(164 days)
Unknown
The term "IntelliSync+" suggests intelligent or adaptive behavior, which could potentially be implemented using AI/ML. However, the summary does not explicitly mention AI, ML, or related terms, and the description of the feature is too brief to confirm the underlying technology.
Yes
The device provides ventilation support to patients, which is a therapeutic intervention for respiratory conditions.
No
The device is a ventilator designed for therapy (ventilation support), not for diagnosing medical conditions. Its purpose is to deliver breathing support, not to identify diseases or pathologies.
No
The device description clearly states it is a ventilator, which is a hardware device, and the submission adds new features to this existing hardware.
Based on the provided text, the HAMILTON-G5 ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HAMILTON-G5 Function: The HAMILTON-G5 ventilator is a medical device that provides mechanical ventilation support to patients by assisting with breathing. It interacts directly with the patient's respiratory system, not with samples taken from the body.
- Intended Use: The intended use clearly states it's for "intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients." This describes a life support function, not a diagnostic test.
- Device Description: The description focuses on ventilation modes and features related to breathing support.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or performing any kind of laboratory test.
Therefore, the HAMILTON-G5 ventilator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK, DQA
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-G5
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient airways
Indicated Patient Age Range
Adult, pediatric, infant and neonatal patients
Intended User / Care Setting
Intended for use by properly trained personnel under the direct supervision of a licensed physician.
Hospital and institutional environment where health care professionals provide patient care.
May be used for transport within a hospital type facility provided compressed gas is supplied.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-G5 operates as intended.
In particular, testing demonstrated that the HAMILTON-G5 is compliant with the following guidelines and standards:
- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General l Requirements for Safety
- -IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- -ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- -IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366 (2014): Medical devices Application of usability engineering to medical devices -
- -ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medical devices
- -IEC 62304 (2006): Medical device software - Software life-cycle processes
- -ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Additional software verification and validation testing was conducted and documentation was provided as recommended by the FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HAMILTON-G5 (K180295)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
HAMILTON-H900 (K152029, K163283), V200 VENTILATOR (K102054)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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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: +41 58 610 25 67 Fax: +41 58 610 00 20
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
| Parameters | Subject device: | Primary predicate device: | Comparison | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| HAMILTON-G5 | Currently marketed HAMILTON-G5 | ||||||||||
| 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 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-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 transport outside the hospital or for use in the home | |||||||||||
| environment. | Same | ||||||||||
| Environment | |||||||||||
| of Use | Hospitals, hospital-type facilities and in-hospital transportation | ||||||||||
| for patients who need ventilation therapy | Hospitals, hospital-type facilities and in-hospital transportation | ||||||||||
| for patients who need ventilation therapy | Same | ||||||||||
| Anatomical | |||||||||||
| Site | Patient airways | Patient airways | Same | ||||||||
| Target | |||||||||||
| 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 | ||||||||||
| critical care ventilator. | Met ISO 80601-2-12 requirements on essential performance of | ||||||||||
| critical care ventilator. | Same | ||||||||||
| Chemicals | |||||||||||
| delivered to | |||||||||||
| patient | Medical Air and Oxygen (optional Heliox) | Medical Air and Oxygen (optional Heliox) | Same | ||||||||
| Parameters | Subject device: | ||||||||||
| HAMILTON-G5 | Primary predicate device: | ||||||||||
| Currently marketed HAMILTON-G5 | Comparison | ||||||||||
| Energy used | |||||||||||
| for device | AC and battery | AC and battery | Same | ||||||||
| New feature; | |||||||||||
| Settings | |||||||||||
| (Ranges) | • HAMILTON-H900 settings: |
- Temperature (HAMILTON-H900 ET 35 to 41 °C / NIV
30 to 35 °C) - Humidity (-2 to 3 °C)
- Standby On (HAMILTON-H900 On/Off)
- Power On/Off (HAMILTON-H900 On/Off)
- Auto Mode (HAMILTON-H900 On/Off)
- NIV (HAMILTON-H900 On/Off)
- Expiratory Lim Temperature Increase (HAMILTON-
H900 On/Off)
• Alarm Silence (HAMILTON-H900 On/Off) | | Added
functionality
based on
HAMILTON-
H900
reference | | | | |
| Modes of
ventilation | • ASV
• APVcmv
• APVsimv
• P-CMV
• P-SIMV
• SPONT
• DuoPAP
• APRV
• (S)CMV
• SIMV
• VS
• nCPAP-PS
• NIV
• NIV-ST | • ASV
• APVcmv
• APVsimv
• P-CMV
• P-SIMV
• SPONT
• DuoPAP
• APRV
• (S)CMV
• SIMV
• VS
• nCPAP-PS
• NIV
• 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;
Trigger | IntelliSync+ | | Please refer
to Table 2 | | | | | | | | |
| Parameters | Subject device:
HAMILTON-G5 | Primary predicate device:
Currently marketed HAMILTON-G5 | Comparison | | | | | | | | |
| Alarms, non-adjustable | • Oxygen alarm limit exceeded
• Oxygen concentration
• Disconnection
• Loss of PEEP
• Exhalation obstruction
• High PEEP
• ASV/APV
• CO2
• Power supply
• Gas supply
• Cuff leakage
• Nebulizer disconnected
• Cannot reach target flow
• Cuff disconnection
• Check for blockage | • Oxygen alarm limit exceeded
• Oxygen concentration
• Disconnection
• Loss of PEEP
• Exhalation obstruction
• High PEEP
• ASV/APV
• CO2
• Power supply
• Gas supply
• Cuff leakage
• Nebulizer disconnected
• Cannot reach target flow
• Cuff disconnection
• Check for blockage | Same | | | | | | | | |
| New feature;
Alarms, non-adjustable | • Following humidifier alarms are transmitted from the
humidifier HAMILTON-H900 to the HAMILTON-G5: - Humidifier tilt
- Humidifier chamber temp high / Humidifier y-piece temp high
- Humidifier water high
- Humidifier chamber temp low / Humidifier y-piece temp low
- Humidifier water low
- Humidifier check chamber
- Humidifier check left tube / Humidifier check right tube
- Humidifier error
- Check humidifier
- Check communication interface humidifier | | Added
functionality
based on
HAMILTON-
H900
reference | | | | | | | | |
| Alarms,
adjustable | • Low/high minute volume
• Low/high pressure | • Low/high minute volume
• 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 | • Low/high PetCO2 | | | | | | | | | |
| | • Low/high pulse | • Low/high pulse | | | | | | | | | |
| | • Low/high SpO2 | • Low/high SpO2 | | | | | | | | | |
| | • Low/high SpMet | • Low/high SpMet | | | | | | | | | |
| | • Low/high SpOC | • Low/high SpOC | | | | | | | | | |
| | • %leak | • %leak | | | | | | | | | |
| | • PI (perfusion index) | • PI (perfusion index) | | | | | | | | | |
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Image /page/5/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line, with a stylized "H" inside a circle. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line.
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Image /page/6/Picture/0 description: The image contains the logo for Hamilton Medical. The logo consists of the word "HAMILTON" in large, bold, blue letters, with a stylized "H" symbol. Below "HAMILTON" is the word "MEDICAL" in the same font and color. Underneath the main logo, the text "Intelligent Ventilation since 1983" is displayed in a smaller, lighter font.
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Image /page/7/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" stacked on top of the word "MEDICAL". To the right of the word "HAMILTON" is a stylized letter "H". Below the logo is the text "Intelligent Ventilation since 1983".
As can be seen in Table 1 above, the subject device HAMLTON-G5 has the same technological characteristics as the primary predicate HAMILTON-G5. Thus, the comparison of the HAMILTON-G5 to its primary predicate device does not raise new safety and effectiveness concerns.
Table 2: Comparison of HAMILTON-G5 with the reference predicate device
| Parameters | Subject device:
HAMILTON-G5 | Reference predicate device:
Respironics V200 Ventilator | Comparison |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 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 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 Respironics V200 Ventilator is a microprocessor-controlled,
electrically powered mechanical ventilator. It is intended for
use by qualified medical personnel to provide continuous or
intermittent ventilatory support for adult, pediatric, and
neonatal patients as prescribed by a physician. The ventilator is
intended for use in either invasive or non-invasive applications
in institutional environments. | Substantially
equivalent |
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Image /page/8/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H". Below the logo is the text "Intelligent Ventilation since 1983" in a smaller font.
| Parameters | Subject device:
HAMILTON-G5 | Reference predicate device:
Respironics V200 Ventilator | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Trigger | IntelliSync+:
• Noninvasive method
• Synchronization independent of ventilation mode
• Automated setting of inspiratory trigger
• Real-time setting of inspiratory trigger within the breath
• Real-time setting of cycling within the breath
• Trigger during negative flow possible | Auto-Trak:
• Noninvasive method
• Synchronization independent of ventilation mode
• Automated setting of inspiratory trigger
• Real-time setting of inspiratory trigger within the breath
• Real-time setting of cycling within the breath
• Trigger during negative flow possible | Same |
| Trigger performance | A bench and waveform testing report has been submitted. | | Substantially equivalent |
The subject device HAMLTON-G5 is compared to the Respironics V200 Ventilator regarding the trigger synchronization algorithm, which resulted in equivalence regarding the trigger features itself and in substantial equivalence regarding the trigger performance (Table 2).
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Image /page/9/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H". Below the logo is the text "Intelligent Ventilation since 1983".
HAMILTON
VIII. PERFORMANCE DATA
The following performance and nonclinical data are provided in support of the substantial equivalence determination.
The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-G5 operates as intended.
In particular, testing demonstrated that the HAMILTON-G5 is compliant with the following guidelines and standards:
- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General l Requirements for Safety
- -IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- -ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- -IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366 (2014): Medical devices Application of usability engineering to medical devices -
- -ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medical devices
- -IEC 62304 (2006): Medical device software - Software life-cycle processes
- -ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Additional software verification and validation testing was conducted and documentation was provided as recommended by the FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device.
Since only materials already used in in the primary predicate (cleared under document number K180295) are used (the new features did not include any material changes, only software adaptions) Hamilton Medical did not conduct any additional biocompatibility testing.
IX. CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-G5 ventilator is substantially equivalent to the legally marketed predicate devices identified herein.