The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.
The HAMILTON-H900 humidifier 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 for patients > 10 kg.
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

Device Description

The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.
The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

-A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
-The controlled heating within the breathing circuits.
The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.
The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.
The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

AI/ML Overview

This document is a 510(k) Summary for medical device clearance, specifically for the Hamilton-H900 respiratory gas humidifier and associated breathing circuits. It details the device's characteristics and compares them to predicate devices to establish substantial equivalence.

Based on the provided text, the document describes performance data regarding electrical safety, electromagnetic compatibility, mechanical testing, software verification and validation, biocompatibility, and a human factors/usability study. However, it does not contain information about studies involving human readers, ground truth established by experts, or specific acceptance criteria and performance data in a comparative table for an AI/human-in-the-loop system.

The document states:

"Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits to have adequate performance."
"The following performance and nonclinical data were provided in support of the substantial equivalence determination."
It then lists various technical tests meeting industry standards (IEC, ISO).

Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance (in the context of an AI/human-in-the-loop system as implied by the prompt's follow-up questions) or any details related to expert ground truth, adjudication, MRMC studies, or multi-reader studies, as these concepts are not mentioned in this regulatory submission for a respiratory humidifier and its circuits. This document focuses on the technical performance and safety of hardware and software components against established engineering standards and predicate devices.

To answer your specific questions based only on the provided text:

A table of acceptance criteria and the reported device performance:

The document provides several comparison tables for "Characteristic used for comparison" (e.g., flow range, accuracy displayed temperature, humidity performance, etc.) against predicate devices (Tables 1, 2, and 3). These characteristics can be interpreted as performance metrics, and the device's reported values are listed. However, explicit "acceptance criteria" for these values are not stated as pass/fail thresholds within these tables, but rather as performance characteristics matched or compared to predicates.
For the non-clinical tests (e.g., Electrical Safety, EMC, Mechanical Testing, Software V&V, Biocompatibility, Human Factors), the acceptance criterion is implicitly compliance with the stated industry standards (e.g., IEC 60601-1, ISO 8185, ISO 5367, ISO 5356-1, ISO 10993-1). The reported device performance is that it "complies with" these standards.

Example (from various sections, not a single explicit table):

Acceptance Criterion (Implied)	Reported Device Performance	Source Section
Compliance with IEC 60601-1 (Electrical Safety)	The devices comply with the IEC 60601-1 standard for safety.	Electrical Safety and Electromagnetic Compatibility
Compliance with ISO 8185 (Respiratory Gas Humidifiers)	The devices comply with the ISO 8185 standard for respiratory gas humidifiers.	Electrical Safety and Electromagnetic Compatibility
Airway temperature control (Invasive mode)	33°C - 43°C	Table 1
Humidity performance (Invasive mode)	>33 mg H2O/L at up to 60 L/min flow and 26°C ambient temp.	Table 1
Software Validation (Level of Concern: Major)	All specified requirements have been implemented correctly and completely.	Software Verification and Validation Testing
Biocompatibility (following ISO 10993-1)	Testing in accordance with ISO 10993-1 performed, including Cytotoxicity, Sensitization & Irritation, Systemic Toxicity, Genotoxicity, Implantation Testing, Extractables and Leachables.	Biocompatibility
Compliance with ISO 5367 (Breathing Tubes)	The breathing circuits comply with the ISO 5367 standard for breathing tubes.	Mechanical Testing
Human Factors / Usability	Conformance with "Applying Human Factors and Usability Engineering to Medical Devices, 2016" guidance.	Human Factors / Usability Study

Sample sizes used for the test set and the data provenance: Not specified in the document for the performance studies. The testing appears to be primarily lab-based performance and safety verification of the device hardware and software. It does not mention clinical trial data or patient data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not evaluating an AI system against expert consensus or ground truth derived from expert review. It's about a hardware medical device (humidifier) and its compliance with engineering standards.
Adjudication method: Not applicable (no expert review process described).
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware and embedded software. The software V&V was done, but it's not a standalone AI algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the functional performance (e.g., temperature, humidity), the "ground truth" would be measurements from calibrated instruments and adherence to the specifications derived from the predicate devices and applicable standards. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is compliance with the specified international standards. No expert consensus, pathology, or outcomes data is mentioned as ground truth.
The sample size for the training set: Not applicable. This document is about a finished medical device (hardware and embedded software), not a machine learning model that undergoes a separate training phase.
How the ground truth for the training set was established: Not applicable. (See #8).

Summary

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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 with three heads facing right, representing health, human services, and the USA. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

May 3, 2016

Hamilton Medical AG Steffen Boden Quality Engineer/ Regulatory Affairs Via Crusch 8, Bonaduz, CH 7402, Grisons Switzerland

Re: K152029

Trade/Device Name: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010. Hamilton-BC4010 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: March 21, 2016 Received: March 24, 2016

Dear Mr. Boden:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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: K152029

HAMILTON-H900 Device Name: HAMILTON-BC8022, HAMILTON-BC8010 HAMILTON-BC4022, HAMILTON-BC4010

Intended Use HAMILTON-H900

The HAMILTON-H900 humidifier 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 for patients > 10 kq.

Intended Use HAMILTON-BC8022

The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.

Intended Use HAMILTON-BC4022

The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of adult and pediatric patients > 10 kg.

Intended Use HAMILTON-BC8010

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

Intended Use HAMILTON-BC4010

The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.

Prescription(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter(21 CFR 801 Subpart C)	Use

Use

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Image /page/3/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".

510(k) Summary - K152029

l. Submitter

Hamilton Medical AG Via Crusch 8 7402 Bonaduz Switzerland

Establishment registrationnumber:	3001421318
Phone:Fax:	+41 58 610 10 20+41 58 610 00 20
Contact person:	Mr. Steffen Boden,Quality Engineer / Regulatory Affairs
Preparation date:	May 03, 2016

II. Device(s)

(Trade) Name of Device(s):	HAMILTON-H900
Common or Usual Name:	Humidifier for Respiratory Gas
Classification Name:	Respiratory gas humidifier (21 CFR § 868.5450)
Regulatory Class:	II
Product Code:	BTT

(Trade) Name of Device(s):	HAMILTON-BC8022, HAMILTON-BC8010HAMILTON-BC4022, HAMILTON-BC4010
Common or Usual Name:	Heated Breathing Circuit Set, with water chamber
Classification Name:	Breathing system heater (21 CFR § 868.5270)
Regulatory Class:	II
Product Code:	BZE

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Image /page/4/Picture/1 description: The image shows 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" in a circle. Below the logo is the tagline "Intelligent Ventilation since 1983".

.............................................................................................................................................................................. Predicate Device(s)

Predicate Device - for Humidifier

Fisher & Paykel MR700 / MR720 / MR730 Respiratory Humidifier, K913368

Fisher & Paykel MR850 Respiratory Humidifier, K983112

Predicate Devices - for Heated Breathing Circuits

Fisher & Paykel RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits, K122432 RT265 and RT266 Dual Heated Infant Breathing Circuits, K103767

References Devices - for Heated Breathing Circuits

Plastiflex Healthcare Hybernite Rainout Control System, K100104

IV. Device Description

HAMILTON-H900

The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

-A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
-The controlled heating within the breathing circuits.

The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.

The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.

HAMILTON-BC8022 / HAMILTON-BC8010

The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

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Image /page/5/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. 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".

HAMILTON-BC4022 / HAMILTON-BC4010

The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

V. Indications for Use / Intended Use

Intended Use HAMILTON-H900

Intended Use HAMILTON-BC8022

Intended Use HAMILTON-BC4022

The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.

Intended Use HAMILTON-BC8010

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.

Intended Use HAMILTON-BC4010

VI. Comparison of Technological Characteristics with the Predicate Device(s)

The Intended Use statements for the HAMILTON-H900 and HAMILTON-BC-series breathing circuits are substantially equivalent to the predicate devices; the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both the subject and predicate devices have the same Indications for use for respiratory gas conditioning.

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Image /page/6/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. There is a stylized "H" in a circle to the right of the word "HAMILTON". Below the logo is the tagline "Intelligent Ventilation since 1983".

The proposed devices and the predicates were evaluated against selected applicable standards, and the technological characteristics and performance specifications of the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits are substantially equivalent to those of the predicate devices. The differences do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the devices relative to the predicates.

Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BCseries breathing circuits to have adequate performance. The HAMILTON-H900 humidifier and HAMILTON-BC-series breathing circuits are considered to be substantially equivalent to currently marketed predicate devices that have been previously cleared by the FDA.

Characteristic usedfor comparison	HAMILTON-H900	F&P MR730(Primary predicate device)	F&P MR850(Secondary predicate device)
510(k) No.	K152029	K913368	K983112
Device Name	HAMILTON-H900Respiratory Gas Humidifier	MR700 / MR720 / MR730Respiratory Humidifier	MR850 Respiratory Humidifier
Classification No. &Product code	868.5450BTT	868.5450BTT	868.5450BTT
Indication for Use	The HAMILTON- H900humidifier is intended to addmoisture and to warm breathinggases during invasive and non-invasive mechanical ventilation.The intended area of use is theintensive care ward or therecovery room.The HAMILTON- H900humidifier is a medical deviceintended for use by qualified,trained personnel under thedirection of a physician andwithin the limits of its statedtechnical specifications forpatients > 10 kg.	To warm and add moisture togases delivered to patientsrequiring mechanical ventilationor positive pressure breathingassistance via an endotrachealtube or face mask.	The MR850 humidifier isintended to add moisture to, andto warm, the breathing gases foradministration to a patient.Gases available for medical usedo not contain sufficientmoisture and may damage orirritate the respiratory tract, ordesiccate secretions of patientswhose supraglottic airwayshave been bypassed.This may be indicated forpatients requiring mechanicalventilation, positive pressurebreathing assistance, or generalmedical gases. These gasesmay be delivered by face maskor through bypassing the upperairways, for example use of anendotracheal tube.
Environment	Hospital use by trainedpersonnel	Hospital use by trainedpersonnel	Hospital use by trainedpersonnel
Type of ventilation	invasive and noninvasive	invasive and noninvasive	invasive and noninvasive
Modes Of operation	Automatic Mode:- Invasive & NoninvasiveManual Mode:- Invasive & NoninvasiveStandby ModeDefault mode:- Invasive mode after power on	Manual ModeStandby Mode	Automatic Mode:- Invasive & NoninvasiveManual Mode:- Invasive & NoninvasiveStandby ModeDefault mode:- Invasive mode after power on
Flow range	Non-invasive - up to 120 L/minInvasive - up to 60 L/min	Up to 80 L/min	Non-invasive - up to 120 L/minInvasive - up to 60 L/min
Maximum operatingduration	Continuously	Continuously	Continuously
Accuracy displayedtemperature	Displayed Range: 10°C to 60°C- Accuracy Range: 10°C to 60°C(±1°C)- Accuracy Range: 30°C to 41°C(±0.5°C)	Displayed Range: 5.0°C to 80.0 °CAccuracy Range: 25°C to 45°C(±0.3°C)	Displayed Range: 10°C to 70 °CAccuracy Range: 25°C to 45°C(±0.3°C)
Resolution ofdisplayedtemperature	0.1 °C	0.1 °C	0.1 °C
Airway temperature	Invasive mode: 33°C - 43°C	29.5 °C to max 41 °C	Invasive mode: 33°C - 43°C
Characteristic usedfor comparison	HAMILTON-H900	F&P MR730(Primary predicate device)	F&P MR850(Secondary predicate device)

Disabling heaterwires	Yes;- expiratory tube is disabledwhen using Single Limb Circuits- temperature alarm can disableall heating wires	Yes:can be disabled manually- temperature alarm can disableall heating wires	Yes:can be disabled manually- temperature alarm can disableall heating wires
Humidityperformance	invasive mode:- humidity of >33 mg H2O/L isreached with a gas flow of up to60 L/min and an ambienttemperature of 26°Cnoninvasive mode:- humidity of > 10 mg H2O/Lwith a gas flow of up to 120L/min and an ambienttemperature of 26°C	- humidity of > 33 mg/L with agas flow of up to 60 L/min	invasive mode:- humidity of > 33 mg/L with agas flow of up to 60 L/minNoninvasive mode:- humidity of > 10 mg/L with agas flow of up to 120 L/min
Invasive /noninvasive mode	Invasive / Noninvasive mode- auto mode and- manual mode available	Mode cannot be selected- only manual modeavailable	Invasive / Noninvasive modeonly auto mode available
Alarm display	Indicators for:- Chamber Temperature- Heater Wire- Humidity Alarm- Patient-end Probe (Y-Piece)- water level (Low / High)- device inclination- tube detection / recognition /connection,- chamber insertion	Amber LED indicators for:- Temperature Probe- Heater Wire- Humidity Alarm- Chamber Probe- Patient-end ProbeRed LED indicator for:- See Manual (red LED).	Amber LED indicators for:- Temperature Probe,- Heater Wire- Humidity Alarm- Chamber Probe- Patient-end Probe- Water Out
Maximum power	283 VA (230 V version) /293 VA (115 V version) /268 VA (100 V version)	230 V / 1.0 A max127 V / 1.9 A max115 V / 2.0 A max100 V / 2.4 A max	230 V / 1.0 A max127 V / 1.8 A max115 V / 2.0 A max100 V / 2.4 A max
Power heated tube	at 22V60 W (dual limb)30 W (single limb)	Internal voltage not specified60 W	at 22 V60 W
Power heating plate	150 W ± 5 %	150 W	150 W
Heating plateoverheat protector	$130°C ± 4°C$	$118 ± 6 °C$	$118 ± 6 °C$
Max gas inputtemperature	$31°C$	$29.5°C$	$31°C$
Max water inputtemperature	$37°C$	$37°C$	$37°C$
Chamber insertiondetection	HAMILTON-H900 is able todetect if a chamber is inserted	No chamber detection available	No chamber detection available
Water level detection	High and Low water level canbe detected via optical sensorsreaching into the water.- Low water level: 5 minutesalarm delay- high water level: immediatealarm	No water level detectionavailable	Only insufficient water in thechamber is detected bymeasuring the amount of powerused to obtain the chambertemperature- Up to 15 minutes to generatean alarm
Breathing circuitrecognition	Via electrical connectors insidethe breathing tubes	No breathing circuit recognition	Via electrical connectors insidethe breathing tubes
Single use / Reuse	Compatible with single use andreusable breathing circuits	Compatible with single use andreusable breathing circuits	Compatible with single use andreusable breathing circuits
Classification	Class I (in accordance with IEC60601-1)	Class I (in accordance with IEC60601-1)	Class I (in accordance with IEC60601-1)
Applied part	Type BF	Type B	Type BF
Characteristic used	HAMILTON-H900	F&P MR730	F&P MR850
for comparison		(Primary predicate device)	(Secondary predicate device)
Standards /Performance	- IEC 60601-1- IEC 60601-1-2- IEC 60601-1-4- IEC 60601-1-8- ISO 8185:2007- ISO 10993- MILSTD 461F- ISO 14971- IEC 62304- IEC 62366- ISO 5356-1- ISO 5367	- CSA-C22.2 No.125- UL2601- IEC60601-1, AS3200.1- EN 60601-1	- AS/NZS 3200.1.0- CAN/CSA-22.2 No.601.1- UL60601-1- IEC 60601-1- EN 60601-1

Table 1: Comparison table of humidifier characteristics and specifications

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Image /page/7/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is 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 text "Intelligent Ventilation since 1983".

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Image /page/8/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. Below the logo is the text "Intelligent Ventilation since 1983".

Table 2: HAMILTON-BC8022 and HAMILTON-BC4022 Comparison table of humidifier breathing circuits characteristics and specifications

Characteristic usedfor comparison	HAMILTON-BC8022 /HAMILTON-BC4022	Predicate Device:F&P RT380
510(k) No.	K152029	K122432
Device name	HAMILTON-BC8022HAMILTON-BC4022	RT380
Description	HAMILTON-BC8022, breathing circuit set, duallimb, heated with water chamberHAMILTON-BC4022, breathing circuit set, singlelimb, heated with water chamber	Dual Limb Adult Breathing Circuit Kit withEvaqua 2 Technology
Classification No. &Product code	868.5270,BZE	868.5270,BZE
Intended use	The HAMILTON-BC8022 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of adult and pediatric patients > 10kg.The HAMILTON-BC4022 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of adult and pediatric patients > 10 kg	The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended asconduits of breathing gas for ventilation of adultpatients, and to maintain the temperature ofhumidified inspired gas.
Indications for use	invasive and noninvasive ventilation	Patients requiring respiratory support
Compatibility withother devices	Hamilton Medical compatible humidifier such asHAMILTON-H900	Compatible with 700 series and MR 850humidifiers (specification sheet)
Environment	during invasive and noninvasive mechanicalventilation, hospital use by trained personnel	Intensive Care environment in conjunction withlife support equipment
Target / Patientpopulation	Adult and pediatric patients requiring mechanicalventilation or positive pressure breathingassistance	Adult patients requiring respiratory support.
Compressible volume	1600 ml (BC8022)1000 ml (BC4022)	1600 ml
maximum chamberoperating pressure	20 kPa	8 kPa (specification sheet)
Length	- inspiration 1.95m- expiration 1.95m	- inspiration 1.5m- expiration 1.5m
Inner diameter	19 mm	22 mm
Flow range	4 to 120 L/min- invasive max. 60 L/min- noninvasive max. 120 L/min	- invasive 60 L/min- noninvasive 120 L/min (MR850)
Rated flow	2 cmH2O @ 85 L/min (BC8022)2 cmH2O @ 125 L/min (BC4022)	40 l/ min, ≤ 0.2 kPa
Flow resistance	BC8022 (@ 30L/min)Inspiration: 0.3 cmH2OExpiration: 0.15 cmH20BC4022 (@ 30L/min)Inspiration: 0.2 cmH2O (inkl. chamber)	RT380 @ 30 L/minInspiration: 0.91 cmH20Expiration: 0.23 cmH20

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Image /page/9/Picture/1 description: The image shows the logo for Hamilton Medical. The words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, blue font. Below the logo, the words "Intelligent Ventilation since 1983" are written in a smaller, lighter blue font.

Characteristic usedfor comparison	HAMILTON-BC8022 /HAMILTON-BC4022	Predicate Device:F&P RT380
Gas leakage	< 50 mL/min @ 60 cmH20 (BC8022)< 25 mL/min @ 60 cmH20 (BC4022)	< 11 mL/min
Compliance	<1 ml/cmH2O/m	2.10 ml/cmH20
Wire resistance	- Inspiration: 15.35 ±1.23 Ω- expiration: 16.45 ±1.23 Ω	- Inspiratory 17.5 Ω- Expiratory 22.6 Ω
Connector	- Interface connections conical according to ISO5356-1- Electrical connector part of breathing tube	Interface connections conical according to ISO-5356-1- Electrical connector part of breathing tube
Breathing circuitrecognition	Tubes can be recognized with a HamiltonMedical Humidifier	No tube recognition
Sterility	Non Sterile, Ready for use	Non Sterile, Ready for use
Single use / Reuse	Single Use	Single Use
Power heated tube	31.53W inspiratory tube @100% power(BC8022/BC4022)29.39W expiratory tube @100% power(BC8022)	27.66W inspiratory tube @100% power21.42W expiratory tube @100% power
Standards /Performance	- IEC 60601-1- IEC 60601-1-2- IEC 60601-1-8- ISO 8185- ISO 10993- IEC 62304- IEC 62366- ISO 5356-1- ISO 5367	- ISO 5367- ISO 5356- ISO 8185- IEC 60601-1- ISO 10993

Table 3: HAMILTON-BC8010 and HAMILTON-BC4010 comparison table of humidifier breathing circuits characteristics and specifications

Characteristic usedfor comparison	HAMILTON-BC8010 /HAMILTON-BC4010	Predicate Device:F&P RT265
510(k) No.	K152029	K103767
Device name	HAMILTON-BC8010HAMILTON-BC4010	RT265
Description	HAMILTON-BC8010, breathing circuit set, duallimb, heated with water chamberHAMILTON-BC4010, breathing circuit set, singlelimb, heated, with water chamber	Dual Limb Infant Breathing Circuit Kit withEvaqua 2 Technology and Pressure Line (/Flow> 4L/min)
Classification No. &Product code	868.5270,BZE	868.5270,BZE
Intended use	The HAMILTON-BC8010 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of infants > 10 kg.The HAMILTON-BC4010 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of infants > 10 kg.	The dual-heated breathing circuits are intendedas conduits of breathing gas for ventilation ofinfant patients, and to maintain the temperatureof humidified inspired gas. The RT265 is usedfor flow rates greater than 4 L/min, and theRT266 is for flow rates between 0.3 and 4 L/min.
Indications for use	invasive and noninvasive ventilation	facemask or through bypassing the upperairways
Compatibility withother devices	Hamilton Medical compatible humidifier such asHAMILTON-H900	Compatible with MR 850 humidifiers, notcompatible with MR810 humidifiers
Where used	during invasive and noninvasive mechanicalventilation, hospital use by trained personnel	Intensive Care environment in conjunction withlife support equipment
Target / Patientpopulation	Infants > 10 kg requiring mechanical ventilationor positive pressure breathing assistance	Infant
Compressible volume	800 ml (BC8010)600 ml (BC4010)	760 ml
Maximum chamberoperating pressure	20 kPa	8 kPa

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Image /page/10/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on top of the word "MEDICAL". Below the logo is the text "Intelligent Ventilation since 1983".

Characteristic usedfor comparison	HAMILTON-BC8010 /HAMILTON-BC4010	Predicate Device:F&P RT265
Length	- Inspiration total length: 1.65 m(heated section 1.3m, unheated section 0.35m)- Expiration: 1.65m	- Inspiration total length: 1.5 m(heated section 1.1m , unheated section 0.4m)- Expiration: 1.5m (IFU)
Inner diameter	12 mm	11.0mm
Flow Range	1 to 30 L/min	For flow rates > 4 L/min
Rated flow	2 cmH2O @ 16 L/min (BC8010)2 cmH2O @ 29 L/min (BC4010)	2 cmH2O @ 13 L/min
Flow resistance	BC8010 (@ 15 L/min)Inspiration: 1.0 cmH2OExpiration: 0.8 cmH2O	RT265 @ 15 L/minInspiration 2.42 cmH2OExpiration 1.32 cmH2O
	BC8010 (@ 2.5 L/min)Inspiration 0.05 cmH20Expiration 0.04 cmH2O	RT265 @ 2.5 L/minInspiration 0.11 cmH2OExpiration 0.08 cmH2O
	BC4010 (@ 15 L/min)Inspiration 0.75 cmH20
	BC4010 (@ 2.5 L/min)Inspiration 0.05 cmH2O
Gas leakage	- 15 mL/min (BC8010)- 4.0 mL/min (BC4010)	< 75 mL/min @ 60 cmH2O
Compliance	< 1 ml/cmH2O/m	0.81 mL/cmH2O
Wire resistance	- inspiration 14.6±0.9Ω- expiration: 18.2±1.2Ω	- inspiration 21.3±0.3Ω- expiration: 21.9±0.3Ω
Connector	- Interface connections conical according to ISO5356-1- electrical connector part of breathing tube	- Interface connections conical according to ISO5356-1- electrical connector part of breathing tube
Breathing circuitrecognition	Tubes can be recognized with a HamiltonMedical Humidifier	No tube recognition
Sterility	Non Sterile, Ready for use	Non Sterile, Ready for use
Single Use / Reuse	Single Use	Single Use
Power heated tube	- 33.15W inspiratory tube @100% power(BC8010/BC4010)- 26.59W expiratory tube @100% power(BC8010)	- 22.72W inspiratory tube @100% power- 22.10W expiratory tube @100% power
Standards /Performance	- IEC 60601-1- IEC 60601-1-2- IEC 60601-1-8- ISO 8185- ISO 10993- IEC 62304- IEC 62366- ISO 5356-1- ISO 5367	- ISO 5367- ISO 5356- ISO 8185- IEC 60601-1- ISO 10993

VII. Performance data

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

Electrical Safety and Electromagnetic Compatibility

Electrical safety and EMC testing were conducted on the HAMILTON-H900 and HAMILTON-BCseries breathing circuits. The devices comply with the IEC 60601-1 standard for safety, the IEC 60601-1-2 standard for EMC, and the ISO 8185 standard for respiratory gas humidifiers.

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Image /page/11/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circle with the letter "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".

Mechanical Testing

Mechanical safety testing was conducted on the HAMILTON-H900. The system complies with the IEC 60601-1 standard for safety. Additional mechanical tests were conducted on the HAMILTON-BC-series breathing circuits. The breathing circuits comply with the ISO 5367 standard for breathing tubes intended for use with anaesthetic apparatus and ventilators, and the ISO 5356-1 standard for conical connectors.

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by 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.

The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.

Biocompatibility

Biocompatibility testing and evaluation was performed on relevant parts of the breathing circuit. The evaluation was performed in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", and the FDA quidance document "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2013." The battery of tests included the following tests:

Cytotoxicity ●
Sensitization & Irritation
Systemic Toxicity ●
Genotoxicity Testing ●
Implantation Testing
Extractables and Leachables

Additional Testing

A Human Factors / Usability Study was conducted and the HAMILTON-H900 humidifier was found to be in conformance with the Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices, 2016". Additional testing on the HAMILTON-H900 device was conducted according to IEC 60601-1-8, IEC 60601-1-6, and IEC 62304 standards. The test results show that the device performs adequately for its intended use.

Summary

Based on the nonclinical performance as documented, the HAMILTON-H900 and the HAMILTON-BC breathing circuits were found to have an adequate performance profile that is similar to the predicate devices.

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Image /page/12/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 circle with a stylized "H" inside of it to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".

Conclusion VIII.

In comparison to the predicates, the HAMILTON-H900 and the HAMILTON-BC breathing circuits are substantially equivalent to the predicates based on patient population, intended uses, comparison of the technological characteristics and performance. The hardware and software verification and validation support a determination of substantial equivalence. In addition, the conclusions drawn from the nonclinical tests demonstrate that the devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).