Hamilton-G5

K193228 · Hamilton Medical AG · CBK · May 4, 2020 · Anesthesiology

Device Facts

• Record ID: K193228
• Device Name: Hamilton-G5
• Applicant: Hamilton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: May 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

Device Story

The HAMILTON-G5 is a continuous ventilator for invasive and non-invasive respiratory support in hospital settings. It processes patient airway pressure and flow data to provide mechanical ventilation. New features include IntelliSync+, which dynamically adjusts inspiratory and cycling triggers to improve patient-ventilator synchrony, and integrated control of the HAMILTON-H900 humidifier via the ventilator GUI. The device is operated by trained clinicians. Output includes ventilation parameters, waveforms, and alarm notifications (including transmitted humidifier alarms). By automating trigger settings and centralizing humidifier management, the device aims to optimize ventilation delivery and simplify clinical workflow, potentially improving patient comfort and reducing the burden on healthcare providers.

Clinical Evidence

Bench testing only. Performance was validated through software verification and waveform testing comparing the IntelliSync+ trigger functionality to the reference predicate. Compliance with safety and performance standards (ISO 80601-2-12, IEC 60601-1, etc.) was demonstrated.

Technological Characteristics

Continuous ventilator; AC/battery powered. Features IntelliSync+ for automated trigger/cycling and integrated humidifier control. Software-based control. Complies with ISO 80601-2-12, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, and ISO 80601-2-55/61. No material changes from predicate.

Indications for Use

Indicated for intensive care ventilation of adult, pediatric, infant, and neonatal patients in hospital/institutional settings under physician supervision. Contraindicated for use with flammable anesthetic agents, in MRI environments, for transport outside the hospital, or for home use.

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-G5 (K180295)

Reference Devices

• HAMILTON-H900 (K152029, K163283)
• RESPIRONICS V200 VENTILATOR (K102054)

Submission Summary (Full Text)

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May 4, 2020

Hamilton Medical AG Simone Haller Regulatory Affairs Specialist Via Crush 8 Bonaduz, 7402 Ch

## Re: K193228

Trade/Device Name: Hamilton-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: April 1, 2020 Received: April 3, 2020

## 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 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

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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,

James J. Lee Ph.D. 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 Quality Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

## 510(k) Number (if known)

K193228

Device Name HAMILTON-G5

### Indications for Use (Describe)

The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.

The HAMILTON-G5 ventilator may be used for transport within a hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

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

> 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 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" in a smaller font size. The logo is simple and professional, and the text below it provides context about the company's focus.

Image /page/3/Picture/1 description: The image shows the word "HAMILTON-G5" in a sans-serif font. The text is a dark blue color. The letters are evenly spaced and the text is left-aligned.

## 510(k) SUMMARY

- l. SUBMITTER
Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland

Phone: [phone] Fax: [phone]

Contact Person: Simone Haller, Regulatory Affairs Specialist

Date Prepared: 2019-11-18

#### II. DEVICE

Name of Devices: HAMILTON-G5 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 DEVICE HAMILTON-G5 (K180295) (primary predicate device)
### IV. REFERENCE DEVICES Hamilton Medical AG: HAMILTON-H900 (K152029, K163283) RESPIRONICS CALIFORNIA, INC: V200 VENTILATOR (K102054)

#### V. DEVICE DESCRIPTION

The HAMILTON-G5 ventilator is designed for adults, pediatrics, infants and neonates requiring invasive or non-invasive ventilation support. It covers a range of clinical modes, including invasive ventilation, Adaptive Support Ventilation (ASV), and noninvasive ventilation. The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-G5:

- IntelliSync+, an option that allows the device to dynamically update the inspiratory or cycling trigger
- Operation of the humidifier HAMILTON-H900 via the GUI of the ventilator HAMILTON-ઉદ

#### VI. INDICATIONS FOR USE

The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

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Image /page/4/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" in a bold, sans-serif font. Above the word "HAMILTON" is a stylized symbol. Below the words "HAMILTON MEDICAL" is the phrase "Intelligent Ventilation since 1983" in a smaller, lighter font.

Image /page/4/Picture/1 description: The image shows the text "HAMILTON-G5" in a sans-serif font. The text is a vibrant blue color. The text is horizontally oriented and centered in the image.

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

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

Table 1: Comparison of HAMILTON-G5 with the primary predicate device

| <b>Parameters</b> | <b>Subject device:</b> | <b>Primary predicate device:</b> | <b>Comparison</b> | | | | | | | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------|
| | <b>HAMILTON-G5</b> | <b>Currently marketed HAMILTON-G5</b> | | | | | | | | | |
| Indication for<br>Use | 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. | 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<br>direct 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 transport outside the hospital or for use in the home<br>environment. | Same | | | | | | | | |
| | | | | Environment<br>of Use | Hospitals, hospital-type facilities and in-hospital transportation<br>for patients who need ventilation therapy | Hospitals, hospital-type facilities and in-hospital transportation<br>for patients who need ventilation therapy | Same | | | | |
| | | | | | | | | Anatomical<br>Site | Patient airways | Patient airways | Same |
| | | | | Target<br>Population | Adult, pediatric, infant and neonatal patients | Adult, pediatric, infant and neonatal patients | Same | | | | |
| | | | | | | | | Performance | Met ISO 80601-2-12 requirements on essential performance of<br>critical care ventilator. | Met ISO 80601-2-12 requirements on essential performance of<br>critical care ventilator. | Same |
| | | | | Chemicals<br>delivered to<br>patient | Medical Air and Oxygen (optional Heliox) | Medical Air and Oxygen (optional Heliox) | Same | | | | |
| | | | | | | | | Parameters | Subject device:<br>HAMILTON-G5 | Primary predicate device:<br>Currently marketed HAMILTON-G5 | Comparison |
| | | | | | | | | Energy used<br>for device | AC and battery | AC and battery | Same |
| | | | | New feature;<br>Settings<br>(Ranges) | • HAMILTON-H900 settings:<br>- Temperature (HAMILTON-H900 ET 35 to 41 °C / NIV<br>30 to 35 °C)<br>- Humidity (-2 to 3 °C)<br>- Standby On (HAMILTON-H900 On/Off)<br>- Power On/Off (HAMILTON-H900 On/Off)<br>- Auto Mode (HAMILTON-H900 On/Off)<br>- NIV (HAMILTON-H900 On/Off)<br>- Expiratory Lim Temperature Increase (HAMILTON-<br>H900 On/Off)<br>• Alarm Silence (HAMILTON-H900 On/Off) | | Added<br>functionality<br>based on<br>HAMILTON-<br>H900<br>reference | | | | |
| Modes of<br>ventilation | • ASV<br>• APVcmv<br>• APVsimv<br>• P-CMV<br>• P-SIMV<br>• SPONT<br>• DuoPAP<br>• APRV<br>• (S)CMV<br>• SIMV<br>• VS<br>• nCPAP-PS<br>• NIV<br>• NIV-ST | • ASV<br>• APVcmv<br>• APVsimv<br>• P-CMV<br>• P-SIMV<br>• SPONT<br>• DuoPAP<br>• APRV<br>• (S)CMV<br>• SIMV<br>• VS<br>• nCPAP-PS<br>• NIV<br>• NIV-ST | Same | | | | | | | | |
| Therapy types | Invasive, non-invasive, Hi Flow O2 (High flow) | Invasive, non-invasive, Hi Flow O2 (High flow) | Same | | | | | | | | |
| Trigger | Pressure trigger, flow trigger, trigger off | Pressure trigger, flow trigger, trigger off | Same | | | | | | | | |
| New feature;<br>Trigger | IntelliSync+ | | Please refer<br>to Table 2 | | | | | | | | |
| Parameters | Subject device:<br>HAMILTON-G5 | Primary predicate device:<br>Currently marketed HAMILTON-G5 | Comparison | | | | | | | | |
| Alarms, non-adjustable | • Oxygen alarm limit exceeded<br>• Oxygen concentration<br>• Disconnection<br>• Loss of PEEP<br>• Exhalation obstruction<br>• High PEEP<br>• ASV/APV<br>• CO2<br>• Power supply<br>• Gas supply<br>• Cuff leakage<br>• Nebulizer disconnected<br>• Cannot reach target flow<br>• Cuff disconnection<br>• Check for blockage | • Oxygen alarm limit exceeded<br>• Oxygen concentration<br>• Disconnection<br>• Loss of PEEP<br>• Exhalation obstruction<br>• High PEEP<br>• ASV/APV<br>• CO2<br>• Power supply<br>• Gas supply<br>• Cuff leakage<br>• Nebulizer disconnected<br>• Cannot reach target flow<br>• Cuff disconnection<br>• Check for blockage | Same | | | | | | | | |
| New feature;<br>Alarms, non-adjustable | • Following humidifier alarms are transmitted from the<br>humidifier HAMILTON-H900 to the HAMILTON-G5:<br>- Humidifier tilt<br>- Humidifier chamber temp high / Humidifier y-piece temp high<br>- Humidifier water high<br>- Humidifier chamber temp low / Humidifier y-piece temp low<br>- Humidifier water low<br>- Humidifier check chamber<br>- Humidifier check left tube / Humidifier check right tube<br>- Humidifier error<br>- Check humidifier<br>- Check communication interface humidifier | | Added<br>functionality<br>based on<br>HAMILTON-<br>H900<br>reference | | | | | | | | |
| Alarms,<br>adjustable | • Low/high minute volume<br>• Low/high pressure | • Low/high minute volume<br>• Low/high pressure | Same | | | | | | | | |
| Parameters | Subject device: | Primary predicate device: | Comparison | | | | | | | | |
| | HAMILTON-G5 | Currently marketed HAMILTON-G5 | | | | | | | | | |
| | • Low/high tidal volume | • Low/high tidal volume | | | | | | | | | |
| | • Low/high respiratory rate | • Low/high respiratory rate | | | | | | | | | |
| | • Apnea time | • Apnea time | | | | | | | | | |
| | • Low/high PetCO2…