Who is the manufacturer of HAMILTON-G5?

Hamilton Medical AG filed the 510(k) submission for HAMILTON-G5 (K131774).

What is the FDA product code for HAMILTON-G5?

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

What is the regulatory pathway for HAMILTON-G5?

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

What are the predicate devices for HAMILTON-G5?

HAMILTON-G5 (K103803); MAQUET Servo-i (K073179); MASIMO RAINBOW SET RADICAL PULSE CO-OXIMETER (K100428); Nihon Kohden SpO2 OXIMETER, PROBES, AND ACCESSORIES (K974292, K011918, K032749, K043517).

Who can help prepare an FDA 510(k) submission like HAMILTON-G5?

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

HAMILTON-G5

K131774 · Hamilton Medical AG · CBK · Oct 9, 2013 · Anesthesiology

Device Facts

Record ID	K131774
Device Name	HAMILTON-G5
Applicant	Hamilton Medical AG
Product Code	CBK · Anesthesiology
Decision Date	Oct 9, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

Electronically controlled pneumatic intensive care ventilator; uses oxygen, air, or heliox. Inputs: patient inspiratory effort, gas supply. Outputs: mechanical ventilation, SpO2 monitoring. Operation: LCD touch screen, keys, press-and-turn knob. New Volume Support (VS) mode: flow-cycled, volume-targeted, pressure-regulated; adjusts support based on patient inspiratory effort. Used in hospitals/institutional environments by trained personnel under physician supervision; supports intra-hospital transport. Benefits: provides appropriate tidal volume support based on patient condition; continuous non-invasive oxygen saturation monitoring.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing confirmed software implementation, SpO2 data integrity, and waveform performance for the new Volume Support mode per ASTM F1100-90. Compliance with IEC 60601-1, 60601-1-2, 60601-2-12, and 60601-2-49 demonstrated.

Technological Characteristics

Electronically controlled pneumatic ventilator; AC power with Li-ion battery backup. Features LCD touch screen interface. Connectivity: SpO2 module integration. Standards: ASTM F1100-90 (waveform performance), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-12 (ventilators), IEC 60601-2-49 (monitoring). Software version 2.30.

Indications for Use

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

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 (K103803)
MAQUET Servo-i (K073179)
MASIMO RAINBOW SET RADICAL PULSE CO-OXIMETER (K100428)
Nihon Kohden SpO2 OXIMETER, PROBES, AND ACCESSORIES (K974292, K011918, K032749, K043517)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the words "HAMILTON MEDICAL" in a bold, sans-serif font. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The text is black and the background is white. The image has some noise and artifacts, which may be due to the image being scanned or photographed. ## HamilTon.G5 ## 510(k) SUMMARY | SUBMITTER: | HAMILTON MEDICAL AG Via Crusch 8 Bonaduz, 7402 SWITZERLAND | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Ralph Aguila Regulatory Affairs / Quality Engineer Phone: +41 81 660 6845 Fax: +41 81 660 6020 e-mail: raaguila@hamilton-medical.ch | | ESTABLISHMENT REGISTRATION NUMBER: | 3001421318 | | PREPARATION DATE: | September 4th, 2013 | | TRADE NAME: | HAMILTON-G5 | | CLASSIFICATION NAME: | CLASS II Ventilator, Continuous (CBK) CLASS II Oximeter (DQA) | | REGULATION NUMBER & PRODUCT CODE | 21 CFR 868.5895 (CBK) 21 CFR 870.2700 (DQA) | | PREDICATE DEVICE: (PRIMARY) | HAMILTON-G5 (K103803) | | PREDICATE DEVICE: (SECONDARY) | MAQUET Servo-i (K073179) For the Volume-Support mode MASIMO RAINBOW SET RADICAL PULSE CO-OXIMETER (K100428) Nihon Kohden SpO2 OXIMETER, PROBES, AND ACCESSORIES (K974292, K011918, K032749, K043517) | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the words "HAMILTON MEDICAL" in bold, black letters. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The letters are slightly distorted, and the image has a grainy texture. Image /page/1/Picture/1 description: The image shows the text "HAMILTON-G5" in a bold, sans-serif font. The letters are black, and the text is slightly distressed, giving it a vintage or worn appearance. The letters "A", "M", "I", "L", "T", "O", and "N" have a white dashed line above them. ## DEVICE DESCRIPTION The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. It uses oxygen and air or heliox to ventilate adults, pediatrics, infants, and neonates. It is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate intra-hospital transport. The HAMILTON-G5's pneumatics deliver gas -- while its electrical systems controls pneumatics, monitors alarms and distributes power. The user interface consists of a LCD-display with touch screen, keys, and a press-and- turn knob. The HAMILTON-G5's new software version 2.30, includes a pulse oximetry function for continuous, non-invasive oxygen saturation monitoring (SpO2). Volume targeting in the HAMILTON-G5 is now supported by a new ventilation mode, called the Volume Support mode (VS). It is a flow-cycled, volume targeted, and pressure-regulated mode. The Volume Support (VS) mode is designed for spontaneously breathing patients. It provides support to patient-initiated breaths so as to deliver the desired tidal volume (V+), at a level appropriate to the patient's efforts. This mode allows the ventilator to change the support in response to changing patient conditions and inspiratory effort levels. To achieve this volume, the device decreases support when the patient's breathing activity increases or, conversely, increases support when the patient's inspiratory effort decreases. #### 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 healthcare 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the words "HAMILTON" and "MEDICAL" stacked on top of each other. The text is in a bold, sans-serif font. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The text is black against a white background. Image /page/2/Picture/1 description: The image shows the text "HAMILTON.G5" in a bold, sans-serif font. The text is black and appears to be a logo or brand name. The letters are closely spaced, and the dot between "HAMILTON" and "G5" is also in bold. ### SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES The indication-of-use statement for the proposed HAMILTON-G5 ventilator is the same as the predicate HAMILTON-G5. In addition, the technological characteristics and performance specifications of the probosed HAMILTON-G5 ventilator are substantially equivalent to those of the predicate devices. The new pulse oximetry function uses previously cleared devices, like the Masimo Rainbow Set Radical Pulse co-oximeter & accessories, as well as the Nihon Kohden SpO2 oximeter & accessories. The new Volume Support mode in the HAMILTON-G5 is substantially equivalent to the MAQUET Servo-i's Volume Support mode. HAMILTON MEDICAL has demonstrated the modified HAMILTON-G5 ventilator to be substantially equivalent. The proposed ventilator is considered to be substantially equivalent to the currently marketed predicate devices, which have been previously cleared by FDA. ## COMPARISON TABLE BETWEEN PROPOSED AND PREDICATE DEVICE The following table compares the proposed HAMILTON-G5 with its predicate device, the HAMILTON-G5 (K103803). | | Proposed device: HAMILTON-G5 | Predicate device: HAMILTON-G5 (K103803) | Equivalence | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Software version | SW 2.30 | SW 2.0 | Substantially Equivalent | | Ventilator modes | (S)CMV, SIMV, SPONT, ASV, P-CMV, P-SIMV, APVcmv, APVsimv, DuoPAP, APRV, NIV, NIV-ST, nCPAP-PS, Volume Support | (S)CMV, SIMV, SPONT, ASV, P-CMV, P-SIMV, APVcmv, APVsimv, DuoPAP, APRV, NIV, NIV-ST, nCPAP-PS | Substantially Equivalent. The Volume Support mode is new in the proposed HAMILTON-G5 | | Pulse Oximetry | Yes. | No | N/A The proposed HAMILTON-G5 Includes both the Masimo (K100428) and Nihon Kohden Pulse Oximetry (K974292, K011918, K032749, K043517) | | | Proposed device: HAMILTON-G5 | Predicate device: HAMILTON-G5 (K103803) | Equivalence | | Indications of 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. | The HAMILTON-GS 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 healthcare professionals provide patient care. The HAMILTON-GS ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-GS 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. In the USA, federal law restricts this device to sale by or on the order of a physician. | Substantially Equivalent | | Operation environmental requirements | •5 to 40 °C (41 to 104 °F) •10 to 95%, non-condensing •1013 to 600 hPa | •5 to 40 °C (41 to 104 °F) •10 to 95%, non-condensing •1013 to 600 hPa | Equivalent | | Input Power | AC: 100 to 240 V, 50/60 Hz | AC: 100 to 240 V, 50/60 Hz | Equivalent | | Power Consumption | 50 VA typical | 50 VA typical | Equivalent | | | Proposed device: HAMILTON-G5 | Predicate device: HAMILTON-G5 (K103803) | Equivalence | | Battery | One batteries, Li-ion, sealed, maintenance-free | One batteries, Li-ion, sealed, maintenance-free | Equivalent | | Battery operating time (typical) | 2 hours | 2 hours | Equivalent | | Safety features | • Apnea backup ventilation • Automatic self-tests • Alarms (operator-adjustable / non-adjustable) • Alarm backup buzzer • External flow sensor failure mode • Safety mode in case of technical failures • Air inlet HEPA filter monitoring • Monitored fan • Event log | • Apnea backup ventilation • Automatic self-tests • Alarms (operator-adjustable / non-adjustable) • Alarm backup buzzer • External flow sensor failure mode • Safety mode in case of technical failures • Air inlet HEPA filter monitoring • Monitored fan • Event log | Equivalent | | Emergency air intake | In case of a power supply, technical, or pneumatics failure the ambient valve allows spontaneous breathing. | In case of a power supply, technical, or pneumatics failure the ambient valve allows spontaneous breathing. | Equivalent | | Maximum working pressure limitation | 60 cmH20 | 60 cmH20 | Equivalent | | Maximum inspiratory flow | 210 L/min | 210 L/min | Equivalent | K131774 {3}------------------------------------------------ # HAMILTON.G5 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "HAMILTON" and "MEDICAL" stacked on top of each other. The word "HAMILTON" is in a larger font than the word "MEDICAL". The text is in black and the background is white. The font is bold. # HzzvilLTOrA-G5 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the words "HAMILTON" and "MEDICAL" stacked on top of each other. The text is in a bold, sans-serif font and appears to be part of a logo or heading. The overall impression is of a professional or corporate identity. ## NON-CLINICAL PERFORMANCE TESTS Safety testing of the HAMILTON-G5, with the new options, was conducted and shows that the device is substantially equivalent to the predicate devices for its intended use. The new Volume Support mode was further subjected to waveform performance testing, as described by the standard ASTM F1100-90. The data provided from these tests were shown to be substantially equivalent to a legally marketed device. Verification and Validation testing also demonstrated that the SpO2 and pulse rate values, calculated by the OEM system, are not corrupted during communication to the HAMILTON-G5 host device. No modifications were made to the previously cleared oximeter systems. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely. | | Draft Reviewer Guidance for Ventilators.1995 | |----------------|---------------------------------------------------------------| | IEC 60601-1 | General Requirements for Safety | | IEC 60601-1-2 | Electromagnetic Compatibility | | IEC 60601-2-12 | Critical Care Ventilators | | IEC 60601-2-49 | Essential performance of multi-function monitoring equipment. | ### CONCLUSION The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-G5 ventilator is substantially equivalent to the legally marketed devices identified above. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002 October 9, 2013 Hamilton Medical AG Mr. Ralph Aguila Regulatory Affairs/Quality Engineer Via Crusch 8 BONADUZ 7402 SWITZERLAND Re: K131774 Trade/Device Name: Hamilton-G5 Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, Continuous Regulatory Class: II Product Code: CBK, DQA Dated: September 5, 2013 Received: September 9, 2013 Dear Mr. Aguila: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class 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 {7}------------------------------------------------ Page 2 - Mr. Aguila or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/7/Picture/7 description: The image contains a combination of text and graphic elements. The text includes the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." There is also the acronym "DAGRID" present. The word "FOR" is located in the bottom right corner of the image. Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT ## K131774 510(k) Number: HAMILTON-G5 Device Name: Indication 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 iqnition 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. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Anya C. Harry -S V: c=US, o=U.S. Government, ou=HHS, Anva C. DA ou=People, cn=Anya C. Harry -S, 2342.19200300.100.1.1=0011315590 Date: 2013:10.09 15:28:27 -04'00'

HAMILTON-G5

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