K Number

Device Name

Hamilton-C6

Manufacturer

Hamilton Medical AG

Date Cleared

2020-12-11

(176 days)

Product Code

CBK

Regulation Number

868.5895

Intended Use

The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates. Intended areas of use: • In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room • During transfer of ventilated patients within the hospital The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Device Description

The HAMILTON-C6 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation. The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

HAMILTON-C3 (K161450)

Reference Devices

HAMILTON-G5 (K193228)

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions "automated ventilation with Adaptive Support Ventilation (ASV)", which is a ventilation mode that adjusts parameters based on patient feedback. While this could be implemented using AI/ML, the document does not explicitly state that AI/ML is used for this function or any other part of the device. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The HAMILTON-C6 ventilator provides positive pressure ventilatory support, which is a form of treatment for patients unable to breathe adequately on their own.

Diagnostic

Explanation: The HAMILTON-C6 ventilator is described as providing positive pressure ventilatory support and covers a range of ventilation requirements. Its intended use is for life support and breathing assistance, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "ventilator," which is a hardware device. The summary also mentions testing against hardware-related standards like IEC 60601-1 and ISO 80601-2-12 (critical care ventilators). While it contains software, it is not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the HAMILTON-C6 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 therapeutic intervention on a living organism.
Device Description: The description focuses on providing ventilation support and controlling related devices like humidifiers and cuff pressure controllers. These are all related to supporting respiratory function in a living patient.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic or other information. The HAMILTON-C6 ventilator operates on the patient to support their breathing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
During transfer of ventilated patients within the hospital
The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

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

CBK, DQA

Device Description

The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.

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
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-C6 operates as intended. In particular, testing demonstrated that the HAMILTON-C6 is compliant with the following guidelines and standards:

ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General । Requirements for Safety
-IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
-IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-IEC 62304 (2015): Medical device software - Software life-cycle processes
IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
-ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
-ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
-ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
-AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
-AAMI / ANSI HE75:2009,Human factors engineering - Design of medical devices

Additional software verification and validation testing was conducted and documentation was provided as recommended by the FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Testing of the HAMILTON-C6 was conducted. The ventilation modes were subjected to waveform performance testing. The data provided from these tests was shown to be substantially equivalent to the legally marketed devices.

No clinical testing was conducted or required in support of this premarket notification.

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.

HAMILTON-C3 (K161450)

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.

HAMILTON-G5 (K193228)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2020

Hamilton Medical AG Annemarie Weideli Team Leader Regulatory Affairs Via Crush 8 Bonaduz, GR 7402 Switzerland

Re: K201658

Trade/Device Name: Hamilton-C6 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: November 10, 2020 Received: November 13, 2020

Dear Annemarie Weideli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee Acting Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K201658

Device Name HAMILTON-C6

Indications for Use (Describe)

The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H". Below the logo is the text "Intelligent Ventilation since 1983".

Image /page/3/Picture/1 description: The image shows the text "HAMILTON-C6" in a sans-serif font. The text is a blue color. The text is horizontally oriented and appears to be a logo or title.

510(k) SUMMARY

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

Phone: +41 58 610 12 25 +41 58 610 00 20 Fax:

Contact Person: Annemarie Weideli, Team Leader Regulatory Affairs

Date Prepared: 2020-11-09

II. DEVICES
Name of Devices: HAMILTON-C6 Common or Usual Name: Continuous ventilator Regulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA)
III. PREDICATE DEVICE HAMILTON-C3 (K161450)
IV. REFERENCE DEVICES HAMILTON-G5 (K193228)

V. DEVICE DESCRIPTION

VI. INDICATIONS FOR USE
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use:
In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
During transfer of ventilated patients within the hospital ●

The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Image /page/4/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" on top of the word "MEDICAL". Below the logo is the text "Intelligent Ventilation since 1983".

HAMILTON-C6

COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES VII.

A comparative summary of the technological characteristics of the HAMILTON-C6 with the predicate and reference devices is presented below.

Parameters	Proposed device:	Predicate device:	Reference device:	Comparison
	HAMILTON-C6	Currently marketed
HAMILTON-C3	Currently marketed
HAMILTON-G5
Intended use	The HAMILTON-C6
ventilator is intended to
provide positive
pressure ventilatory
support to adults and
pediatrics and
optionally infants and
neonates.
Intended areas of use:
• In the intensive
care ward,
intermediate care
ward, emergency
ward, long term
acute care hospital
or in the recovery
room
• During transfer of
ventilated patients
within the hospital
The HAMILTON-C6
ventilator is a medical
device intended for use
by qualified, trained
personnel under the
direction of a physician
and within the limits of
its stated technical
specifications.	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
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 pediatric
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 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.	Substantially
equivalent
Product
classification
code	CBK (subsequent: DQA)	CBK (subsequent: DQA)	CBK (subsequent: DQA)	Equivalent
CFR citation	21 CFR 868.5895	21 CFR 868.5895	21 CFR 868.5895	Equivalent
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	Equivalent
Parameters	Proposed device:
HAMILTON-C6	Predicate device:
Currently marketed
HAMILTON-C3	Reference device:
Currently marketed
HAMILTON-G5	Comparison
Environment
of use	Intended areas of use:
• Health care facilities
• During transfer of ventilated
patients within health care facilities	Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital	Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital	Equivalent
Intended
patient
population	Adults, pediatrics, infants and neonates	Adults, pediatrics, infants and neonates	Adults, pediatrics, infants and neonates	Equivalent
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)	Equivalent
Power source	AC, Battery	AC, DC, Battery	AC, Battery	Substantially Equivalent
Operational
modes	• (S)CMV (only for adult/pediatric patients)
• SIMV (only for adult/pediatric patients)
• APVcmv / (S)CMV+
• APVsimv / SIMV+
• PCV+
• PSIMV+
• DuoPAP
• APRV
• SPONT
• ASV (only for adult/pediatric patients)
• NIV
• NIV-ST
• nCPAP-PS (only for neonatal patients)	• (S)CMV (only for adult/pediatric patients)
• SIMV (only for adult/pediatric patients)
• APVcmv / (S)CMV+
• APVsimv / SIMV+
• PCV+
• PSIMV+
• DuoPAP
• APRV
• SPONT
• ASV (only for adult/pediatric patients)
• NIV
• NIV-ST
• nCPAP-PS (only for neonatal patients)	• (S)CMV (only for adult and pediatric patients)
• SIMV (only for adult and pediatric patients)
• APVcmv
• APVsimv
• P-CMV
• P-SIMV
• DuoPAP
• APRV
• SPONT
• VS
• ASV (only for adult and pediatric patients)
• NIV (only for adult and pediatric patients)
• NIV-ST (only for adult and pediatric patients)
• nCPAP-PS (only for neonatal patients)	Substantially Equivalent
Therapy Types	Invasive, Non-invasive, HiFlowO2	Invasive, Non-invasive	Invasive, Non-invasive, HiFlowO2	Substantially Equivalent
Electrical
safety	IEC 60601-1: 2005 (3rd Edition): all applicable requirements met.	IEC 60601-1: 2005 (3rd Edition): all applicable requirements met.	IEC 60601-1: 2005 (3rd Edition): all applicable requirements met.	Equivalent
Parameters	Proposed device:
HAMILTON-C6	Predicate device:
Currently marketed
HAMILTON-C3	Reference device:
Currently marketed
HAMILTON-G5	Comparison
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.	Equivalent
Active
exhalation
valve?	Yes, pneumatic	Yes, pneumatic	Yes, pneumatic	Equivalent
Alarms and
monitoring	Yes	Yes	Yes	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
O2	Internal turbine for air,
compressed source for
O2	Compressed source for
Air, O2, Heliox	Substantially
Equivalent
CO2
monitoring
option	Yes	Yes	Yes	Equivalent
SpO2
monitoring
option	Yes	Yes	Yes	Equivalent

Table 1: Comparison of HAMILTON-C6 with predicate and reference device

Image /page/5/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line, with a stylized "H" symbol to the right. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line.

HAMILTON-C6

Image /page/6/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and features the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a small icon. Below the logo is the text "Intelligent Ventilation since 1983".

HAMIL

As can be seen in Table 1 above, the proposed device HAMILTON-C6 has the same technological characteristics as the predicate HAMILTON-C3.

Altogether, the technological characteristics of the proposed device HAMILTON-C6 are substantially equivalent to the predicate devices. Thus, the comparison of the HAMILTON-C6 to its predicate device does not raise new safety and effectiveness concerns.

VIII. PERFORMANCE DATA

The following performance and nonclinical data are provided in support of the substantial equivalence determination.

The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-C6 operates as intended.

In particular, testing demonstrated that the HAMILTON-C6 is compliant with the following guidelines and standards:

ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General । Requirements for Safety
-IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
-IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-IEC 62304 (2015): Medical device software - Software life-cycle processes

Image /page/7/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H". Below the logo is the text "Intelligent Ventilation since 1983" in a smaller font.

Image /page/7/Picture/1 description: The image shows the text "HAMILTON-C6" in a sans-serif font. The text is a vibrant blue color. The text appears to be a logo or brand name.

IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
-ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
-ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
-ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
-AIM Standard 7351731 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
-AAMI / ANSI HE75:2009,Human factors engineering - Design of medical devices

IX. BIOCOMPATIBILITY

The gas pathway of the HAMILTON-C6 was evaluated according to ISO 18562 series. The materials have been evaluated and found to be acceptable for the intended patient population, and type of patient contact.

X. SUMMARY OF CLINICAL TESTING No clinical testing was conducted or required in support of this premarket notification.

XI. CONCLUSION

Substantial equivalence has shown similar technological characteristics, intended use, principles of operation and verification and validation. The proposed device HAMILTON-C6 has software and hardware enhancements to maintain the intended performance of the device.

No new questions of safety and effectiveness have been raised. The HAMILTON-C6 ventilator is as safe and as effective as the legally marketed devices identified herein. From the evidence presented in the premarket notification, the proposed device can be considered substantially equivalent to the predicate devices.