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.

Device Description

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.

The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
The ability to turn off the Apnea alarm in the nCPAP-PS mode.
The HAMILTON-C3 includes a 12.1" wide-screen monitor.

AI/ML Overview

The Hamilton-C3 is a continuous ventilator. The provided text outlines its characteristics, intended use, and a comparison with a predicate device and other FDA-cleared ventilators. However, it does not include detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or F1-score.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance. The "acceptance criteria" discussed are primarily related to safety, effectiveness, and adherence to recognized standards, rather than specific performance metrics for a novel diagnostic function.

Here's a breakdown based on the information provided, and where information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the document, "acceptance criteria" are inferred from the demonstration of substantial equivalence and adherence to recognized standards. The "reported device performance" is largely presented as meeting the same functional capabilities as the predicate device (HAMILTON-C2) and adhering to various medical device standards.

Acceptance Criteria (Inferred from Substantial Equivalence & Standards)	Reported Device Performance (HAMILTON-C3)
Safety and Effectiveness: Demonstrated by adherence to recognized standards for medical devices (e.g., IEC 60601-1, IEC 60601-2-12, ISO 14971, etc.)	Non-clinical test results show the HAMILTON-C3 is safe and effective for its intended use. Software verification and validation testing demonstrate correct and complete implementation of specified requirements. A hazard analysis and traceability analysis were done.
Intended Use Equivalence: Ventilate adult, pediatric, infant, and neonatal patients in critical care.	"The intended use statement for the modified HAMILTON-C3 ventilator is substantially equivalent to that of the predicate device."
Technological Characteristics Equivalence: Similar design, material, energy source as predicate.	"The technological characteristics (i.e., design, material, energy source) and performance specifications of the proposed HAMILTON-C3 ventilator are substantially equivalent to those of the predicate device."
Ventilation Modes: Offer similar conventional and advanced modes as predicate.	Offers all conventional modes, as well as ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync (same as HAMILTON-C2).
Monitoring Parameters: Ability to trend 41 parameters.	All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
Apnea Alarm Control: Ability to turn off apnea alarm in nCPAP-PS mode.	The ability to turn off the Apnea alarm in the nCPAP-PS mode is included.
Display (Screen Size, Waveforms, Alarms, I:E values): Improved display features compared to predicate, but still within acceptable clinical parameters.	12.1" wide-screen monitor (vs. 10.4" on C2). Displays up to 4 waveforms (vs. 2 on C2). Displays all 7 alarm-limitation parameters (vs. divided on C2). I:E values shown on main screen (new feature).
Specific Performance Metrics (e.g., Minimal Tidal Volume, Max Inspiratory Flow, Battery Time): Match or exceed predicate device.	Minimal Tidal Volume: 2mL (matches C2). Maximum Inspiratory Flow: 240 L/min (matches C2). Battery time: 390 min (matches C2).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the traditional sense for this submission type. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data to evaluate a diagnostic algorithm's performance. The "testing" referred to is non-clinical verification and validation of the device's functionality and adherence to standards. There is no mention of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As per point 2, there is no "test set" with ground truth in the context of diagnostic performance presented in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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 document describes a continuous ventilator, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a medical device (ventilator), not a standalone algorithm. While it contains software, the evaluation in this document focuses on the integrated system's safety and effectiveness and its equivalence to a predicate device, not on the performance of a standalone algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. As per point 2, there is no "test set" requiring ground truth for diagnostic performance evaluation. The "ground truth" for the device's functionality is its design specifications and compliance with recognized standards.

8. The sample size for the training set

Not Applicable. This document does not describe the development or evaluation of an AI/ML algorithm that would require a "training set" of data.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is composed of two lines of text, with "HAMILTON" on the top line and "MEDICAL" on the bottom line. To the right of the word "HAMILTON" is a circular logo with a stylized "H" inside. The text is in a bold, sans-serif font.

Image /page/0/Picture/1 description: The image shows the text "HAMILTON-C3" in a bold, sans-serif font. The text is all uppercase, with a hyphen separating "HAMILTON" and "C3". The letters are solid black against a white background, creating a high-contrast image.

510(k) SUMMARY

K123637

SUBMITTER:	HAMILTON MEDICAL AGVia Crusch 8Bonaduz, Grisons 7402SWITZERLAND	DEC 2 1 2012
CONTACT PERSON:	Ralph AguilaRegulatory Affairs / Quality EngineerPhone: +41 81 660 6845Fax: +41 81 660 6020e-mail: raaguila@hamilton-medical.ch
ESTABLISHMENTREGISTRATION #:	3001421318
PREPARATION DATE:	December 19th, 2012
TRADE NAME:	HAMILTON-C3
COMMON NAME:	Continuous Ventilator
CLASSIFICATION NAME:	Class II Ventilator, Continuous
REGULATION NUMBER:	21 CFR 868.5895
PRODUCT CODE:	CBK
PREDICATE DEVICE:	HAMILTON-C2 (K121225)

Image /page/0/Picture/9 description: The image shows the "Swiss Quality" logo. The logo consists of a white cross inside of a black circle on the left. To the right of the symbol, the words "Swiss Quality" are written in black.

Image /page/0/Picture/6 description: The image shows the logo for IntelliSync NEO. The logo consists of a stylized "S" inside a circle, followed by the word "INTELLISYNC" in bold, sans-serif font. To the right of "INTELLISYNC" is the word "NEO", also in bold, sans-serif font.

・

Image /page/0/Picture/7 description: The image shows a recycling symbol with the letters "ASV" in the center. The symbol consists of three arrows forming a triangle, which is a common representation of recycling. The letters "ASV" are placed within the triangle, possibly indicating a specific recycling program or company.

INTELLITRIQ

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DEVICE DESCRIPTION

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.
1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
1. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
1. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
1. The HAMILTON-C3 includes a 12.1" wide-screen monitor.

INTENDED USE

The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, 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.

SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATE DEVICES

The intended use statement for the modified HAMILTON-C3 ventilator is substantially equivalent to that of the predicate device. The technological characteristics (i.e., design, material, energy source) and performance specifications of the proposed HAMILTON-C3 ventilator are substantially equivalent to those of the predicate device. The only difference between the predicate HAMILTON-C2 and the HAMILTON-C3 is the screen size. The HAMILTON-C2 has a 10.4" screen size. Alternatively, the HAMILTON-C3 has a 12.1" screen size. Additionally, because of the extra space from the larger and wider screen, the HAMILTON-C3 displays up to 4 waveforms simultaneously, as well as all the 7 different alarm-limitation parameters, while the HAMILTON-C2 can only display 2 waveforms and the alarm-limitation parameters are divided in two different windows. In addition, the I:E values are now shown on the main screen of the HAMILTON-C3 on the lower left-hand corner.

Image /page/1/Picture/17 description: The image contains a logo with a white cross inside of a black circle. To the right of the logo, the words "Swiss Quality" are written in black font. The text is stacked vertically, with "Swiss" on top of "Quality". The image appears to be a close-up of a product label or advertisement.

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HAMIL

Image /page/2/Figure/2 description: The image shows a screen display from a medical device, likely a ventilator, displaying various parameters and waveforms. Numerical values such as '26', '3.1', '507', '16', and '1:1' are visible on the left side, possibly representing respiratory measurements. The right side of the screen displays 'ASV Adult/Ped', '155% MinVol', '10 cmH2O PEEP/CPAP', and '50% Oxygen', along with buttons labeled 'Controls' and 'Alarms'.

COMPARISON TABLE BETWEEN PROPOSED AND PREDICATE DEVICE

The following table compares the HAMILTON-C3 with its predicate device, the HAMILTON-C2. In addition, a further comparison is made with other FDA-cleared ventilators with similar features.

	Proposeddevice:HAMILTON-C3	Predicatedevice:HAMILTON-C2(K102775)	DraegerEvita XL(K083050)	MaquetServo-i(K073179)	CareFusionAvea(K103211)	GECarestation(K111116)	HAMILTON-G5(K103803)
Screen size	12.1"	10.4"	15"	12"	12"	12"	15"
# of Waveforms	4	2	3	3	3	3	4
Minimal TidalVolume	2 mL	2mL	3 mL	2mL	2 mL	2 mL	2 mL
Maximum In-spiratory Flow	240L/min	240L/min	120L/min	180L/min	150L/min	160L/min	180L/min
Monitoring	Ti, Te, PTP,RCexp	Ti, Te, PTP,RCexp	No Ti / Te	N/A	No Te /PTP	No PTP /RCexp	Ti, Te, PTP,RCexp
Battery time	390 min.	390 min.	120 min.	180 min.	60 min.	120 min.	120 min.
Sidestream CO2	Yes	Yes	No	No	No	Yes	Yes

Image /page/2/Picture/6 description: The image shows a logo with the words "Swiss Quality" next to a white cross inside of a gray circle. The cross is a symbol often associated with Switzerland. The text is in a simple, sans-serif font and is aligned to the right of the cross.

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HAMILTON.C3

DISCUSSION ON THE NON-CLINICAL PERFORMANCE TESTS

The non-clinical test results show that the HAMILTON-C3 is safe and effective for its intended use. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.

Below is a list of standards and guidance documents recognized by FDA to establish the basis of safety and effectiveness for the HAMILTON-C3:

	Draft Reviewer Guidance for Ventilators.1995.
IEC 60601-1	General Requirements for Safety.
IEC 60601-1-2	Electromagnetic Compatibility.
IEC 60601-1-4	Programmable electrical medical systems.
IEC 60601-1-8	Alarm Systems
IEC 60601-2-12	Critical Care Ventilators.
IEC 62304	Software life-cycle processes.
IEC 62366	Application of usability engineering to medical devices.
ISO 5356-1	Conical connectors: Part 1: Cones and sockets.
AAMI/ANSI HE75	Human factors engineering. Design of medical devices.
ISO 14971	Application of risk management to medical devices.

CONCLUSION

A complete revision level history, hazard analysis, and a traceability analysis linking requirements to validation were done. The results of foregoing tests, along with the necessary verification and validation tests, demonstrate that the modified HAMILTON-C3 ventilator is as safe, as effective, and performs just as well as the HAMILTON-C2. HAMILTON MEDICAL has demonstrated the proposed HAMILTON-C3 ventilator to be as safe and effective as the predicate device.

Image /page/3/Picture/8 description: The image contains a logo with a white cross inside a black circle on the left. To the right of the logo, the words "Swiss Quality" are written in a simple, sans-serif font. The text is stacked vertically, with "Swiss" on top of "Quality". The overall design is clean and professional, suggesting a focus on quality and Swiss origin.

Image /page/3/Picture/10 description: The image shows a logo with the letters "ASV" inside a circle. The letters are in bold, and the circle has a thick border. There are some other markings around the logo, but they are not clear enough to identify.

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2012

Mr. Ralph Aguila Regulatory Affairs / Quality Engineer Hamilton Medical AG Via Crusch 8 Bonaduz, Grisons Switzerland 7402

Re: K123637

Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 21, 2012 Received: November 26, 2012

Dear Mr. Aguila:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Aguila

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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INDICATIONS FOR USE STATEMENT

510(k) Number:

K123637

Device Name:

HAMILTON-C3

Indication for Use:

The HAMILTON-C3 ventilator is intended to provide positive pres-I ne NAMETOR Sport to adults, pediatrics, 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.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E. Moyal Albert E. 2012.12.19 Moyal 22:18:25 -05'00' · for LS

(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division of Ancol. Dental Devices

510(k) Number,

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).