201306 · Hamilton Medical AG · CBK · Feb 5, 2021 · Anesthesiology

Device Facts

• Record ID: K201306
• Device Name: HAMILTON-C3
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 5, 2021
• 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 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

The HAMILTON-C3 is a continuous ventilator providing invasive and noninvasive ventilatory support. This submission introduces the 'HiFlowO2' therapy mode. The device takes medical air and oxygen as inputs, delivering them via positive pressure to patient airways. It features automated ventilation modes, including Adaptive Support Ventilation (ASV). Used in hospital environments (ICU, emergency, recovery) by trained clinicians, the device monitors respiratory parameters and provides alarms for high/low oxygen and blockages. The HiFlowO2 feature allows for high-flow oxygen therapy with adjustable flow and oxygen concentration settings. Clinicians use the device interface to set ventilation parameters, which the device executes to support patient breathing. The system benefits patients by providing controlled respiratory support across a wide range of patient sizes, from neonates to adults.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing compared HiFlowO2 flow and oxygen delivery values against the reference device (HAMILTON-G5) to demonstrate substantial equivalence. Software verification and validation were conducted per FDA guidance.

Technological Characteristics

Continuous ventilator; provides invasive/noninvasive ventilation and HiFlowO2 therapy. Materials are identical to the predicate (K161450). Complies with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, IEC 80601-2-49, IEC 62304, and IEC 62366. Software-controlled; major level of concern. Connectivity includes standard ventilator interfaces.

Indications for Use

Indicated for positive pressure ventilatory support in adult, pediatric, infant, and neonatal patients. Used in intensive care, intermediate care, emergency wards, long-term acute care, recovery rooms, and during intra-hospital transport. Intended for use by qualified, trained personnel under physician direction.

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 (K161450)

Reference Devices

• HAMILTON-G5 (K180295)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hamilton Medical AG Simone Haller Regulatory Affairs Specialist Via Crusch 8 Bonaduz, GR 7402 Switzerland

Re: K201306

Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: January 5, 2021 Received: January 7, 2021

Dear Simone Haller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K201306

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.

Intende 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY

l. SUBMITTER

Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland

Phone: [phone] Fax: [phone]

Contact Person: Timo Tscharntke, Regulatory Affairs Specialist

Date prepared: 2020-02-05

#### 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 (secondary: DQA)
#### III. PREDICATE DEVICES

- Primary predicate device for the ventilator HAMILTON-C3 itself: HAMILTON-C3 (K161450) (Company Hamilton Medical AG)
#### IV. REFERENCE DEVICE

- Reference device regarding introduced therapy type HiFlowO2: HAMILTON-G5 (K180295) (Company Hamilton Medical AG)
#### V. DEVICE DESCRIPTION

The HAMILTON-C3 is designed for adult, pediatric, 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:

- . Therapy type: HiFlowO2
#### VI. INDICATIONS FOR USE

#### Ventilator HAMILTON-C3 ●

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.

{4}------------------------------------------------

#### COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PRIMARY PREDICATE AND PREDICATE DEVICES VII.

A comprative summary of the technological characteristics of the primary predicate and the predicate device is presented in the tables below.

| Parameters | Subject device: HAMILTON-C3 | Primary predicate device: Currently marketed HAMILTON-C3 | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indication<br>for use | The HAMILTON-C3 ventilator is intended to provide positive pressure<br>ventilatory support to adults, pediatrics, and optionally infants and<br>neonates.<br>Intended areas of use:<br>In the intensive care ward, intermediate care ward, emergency<br>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<br>by qualified, trained personnel under the direction of a physician<br>and within the limits of its stated technical specifications. | The HAMILTON-C3 ventilator is intended to provide positive pressure<br>ventilatory support to adults, pediatrics, and optionally infants and<br>neonates.<br>Intended areas of use:<br>In the intensive care ward, intermediate care ward, emergency<br>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<br>qualified, trained personnel under the direction of a physician and<br>within the limits of its stated technical specifications. | Same |
| Modes of<br>ventilation | (S)CMV (only for adult/pediatric patients)APVcmv / (S)CMV+SIMV (only for adult/pediatric patients)APVsimv / SIMV+PCV+PSIMV+DuoPAPAPRVSPONT and NIVNIV STnCPAP-PS (only for neonatal patients)ASV (only for adult/pediatric patients) | (S)CMV (only for adult/pediatric patients)APVcmv / (S)CMV+SIMV (only for adult/pediatric patients)APVsimv / SIMV+PCV+PSIMV+DuoPAPAPRVSPONT and NIVNIV STnCPAP-PS (only for neonatal patients)ASV (only for adult/pediatric patients) | Same |
| Therapy<br>type | High Flow O2 (HiFlowO2)Control settings (ranges), adult: Flow (2 to 60 l/min)Control settings (ranges), neonatal: Flow (2 to 12 l/min)Control settings (defaults), adult: Flow (15 l/min)Control settings (defaults), neonatal: Flow (2 l/min) | | please refer<br>to Table 2 |

Hamilton Medical AG has demonstrated the proposed HAMLTON-C3 ventilator to the currently marketed (here primary predicate device) HAMILTON-C3 (K161450) that has been previously cleared by FDA.

Table 2: Comparison of HAMILTON-C3 with the reference device

{5}------------------------------------------------

| Parameters | Subject device: HAMILTON-C3 | Reference device: HAMILTON-G5 | Comparison | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------|
| Intended use | The HAMILTON-C3 ventilator is intended to provide positive pressure<br>ventilatory support to adults, pediatrics, infants and neonates<br>depending on its configuration.<br>Intended areas of use:<br>• In the intensive care ward, intermediate care ward, emergency<br>ward, long term acute care hospital or in the recovery room.<br>• During transfer of ventilated patients within the hospital.<br>The HAMILTON-C3 ventilator is a medical device intended for use by<br>qualified, trained personnel under the direction of a physician and<br>within the limits of its stated technical specifications. | The HAMILTON-G5 ventilator is designed for intensive care<br>ventilation of adult and pediatric patients, and optionally infant<br>and neonatal patients. The device is intended for use in the<br>hospital and institutional environment where health care<br>professionals provide patient care. The HAMILTON-G5 ventilator<br>is intended for use by properly trained personnel under the direct<br>supervision of a licensed physician.<br>The HAMILTON-G5 ventilator may be used for transport within a<br>hospital or hospital type facility provided compressed gas is<br>supplied. The device is not to be used in the presence of<br>flammable anesthetic agents or other ignition sources. The<br>ventilator is not to be used in an environment with magnetic<br>resonance imaging (MRI) equipment. The device is not intended<br>for transportation outside the hospital or for use in the home<br>environment. | Substantially<br>equivalent | |
| Environment<br>of use | The device is intended for use in the hospital and institutional<br>environment where healthcare professionals provide patient care | The device is intended for use in the hospital and institutional<br>environment where healthcare professionals provide patient care | Same | |
| Anatomical<br>site | Patient airways | Patient airways | Same | |
| Target<br>population | Adult, pediatric and neonatal patients | Adult, pediatric and neonatal patients | Same | |
| HiFlowO2<br>flow range<br>and settings | Range<br>• 2 to 12 l/min (neonatal)<br>• 2 to 60 l/min (adult/pediatric)<br><br>Settings<br>• Flow adult/pediatric: 15 l/min<br>• Flow neonatal: 2 l/min<br>• Oxygen adult/pediatric: 50 %<br>• Oxygen neonatal: 40 % | Range<br>• 1 to 12 l/min (neonatal)<br>• 1 to 60 l/min (adult/pediatric)<br><br>Settings<br>• Flow adult/pediatric: 15 l/min<br>• Flow neonatal: 1 l/min<br>• Oxygen adult/pediatric: 50 %<br>• Oxygen neonatal: 40 % | Similar | |
| Alarms,<br>adjustable | • High oxygen<br>• Low oxygen | • High oxygen<br>• Low oxygen | Same | |
| Alarms, non-<br>adjustable | • Check for blockage | • Check for blockage<br>• Cannot reach target flow | Different | |
| Parameters | Subject device: HAMILTON-C3 | Reference device: HAMILTON-G5 | Comparison | |
| Chemicals<br>delivered to<br>patient | Medical air and oxygen | Medical air and oxygen1 | Same | |
| | Delivery<br>method to<br>patient | Positive pressure | Positive pressure | Same |
| | | Energy used<br>for device | AC, DC, battery | AC, battery |
| Therapy types | | Invasive, non-invasive, HiFlowO2 | Invasive, non-invasive, HiFlowO2 | Same |
| Performance<br>test | A bench test with a comparison of the HiFlowO2 performance is submitted. | | Substantially<br>equivalent | |

{6}------------------------------------------------

The subject device HAMLTON-CS is compared to the reference device HAMLTON-G5 regarding the introduced therapy type HFlowO2, which resulted in substantial equivalence with respect to the HiFlowO2 therapy type (Table 2).

¹ Optional Heliox

{7}------------------------------------------------

#### VIII. PERFORMANCE DATA

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

## HAMILTON-C3

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:

- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment Part 1 General । requirements for basic safety and essential performance
- । IEC 60601-1:2005 3rd Edition US National deviations
- -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
- -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 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
- -ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ISO 80601-2-55 (2018): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- -ISO 80601-2-61 (2018): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- -IEC 80601-2-49 (2018): Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- -IEC 62304 (2015): Medical device software - Software life-cycle processes
- IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
- -AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers

Additional software verification and validation testing was 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 to be 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 new feature, the therapy type HiFlowO2, was conducted by a bench test comparing the flow and oxygen values. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device.

Since only materials in relation to the ventilator itself, which are already used in in the primary predicate (cleared under document number K161450) are used (the new features did not include any material changes, only software adaptions), Hamilton Medical AG did not conduct any additional biocompatibility testing.

{8}------------------------------------------------

#### IX. CONCLUSION

The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-C3 ventilator is substantially equivalent to the legally marketed primary predicate device and substantially equivalent to the reference device (with respect to the new feature HiFlowO2) identified herein.