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.

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 pediatric and neonatal patients.

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 pediatric and neonatal patients.

Device Description

HAMILTON-H900

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.

HAMILTON-BC8010

The HAMILTON-BC8010 is a single-use, dual-limb breathing circuit 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.

HAMILTON-BC4010

The HAMILTON-BC4010 is a single-imb breathing circuit comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-HC322/HC310

The HAMILTON-HC322/HC310 are single-use humidifier chambers with a float mechanism to keep a constant water level inside the auto-feed chamber. The HAMILTON-HC322 humidifier chamber is part of the HAMILTON-BC8022/BC4022 breathing sets and the HAMILTON-HC310 humidifier chamber is part of the HAMILTON-BC8010/BC4010 breathing sets, as cleared in K152029.

AI/ML Overview

This is a 510(k) summary for a medical device (respiratory gas humidifier and breathing circuits), not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device submissions, are not primarily available or applicable in the provided text.

The document discusses substantial equivalence to predicate devices based on technological characteristics and performance, focusing on non-clinical data. It does not describe an AI/ML algorithm that predicts or diagnoses based on medical images or other data, nor does it detail a study that evaluates the performance of such an algorithm against a ground truth established by experts.

However, I can provide the acceptance criteria and performance as described for this specific device, based on the provided text, recognizing that it's not in the context of an AI/ML model.

Here's an analysis of the provided text, focusing on the closest equivalents to your requested information, understanding the context is a medical device, not an AI/ML diagnostic:

The provided text is a 510(k) summary for the Hamilton-H900 Humidifier and Hamilton-BC series breathing circuits. This document outlines the rationale for the device's substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications and non-clinical testing, rather than the type of clinical performance study typically conducted for AI/ML diagnostic or predictive devices.

Therefore, many of the requested points (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone performance for an algorithm) are not applicable to this type of device submission.

Here is the information extractable from the document, focusing on performance characteristics and non-clinical testing rather than AI/ML specific criteria:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

The acceptance criteria are implied by the "Characteristic used for comparison" and the "HAMILTON-H900 (Subject device)" column in Table 1 for the humidifier and Table 2 for the breathing circuits. The "reported device performance" is the statement that the subject device meets these established characteristics, which are largely identical to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

For HAMILTON-H900 (Humidifier):

Characteristic Used for Comparison	Acceptance Criteria (Implied by Subject Device Spec)	Reported Device Performance
Indication for Use	Add moisture and warm breathing gases during invasive/non-invasive mechanical ventilation for adult, pediatric, and neonatal patients in ICU/recovery room.	Device intended for this use, within limits of stated technical specifications. Patient population expanded from predicate to include pediatric and neonatal.
Environment	Hospital use by trained personnel.	Confirmed.
Type of Ventilation	Invasive and non-invasive.	Confirmed.
Modes of Operation	Automatic Mode (Invasive & Noninvasive), Manual Mode (Invasive & Noninvasive), Standby Mode, Default Mode (Invasive after power on).	Confirmed.
Flow Range	Non-invasive: up to 120 L/min; Invasive: up to 60 L/min.	Confirmed.
Maximum Operating Duration	Continuously.	Confirmed.
Accuracy Displayed Temperature	Displayed Range: 10°C to 60°C; Chamber exit: 10°C to 60°C ± 1°C, 30°C to 41°C ± 0.5°C; Y-piece: 28°C to 43°C ± 0.5°C.	Confirmed.
Resolution of Displayed Temp.	0.1 °C.	Confirmed.
Temp Control Setting: Airway	Invasive: 33°C to 42°C; Noninvasive: 28°C to 38°C; in steps of 0.5°C (manually).	Confirmed.
Temp Control Setting: Chamber	Invasive: 35°C to 41°C; Noninvasive: 30°C to 35°C; in steps of 0.5°C (manually).	Confirmed.
Disabling Heater Wires	Yes; expiratory tube disabled with Single Limb Circuits; temp alarm can disable all heating wires.	Confirmed.
Humidity Performance	Invasive mode: >33 mg H2O/L @ 60 L/min and 26°C ambient; Noninvasive mode: >10 mg H2O/L @ 120 L/min and 26°C ambient.	Confirmed.
Alarm Display	Indicators for Chamber Temp, Heater Wire, Humidity Alarm, Patient-end Probe (Y-Piece), water level (Low/High), device inclination, tube detection/recognition/connection, chamber insertion.	Confirmed.
Maximum Power	283 VA (230V), 293 VA (115V), 268 VA (100V).	Confirmed.
Power Heated Tube	22V; 60 W (dual limb), 30 W (single limb).	Confirmed.
Power Heating Plate	150 W ± 5 %.	Confirmed.
Heating Plate Overheat Prot.	130°C ± 4°C.	Confirmed.
Chamber Insertion Detection	Able to detect if a chamber is inserted.	Confirmed.
Water Level Detection	High and Low water level detected via optical sensors.	Confirmed.
Breathing Circuit Recognition	Via electrical connectors inside the breathing tubes.	Confirmed.
Single Use / Reuse	Compatible with single use and reusable breathing circuits.	Confirmed.
Classification	Class I (IEC 60601-1).	Confirmed.
Applied Part	Type BF.	Confirmed.
Standards / Performance	Compliance with IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-8:2005+Amd1:2012, ISO 8185:2007, MIL-STD-461F:2007, IEC 62304:2006, IEC 62366:2007+Amd1:2014.	Confirmed.

For HAMILTON-BC8010 / BC4010 (Breathing Circuits):

Characteristic Used for Comparison	Acceptance Criteria (Implied by Subject Device Spec)	Reported Device Performance
Description	BC8010: dual limb, heated with water chamber; BC4010: single limb, heated, with water chamber.	Confirmed.
Classification No. & Product	868.5270, BZE.	Confirmed.
Intended Use	Use with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.	Patient population expanded from predicate to include pediatric and neonatal.
Patient Population	Pediatric and neonatal patients.	Confirmed.
Environment	Hospital use by trained personnel.	Confirmed.
Indications for Use	Invasive and noninvasive ventilation.	Confirmed.
Compatibility with other Devices	Hamilton Medical compatible humidifier (e.g., HAMILTON-H900).	Confirmed.
Where Used	During invasive and noninvasive mechanical ventilation, hospital use by trained personnel.	Confirmed.
Target/Patient Population	Pediatric and neonatal patients requiring mechanical ventilation or positive pressure breathing assistance.	Confirmed.
Compressible Volume	800 ml (BC8010), 600 ml (BC4010).	Confirmed.
Maximum Chamber Operating Press.	20 kPa.	Confirmed.
Length	Inspiration: 1.65m total (1.3m heated, 0.35m unheated); Expiration: 1.65m.	Confirmed.
Inner Diameter	12 mm.	Confirmed.
Flow Range	1 to 30 L/min.	Confirmed.
Flow Resistance	@ 2.5 l/min: Inspiration: 0.03 cmH2O/(l/min), Expiration: 0.02 cmH2O/(l/min). @ 15 l/min: Inspiration: 0.06 cmH2O/(l/min), Expiration: 0.04 cmH2O/(l/min).	Confirmed.
Gas Leakage	15 mL/min (BC8010), 4.0 mL/min (BC4010).	Confirmed.
Compliance	< 1 ml/cmH2O/m.	Confirmed.
Wire Resistance	Inspiration: 14.6±0.9Ω; Expiration: 18.2±1.2Ω.	Confirmed.
Connector	Conical according to ISO 5356-1; electrical connector part of breathing tube.	Confirmed.
Breathing Circuit Recognition	Tubes recognized by Hamilton Medical Humidifier.	Confirmed.
Sterility	Non-sterile, ready for use.	Confirmed.
Single Use / Reuse	Single Use.	Confirmed.
Power Heated Tube	33.15W inspiratory tube @100% power (BC8010/BC4010); 26.59W expiratory tube @100% power (BC8010).	Confirmed.
Standards / Performance	Compliance with various ISO and IEC standards listed (e.g., IEC 60601-1:2012, ISO 8185:2007, ISO 10993 series).	Confirmed.

2. Sample Size Used for the Test Set and Data Provenance

As this is a medical device submission based on substantial equivalence and non-clinical testing rather than an AI/ML study with a "test set" of patient data, specific "sample sizes" in the sense of clinical cohorts are not detailed. The testing involved:

Electrical Safety and Electromagnetic Compatibility: Conducted on the HAMILTON-H900 and HAMILTON-BC-series breathing circuits.
Mechanical Testing: Conducted on the HAMILTON-H900 and HAMILTON-BC-series breathing circuits.
Software Verification and Validation Testing: Conducted for the software within the HAMILTON-H900.
Biocompatibility Testing: Performed on "relevant parts of the breathing circuit."
Human Factors / Usability Study: Conducted on the HAMILTON-H900.

The document does not specify the number of units tested for each category, which is typical for non-clinical testing reports summarized in 510(k)s.

Data Provenance: The document does not specify the country of origin of the data or explicitly state whether the tests were retrospective or prospective. Given these are physical device tests, they would be prospective (performed specifically for this submission). The applicant is based in Switzerland (Hamilton Medical AG, Via Crusch 8, 7402 Bonaduz, Switzerland).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" in the context of an AI/ML algorithm with expert adjudication is not relevant here. The "ground truth" for this device's performance is objective measurements against engineering specifications and international standards (e.g., temperature accuracy, flow resistance, humidity output).

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for this type of device testing. Performance is measured against predefined engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is for evaluating human reader performance, often with and without AI assistance, typically in diagnostic imaging. This device is a respiratory gas humidifier and breathing circuit, not a diagnostic AI/ML system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable directly. This device is a physical medical device, not a standalone algorithm. Its performance is evaluated against its physical and electronic specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, adherence to international standards (e.g., IEC 60601 series, ISO 8185, ISO 5367, ISO 5356-1, ISO 10993 series), and objective measurements during non-clinical testing. For example, temperature accuracy is measured against a calibrated standard, not against a human expert's assessment.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

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

September 20, 2017

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

Re: K163283

Trade/Device Name: Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: August 17, 2017 Received: August 21, 2017

Dear Steffen 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,

Tara A. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known)

K163283

Device Name

HAMILTON-H900

HAMILTON-BC8010; HAMILTON-BC4010

Indications for Use (Describe)

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.

Intended Use HAMILTON-BC8010

Intended Use HAMILTON-BC4010

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

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Image /page/3/Picture/1 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".

510(k) Summary - K163283

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:	September 18, 2017

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-BC8010HAMILTON-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/0 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 letter "H" inside of a circle. Below the logo is the text "Intelligent Ventilation since 1983".

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

Predicate Device for Humidifier

Hamilton Medical AG HAMILTON-H900, respiratory gas humidifier, K152029

Predicate Devices for Heated Breathing Circuits

Hamilton Medical AG HAMILTON-BC8010 and HAMILTON-BC4010 heated breathing circuits, K152029

References Devices

Fisher & Paykel MR850 Respiratory Humidifier, K983112

Fisher & Paykel RT265 and RT266 Dual Heated Infant Breathing Circuits, K103767

CareFusion Inc. AirLife Infant Single Limb Heated Wire Circuit, K151959

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.

HAMILTON-BC8010

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Image /page/5/Picture/0 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 letter "H". Below the logo is the text "Intelligent Ventilation since 1983".

HAMILTON-BC4010

The HAMILTON-BC4010 is a single-imb breathing circuit comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-HC322/HC310

V. Indications for Use / Intended Use

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.

Intended Use HAMILTON-BC8010

Intended Use HAMILTON-BC4010

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

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.

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.

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Image /page/6/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" 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."

Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BCseries breathing circuits, including humidifier chambers 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.

				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 words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, blue font. To the right of the word "HAMILTON" is a stylized "H" in a lighter blue color. Below the logo is the tagline "Intelligent Ventilation since 1983" in a smaller, lighter blue font.

Characteristic usedfor comparison	HAMILTON-H900 (Predicate device)	HAMILTON-H900 (Subject device)
Humidityperformance	invasive mode:- humidity of >33 mg H2O/L is reached with agas flow of up to 60 L/min and an ambienttemperature of 26°Cnoninvasive mode:- humidity of > 10 mg H2O/L with a gas flow ofup to 120 L/min and an ambient temperature of26°C	invasive mode:- humidity of >33 mg H2O/L is reached with a gasflow of up to 60 L/min and an ambient temperatureof 26°Cnoninvasive mode:- humidity of > 10 mg H2O/L with a gas flow of upto 120 L/min and an ambient temperature of 26°C
Invasive /noninvasive mode	Invasive / Noninvasive mode- auto mode and- manual mode available	Invasive / Noninvasive mode- auto mode and- manual 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	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
Maximum power	283 VA (230 V version) /293 VA (115 V version) /268 VA (100 V version)	283 VA (230 V version) /293 VA (115 V version) /268 VA (100 V version)
Power heated tube	at 22V60 W (dual limb)30 W (single limb)	at 22V60 W (dual limb)30 W (single limb)
Power heating plate	150 W ± 5 %	150 W ± 5 %
Heating plateoverheat protector	130°C ±4°C	130°C ±4°C
Chamber insertiondetection	HAMILTON-H900 is able to detect if a chamberis inserted	HAMILTON-H900 is able to detect if a chamber isinserted
Water leveldetection	High and Low water level can be detected viaoptical sensors reaching into the water.	High and Low water level can be detected viaoptical sensors reaching into the water.
Breathing circuitrecognition	Via electrical connectors inside the breathingtubes	Via electrical connectors inside the breathing tubes
Single use / Reuse	Compatible with single use and reusablebreathing circuits	Compatible with single use and reusable breathingcircuits
Classification	Class I (in accordance with IEC 60601-1)	Class I (in accordance with IEC 60601-1)
Applied part	Type BF	Type BF
Standards /Performance	- IEC 60601-1:2012- IEC 60601-1-2:2007- IEC 60601-1-8:2005+Amd1: 2012- ISO 8185:2007- MIL-STD-461F:2007- IEC 62304:2006- IEC 62366:2007+Amd1:2014	- IEC 60601-1:2012- IEC 60601-1-2:2007- IEC 60601-1-8:2005+Amd1: 2012- ISO 8185:2007- MIL-STD-461F:2007- IEC 62304:2006- IEC 62366:2007+Amd1:2014

Table 2: HAMILTON-BC8010 and HAMILTON-BC4010 comparison table of humidifier breathing circuits characteristics and specifications

Characteristic usedfor comparison	HAMILTON-BC8010 /HAMILTON-BC4010 (Predicate devices)	HAMILTON-BC8010 /HAMILTON-BC4010 (Subject devices)
510(k) No.	K152029	K163283
Device name	HAMILTON-BC8010HAMILTON-BC4010	HAMILTON-BC8010HAMILTON-BC4010
Description	HAMILTON-BC8010, breathing circuit set, duallimb, heated with water chamberHAMILTON-BC4010, breathing circuit set, singlelimb, heated, with water chamber	HAMILTON-BC8010, breathing circuit set, duallimb, heated with water chamberHAMILTON-BC4010, breathing circuit set, singlelimb, heated, with water chamber
Classification No. &Product code	868.5270,BZE	868.5270,BZE
Characteristic usedfor comparison	HAMILTON-BC8010 /HAMILTON-BC4010 (Predicate devices)	HAMILTON-BC8010 /HAMILTON-BC4010 (Subject devices)
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 HAMILTON-BC8010 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of pediatric and neonatal patients.The HAMILTON-BC4010 breathing set isintended to be used together with compatibleHamilton Medical respiratory gas humidifiersduring invasive and noninvasive mechanicalventilation of pediatric and neonatal patients.
Patient Population	infants > 10 kg	pediatric and neonatal patients
Environment	Hospital use by trained personnel	Hospital use by trained personnel
Indications for use	invasive and noninvasive ventilation	invasive and noninvasive ventilation
Compatibility withother devices	Hamilton Medical compatible humidifier such asHAMILTON-H900	Hamilton Medical compatible humidifier such asHAMILTON-H900
Where used	during invasive and noninvasive mechanicalventilation, hospital use by trained personnel	during invasive and noninvasive mechanicalventilation, hospital use by trained personnel
Target / Patientpopulation	infants > 10 kg requiring mechanical ventilationor positive pressure breathing assistance	pediatric and neonatal patients requiringmechanical ventilation or positive pressurebreathing assistance
Compressible volume	800 ml (BC8010)600 ml (BC4010)	800 ml (BC8010)600 ml (BC4010)
Maximum chamberoperating pressure	20 kPa	20 kPa
Length	- Inspiration total length: 1.65 m(heated section 1.3m, unheated section 0.35m)- Expiration: 1.65m	Inspiration total length: 1.65 m(heated section 1.3m, unheated section 0.35m)Expiration: 1.65m
Inner diameter	12 mm	12 mm
Flow Range	1 to 30 L/min	1 to 30 L/min
Flow resistance(at 2.5 l/min	Inspiration:0.03 cmH2O/(l/min)Expiration:0.02 cmH2O/(l/min)	Inspiration:0.03 cmH2O/(l/min)Expiration:0.02 cmH2O/(l/min)
Flow resistance(at 15 l/min)	Inspiration:0.06 cmH2O/(l/min)Expiration:0.04 cmH2O/(l/min)	Inspiration:0.06 cmH2O/(l/min)Expiration:0.04 cmH2O/(l/min)
Gas leakage	- 15 mL/min (BC8010)- 4.0 mL/min (BC4010)	- 15 mL/min (BC8010)- 4.0 mL/min (BC4010)
Compliance	< 1 ml/cmH2O/m	< 1 ml/cmH2O/m
Wire resistance	- inspiration 14.6±0.9Ω- expiration: 18.2±1.2Ω	- inspiration 14.6±0.9Ωexpiration: 18.2±1.2Ω
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	Tubes can be recognized with a HamiltonMedical Humidifier
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)	- 33.15W inspiratory tube @100% power(BC8010/BC4010)- 26.59W expiratory tube @100% power(BC8010)
Standards /Performance	- IEC 60601-1:2012- IEC 60601-1-2:2007- ISO 8185:2007- ISO 10993-3:2014- ISO 10993-5:2009- ISO 10993-6:2007- ISO 10993-10:2010- ISO 10993-11:2006- ISO 10993-17:2002- ISO 5356-1:2004- ISO 5367:2014	- IEC 60601-1:2012- IEC 60601-1-2:2007- ISO 8185:2007- ISO 10993-3:2014- ISO 10993-5:2009- ISO 10993-6:2007- ISO 10993-10:2010- ISO 10993-11:2006- ISO 10993-17:2002- ISO 5356-1:2004- ISO 5367:2014

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Image /page/8/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" on top, with a stylized "H" inside a circle to the right. Below that is the word "MEDICAL" in a larger font. Underneath the logo is the text "Intelligent Ventilation since 1983".

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Image /page/9/Picture/0 description: The image shows the logo for Hamilton Medical. The words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, sans-serif font. The letter "H" in "HAMILTON" is stylized with a swirl design. Below the logo, the text "Intelligent Ventilation since 1983" is written in a smaller, lighter font.

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 60601-1:2012 standard for safety, the IEC 60601-1-2:2007 standard for EMC, and the ISO 8185:2007 standard for respiratory gas humidifiers.

Mechanical Testing

Mechanical safety testing was conducted on the HAMILTON-H900. The system complies with the IEC 60601-1:2012 standard for safety. Additional mechanical tests were conducted on the HAMILTON-BC-series breathing circuits. The breathing circuits comply with the ISO 5367:2014 standard for breathing tubes intended for use with anaesthetic apparatus and ventilators, and the ISO 5356-1:2004 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 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 60601-1-8:2012, IEC 62366:2014, IEC 60601-1-6:2013, and IEC 62304:2006 standards. The test results show that the device performs adequately for its intended use.

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Image /page/10/Picture/0 description: The image is a logo for Hamilton Medical. The words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, sans-serif font. There is a stylized "H" in a circle to the right of the word "HAMILTON". Below the words "HAMILTON MEDICAL" is the phrase "Intelligent Ventilation since 1983".

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.

VIII. Conclusion

In comparison to the predicates, the HAMILTON-H900 and the HAMILTON-BC breathing circuits including humidifier chambers 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).