(93 days)
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use:
• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.
The HAMILTON-C1 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-C1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. The HAMILTON-C1 ventilator covers a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation (NIV).
The HAMILTON-C1 is suitable for ICU special-care areas, cardiac surgery recovery rooms, stepdown or sub-acute care units, and long-term care centers. With its IntelliTria technology. the HAMILTON-C1 responds to the changing breathing patterns or circuit leaks found in non-invasive ventilation by automatically varying leaks and adapting sensitivity thresholds for optimal response to the patient's breath.
The HAMILTON-C1's software and ventilation modes are identical to the HAMILTON-T1's software and ventilation modes. One can operate the HAMILTON-C1 with the touchscreen or with a single turn wheel. Hard keys give direct access to the most important functions. In effect, the HAMILTON-C1 is a HAMILTON-T1, but with the features related to transportventilation stripped off.
With the large alarm lamp, a clinician can immediately identify an alarming HAMILTON-C1 ventilator because of the alarm lamp located at the top of the device, even if the clinician is at a long distance away or when several different devices are operating simultaneously in the same room.
Interface for PDMS, patient monitor, and nurse call are available as well. The optional interfaces provide ports for connection to hospital monitors, Patient Data Management Systems (PDMS), and nurse call systems.
The high-performance turbine can deliver up to 210 L/min flow; this relatively high flow rate is potentially helpful when utilizing NIV modes of ventilation.
The provided text describes the HAMILTON-C1 ventilator and asserts its substantial equivalence to a predicate device, the HAMILTON-T1. The demonstration of equivalence is primarily based on non-clinical testing and a comparison of technical specifications, rather than a clinical study evaluating the device's diagnostic or therapeutic performance against specific acceptance criteria.
Therefore, many sections of your request regarding acceptance criteria for device performance in a clinical context, sample sizes for test sets, expert ground truth establishment, adjudication methods, and comparative effectiveness studies cannot be fully answered from the provided document. The document focuses on regulatory compliance through comparison to a predicate device and adherence to recognized standards.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for device performance in a clinical setting with corresponding reported performance from a study. Instead, it lists standards that the device meets, which function as regulatory acceptance criteria for safety and effectiveness.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| Draft Reviewer Guidance for Ventilators. 1995. | Met/Exceeded |
| IEC 60601-1 (General Requirements for Safety) | Met/Exceeded |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Met/Exceeded |
| IEC 60601-1-4 (Programmable electrical medical systems) | Met/Exceeded |
| IEC 60601-1-8 (Alarm Systems) | Met/Exceeded |
| IEC 60601-2-12 (Critical Care Ventilators) | Met/Exceeded |
| IEC 62304 (Software life-cycle processes) | Met/Exceeded |
| IEC 62366 (Application of usability engineering to medical devices) | Met/Exceeded |
| ISO 5356-1 (Conical connectors: Part 1: Cones and sockets) | Met/Exceeded |
| AAMI/ANSI HE75 (Human factors engineering. Design of medical devices) | Met/Exceeded |
| EN ISO 14971 (Application of risk management to medical devices) | Met/Exceeded |
| EN ISO 13485 (Medical devices -- Quality management systems) | Met/Exceeded |
| EN ISO 9001 (Quality management systems) | Met/Exceeded |
| EN ISO 5359 (Low-pressure hose assemblies for use with medical gases) | Met/Exceeded |
| EN 794-1 (Particular requirements for critical care ventilators) | Met/Exceeded |
| IEC 62133 (Battery Safety. Non-Spillable) | Met/Exceeded |
| ASTM F1100-90 (Standard Specification for Ventilators Intended for Use in Critical Care) | Met/Exceeded |
| MIL-STD-461E (RS101, CS114 (curve #3), and RE101 (Army 7-cm limit)) | Met/Exceeded (where applicable, for predicate device) |
The document also provides comparisons to the predicate device (HAMILTON-T1) on certain specifications:
| Feature | Predicate (HAMILTON-T1) | Proposed (HAMILTON-C1) | Comment (Performance) |
|---|---|---|---|
| Intended Use | More extensive (includes transport out-of-hospital) | More limited (in-hospital transfer only) | Differences do not affect safety/effectiveness for labeled use. |
| Patient Population | Adults and pediatrics | Adults and pediatrics | Equivalent |
| Max Insp. Flow | 210 l/min | 210 l/min | Equivalent |
| Airworthiness | Yes | No | Not designed for air transport. |
| Water Protection | IPX4 | IPX1 | Lower protection (not designed for harsh transport). |
| Temperature Range | -15 to 40 °C (operating), -15 to 70 °C (storage) | 5 to 40 °C (operating), -20 to 60 °C (storage) | Lower tolerance for temperature extremes (not designed for harsh transport). |
| Software Version | 1.1.2 | 1.1.2 | Equivalent |
| Number of Batteries | 2 | 1 | One less battery. |
| Weight | 6.5 kg | 4.9 kg | Lighter. |
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 explicitly states that the device was cleared based on non-clinical tests and comparison to a predicate device. It does not mention any clinical test sets or patient data. Therefore, this information is not available in the provided text.
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)
No clinical test set or ground truth establishment by experts is described in this document. The clearance is based on technical specifications and adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No clinical test set or adjudication method is described in this 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 or comparative effectiveness study involving human readers or AI assistance is mentioned. The HAMILTON-C1 is a continuous ventilator, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe the performance of a standalone algorithm. The device is a medical device, not solely an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No patient-specific ground truth (expert consensus, pathology, outcomes data) was used for device clearance based on this document. The "ground truth" for the device's substantial equivalence is its performance against established engineering, safety, and performance standards, and comparison to the predicate device's cleared specifications.
8. The sample size for the training set
The document does not describe any training set data, as it focuses on the regulatory clearance of a medical device based on non-clinical testing and substantial equivalence, not a machine learning model's training.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth establishment is mentioned in the provided text.
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HAMILTON
MEDICAL
HAMILTON.CI
MAY 3 0 2012
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: raquila@hamilton-medical.ch |
| ESTABLISHMENTREGISTRATIONNUMBER: | 3001421318 |
| PREPARATION DATE: | 2012-04-19 |
| TRADE NAME: | HAMILTON-C1 |
| COMMON NAME: | Continuous Ventilator |
| CLASSIFICATION NAME: | CLASS II Ventilator, Continuous |
| REGULATION NUMBER: | 21 CFR 868.5895 |
| PRODUCT CODE: | CBK |
| PREDICATE DEVICE: | HAMILTON-T1510(k) Number: K112006 |
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DEVICE DESCRIPTION
The HAMILTON-C1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. The HAMILTON-C1 ventilator covers a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation (NIV).
The HAMILTON-C1 is suitable for ICU special-care areas, cardiac surgery recovery rooms, stepdown or sub-acute care units, and long-term care centers. With its IntelliTria technology. the HAMILTON-C1 responds to the changing breathing patterns or circuit leaks found in non-invasive ventilation by automatically varying leaks and adapting sensitivity thresholds for optimal response to the patient's breath.
The HAMILTON-C1's software and ventilation modes are identical to the HAMILTON-T1's software and ventilation modes. One can operate the HAMILTON-C1 with the touchscreen or with a single turn wheel. Hard keys give direct access to the most important functions. In effect, the HAMILTON-C1 is a HAMILTON-T1, but with the features related to transportventilation stripped off.
With the large alarm lamp, a clinician can immediately identify an alarming HAMILTON-C1 ventilator because of the alarm lamp located at the top of the device, even if the clinician is at a long distance away or when several different devices are operating simultaneously in the same room.
Interface for PDMS, patient monitor, and nurse call are available as well. The optional interfaces provide ports for connection to hospital monitors, Patient Data Management Systems (PDMS), and nurse call systems.
The high-performance turbine can deliver up to 210 L/min flow; this relatively high flow rate is potentially helpful when utilizing NIV modes of ventilation.
INTENDED USE
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- In the intensive care ward or in the recovery room. .
- . During transfer of ventilated patients within the hospital.
The HAMILTON-C1 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.
ﻟﺴ
510(k) Number: K120574
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Image /page/2/Picture/0 description: The image contains the words "HAMILTON" and "MEDICAL" in bold, black font. The word "HAMILTON" is on the top line, and the word "MEDICAL" is on the bottom line. The letters are all capitalized and sans-serif. There is a logo to the right of the word "HAMILTON".
HAN
DISCUSSION ON THE NON-CLINICAL TESTS
The non-clinical test results show that the HAMILTON-C1 is safe and effective for its intended use. Below is a list of standards and guidance documents recognized by FDA to establish the basis of safety and effectiveness for the HAMILTON-C1. These standards are the exact ones used by the HAMILTON-T1 for its 510(k) clearance, except for the transportrelated standards, such as the RTCA/DO 160F, which the HAMILTON-C1 is not designed for. The results of the following non-clinical tests support a determination of substantial equivalence. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs just as well as the predicate device.
| Draft Reviewer Guidance for Ventilators. 1995. | |
|---|---|
| IEC 60601-1 | General Requirements for Safety. |
| IEC 60601-1-2 | Electromagnetic Compatibility. |
| IEC 60601-1-4 | Programmable electrical medical systems. |
| IEC 60601-1-8 | Alarm Systems |
| IEC 60601-2-12 | Critical Care Ventilators. |
| IEC 62304 | Software life-cycle processes. |
| IEC 62366 | Application of usability engineering to medical devices. |
| ISO 5356-1 | Conical connectors: Part 1: Cones and sockets. |
| AAMI/ANSI HE75 | Human factors engineering. Design of medical devices. |
| EN ISO 14971 | Application of risk management to medical devices. |
Other internationally recognized standards which the HAMILTON-C1 meets or exceeds:
| EN ISO 13485 | Medical devices -- Quality management systems. |
|---|---|
| EN ISO 9001 | Quality management systems. |
| EN ISO 5359 | Low-pressure hose assemblies for use with medicalgases. |
| EN 794-1 | Particular requirements for critical care ventilators. |
| IEC 62133 | Battery Safety. Non-Spillable. |
| ASTM F1100-90 | Standard Specification for Ventilators Intended for Use inCritical Care. |
| MIL-STD-461E | RS101, CS114 (curve #3), and RE101 (Army 7-cmlimit). |
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Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white, with the words "HAMILTON" and "MEDICAL" stacked on top of each other. The word "HAMILTON" is in a larger font than the word "MEDICAL". There is a symbol to the right of the word "HAMILTON".
HAMILTON.Cl
COMPARISON WITH THE PREDICATE DEVICE
| HAMILTON-T1Predicate device:K112006 | HAMILTON-C1Proposed device:K120574 | COMMENTS | |
|---|---|---|---|
| Intended Use | The HAMILTON-T1ventilator is intended toprovide positive pressureventilatory support toadults and pediatrics.Intended areas of use:• In the intensive careward or in therecovery room.• For emergencymedical care orprimary care.• During transportwithin and outsidethe hospital.• During transfer byrescue vehicles, jetor helicopter.The HAMILTON-T1ventilator is a medicaldevice intended for useby qualified, trainedpersonnel under thedirection of a physicianand within the limits of itsstated technicalspecifications. | The HAMILTON-C1ventilator is intended toprovide positive pressureventilatory support toadults and pediatrics.Intended areas of use:• In the intensive careward or in therecovery room.• During transfer ofventilated patientswithin the hospital.The HAMILTON-C1ventilator is a medicaldevice intended for use byqualified, trainedpersonnel under thedirection of a physicianand within the limits of itsstated technicalspecifications. | The only major differencebetween the HAMILTON-C1and the HAMILTON-T1 isthe transport aspect.Because of the differentenvironment of use, theenclosure for the HAMIL-TON-T1 has been rugged-ized in accordance with theRTCA/DO 160F to with-stand shock, vibrations,water ingress, and dropsfrom >1 meter heights. TheHAMILTON-C1 is not desi-gned for such an environ-ment of use.The HAMILTON-C1 onlyhas one battery, comparedto the two batteries foundon the HAMILTON-T1. TheHAMILTON-T1 has a DC-power inlet and can with-stand greater temperatureextremes.The HAMILTON-T1 alsohas extra safety featurescompared to theHAMILTON-C1 for theEMD, ESD, and RFI envi-ronments found on aircraft.In all other respects, how-ever, the HAMILTON-C1 isexactly the same as theHAMILTON-T1. |
| IntendedPatientPopulation | Patients include adultsand pediatrics. | Patients include adultsand pediatrics. | The HAMILTON-C1 isequivalent. |
| Maximum Ins-piratory Flow | 210 l/min | 210 l/min | Equivalent |
| Is it air-worthy? | Yes | No | The HAMILTON-C1 is notdesigned for air transport. |
| WaterProtection | IPX4 | IPX1 | The HAMILTON-T1 hasgreater protection againstwater ingress for thetransport environment. |
| TemperatureRange | -15 to 40 °C (operating),-15 to 70 °C (storage) | 5 to 40 °C (operating),-20 to 60 °C (storage) | The HAMILTON-T1 has agreater tolerance of widertemperature variances forthe transport environment. |
| Softwareversion | Version 1.1.2 | Version 1.1.2 | Equivalent |
| Number ofbatteries | 2 | 1 | The HAMILTON-T1 has anadditional battery. |
| Weight | 6.5 kg (14.3 lb) with 2batteries and a handle | 4.9 kg (10.8 lb)without trolley | The HAMILTON-C1 islighter in weight. |
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Image /page/4/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in black and white and features the words "HAMILTON" stacked on top of "MEDICAL". There is a small design to the right of the word "HAMILTON".
Image /page/4/Picture/1 description: The image shows the text "HAMILTON-C1" in a bold, sans-serif font. The letters are black and the background is white. The text appears to be a label or identifier, possibly for a product or location. The letters are evenly spaced and the text is horizontally aligned.
The intended use statement for the HAMILTON-C1 ventilator is comparable to the predicate device. The only difference is that the HAMILTON-C1 has a more limited intended use due to the fact that it is not hardened for transport environments. However, the technological characteristics (i.e., design, material, energy source) and performance specifications of the HAMILTON-C1 ventilator are equivalent to those of the predicate device. The HAMILTON-C1 meets all the standards set by FDA for non-transport ventilators. The differences do not affect the safety and effectiveness of the device when used as labeled.
The intended use of the HAMILTON-C1 is covered by the referenced predicate device. The technical characteristics of the HAMILTON-C1 do not raise any new questions regarding the safety or effectiveness of ventilators. The HAMILTON-C1's software has gone through verification/validation tests. A complete revision level history, hazard analysis, and a traceability analysis linking requirements to validation were done. The conclusions drawn from the non-clinical tests demonstrate that the HAMILTON-C1 is as safe, as effective, and performs as well as the legally marketed device. The differences are not critical to the intended therapeutic use of the device. The HAMILTON-C1 is, therefore, considered to be substantially equivalent to the currently marketed predicate device which has been previously cleared by FDA.
{5}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ralph Aguila Quality Engineer, Regulatory Affairs . Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 SWITZERLAND
K120574 Re:
Trade/Device Name: HAMILTON-C1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 19, 2012 Received: May 7, 2012
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.
MAY 3.0 2012
{6}------------------------------------------------
Page 2 - Mr. Aguila
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
HAMILTON-C1
Indication for Use:
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use:
· In the intensive care ward or in the recovery room.
· During transfer of ventilated patients within the hospital.
The HAMILTON-C1 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.
Prescription Use X
(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)
L. Schultze
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
§ 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).