(176 days)
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C6 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.
This document is a 510(k) summary for the Hamilton-C6 continuous ventilator. It focuses on demonstrating substantial equivalence to a predicate device (Hamilton-C3) and a reference device (Hamilton-G5), rather than providing details of an AI-based system. Therefore, much of the requested information regarding acceptance criteria and a study proving an AI device's performance cannot be extracted directly from this document.
However, I can provide information about the general performance criteria that were referenced for the device in question, a continuous ventilator.
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Design and Validation | Demonstrated that the HAMILTON-C6 operates as intended. |
| Bench Testing | Demonstrated that the HAMILTON-C6 operates as intended. |
| Compliance with Guidelines and Standards | Compliant with: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, AIM Standard 7351731, AAMI / ANSI HE75. |
| Software Verification and Validation | Conducted as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software considered "major" level of concern. |
| Waveform Performance Testing (Ventilation Modes) | Data shown to be substantially equivalent to legally marketed devices. |
| Biocompatibility | Evaluated according to ISO 18562 series. Materials found acceptable for intended patient population and type of patient contact. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI algorithm, nor does it provide details about sample sizes, data provenance, or whether data was retrospective or prospective. The testing mentioned appears to be general device performance and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described in the document. Ground truth for an AI algorithm is not mentioned as this is not an AI device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the type of device and testing described in the document.
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
No MRMC comparative effectiveness study was done as the HAMILTON-C6 is a continuous ventilator, not an AI-assisted diagnostic or interpretive device. There is no mention of human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The HAMILTON-C6 is a physical medical device (ventilator), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applied in this document, as it is a submission for a continuous ventilator, not an AI diagnostic/interpretive system. The "ground truth" used for performance testing of the ventilator would have been based on established engineering standards and validated physical measurements against expected device outputs.
8. The sample size for the training set
This information is not applicable to the type of device and testing described in the document. There is no training set for an AI algorithm mentioned.
9. How the ground truth for the training set was established
This information is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2020
Hamilton Medical AG Annemarie Weideli Team Leader Regulatory Affairs Via Crush 8 Bonaduz, GR 7402 Switzerland
Re: K201658
Trade/Device Name: Hamilton-C6 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: November 10, 2020 Received: November 13, 2020
Dear Annemarie Weideli:
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 J. Lee Acting 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
510(k) Number (if known) K201658
Device Name HAMILTON-C6
Indications for Use (Describe)
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
· During transfer of ventilated patients within the hospital
The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON 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".
Image /page/3/Picture/1 description: The image shows the text "HAMILTON-C6" in a sans-serif font. The text is a blue color. The text is horizontally oriented and appears to be a logo or title.
510(k) SUMMARY
- l. SUBMITTER Hamilton Medical AG Via Crusch 8 Bonaduz, 7402
Switzerland
Phone: +41 58 610 12 25 +41 58 610 00 20 Fax:
Contact Person: Annemarie Weideli, Team Leader Regulatory Affairs
Date Prepared: 2020-11-09
-
II. DEVICES
Name of Devices: HAMILTON-C6 Common or Usual Name: Continuous ventilator Regulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA) -
III. PREDICATE DEVICE HAMILTON-C3 (K161450)
-
IV. REFERENCE DEVICES HAMILTON-G5 (K193228)
V. DEVICE DESCRIPTION
The HAMILTON-C6 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.
-
VI. INDICATIONS FOR USE
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use: -
In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
-
During transfer of ventilated patients within the hospital ●
The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
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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 word "HAMILTON" on top of the word "MEDICAL". Below the logo is the text "Intelligent Ventilation since 1983".
HAMILTON-C6
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES VII.
A comparative summary of the technological characteristics of the HAMILTON-C6 with the predicate and reference devices is presented below.
| Parameters | Proposed device: | Predicate device: | Reference device: | Comparison |
|---|---|---|---|---|
| HAMILTON-C6 | Currently marketedHAMILTON-C3 | Currently marketedHAMILTON-G5 | ||
| Intended use | The HAMILTON-C6ventilator is intended toprovide positivepressure ventilatorysupport to adults andpediatrics andoptionally infants andneonates.Intended areas of use:• In the intensivecare ward,intermediate careward, emergencyward, long termacute care hospitalor in the recoveryroom• During transfer ofventilated patientswithin the hospitalThe HAMILTON-C6ventilator is a medicaldevice intended for useby qualified, trainedpersonnel under thedirection of a physicianand within the limits ofits stated technicalspecifications. | The HAMILTON-C3ventilator is intended toprovide positivepressure ventilatorysupport to adults andpediatrics andoptionally infants andneonates.Intended areas of use:• In the intensivecare ward,intermediate careward, emergencyward, long termacute care hospitalor in the recoveryroom• During transfer ofventilated patientswithin the hospitalThe HAMILTON-C3ventilator is a medicaldevice intended for useby qualified, trainedpersonnel under thedirection of a physicianand within the limits ofits stated technicalspecifications. | The HAMILTON-G5ventilator is designed forintensive care ventilationof adult and pediatricpatients, and optionallyinfant and neonatalpatients. The device isintended for use in thehospital and institutionalenvironment wherehealthcare professionalsprovide patient care. TheHAMILTON-G5 ventilatoris intended for use byproperly trainedpersonnel under thedirect supervision of alicensed physician. TheHAMILTON-G5 ventilatormay be used fortransport within ahospital or hospital-typefacility providedcompressed gas issupplied.The device is not to beused in the presence offlammable anestheticagents or other ignitionsources. The ventilator isnot to be used in anenvironment withmagnetic resonanceimaging (MRI)equipment. The device isnot intended fortransportation outsidethe hospital or for use inthe home environment. | Substantiallyequivalent |
| Productclassificationcode | CBK (subsequent: DQA) | CBK (subsequent: DQA) | CBK (subsequent: DQA) | Equivalent |
| CFR citation | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5895 | Equivalent |
| Principaloperator | Qualified, trainedpersonnel under thedirection of a physician | Qualified, trainedpersonnel under thedirection of a physician | Qualified, trainedpersonnel under thedirection of a physician | Equivalent |
| Parameters | Proposed device:HAMILTON-C6 | Predicate device:Currently marketedHAMILTON-C3 | Reference device:Currently marketedHAMILTON-G5 | Comparison |
| Environmentof use | Intended areas of use:• Health care facilities• During transfer of ventilatedpatients within health care facilities | Intended areas of use:• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room• During transfer of ventilated patients within the hospital | Intended areas of use:• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room• During transfer of ventilated patients within the hospital | Equivalent |
| Intendedpatientpopulation | Adults, pediatrics, infants and neonates | Adults, pediatrics, infants and neonates | Adults, pediatrics, infants and neonates | Equivalent |
| Patientinterface | Delivered invasively (via ET tube) or noninvasively (via mask) | Delivered invasively (via ET tube) or noninvasively (via mask) | Delivered invasively (via ET tube) or noninvasively (via mask) | Equivalent |
| Power source | AC, Battery | AC, DC, Battery | AC, Battery | Substantially Equivalent |
| Operationalmodes | • (S)CMV (only for adult/pediatric patients)• SIMV (only for adult/pediatric patients)• APVcmv / (S)CMV+• APVsimv / SIMV+• PCV+• PSIMV+• DuoPAP• APRV• SPONT• ASV (only for adult/pediatric patients)• NIV• NIV-ST• nCPAP-PS (only for neonatal patients) | • (S)CMV (only for adult/pediatric patients)• SIMV (only for adult/pediatric patients)• APVcmv / (S)CMV+• APVsimv / SIMV+• PCV+• PSIMV+• DuoPAP• APRV• SPONT• ASV (only for adult/pediatric patients)• NIV• NIV-ST• nCPAP-PS (only for neonatal patients) | • (S)CMV (only for adult and pediatric patients)• SIMV (only for adult and pediatric patients)• APVcmv• APVsimv• P-CMV• P-SIMV• DuoPAP• APRV• SPONT• VS• ASV (only for adult and pediatric patients)• NIV (only for adult and pediatric patients)• NIV-ST (only for adult and pediatric patients)• nCPAP-PS (only for neonatal patients) | Substantially Equivalent |
| Therapy Types | Invasive, Non-invasive, HiFlowO2 | Invasive, Non-invasive | Invasive, Non-invasive, HiFlowO2 | Substantially Equivalent |
| Electricalsafety | IEC 60601-1: 2005 (3rd Edition): all applicable requirements met. | IEC 60601-1: 2005 (3rd Edition): all applicable requirements met. | IEC 60601-1: 2005 (3rd Edition): all applicable requirements met. | Equivalent |
| Parameters | Proposed device:HAMILTON-C6 | Predicate device:Currently marketedHAMILTON-C3 | Reference device:Currently marketedHAMILTON-G5 | Comparison |
| Emergency airintake | In case of a powersupply, technical, orpneumatics failure theambient valve allowsspontaneous breathing. | In case of a powersupply, technical, orpneumatics failure theambient valve allowsspontaneous breathing. | In case of a powersupply, technical, orpneumatics failure theambient valve allowsspontaneous breathing. | Equivalent |
| Activeexhalationvalve? | Yes, pneumatic | Yes, pneumatic | Yes, pneumatic | Equivalent |
| Alarms andmonitoring | Yes | Yes | Yes | Equivalent |
| Supply gas | Oxygen, ambient air | Oxygen, ambient air | Oxygen, Air, Heliox | SubstantiallyEquivalent |
| Method ofsupply gaspressurization | Internal turbine for air,compressed source forO2 | Internal turbine for air,compressed source forO2 | Compressed source forAir, O2, Heliox | SubstantiallyEquivalent |
| CO2monitoringoption | Yes | Yes | Yes | Equivalent |
| SpO2monitoringoption | Yes | Yes | Yes | Equivalent |
Table 1: Comparison of HAMILTON-C6 with predicate and reference device
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Image /page/5/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line, with a stylized "H" symbol to the right. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line.
HAMILTON-C6
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Image /page/6/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and features the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a small icon. Below the logo is the text "Intelligent Ventilation since 1983".
HAMIL
As can be seen in Table 1 above, the proposed device HAMILTON-C6 has the same technological characteristics as the predicate HAMILTON-C3.
Altogether, the technological characteristics of the proposed device HAMILTON-C6 are substantially equivalent to the predicate devices. Thus, the comparison of the HAMILTON-C6 to its predicate device does not raise new safety and effectiveness concerns.
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-C6 operates as intended.
In particular, testing demonstrated that the HAMILTON-C6 is compliant with the following guidelines and standards:
- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General । 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
- -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 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 62304 (2015): Medical device software - Software life-cycle processes
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Image /page/7/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON 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.
Image /page/7/Picture/1 description: The image shows the text "HAMILTON-C6" in a sans-serif font. The text is a vibrant blue color. The text appears to be a logo or brand name.
- IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
- -ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -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
- -AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
- -AAMI / ANSI HE75:2009,Human factors engineering - Design of medical devices
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 HAMILTON-C6 was conducted. The ventilation modes were subjected to waveform performance testing. The data provided from these tests was shown to be substantially equivalent to the legally marketed devices.
IX. BIOCOMPATIBILITY
The gas pathway of the HAMILTON-C6 was evaluated according to ISO 18562 series. The materials have been evaluated and found to be acceptable for the intended patient population, and type of patient contact.
X. SUMMARY OF CLINICAL TESTING No clinical testing was conducted or required in support of this premarket notification.
XI. CONCLUSION
Substantial equivalence has shown similar technological characteristics, intended use, principles of operation and verification and validation. The proposed device HAMILTON-C6 has software and hardware enhancements to maintain the intended performance of the device.
No new questions of safety and effectiveness have been raised. The HAMILTON-C6 ventilator is as safe and as effective as the legally marketed devices identified herein. From the evidence presented in the premarket notification, the proposed device can be considered substantially equivalent to the predicate devices.
§ 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).