Who is the manufacturer of HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

Hamilton Medical AG filed the 510(k) submission for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 (K163283).

What is the FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

BTT. It is classified under 21 CFR 868.5450 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900 (K152029); HAMILTON-BC8010 (K152029); HAMILTON-BC4010 (K152029).

Who can help prepare an FDA 510(k) submission like HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

K163283 · Hamilton Medical AG · BTT · Sep 20, 2017 · Anesthesiology

Device Facts

Record ID	K163283
Device Name	HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
Applicant	Hamilton Medical AG
Product Code	BTT · Anesthesiology
Decision Date	Sep 20, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5450
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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. 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. 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 Story

HAMILTON-H900 is a respiratory gas humidifier for invasive/non-invasive ventilation in intensive care/recovery rooms. It warms and humidifies breathing gases using a heating plate (for water chamber) and heated breathing circuits. System automatically recognizes connected breathing circuits (BC8010/BC4010). Integrated temperature sensors in the base and a probe in the breathing tube monitor gas temperature. A float mechanism and autofill system maintain constant water levels in the chamber. Operated by trained personnel under physician direction. Output is conditioned gas delivered to patient airway. Device provides continuous monitoring and alarms for temperature, water level, and circuit integrity. Benefits include optimized gas conditioning to support patient respiratory function.

Clinical Evidence

Bench testing only. Performance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and respiratory humidifier standards (ISO 8185). Mechanical testing confirmed compliance with ISO 5367 and ISO 5356-1. Biocompatibility evaluated per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, extractables/leachables). Human factors/usability study conducted per 2016 FDA guidance.

Technological Characteristics

Respiratory gas humidifier with heated breathing circuits. Features: heating plate (150W), heated inspiratory/expiratory tubes, optical water level sensors, float-based auto-feed chamber. Connectivity: electrical connectors for circuit recognition. Power: 100-230V. Standards: IEC 60601-1, IEC 60601-1-2, ISO 8185, ISO 5367, ISO 5356-1. Applied part: Type BF. Software: IEC 62304 compliant.

Indications for Use

Indicated for pediatric and neonatal patients requiring invasive or non-invasive mechanical ventilation or positive pressure breathing assistance.

Regulatory Classification

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.

Predicate Devices

HAMILTON-H900 (K152029)
HAMILTON-BC8010 (K152029)
HAMILTON-BC4010 (K152029)

Reference 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)

Related Devices

K152029 — HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 · Hamilton Medical AG · May 3, 2016
K133766 — HUMICARE D900 · Gruendler GmbH · Nov 24, 2014
K122705 — HUMICARE D900 · Grundler GmbH · May 21, 2013
K220703 — F&P 950 Respiratory Humidifier · Fisher & Paykel Healthcare · Jun 16, 2023
K251448 — FL-10000U Respiratory Humidifier · Flexicare Medical Limited. · Jan 16, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 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. 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. {3}------------------------------------------------ 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 registration number: | 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-BC8010 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 | {4}------------------------------------------------ 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 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. {5}------------------------------------------------ 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 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. #### V. Indications for Use / Intended Use #### Intended Use HAMILTON-H900 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. #### 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. {6}------------------------------------------------ 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. | Characteristic used for comparison | HAMILTON-H900 (Predicate device) | HAMILTON-H900 (Subject device) | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K152029 | K163283 | | Device Name | HAMILTON-H900 Respiratory Gas Humidifier | HAMILTON-H900 Respiratory Gas Humidifier | | Classification No. & Product code | 868.5450 BTT | 868.5450 BTT | | Indication for Use | 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- 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. | | Patient Population | Patients > 10 kg | Adult, pediatric and neonatal patients | | Environment | Hospital use by trained personnel | Hospital use by trained personnel | | Type of ventilation | invasive and noninvasive | invasive and noninvasive | | Modes Of operation | Automatic Mode: - Invasive & Noninvasive Manual Mode: - Invasive & Noninvasive Standby Mode Default mode: - Invasive mode after power on | Automatic Mode: - Invasive & Noninvasive Manual Mode: - Invasive & Noninvasive Standby Mode Default mode: - Invasive mode after power on | | Flow range | Non-invasive - up to 120 L/min Invasive - up to 60 L/min | Non-invasive - up to 120 L/min Invasive - up to 60 L/min | | Maximum operating duration | Continuously | Continuously | | Accuracy displayed temperature | Displayed Range: 10°C to 60°C Chamber exit: - 10°C to 60°C $\pm$ 1°C - 30°C to 41°C $\pm$ 0.5°C Y-piece: - 28°C to 43°C $\pm$ 0.5°C | Displayed Range: 10°C to 60°C Chamber exit: - 10°C to 60°C $\pm$ 1°C - 30°C to 41°C $\pm$ 0.5°C Y-piece: - 28°C to 43°C $\pm$ 0.5°C | | Resolution of displayed temperature | 0.1 °C | 0.1 °C | | Temperature Control Setting: Airway | Airway Temperature Setting: - invasive: 33°C to 42°C - noninvasive: 28°C to 38°C - in steps of 0.5 °C (manually) | Airway Temperature Setting: - invasive: 33°C to 42°C - noninvasive: 28°C to 38°C - in steps of 0.5 °C (manually) | | Temperature Control Setting: Chamber | Chamber outlet temperature - invasive: 35°C - 41°C - Noninvasive: 30°C - 35°C - in steps of 0.5°C (manually) | Chamber outlet temperature - invasive: 35°C - 41°C - Noninvasive: 30°C - 35°C - in steps of 0.5°C (manually) | | Disabling heater wires | Yes; - expiratory tube is disabled when using Single Limb Circuits - temperature alarm can disable all heating wires | Yes: - expiratory tube is disabled when using Single Limb Circuits - temperature alarm can disable all heating wires | | | | | | Table 1: Comparison table of humidifier characteristics and specifications | |--|--|--|--|----------------------------------------------------------------------------| |--|--|--|--|----------------------------------------------------------------------------| {7}------------------------------------------------ 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 used for comparison | HAMILTON-H900 (Predicate device) | HAMILTON-H900 (Subject device) | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Humidity performance | invasive mode: - humidity of >33 mg H2O/L is reached with a gas flow of up to 60 L/min and an ambient temperature of 26°C noninvasive mode: - humidity of > 10 mg H2O/L with a gas flow of up to 120 L/min and an ambient temperature of 26°C | invasive mode: - humidity of >33 mg H2O/L is reached with a gas flow of up to 60 L/min and an ambient temperature of 26°C noninvasive mode: - humidity of > 10 mg H2O/L with a gas flow of up to 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 22V 60 W (dual limb) 30 W (single limb) | at 22V 60 W (dual limb) 30 W (single limb) | | Power heating plate | 150 W ± 5 % | 150 W ± 5 % | | Heating plate overheat protector | 130°C ±4°C | 130°C ±4°C | | Chamber insertion detection | HAMILTON-H900 is able to detect if a chamber is inserted | HAMILTON-H900 is able to detect if a chamber is inserted | | Water level detection | High and Low water level can be detected via optical sensors reaching into the water. | High and Low water level can be detected via optical sensors reaching into the water. | | Breathing circuit recognition | Via electrical connectors inside the breathing tubes | Via electrical connectors inside the breathing tubes | | Single use / Reuse | Compatible with single use and reusable breathing circuits | Compatible with single use and reusable breathing circuits | | 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 used for comparison | HAMILTON-BC8010 / HAMILTON-BC4010 (Predicate devices) | HAMILTON-BC8010 / HAMILTON-BC4010 (Subject devices) | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K152029 | K163283 | | Device name | HAMILTON-BC8010 HAMILTON-BC4010 | HAMILTON-BC8010 HAMILTON-BC4010 | | Description | HAMILTON-BC8010, breathing circuit set, dual limb, heated with water chamber HAMILTON-BC4010, breathing circuit set, single limb, heated, with water chamber | HAMILTON-BC8010, breathing circuit set, dual limb, heated with water chamber HAMILTON-BC4010, breathing circuit set, single limb, heated, with water chamber | | Classification No. & Product code | 868.5270, BZE | 868.5270, BZE | | Characteristic used for comparison | HAMILTON-BC8010 / HAMILTON-BC4010 (Predicate devices) | HAMILTON-BC8010 / HAMILTON-BC4010 (Subject devices) | | Intended use | 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. 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. | 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. 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. | | 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 with other devices | Hamilton Medical compatible humidifier such as HAMILTON-H900 | Hamilton Medical compatible humidifier such as HAMILTON-H900 | | Where used | during invasive and noninvasive mechanical ventilation, hospital use by trained personnel | during invasive and noninvasive mechanical ventilation, hospital use by trained personnel | | Target / Patient population | infants > 10 kg requiring mechanical ventilation or positive pressure breathing assistance | pediatric and neonatal patients requiring mechanical ventilation or positive pressure breathing assistance | | Compressible volume | 800 ml (BC8010) 600 ml (BC4010) | 800 ml (BC8010) 600 ml (BC4010) | | Maximum chamber operating 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±0.9Ω expiration: 18.2±1.2Ω | | Connector | - Interface connections conical according to ISO 5356-1 - electrical connector part of breathing tube | - Interface connections conical according to ISO 5356-1 - electrical connector part of breathing tube | | Breathing circuit recognition | Tubes can be recognized with a Hamilton Medical Humidifier | Tubes can be recognized with a Hamilton Medical 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 | {8}------------------------------------------------ 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". {9}------------------------------------------------ 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. {10}------------------------------------------------ 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.