Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions "automated ventilation with Adaptive Support Ventilation (ASV)", which is a control algorithm, but there is no mention of AI, ML, or any learning-based approach in the device description or performance studies. The focus is on standard ventilation modes and MR compatibility.

Therapeutic

Yes
The device is a ventilator that provides "positive pressure ventilatory support" and "appropriate modes of therapy" for patients, which are therapeutic actions.

Diagnostic

No.
The HAMILTON-MR1 ventilator provides ventilatory support and is designed for providing therapy, not for diagnosing medical conditions. While it includes an integrated gaussmeter for safe positioning within an MRI environment, this feature serves to ensure operational safety and image quality, not to diagnose a patient.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "ventilator" and mentions hardware components like a "gaussmeter" and "battery duration," indicating it is a physical medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, the HAMILTON-MR1 ventilator is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device provides "positive pressure ventilatory support" to patients. This is a direct medical intervention on a living patient, not a test performed on biological samples outside the body.
Device Description: The description focuses on the device's function in providing ventilation and its compatibility with MRI environments. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.

The HAMILTON-MR1 is a life-support medical device used to assist breathing in patients.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

CBK

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
An increase in the battery duration from 5 hours and 20 minutes to 9 hours and 20 minutes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults and pediatrics, and optionally infants and neonates.

Intended User / Care Setting

Qualified, trained personnel under the direction of a physician.
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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122438, K140939

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

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

2

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

3

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

1. SUBMITTER
  Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland

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

4

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-MR1
ventilator is intended to
provide positive pressure
ventilatory support to adults
and pediatrics, and
optionally infants and
neonates.	The HAMILTON-MR1
ventilator is intended to
provide positive pressure
ventilatory support to adults
and pediatrics.	The HAMILTON-C1
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	Intended areas of use:
• In the MRI department
• In the intensive care ward
or in the recovery room
• During transfer of
ventilated patients within
the hospital
The HAMILTON-MR1
ventilator is classified as MR	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-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.	Conditional with the use of
1.5 T and 3.0 Tesla static
magnetic field scanners.
The HAMILTON-MR1
ventilator is a restricted
medical device intended for
use by qualified, trained
personnel under the
direction of a physician and
within the limits of its stated
technical specifications.	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.
Environment
of use	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	Intended areas of use:
• In the MRI department
• In the intensive care ward
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
Product
classification
code	CBK	CBK	CBK
CFR citation	21 CFR 868.5895	21 CFR 868.5895	21 CFR 868.5895
Principal
operator	Qualified, trained personnel
under the direction of a
physician	Qualified, trained personnel
under the direction of a
physician	Qualified, trained personnel
under the direction of a
physician
Intended
patient
population	Patients include adults and
pediatrics, and optionally
infants and neonates.	Patients include adults and
pediatrics.	Patients include adults and
pediatrics, and optionally
infants and neonates.
Operational
environmental
requirements	• 5°C to 40°C (41°F to
104°F)
• 10% to 95%,
noncondensing
• 1100 to 700 hPa (9.842 ft)	• 5°C to 40°C (41°F to
104°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 powered
with two batteries, can be
run while batteries are
charging. With a typical
battery run time of 8 hours	AC and battery powered
with two batteries, can be
run while batteries are
charging. With a typical
battery run time of
5.5 hours	AC and battery powered
with one battery, can be run
while battery is charging
with a maximal run time of
4.30 hours.
Number of
batteries	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.

6

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 gas
Method of
supply gas
pressurization | Oxygen, ambient air
Internal turbine for air,
compressed source for O2 | Oxygen, ambient air
Internal turbine for air,
compressed source for O2 | Oxygen, ambient air
Internal turbine for air,
compressed source for O2 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fresh gas
intake filter | • Monitored HEPA (High
Efficiency Particulate Air
filter):
• Alarm "Replace HEPA
filter" in case of clogging.
• Yearly or every 5.000 h
filter replacement specified. | • Monitored HEPA (High
Efficiency Particulate Air
filter):
• Alarm "Replace HEPA
filter" in case of clogging.
• Yearly or every 5.000 h
filter replacement specified. | • Monitored HEPA (High
Efficiency Particulate Air
filter):
• Alarm "Replace HEPA
filter" in case of clogging.
• Yearly or every 5.000 h filter
replacement specified. |
| Patient
interface | 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) |
| Safety
features | • Apnea backup ventilation
• Automatic self-tests
• Alarms (operator-
adjustable / non-adjustable)
• Alarm backup buzzer
• External flow sensor
failure mode
• Safety mode in case of
technical failures
• Air inlet HEPA filter
monitoring
• Monitored fan
• Event log | • Apnea backup ventilation
• Automatic self-tests
• Alarms (operator-
adjustable / non-adjustable)
• Alarm backup buzzer
• External flow sensor
failure mode
• Safety mode in case of
technical failures
• Air inlet HEPA filter
monitoring
• Monitored fan
• Event log | • Apnea backup ventilation
• Automatic self-tests
• Alarms (operator-
adjustable / non-adjustable)
• Alarm backup buzzer
• External flow sensor
failure mode
• Safety mode in case of
technical failures
• Air inlet HEPA filter
monitoring
• Monitored fan
• Event log |
| Emergency air
intake | In case of a power supply,
technical, or pneumatics
failure the ambient valve
allows spontaneous
breathing. | In case of a power supply,
technical, or pneumatics
failure the ambient valve
allows spontaneous
breathing. | In case of a power supply,
technical, or pneumatics
failure the ambient valve
allows spontaneous
breathing. |
| Operational
modes | • ASV
• (S)CMV+
• SIMV+
• PCV+
• PSIMV+ (incl. the
possibility to set IntelliSync
to "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. the
possibility to set IntelliSync
to "Off")
• SPONT
• DuoPAP
• APRV
• NIV
• NIV-ST
• nCPAP
• nCPAP-PC |
| Electrical
safety | IEC 60601-1: 2005 (3rd
Edition): all applicable
requirements met. | IEC 60601-1:1988 (A1:1991

A2:1995): all applicable
requirements met. | IEC 60601-1: 2005 (3rd
Edition): all applicable
requirements met. |
| exhalation
valve? | | | |
| Volume
setting range | 2-2000 ml | 20-2000 ml | 2-2000 ml |
| Maximum
working
pressure
limitation | 60 cmH2O | 60 cmH2O | 60 cmH2O |
| PEEP setting | 0-35 cmH2O
Neo: 3-25 cmH2O | 0-35 cmH2O | 0-35 cmH2O
Neo: 3-25 cmH2O |
| Alarms and
monitoring | Yes | Yes | Yes |
| Adjustable
inspiration
time total
range | 0.1-40 sec | 0.1-40 sec | 0.1-40 sec |
| MRI
department
compatible? | Yes | Yes | No |
| Differences in
technological
characteristics | - 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 |

7

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.

8

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.