(337 days)
HAMILTON-C3 (K123637)
HAMILTON-G5 (K131774)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its new features does not mention any AI/ML capabilities. The "Adaptive Support Ventilation (ASV)" mode is mentioned, but this is a known ventilation strategy that predates widespread AI/ML in medical devices and is typically based on physiological feedback loops and algorithms, not machine learning.
Yes
The device is a ventilator, which provides ventilatory support, a therapeutic intervention for patients requiring assistance with breathing.
No
Explanation: The HAMILTON-C3 ventilator is intended to provide "positive pressure ventilatory support," which is a therapeutic function, not a diagnostic one. While it can monitor SpO2, this is a measurement for managing ventilation rather than diagnosing a condition.
No
The device is described as a ventilator, which is a hardware medical device. The 510(k) submission adds new software features and a hardware option (SpO2 monitoring) to this existing hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HAMILTON-C3 ventilator is for providing "positive pressure ventilatory support". This is a life support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and software aspects of providing ventilation, including different ventilation modes and monitoring options like SpO2. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The document 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 the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The HAMILTON-C3 is a medical device used for treatment and life support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The HAMILTON-C3 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-C3 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
CBK, DQA
Device Description
The HAMILTON-C3 is designed for adult, paediatric, 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 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
- The following two new ventilation modes for adult / pediatric patient group: (S)CMV and SIMV
- SpO2 monitoring option
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
Intended User: qualified, trained personnel under the direction of a physician
Care Setting: 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 Software Design and Validation process, together with the bench testing of the device, demonstrated that the HAMILTON-C3 operates as intended.
In particular, testing demonstrated that the HAMILTON-C3 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
- -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
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Additional software verification and validation testing were 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-C3, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HAMILTON-C3 (K123637)
Reference Device(s)
HAMILTON-G5 (K131774)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Hamilton Medical AG Annemarie Höft Quality Engineer Via Crusch 8 Bonaduz, 7402 SWITZERLAND
Re: K161450
Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: March 20, 2017 Received: March 23, 2017
Dear Ms. Höft:
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.
1
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 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,
Image /page/1/Picture/8 description: The image contains a signature and a name. The signature is a complex series of loops and lines. The name next to the signature reads "Tina Kiang-S".
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
Indications for Use
510(k) Number (if known) K161450
Device Name HAMILTON-C3
Indications for Use (Describe)
The HAMILTON-C3 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-C3 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 blue and consists of the word "HAMILTON" in large, bold letters, with a stylized "H" symbol to the right. Below "HAMILTON" is the word "MEDICAL" in a similar font but slightly smaller. Underneath the two words is the phrase "Intelligent Ventilation since 1983" in a smaller, lighter font.
Image /page/3/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a soft appearance. The word "HAMILTON" is followed by a dot and then "C3".
510(k) SUMMARY
l. SUBMITTER
Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland
Phone: +41 58 610 1225 +41 58 610 0020 Fax:
Contact Person: Annemarie Höft, Quality Engineer Frederike Brühschwein, Senior Manager Regulatory Affairs Date Prepared: 2017-04-24
-
II. DEVICE
Name of Devices: HAMILTON-C3 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 DEVICES HAMILTON-C3 (K123637) HAMILTON-G5 (K131774)
IV. DEVICE DESCRIPTION
The HAMILTON-C3 is designed for adult, paediatric, 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 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
- The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
- SpO2 monitoring option
V. INDICATIONS FOR USE
The HAMILTON-C3 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
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 MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/4/Picture/1 description: The image shows the word "HAMILTON-C3" in a stylized, sans-serif font. The letters are all in blue. The letters are rounded and have a playful appearance.
The HAMILTON-C3 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.
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES VI.
A comparative summary of the technological characteristics of the HAMILTON-C3 with the primary predicate and reference devices is presented below.
| Parameters | Application device:
HAMILTON-C3 | Predicate device:
Currently
marketed
HAMILTON-C3 | Predicate device:
Currently
marketed
HAMILTON-G5 | Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended use | The HAMILTON-C3
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
roomDuring
transfer of
ventilated
patients
within the
hospitalThe HAMILTON-C3
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 | The HAMILTON-C3
ventilator is
intended to
provide positive
pressure
ventilatory support
to adults,
paediatrics,
infants, and
neonates.
Intended areas of
use:
In the
intensive care
ward or in the
recovery
room.During
transfer of
ventilated
patients
within the
hospital.The HAMILTON-C3
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-G5
ventilator is
designed for
intensive care
ventilation of adult
and paediatric
patients, and
optionally infant
and neonatal
patients. The
device is intended
for use in the
hospital and
institutional
environment
where healthcare
professionals
provide patient
care. The
HAMILTON-G5
ventilator is
intended for use by
properly trained
personnel under
the direct
supervision of a
licensed physician.
The HAMILTON-G5
ventilator may be
used for transport
within a hospital or
hospital-type
facility -- provided
compressed gas is
supplied.
The device is not to
be used in the
presence of
flammable
anesthetic agents | Substantially
equivalent |
| | specifications. | | or other ignition
sources. The
ventilator is not to
be used in an
environment with
magnetic
resonance imaging
(MRI) equipment.
The device is not
intended for
transportation
outside the
hospital or for use
in the home
environment. | |
| Product
classification
code | CBK (subsequent:
DQA) | CBK | CBK (subsequent:
DQA) | Substantially
Equivalent |
| CFR citation | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5895 | Substantially
Equivalent |
| 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 | Substantially
Equivalent
Same principal
operator as on
HAMILTON-C3 and
HAMILTON-G5 |
| Environment
of use | 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 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 | Substantially
Equivalent
Same environment
of us as on
HAMILTON-C3 and
HAMILTON-G5 |
| Intended
patient
population | Adults, pediatrics,
infants and
neonates | Adults, pediatrics,
infants and
neonates | Adults, pediatrics,
infants and
neonates | Substantially
Equivalent
Same Intended
patient population
as on HAMILTON-
C3 and HAMILTON-
G5 |
| 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) | Substantially
Equivalent
Same patient
interface as on
HAMILTON-C3 and
HAMILTON-G5 |
| Power source | AC, DC, Battery | AC, DC, Battery | AC, Battery | Substantially
Equivalent
Power source is
unchanged. |
| Operational
modes | PCV+ SPONT APVcmv /
(S)CMV+ APVsimv /
SIMV+ ASV (only for
adult/pediatric patients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS
(only for
neonatal
patients) (S)CMV (only
for
adult/pediatric
patients) SIMV (only
for
adult/pediatric
patients) | PCV+ SPONT (S)CMV+
SIMV+ ASV (only for
adult/pediatric
patients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS
(only for
neonatal
patients) | (S)CMV (only
for adult and
pediatric
patients) P-CMV SIMV (only for
adult and
pediatric
patients) P-SIMV SPONT APVcmv
APVsimv ASV (only for
adult and
pediatric
patients) DuoPAP APRV NIV (only for
adult and
pediatric
patients) NIV-ST (only
for adult and
pediatric
patients) nCPAP-PS
(only for
neonatal
patients) VS | Substantially
Equivalent |
| 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. | Substantially
Equivalent |
| Emergency air
intake | In case of a power
supply, technical,
or pneumatics
failure the ambient
valve allows
spontaneous | In case of a power
supply, technical,
or pneumatics
failure the ambient
valve allows
spontaneous | In case of a power
supply, technical,
or pneumatics
failure the ambient
valve allows
spontaneous | Substantially
Equivalent
Same emergency
air intake as on
HAMILTON-C3 and
HAMILTON-G5 |
| Active
exhalation
valve? | Yes, pneumatic | Yes, pneumatic | Yes, pneumatic | Substantially
Equivalent
Active exhalation is
unchanged. |
| Alarms and
monitoring | Yes | Yes | Yes | Substantially
Equivalent |
| Supply gas | Oxygen, ambient
air | Oxygen, ambient
air | Oxygen, Air, Heliox | Substantially
Equivalent |
| Method of
supply gas
pressurization | Internal turbine for
air, compressed
source for 02 | Internal turbine for
air, compressed
source for 02 | Compressed
source for Air, 02,
Heliox | Substantially
Equivalent |
| CO2
monitoring
option | Yes | Yes | Yes | Substantially
Equivalent
CO2 monitoring is
unchanged. |
| SpO2
monitoring
option | Yes | No | Yes | Substantially
Equivalent |
| Differences in
technological
characteristics | Embedded
system type:
EM10A
Internal flow
sensor with
the ability to
detect reflow
Flashing
alarm lamp | Embedded
system type:
EM10A
Internal flow
sensor
without the
ability to
detect reflow
Alarm lamp
not flashing,
only
illuminated | Embedded
system type:
EM01A
Internal flow
valve without
the ability to
detect reflow
Flashing
alarm lamp | Substantially
Equivalent |
Table 1: Comparison of HAMILTON-C3 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 words "HAMILTON" and "MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/5/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is a bright blue color. The letters are bold and easy to read.
6
Image /page/6/Picture/0 description: The image contains the logo for Hamilton Medical. The logo has the word "HAMILTON" on the top line with a symbol to the right of the word. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line. All of the text and the symbol are in blue.
Image /page/6/Picture/1 description: The image shows the word "HAMILTON.C3" in blue font. The letters are bold and rounded. The word is written in all capital letters.
7
Image /page/7/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 blue circle with a white "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/7/Picture/1 description: The image shows the text "HAMILTON-C3" in a bold, sans-serif font. The text is a solid blue color. The letters are rounded and have a slightly cartoonish appearance. The word "HAMILTON" is followed by a dot and then the letter "C" and the number "3".
As can be seen in the table above, the application device HAMILTON-C3 has the same technological characteristics as the predicate HAMILTON-C3, with the exception of its internal flow sensor. The applicant device HAMILTON-C3 add new (S)CMV and SIMV ventilation mode which have same algorithms for delivering breaths as the predicate device HAMILTON-G5.
Altogether, the technological characteristics of the application device HAMILTON-C3 are substantially equivalent to the predicate devices. Thus, the comparison of the HAMILTON-C3 to its predicate devices does not raise new safety and effectiveness concerns.
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-C3 operates as intended.
In particular, testing demonstrated that the HAMILTON-C3 is compliant with the following guidelines and standards:
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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 words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circular symbol. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/8/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a playful appearance. The word "HAMILTON" is followed by a dot and then the number "C3".
- 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
- -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
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Additional software verification and validation testing were 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-C3, 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 materials already used in earlier 510(k)s are introduced with this 510(k), Hamilton Medical did not conduct any additional biocompatibility testing.
VIII. CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-C3 ventilator is as safe and as effective as the legally marketed devices identified herein.