Hamilton-G5

K180295 · Hamiton Medical AG · CBK · Jul 30, 2019 · Anesthesiology

Device Facts

• Record ID: K180295
• Device Name: Hamilton-G5
• Applicant: Hamiton Medical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 30, 2019
• 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 noninvasive respiratory support in hospital settings. It processes patient airway pressure, flow, and volume data to deliver controlled ventilation. The device features various modes, including Adaptive Support Ventilation (ASV) and the new cFlow (high-flow oxygen therapy). It is operated by trained personnel under physician supervision. The system provides real-time monitoring and alarm functions for parameters like pressure, volume, and gas concentration. Output is displayed to clinicians to guide ventilation settings and therapy adjustments. The device benefits patients by providing life-sustaining respiratory support and optimized gas delivery. It is intended for in-hospital use, including intra-hospital transport.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and software verification/validation. Testing confirmed compliance with safety and performance standards including ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, and IEC 62304. The new cFlow feature was subjected to comparison testing against legally marketed devices, demonstrating equivalent performance.

Technological Characteristics

Critical care ventilator; provides invasive/noninvasive ventilation and high-flow O2 therapy (cFlow). Energy source: AC/DC (battery). Connectivity: Standalone. Software: Major level of concern. Standards: ISO 80601-2-12, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, ISO 80601-2-55, ISO 80601-2-61. Materials: Same as predicate (K131774).

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, MRI environments, home use, or transport outside the hospital.

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 (K131774)

Reference Devices

• Nihon Kohden NKV-550 Series Ventilator System (K181695)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 30, 2019

Hamilton Medical AG Annemarie Hoft Quality Engineer Via Crusch 8 Bonaduz, 7402 CH

Re: K180295

Trade/Device Name: Hamilton-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: May 28, 2019 Received: May 31, 2019

# Dear Annemarie Hoft:

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

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

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 mediation-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 Lee 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

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

## Indications for Use

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

## 510(k) Number (if known)

K180295

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 persomel 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 com-pressed 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)

## 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 [e-mail]

"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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone] BF

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

Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is composed of two lines of text, with "HAMILTON" on the top line and "MEDICAL" on the bottom line. To the right of the word "HAMILTON" is a circle with the letter "H" inside. The text is in a bold, sans-serif font.

# 510(k) SUMMARY

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

Phone: [phone] Fax: [phone]

Contact Person: Frederike Brühschwein-Mandic, Senior Manager Regulatory Affairs Date Prepared: 13th March 2019

- 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 (K131774)
- IV. REFERENCE DEVICE Nihon Kohden NKV-550 Series Ventilator System (K181695)

### V. DEVICE DESCRIPTION

The HAMILTON-G5 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive 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:

- The following new feature for adult, pediatric, infant and neonatal patient group: cFlow

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

### 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 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.

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

| Technical<br>Characteris-<br>tic | Predicate device:<br>HAMILTON-G5<br>(K131774) | Proposed device:<br>HAMILTON-G5 | Comparison |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications of<br>Use | The HAMILTON-G5 ventilator is designed<br>for intensive care ventilation of adult and<br>paediatric patients, and optionally infant<br>and neonatal patients. The device is in-<br>tended for use in the hospital and<br>institu- tional environment where health<br>care professionals provide patient care.<br>The HAMILTON-G5 ventilator is intended<br>for use by properly trained personnel<br>under the direct supervision of a licensed<br>physi- cian. The HAMILTON-G5 ventilator<br>may be used for transport within a<br>hospital or hospital type facility provided<br>com- pressed gas is supplied.<br>The device is not to be used in the pres-<br>ence of flammable anaesthetic agents or<br>other ignition sources. The ventilator is<br>not to be used in an environment with<br>magnetic resonance imaging (MRI)<br>equipment. The device is not intended<br>for transportation outside the hospital or<br>for use in the home environment. | The HAMILTON-G5 ventilator is designed<br>for intensive care ventilation of adult and<br>paediatric patients, and optionally infant<br>and neonatal patients. The device<br>is intended for use in the hospital and in-<br>stitutional environment where health<br>care professionals provide patient care.<br>The HAMILTON-G5 ventilator is intended<br>for use by properly trained personnel<br>under the direct supervision of a li-<br>censed physician. The HAMILTON-G5<br>ventilator may be used for transport<br>within a hospital or hospital type facility<br>provided compressed gas is supplied.<br>The device is not to be used in the pres-<br>ence of flammable anaesthetic agents or<br>other ignition sources. The ventilator is<br>not to be used in an environment with<br>magnetic resonance imaging (MRI)<br>equipment. The device is not intended<br>for transportation outside the hospital<br>or for use in the home environment. | Same |
| Settings<br>(Ranges) | • Ventilation modes<br>(ASV,APVcmv,APVsimv,P-CMV,P-<br>SIMV, SPONT, DuoPAP, APRV,(S)CMV,<br>SIMV, VS, NIV, NIV-ST, nCPAP-PS)<br>• Patient groups(Adult, Pediatric, Neo-<br>nates (optional)<br>• Patient height (30 to 250 cm)<br>• Patient gender (male/female)<br>• (S)CMV (5 to 120 b/min)<br>• P-CMV (5 to 150 b/min) | • Ventilation modes<br>(ASV,APVcmv,APVsimv,P-CMV,P-<br>SIMV, SPONT, DuoPAP, APRV,(S)CMV,<br>SIMV, VS, NIV, NIV-ST, nCPAP-PS)<br>• Patient groups(Adult, Pediatric, Neo-<br>nates (optional)<br>• Patient height (30 to 250 cm)<br>• Patient gender (male/female)<br>• (S)CMV (5 to 120 b/min)<br>• P-CMV (5 to 150 b/min) | Substantially<br>Equivalent |
| Technical<br>Characteristic | Predicate device:<br>HAMILTON-G5 (K131774) | Proposed device:<br>HAMILTON-G5 | Comparison |
| | • SIMV (1 to 60 b/min) | • SIMV (1 to 60 b/min) | |
| | • P-SIMV (1 to 60 b/min) | • P-SIMV (1 to 60 b/min) | |
| | • APVcmv (5 to 150 b/min) | • APVcmv (5 to 150 b/min) | |
| | • APVsimv (1 to 80 b/min) | • APVsimv (1 to 80 b/min) | |
| | • DuoPAP (1 to 80 b/min) | • DuoPAP (1 to 80 b/min) | |
| | • APRV (5 to 150 b/min) | • APRV (5 to 150 b/min) | |
| | • nCPAP-PS (15 to 150 b/min) | • nCPAP-PS (15 to 150 b/min) | |
| | | • cFlow (Flow 1-60 l/min) | |
| | • Tidal volume (2 to 2000 ml) | • Tidal volume (2 to 2000 ml) | |
| | • PEEP/CPAP (Plow) (0 to 50 cmH2O) | • PEEP/CPAP (Plow) (0 to 50 cmH2O) | |
| | • Oxygen (21% to 100%) | • Oxygen (21% to 100%) | |
| | • I:E ratio (1:9 to 4:1) | • I:E ratio (1:9 to 4:1) | |
| | • I:E ratio APRV/DuoPAP(1:599 to 149:1) | • I:E ratio APRV/DuoPAP(1:599 to 149:1) | |
| | • Inspiratory time (0.1 to 10s) | • Inspiratory time (0.1 to 10s) | |
| | • Inspiratory time spont (0.25 to 3 s) | • Inspiratory time spont (0.25 to 3 s) | |
| | • % Inspiratory time (10% to 80% of cycle time, max 10s) | • % Inspiratory time (10% to 80% of cycle time, max 10s) | |
| | • Inspiratory pause time (0 to 8 s) | • Inspiratory pause time (0 to 8 s) | |
| | • Pause time (0 to 8 s, 0% to 70% of cycle time) | • Pause time (0 to 8 s, 0% to 70% of cycle time) | |
| | • Peak flow (1 to 180l/min) | • Peak flow (1 to 180l/min) | |
| | • T low APRV (0.1 to 30s) | • T low APRV (0.1 to 30s) | |
| | • T high DuoPAP/APRV (0.1 to 30s) | • T high DuoPAP/APRV (0.1 to 30s) | |
| | • Pressure trigger below PEEP/CPAP (off, 0.1 to 10 cmH2O) | • Pressure trigger below PEEP/CPAP (off, 0.1 to 10 cmH2O) | |
| | • Flow trigger (0.5 to 15 l/min) | • Flow trigger (0.5 to 15 l/min) | |
| | • Automatic base flow (1 to 30 l/min) | • Automatic base flow (1 to 30 l/min) | |
| | • Pressure control (3 to 100 cmH2O) | • Pressure control (3 to 100 cmH2O) | |
| | • Pressure support (3 to 100 cmH2O) | • Pressure support (3 to 100 cmH2O) | |
| | • P high DuoPAP/APRV (0 to 50 cmH2O) | • P high DuoPAP/APRV (0 to 50 cmH2O) | |
| | • Pressure ramp (50 to 200 ms (P-CMV and APRV) 25 - 200 other modes) | • Pressure ramp (50 to 200 ms (P-CMV and APRV) 25 - 200 other modes) | |
| | • Cuff pressure (0 to 50 cm H2O) | • Cuff pressure (0 to 50 cm H2O) | |
| | • % minute volume (25% to 350%) | • % minute volume (25% to 350%) | |
| | • Flow patterns (Sine, square, dec., 50% dec.) | • Flow patterns (Sine, square, dec., 50% dec.) | |
| | • Expiratory trigger sensitivity (5% to 70% of inspiratory peak flow) | • Expiratory trigger sensitivity (5% to 70% of inspiratory peak flow)…