(544 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 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 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
Based on the provided text, the acceptance criteria and study information for the HAMILTON-G5 ventilator are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI ES60601-1 (2005/(R) 2012): Medical electrical equipment General Re-quirements for Safety | Compliant |
| 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 | Compliant |
| ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | Compliant (Met ISO 80601-2-12 requirements on essential performance of critical care ventilator, also for the reference device) |
| 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 | Compliant |
| IEC 60601-1-6 (2010 + A1:2013): Medical electrical equipment Part 1-6: General re-quirements for basic safety and essential performance - Collateral standard: Usability | Compliant |
| IEC 62366 (2014): Medical devices - Application of usability engineering to medical devices | Compliant |
| ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medicaldevices | Compliant |
| IEC 62304 (2006): Medical device software Software life-cycle processes | Compliant |
| ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gasmonitors | Compliant |
| ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Compliant |
| Software Design and Validation Process (for "major" level of concern software) | Demonstrated that the HAMILTON-G5 operates as intended. |
| Comparison testing of new cFlow feature with legally marketed devices | Data shown to be equivalent to legally marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for the test set in terms of patient data or case numbers. It refers to "bench testing of the device" and "comparison testing with legally marketed devices" for the cFlow feature.
The data provenance is implied to be retrospective in the sense that the device is being compared against already marketed devices (both predicate and reference devices) and established standards. There is no indication of prospective clinical trials in this 510(k) summary. The testing appears to be primarily laboratory/bench-based and validation of software and device performance against technical standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document mentions "properly trained personnel under the direct supervision of a licensed physician" for its intended use, but not for the establishment of ground truth during testing. The "ground truth" for this device appears to be defined by adherence to recognized international technical standards and comparison to previously cleared devices.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the testing described (compliance with technical standards, bench testing, software validation, and comparison to predicate/reference devices), a formal adjudication method like 2+1 or 3+1 typically used in image-based diagnostic AI studies is not applicable or mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable to this device described. The HAMILTON-G5 is a medical ventilator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable as this is a medical ventilator. The device itself operates as a standalone system (an "algorithm only" analogy here would be the ventilator's internal software controlling ventilation parameters). The "human-in-the-loop" is the healthcare professional operating and monitoring the ventilator, as per its indications for use. The performance data refers to the device's technical compliance and functional equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this submission is primarily:
- Compliance with recognized international technical standards (e.g., ISO, IEC, ANSI/AAMI standards for medical electrical equipment and ventilators).
- Functional equivalence to legally marketed predicate and reference devices (HAMILTON-G5 K131774 and Nihon Kohden NKV-550 Series Ventilator System K181695).
- Intended operation as designed as demonstrated through software design and validation processes and bench testing.
8. The sample size for the training set
The concept of a "training set" in the context of machine learning or AI is not applicable here. The HAMILTON-G5 is a traditional medical device (ventilator) with added features, not an AI/ML-driven model that undergoes training on a dataset. The software itself is validated, but not "trained" in the AI sense.
9. How the ground truth for the training set was established
As explained above, there is no "training set" in the AI/ML context for this device. The verification and validation activities were based on established engineering principles, regulatory standards, and comparison to existing cleared devices.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 BF
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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: +41 58 610 2564 Fax: +41 58 610 0020
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
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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.
| TechnicalCharacteris-tic | Predicate device:HAMILTON-G5(K131774) | Proposed device:HAMILTON-G5 | Comparison |
|---|---|---|---|
| Indications ofUse | The HAMILTON-G5 ventilator is designedfor intensive care ventilation of adult andpaediatric patients, and optionally infantand neonatal patients. The device is in-tended for use in the hospital andinstitu- tional environment where healthcare professionals provide patient care.The HAMILTON-G5 ventilator is intendedfor use by properly trained personnelunder the direct supervision of a licensedphysi- cian. The HAMILTON-G5 ventilatormay be used for transport within ahospital or hospital type facility providedcom- pressed gas is supplied.The device is not to be used in the pres-ence of flammable anaesthetic agents orother ignition sources. The ventilator isnot to be used in an environment withmagnetic resonance imaging (MRI)equipment. The device is not intendedfor transportation outside the hospital orfor use in the home environment. | The HAMILTON-G5 ventilator is designedfor intensive care ventilation of adult andpaediatric patients, and optionally infantand neonatal patients. The deviceis intended for use in the hospital and in-stitutional environment where healthcare professionals provide patient care.The HAMILTON-G5 ventilator is intendedfor use by properly trained personnelunder the direct supervision of a li-censed physician. The HAMILTON-G5ventilator may be used for transportwithin a hospital or hospital type facilityprovided compressed gas is supplied.The device is not to be used in the pres-ence of flammable anaesthetic agents orother ignition sources. The ventilator isnot to be used in an environment withmagnetic resonance imaging (MRI)equipment. The device is not intendedfor transportation outside the hospitalor for use in the home environment. | Same |
| Settings(Ranges) | • Ventilation modes(ASV,APVcmv,APVsimv,P-CMV,P-SIMV, SPONT, DuoPAP, APRV,(S)CMV,SIMV, VS, NIV, NIV-ST, nCPAP-PS)• Patient groups(Adult, Pediatric, Neo-nates (optional)• Patient height (30 to 250 cm)• Patient gender (male/female)• (S)CMV (5 to 120 b/min)• P-CMV (5 to 150 b/min) | • Ventilation modes(ASV,APVcmv,APVsimv,P-CMV,P-SIMV, SPONT, DuoPAP, APRV,(S)CMV,SIMV, VS, NIV, NIV-ST, nCPAP-PS)• Patient groups(Adult, Pediatric, Neo-nates (optional)• Patient height (30 to 250 cm)• Patient gender (male/female)• (S)CMV (5 to 120 b/min)• P-CMV (5 to 150 b/min) | SubstantiallyEquivalent |
| TechnicalCharacteristic | Predicate device:HAMILTON-G5 (K131774) | Proposed device: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) | ||
| • Alarm silence (On/OFF) | • Alarm silence (On/OFF) | ||
| • Alarm loudness (51 dB to 73 dB) | • Alarm loudness (51 dB to 73 dB) | ||
| Modes ofventilation | • ASV• APVcmv• APVsimv• P-CMV• P-SIMV | • ASV• APVcmv• APVsimv• P-CMV• P-SIMV | Same |
| TechnicalCharacteris-tic | Predicate device:HAMILTON-G5 (K131774) | Proposed device:HAMILTON-G5 | Comparison |
| SPONT DuoPAP APRV (S)CMV SIMV VS nCPAP-PS NIV NIV-ST | SPONT DuoPAP APRV (S)CMV SIMV VS nCPAP-PS NIV NIV-ST | ||
| Alarms, non-adjustable | Oxygen alarm limit exceeded Oxygen concentration Disconnection Loss of PEEP Exhalation obstruction High PEEP ASV/APV CO2 Power supply Gas supplies Cuff leakage Nebulizer disconnected Cannot reach target flow Cuff Disconnection | Oxygen alarm limit exceeded Oxygen concentration Disconnection Loss of PEEP Exhalation obstruction High PEEP ASV/APV CO2 Power supply Gas supplies Cuff leakage Nebulizer disconnected Cannot reach target flow Cuff Disconnection Check for blockage | SubstantiallyEquivalent |
| Alarms,adjustable | Low/high minute volume Low/high pressure Low/high tidal volume Low/high respiratory rate Apnea time Low/high PetCO2 Low/high pulse Low/high SpO2 Low/high SpMet Low/high SpOC % leak PI (perfusion index) | Low/high minute volume Low/high pressure Low/high tidal volume Low/high respiratory rate Apnea time Low/high PetCO2 Low/high pulse Low/high SpO2 Low/high SpMet Low/high SpOC % leak PI (perfusion index) | Same |
Table 1: Comparison of the HAMILTON-G5 with predicate device
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Hamilton Medical has demonstrated the modified HAMILTON-G5 ventilator to be substantial equivalent to the currently marketed predicate device HAMILTON-G5 (K131744) that has been previously cleared by FDA.
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VIII. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE REFERENCE DEVICES
Table 2: Comparison of the HAMILTON-G5 with Reference device (Nihon Kohden NKV-550 Series Ventilator System.
The Nihon Kohden NKV-550 Series Ventilator System is used as a reference device for the proposed HAMILTON-G5 as both the reference device and the proposed device are intensive care ventilators which have the O2 therapy/cFlow feature.
| TechnicalCharacteristic | Reference Device:Nihon Kohden NKV-550 Series Ven-tilator System (K181695) | Proposed Device:HAMILTON-G5 | Comparison |
|---|---|---|---|
| Indication forUse | The Nihon Kohden NKV-550Series Ventilator System isintended to provide continuousventilation for adult, pediatric andneonatal patients who requireinvasive or noninvasive respiratorysupport. The NKV-550 offersmandatory and spontaneousventilation modes as well asRespiratory monitoring. The NKV-550 is intended for use in hospitalsand hospital-type facilities, as wellas for in-hospital transportation | The HAMILTON-G5 ventilatoris designed for intensive careventilation of adult and pediat-ric patients, and optionally in-fant and neonatal patients.The device is intended for usein the hospital and institu-tional environment wherehealth care professionals pro-vide patient care. The HAMIL-TON-G5 ventilator is intendedfor use by properly trainedpersonnel under the direct su-pervision of a licensed physi-cian. The HAMILTON-G5 venti-lator may be used fortransport within a hospital orhospital type facility providedcompressed gas is supplied.The device is not to be used inthe presence of flammable an-esthetic agents or other igni-tion sources. The ventilator isnot to be used in an environ-ment with magnetic resonanceimaging (MRI) equipment. Thedevice is not intended fortransportation outside thehospital or for use in the homeenvironment | SubstantiallyEquivalent |
| EnvironmentofUse | Hospitals, hospital-type facilitiesand in-hospital transportation forpatients who need ventilationtherapy | The device is intended for usein the hospital and institu-tional environment wherehealthcare professionals pro-vide patient care | SubstantiallyEquivalent |
| AnatomicalSite | Patient airways | Patient airways | Same |
| TargetPopulation | Adult, pediatric and neonatalpatients | Adult, pediatric, infant andneonatal patients | SameFurther definedpediatric toinclude infant |
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| HAMILTON |
|---|
| MEDICAL |
| Technical | Reference Device:Nihon Kohden NKV-550 Series Ventilator System (K181695) | Proposed Device:HAMILTON-G5 | Comparison |
|---|---|---|---|
| Characteristic | |||
| 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 |
| Modes ofventilation | A/CMV-PC A/CMV-VC A/CMC-PRVC SIMV-PC-PS SIMV-VC-PS SIMV-PRVC-PS SPONT-CPAP SPONT-PS SPONT-VS APRV nCPAP | ASV APVcmv APVsimv P-CMV P-SIMV SPONT DuoPAP APRV (S)CMV SIMV VS nCPAP-PS NIV NIV-ST | Substantiallyequivalent |
| Alarms,adjustable | Airway Pressure (Paw), High Minute Ventilation (MV), High/Low Low/high tidal volume Low/high SpO2 Low/High Pulse rate High respiratory rate Apnea High/Low EtCO2 | Low/high minute volume Low/high pressure Low/high tidal volume Low/high respiratory rate Apnea time PetCO2, low/high Low/high pulse Low/high SpO2 Low/high SpMet Low/high SpOC % leak | SubstantiallyEquivalent |
| ChemicalsDelivered toPatient | Medical Air and Oxygen | Medical Air and Oxygen (Optional Heliox) | SubstantiallyEquivalent |
| Deliverymethodto Patient | Positive pressure | Positive pressure | Same |
| Energy UsedforDevice | AC Power and DC Power (battery) | AC Power and DC Power (battery) | Same |
| TherapyTypes | Invasive, Non-invasive, O2 Therapy (High flow) | Invasive, Non-invasive, cFlow (High flow) | Same |
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IX. 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 Re-quirements 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 re-quirements 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 medicaldevices
- 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 gasmonitors
- -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 were completed 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 as 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 modified HAMILTON-G5, with the new features, was conducted. The new therapy cFlow was subjected to comparison testing with legally marketed devices. The data provided from these tests was shown to be equivalent to the legally marketed devices.
Since only materials already used in in the predicate (cleared under document number K131774) are described with this 510(k), Hamilton Medical did not conduct any additional biocompatibility testing.
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x. 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 herein.
§ 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).