(323 days)
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
- In the MRI department
- 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-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners.
The HAMILTON-MR1 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-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It 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. It can be used at the gauss line, in the presence of either 1.5T or 3T MRI machines.
With the shielded, MRI-compatible HAMILTON-MR1 ventilation performance and MR image quality is as safe and as effective as the predicate device throughout the MRI procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-MR1:
- Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL
- . The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC
- An increase in the battery duration from 5 hours and 20 minutes to 9 hours and 20 minutes.
The provided document describes a 510(k) submission for the HAMILTON-MR1 ventilator, focusing on its substantial equivalence to previously cleared predicate devices. The submission concerns adding new features, specifically the capability to ventilate neonatal patients and two new ventilation modes (nCPAP and nCPAP-PC).
This document does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as it is a ventilator and not an AI/ML diagnostic tool. Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of device submission.
However, I can extract information regarding performance testing and regulatory compliance relevant to this specific device.
Acceptance Criteria and Device Performance (Based on the provided document)
Since this is a ventilation device rather than an AI/ML diagnostic, "acceptance criteria" here refer to compliance with relevant medical device standards and demonstrating functionality for the newly added features.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Regulatory Compliance & Testing) | Reported Device Performance (Summary from Document) |
|---|---|
| Safety and Essential Performance Standards: - ANSI/AAMI ES60601-1 (2005/(R) 2012): Medical electrical equipment General — Requirements for Safety | Compliant: Testing demonstrated compliance with this standard. |
| - IEC 60601-1-2 (2007): Electromagnetic Compatibility | Compliant: Testing demonstrated compliance with this standard. |
| - ISO 80601-2-12 (2011): Critical Care Ventilators Specific Requirements | Compliant: Testing demonstrated compliance with this standard. |
| - IEC 60601-1-8 (2006 + Am.1: 2012): Alarm Systems | Compliant: Testing demonstrated compliance with this standard. |
| - IEC 60601-1-6 (2010 + A1 :2013): Usability | Compliant: Testing demonstrated compliance with this standard. |
| - IEC 62366 (2008)+A1(2014): Usability Engineering | Compliant: Testing demonstrated compliance with this standard. |
| - IEC 62304 (2006): Medical Device Software Life-Cycle Processes | Compliant: Software design and validation process, together with bench testing, demonstrated the device operates as intended. Additional software verification and validation conducted as per FDA guidance. Software classified as "major" level of concern. |
| - ISO 80601-2-55 (2011): Respiratory Gas Monitors Specific Requirements | Compliant: Testing demonstrated compliance with this standard. |
| Added Features Functionality: - Neonatal patient compatibility (min. 0.2 kg, min. 2 mL tidal volume) | Demonstrated Functionality: Covered by the overall testing of modified HAMILTON-MR1. |
| - New modes nCPAP and nCPAP-PC performance for neonatal use | Functionality Demonstrated & Substantially Equivalent: New ventilation modes subjected to waveform performance testing. Data provided showed substantial equivalence to legally marketed devices (specifically, the HAMILTON-C1/T1 which already has these modes and neonatal capability). |
| Extended Battery Duration: - Increase from 5 hours 20 minutes to 9 hours 20 minutes | Demonstrated: Battery duration increased to 9 hours 20 minutes (with typical run time stated as 8 hours). |
| MR-Conditional Performance: - Does not generate artifacts in MRI - Not negatively influenced by magnetic fields (1.5T and 3.0T static magnetic fields) | Verified: MRI environment test for RF-Noise redone to verify no artifacts. System test for magnetic immunity redone to verify no negative influence by magnetic field. The device is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners, and the integrated gaussmeter alarms when too close to the MRI magnet (50mT line or less). |
| Material Biocompatibility: - Biocompatibility of new materials | Confirmed: Only biocompatible materials or materials already used in earlier 510(k)s were introduced; no additional testing conducted (implying prior acceptance). |
Study Details (Contextualized for a Ventilator Submission):
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in terms of patient data or clinical trials, as it's a 510(k) for a ventilator modification based on bench testing, engineering verification, and comparison to predicate devices, rather than a clinical performance study involving human subjects.
- The data provenance is from bench testing and software verification/validation activities conducted in support of the submission. The company is Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The testing is implied to be prospective as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission for a ventilator. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated via bench testing and engineering verification.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical study design for image interpretation or diagnosis, which is not part of this ventilator submission.
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. This is a ventilator, not an imaging device or an AI assistant for human readers. MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a ventilator, a physical machine that provides mechanical ventilation. Its "performance" is its ability to deliver specified ventilation parameters safely and effectively, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this ventilator device is its compliance with internationally recognized medical device standards (e.g., IEC, ISO, ANSI/AAMI), its engineering specifications, and its demonstrated performance in bench testing (e.g., waveform performance testing for new ventilation modes, magnetic immunity, RF-noise generation). The comparison to predicate devices also serves as a baseline for "truth" in terms of substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device does not use an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is used for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Hamilton Medical AG Katrin Vogt Quality Engineer Via Crusch 8 Bonaduz, Grisons, 7402 Switzerland
Re: K153046
Trade/Device Name: HAMILTON-MR1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: August 5, 2016 Received: August 8, 2016
Dear Katrin Vogt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Project-Name: | HAMILTON-MR1 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No.: | MR1 Part |
|---|---|---|---|---|
| Doc.-Title: | Part 4: Indications for use | Doc.-Version: | 1.0 |
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K153046 |
|---|---|
| Device Name: | HAMILTON-MR1 |
| Indication for Use: | The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.Intended areas of use: In the MRI departmentIn the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery roomDuring transfer of ventilated patients within the hospital The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 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(Part 21 CFR 801 Subpart D) | X |
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| K. Vogt | Page 4 - 2 | 2015-10-13 |
|---|---|---|
| © Copyright by HAMILTON MEDICAL AG | CONFIDENTIAL |
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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 circle with a stylized "H" inside. Below the logo is the phrase "Intelligent Ventilation since 1983".
Image /page/3/Picture/1 description: The image shows the text "HAMILTON-MR1" in a bold, sans-serif font. The text is a solid blue color, and the background is a light blue or white. The letters are evenly spaced and the text is horizontally aligned.
510(k) SUMMARY
-
- SUBMITTER
Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland
- SUBMITTER
Phone: +41 58 610 1479 Fax: +41 58 610 0020
Contact Person: Katrin Vogt, Quality Engineer Date Prepared: 2016-09-05
-
II. DEVICE
Name of Devices: HAMILTON-MR1 Common or Usual Name: MRI department/ICU ventilator Regulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK -
III. PREDICATE DEVICES HAMILTON-MR1 (K122438) HAMILTON-C1/T1 (K140939)
IV. DEVICE DESCRIPTION
The HAMILTON-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It 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. It can be used at the gauss line, in the presence of either 1.5T or 3T MRI machines.
With the shielded, MRI-compatible HAMILTON-MR1 ventilation performance and MR image quality is as safe and as effective as the predicate device throughout the MRI procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-MR1:
- Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL
- . The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC
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Image /page/4/Picture/0 description: The image contains 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 stylized "H" symbol. Below the logo is the tagline "Intelligent Ventilation since 1983".
Image /page/4/Picture/1 description: The image shows the text "HAMILTON-MR1" in a sans-serif font. The text is a blue color and appears to be bolded. The background is a light blue color.
- An increase in the battery duration from 5 hours and 20 minutes to 9 hours and 20 minutes.
V. INDICATIONS FOR USE
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Intended areas of use:
- In the MRI department
- . 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-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners.
The HAMILTON-MR1 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.
- VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES The indication-of-use statement, for the modified HAMILTON-MR1 ventilator, has been adjusted to include infant and neonatal patients.
The new nCPAP and nCPAP-PC modes are substantially equivalent to those in the HAMILTON-C1/T1 ventilators.
| Parameters | Application device: | Predicate device: previous | Predicate device: |
|---|---|---|---|
| HAMILTON-MR1 | version of HAMILTON-MR1 | HAMILTON-C1 (K140939) | |
| Intended use | The HAMILTON-MR1ventilator is intended toprovide positive pressureventilatory support to adultsand pediatrics, andoptionally infants andneonates. | The HAMILTON-MR1ventilator is intended toprovide positive pressureventilatory support to adultsand pediatrics. | The HAMILTON-C1ventilator is intended toprovide positive pressureventilatory support to adultsand pediatrics, andoptionally infants andneonates. |
| Intended areas of use:• In the MRI department• In the intensive care ward,intermediate care ward,emergency ward, long termacute care hospital or in therecovery room• During transfer of | Intended areas of use:• In the MRI department• In the intensive care wardor in the recovery room• During transfer ofventilated patients withinthe hospitalThe HAMILTON-MR1ventilator is classified as MR | Intended areas of use:• In the intensive careward, intermediate careward, emergency ward,long term acute carehospital, or in therecovery room• During transfer of | |
| ventilated patients withinthe hospitalThe HAMILTON-MR1ventilator is classified as MRConditional with the use of1.5 Tesla and 3.0 Tesla staticmagnetic field scanners.The HAMILTON-MR1ventilator is a medicaldevice intended for use byqualified, trained personnelunder the direction of aphysician and within thelimits of its stated technicalspecifications. | Conditional with the use of1.5 T and 3.0 Tesla staticmagnetic field scanners.The HAMILTON-MR1ventilator is a restrictedmedical device intended foruse by qualified, trainedpersonnel under thedirection of a physician andwithin the limits of its statedtechnical specifications. | ventilated patientswithin the hospitalThe HAMILTON-C1ventilator is a medicaldevice intended for use byqualified, trained personnelunder the direction of aphysician and within thelimits of its stated technicalspecifications. | |
| Environmentof use | Intended areas of use:• In the MRI department• In the intensive care ward,intermediate care ward,emergency ward, long termacute care hospital, or in therecovery room• During transfer ofventilated patients withinthe hospital | Intended areas of use:• In the MRI department• In the intensive care wardor in the recovery room• During transfer ofventilated patients withinthe hospital | Intended areas of use:• In the intensive careward, intermediate careward, emergency ward,long term acute carehospital, or in therecovery room• During transfer ofventilated patientswithin the hospital |
| Productclassificationcode | CBK | CBK | CBK |
| CFR citation | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5895 |
| Principaloperator | Qualified, trained personnelunder the direction of aphysician | Qualified, trained personnelunder the direction of aphysician | Qualified, trained personnelunder the direction of aphysician |
| Intendedpatientpopulation | Patients include adults andpediatrics, and optionallyinfants and neonates. | Patients include adults andpediatrics. | Patients include adults andpediatrics, and optionallyinfants and neonates. |
| Operationalenvironmentalrequirements | • 5°C to 40°C (41°F to104°F)• 10% to 95%,noncondensing• 1100 to 700 hPa (9.842 ft) | • 5°C to 40°C (41°F to104°F)• 10% to 95%,noncondensing• 1100 to 700 hPa | • 5 to 40 °C (41 to 104°F)• 10 to 95%, non-condensing• 1013 to 600 hPa |
| Power source | AC and battery poweredwith two batteries, can berun while batteries arecharging. With a typicalbattery run time of 8 hours | AC and battery poweredwith two batteries, can berun while batteries arecharging. With a typicalbattery run time of5.5 hours | AC and battery poweredwith one battery, can be runwhile battery is chargingwith a maximal run time of4.30 hours. |
| Number ofbatteries | 2 | 2 | 1 |
Table 1: Comparison of HAMILTON-MR1 with predicate 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" stacked on top of the word "MEDICAL". There is a symbol to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/5/Picture/1 description: The image shows the text "HAMILTON-MR1" in a bold, sans-serif font. The text is a dark blue color, and the background is a light blue color. The text is centered in the image and takes up most of the space.
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Image /page/6/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. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/6/Picture/1 description: The image shows the text "HAMILTON-MR1" in a blue, rounded font. The text is set against a light blue background. The letters are bold and have a slightly cartoonish appearance due to their rounded edges.
| Supply gasMethod ofsupply gaspressurization | Oxygen, ambient airInternal turbine for air,compressed source for O2 | Oxygen, ambient airInternal turbine for air,compressed source for O2 | Oxygen, ambient airInternal turbine for air,compressed source for O2 |
|---|---|---|---|
| Fresh gasintake filter | • Monitored HEPA (HighEfficiency Particulate Airfilter):• Alarm "Replace HEPAfilter" in case of clogging.• Yearly or every 5.000 hfilter replacement specified. | • Monitored HEPA (HighEfficiency Particulate Airfilter):• Alarm "Replace HEPAfilter" in case of clogging.• Yearly or every 5.000 hfilter replacement specified. | • Monitored HEPA (HighEfficiency Particulate Airfilter):• Alarm "Replace HEPAfilter" in case of clogging.• Yearly or every 5.000 h filterreplacement specified. |
| Patientinterface | Delivered invasively (via ETtube) or noninvasively (viamask) | Delivered invasively (via ETtube) or noninvasively (viamask) | Delivered invasively (via ETtube) or noninvasively (viamask) |
| Safetyfeatures | • Apnea backup ventilation• Automatic self-tests• Alarms (operator-adjustable / non-adjustable)• Alarm backup buzzer• External flow sensorfailure mode• Safety mode in case oftechnical failures• Air inlet HEPA filtermonitoring• Monitored fan• Event log | • Apnea backup ventilation• Automatic self-tests• Alarms (operator-adjustable / non-adjustable)• Alarm backup buzzer• External flow sensorfailure mode• Safety mode in case oftechnical failures• Air inlet HEPA filtermonitoring• Monitored fan• Event log | • Apnea backup ventilation• Automatic self-tests• Alarms (operator-adjustable / non-adjustable)• Alarm backup buzzer• External flow sensorfailure mode• Safety mode in case oftechnical failures• Air inlet HEPA filtermonitoring• Monitored fan• Event log |
| Emergency airintake | In case of a power supply,technical, or pneumaticsfailure the ambient valveallows spontaneousbreathing. | In case of a power supply,technical, or pneumaticsfailure the ambient valveallows spontaneousbreathing. | In case of a power supply,technical, or pneumaticsfailure the ambient valveallows spontaneousbreathing. |
| Operationalmodes | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+ (incl. thepossibility to set IntelliSyncto "Off")• SPONT• DuoPAP• APRV• NIV• NIV-ST• nCPAP• nCPAP-PC | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+• SPONT• DuoPAP• APRV• NIV• NIV-ST | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+ (incl. thepossibility to set IntelliSyncto "Off")• SPONT• DuoPAP• APRV• NIV• NIV-ST• nCPAP• nCPAP-PC |
| Electricalsafety | IEC 60601-1: 2005 (3rdEdition): all applicablerequirements met. | IEC 60601-1:1988 (A1:1991+ A2:1995): all applicablerequirements met. | IEC 60601-1: 2005 (3rdEdition): all applicablerequirements met. |
| exhalationvalve? | |||
| Volumesetting range | 2-2000 ml | 20-2000 ml | 2-2000 ml |
| Maximumworkingpressurelimitation | 60 cmH2O | 60 cmH2O | 60 cmH2O |
| PEEP setting | 0-35 cmH2ONeo: 3-25 cmH2O | 0-35 cmH2O | 0-35 cmH2ONeo: 3-25 cmH2O |
| Alarms andmonitoring | Yes | Yes | Yes |
| Adjustableinspirationtime totalrange | 0.1-40 sec | 0.1-40 sec | 0.1-40 sec |
| MRIdepartmentcompatible? | Yes | Yes | No |
| Differences intechnologicalcharacteristics | - MR conditionality- Included Gaussmeter- Embedded system type: EM10A- Internal flow sensor with the ability to detect reflow- Expiratory valve recognition- Flashing alarm lamp- Batteries with prolonged operating time | - MR conditionality- Included Gaussmeter- Embedded system type: EM01A- Internal flow sensor without the ability to detect reflow- No expiratory valve recognition- Alarm lamp not flashing, only illuminated- Batteries without prolonged operating time | - MR unsafe- No Gaussmeter included- Embedded system type: EM10A- Internal flow sensor with the ability to detect reflow- Expiratory valve recognition- Flashing alarm lamp- Batteries with prolonged operating time |
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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 words "HAMILTON" and "MEDICAL" stacked on top of each other. There is a small icon to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/7/Picture/1 description: The image shows the words "HAMILTON-MR1" in a blue, rounded sans-serif font. The text is set against a light blue background. The letters are bold and evenly spaced, creating a clear and legible design. The overall impression is clean and professional.
Hamilton Medical has demonstrated the modified HAMILTON-MR1 ventilator to be substantial equivalent to currently marketed predicate devices that have been previously cleared by FDA.
VII. 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-MR1 operates as intended.
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Image /page/8/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 small icon that appears to be the letter "H" inside of a circle. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/8/Picture/1 description: The image shows the words "HAMILTON-MR1" in a stylized, sans-serif font. The text is a solid blue color, and the background is a light blue or white. The letters are thick and rounded, giving the text a bold and modern appearance. The hyphen between "HAMILTON" and "MR1" is also blue and of similar thickness to the letters.
In particular, testing demonstrated that the HAMILTON-MR1 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 (2007): 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 (2008)+A1(2014): Medical devices - Application of usability engineering to 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
Additional software verification and validation testing were 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 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-MR1, with the new features, was conducted. The new 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.
Since only biocompatible materials or materials already used in earlier 510(k)s are introduced with this 510(k), Hamilton Medical did not conduct any additional testing.
The MRI environment test RF-Noise was redone to verify, that the modified device does not generate artifacts in the magnetic resonance image.
The system test magnetic immunity was redone to verify that the modified HAMILTON-MR1 is not negatively influenced by the magnetic field of a magnetic resonance imaging tomograph.
VIII. CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified
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Image /page/9/Picture/0 description: The image shows the logo for Hamilton Medical. The logo has the words "HAMILTON MEDICAL" in blue, with the word "HAMILTON" stacked on top of the word "MEDICAL". To the right of the word "HAMILTON" is a blue circle with a white design inside. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/9/Picture/1 description: The image shows the text "HAMILTON-MR1" in a bold, sans-serif font. The text is a bright blue color, and the background is a light blue or white color. The letters are rounded and have a soft, friendly appearance. The text is likely a logo or branding for a product or company.
HAMILTON-MR1 ventilator is as safe and as effective as 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).