(114 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the HAMILTON-G5 device, based on the provided document:
The document is a 510(k) summary for the HAMILTON-G5 ventilator, specifically for an updated version (SW 2.30) that includes a pulse oximetry function and a new Volume Support (VS) ventilation mode. It focuses on demonstrating substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly present a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it describes compliance with recognized standards and uses qualitative statements of "substantial equivalence" for the new features.
| Feature | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| New Volume Support (VS) Mode | Performance testing as described by the standard ASTM F1100-90. Demonstrated to be substantially equivalent to a legally marketed device (MAQUET Servo-i). | Substantially Equivalent: The new Volume Support mode was 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 (MAQUET Servo-i - K073179). The HAMILTON-G5 (SW 2.30) includes the Volume Support mode while the predicate HAMILTON-G5 (SW 2.0) does not, but it is substantially equivalent to the mode in the MAQUET Servo-i. |
| Pulse Oximetry (SpO2) Function | Verification and Validation testing demonstrating that SpO2 and pulse rate values, calculated by the OEM system, are not corrupted during communication to the HAMILTON-G5 host device. Utilizes previously cleared devices (Masimo Rainbow Set Radical Pulse co-oximeter & accessories, Nihon Kohden SpO2 oximeter & accessories). | Substantially Equivalent: Verification and Validation testing 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 proposed HAMILTON-G5 includes both the Masimo (K100428) and Nihon Kohden Pulse Oximetry (K974292, K011918, K032749, K043517) components. |
| General Safety and EMC | Compliance with relevant IEC standards: 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). Also "Draft Reviewer Guidance for Ventilators. 1995." (While not a standard, this guidance document outlines expectations for ventilator safety and performance.) | Substantially Equivalent: 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 product's compliance with these standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, IEC 60601-2-49, and Draft Reviewer Guidance for Ventilators. 1995) is implicitly stated as part of demonstrating substantial equivalence. The document states, "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." |
| Software Verification and Validation | All specified requirements have been implemented correctly and completely for the new software version 2.30. | Verified and Validated: "The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely." This applies to the overall software update, including the new VS mode and SpO2 functionality. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or a number of test cases. The testing appears to be primarily bench testing (waveform performance, communication integrity) and compliance with standards rather than clinical trials with patient populations.
- Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing mentioned (waveform testing per ASTM F1100-90, software V&V) is likely performed in a lab or simulate environment. The country of origin of the device manufacturer is Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The document describes compliance with engineered performance standards and internal verification/validation, not the establishment of ground truth by human experts for a test set.
4. Adjudication Method for the Test Set:
- This information is not provided as the testing described does not involve expert adjudication of a test set in the way a clinical study or diagnostic imaging study would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This document is for a medical device (ventilator) seeking 510(k) clearance, which typically relies on
bench testing and substantial equivalence to predicates, not comparative effectiveness studies of human readers with vs. without AI assistance. The device itself is not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This question is not directly applicable in the context of this device. The HAMILTON-G5 is a ventilator, a physical device with embedded software and functions. The new features (VS mode, SpO2) are integrated functionalities of the device. The "standalone performance" of these functions (e.g., the SpO2 calculation itself) is established by using previously cleared OEM components and by verifying their integration into the HAMILTON-G5, not as a separate, algorithm-only performance assessment like that for a diagnostic AI.
7. The Type of Ground Truth Used:
- The "ground truth" for the new functionalities would be established by:
- Engineering Specifications / Reference Devices: For the Volume Support mode, the "ground truth" for its performance is derived from the established performance characteristics and waveforms defined by the ASTM F1100-90 standard and comparison to the MAQUET Servo-i predicate device.
- Calibration & Known Standards: For the SpO2 function, the "ground truth" for oxygen saturation and pulse rate values would come from the calibrated performance of the OEM pulse oximeter systems (Masimo, Nihon Kohden) and ensuring these values are accurately transmitted and displayed by the HAMILTON-G5.
- Regulatory Standards: Overall safety and electromagnetic compatibility ("ground truth" for compliance) are established by fulfilling the requirements of the cited IEC standards.
8. The Sample Size for the Training Set:
- Not applicable. This document describes a medical device undergoing 510(k) clearance, not an AI or machine learning model that requires a "training set" in the conventional sense. The device's software (SW 2.30) is developed and verified through engineering processes, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set." The software development and verification process would involve testing against validated specifications and expected outputs based on engineering principles and regulatory standards.
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HamilTon.G5
510(k) SUMMARY
| SUBMITTER: | HAMILTON MEDICAL AGVia Crusch 8Bonaduz, 7402SWITZERLAND |
|---|---|
| CONTACT PERSON: | Ralph AguilaRegulatory Affairs / Quality EngineerPhone: +41 81 660 6845Fax: +41 81 660 6020e-mail: raaguila@hamilton-medical.ch |
| ESTABLISHMENTREGISTRATION 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 modeMASIMO RAINBOW SET RADICALPULSE CO-OXIMETER (K100428)Nihon Kohden SpO2 OXIMETER,PROBES, AND ACCESSORIES(K974292, K011918, K032749, K043517) |
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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.
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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 | |
|---|---|---|---|
| Softwareversion | SW 2.30 | SW 2.0 | SubstantiallyEquivalent |
| Ventilatormodes | (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 | SubstantiallyEquivalent.The Volume Supportmode is new in theproposedHAMILTON-G5 |
| Pulse Oximetry | Yes. | No | N/AThe proposedHAMILTON-G5Includes both theMasimo (K100428)and Nihon KohdenPulse Oximetry(K974292, K011918,K032749, K043517) |
| Proposed device:HAMILTON-G5 | Predicate device:HAMILTON-G5(K103803) | Equivalence | |
| Indications ofUse | The HAMILTON-G5 ventilatoris designed for intensive careventilation of adult andpediatric patients, andoptionally infant and neonatalpatients. The device isintended for use in the hospitaland institutional environmentwhere health careprofessionals provide patientcare. The HAMILTON-G5ventilator is intended for use byproperly trained personnelunder the direct supervision ofa licensed physician. TheHAMILTON-G5 ventilator maybe used for transport within ahospital or hospital type facilityprovided compressed gas issupplied.The device is not to be used inthe presence of flammableanesthetic agents or otherignition sources. The ventilatoris not to be used in anenvironment with magneticresonance imaging (MRI)equipment. The device is notintended for transportationoutside the hospital or for usein the home environment. | The HAMILTON-GS ventilatoris designed for intensive careventilation of adult and pediatricpatients, and optionally infantand neonatal patients. Thedevice is intended for use in thehospital and institutionalenvironment where healthcareprofessionals provide patientcare. The HAMILTON-GSventilator is intended for use byproperly trained personnelunder the direct supervision ofa licensed physician. TheHAMILTON-GS ventilator maybe used for transport within ahospital or hospital-type facilityprovided compressed gas issupplied.The device is not to be used inthe presence of flammableanesthetic agents or otherignition sources. The ventilatoris not to be used in anenvironment with magneticresonance imaging (MRI)equipment.The device is not intended fortransportation outside thehospital or for use in the homeenvironment. In the USA,federal law restricts this deviceto sale by or on the order of aphysician. | SubstantiallyEquivalent |
| Operationenvironmentalrequirements | •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 |
| PowerConsumption | 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 |
| Batteryoperating 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 failuremode• Safety mode in case oftechnical failures• Air inlet HEPA filtermonitoring• Monitored fan• Event log | • Apnea backup ventilation• Automatic self-tests• Alarms (operator-adjustable /non-adjustable)• Alarm backup buzzer• External flow sensor failuremode• Safety mode in case oftechnical failures• Air inlet HEPA filtermonitoring• Monitored fan• Event log | Equivalent |
| Emergency airintake | In case of a power supply,technical, or pneumatics failurethe ambient valve allowsspontaneous breathing. | In case of a power supply,technical, or pneumatics failurethe ambient valve allowsspontaneous breathing. | Equivalent |
| Maximumworkingpressurelimitation | 60 cmH20 | 60 cmH20 | Equivalent |
| Maximuminspiratory flow | 210 L/min | 210 L/min | Equivalent |
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HAMILTON.G5
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HzzvilLTOrA-G5
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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.
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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
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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
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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'
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).