(303 days)
No
The document describes a respiratory gas humidifier and associated breathing circuits, focusing on heating, humidification, and automatic circuit recognition. There is no mention of AI, ML, or any related technologies in the device description or performance studies.
No
The device is a humidifier designed to add moisture and warm breathing gases during mechanical ventilation, not to treat a disease or condition itself.
No
The device is a humidifier designed to add moisture and warm breathing gases during mechanical ventilation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components such as a heating plate, temperature sensors, breathing tubes with integrated heating, and a float mechanism for water level control. While software is mentioned for verification and validation, the core functionality relies on physical hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for adding moisture and warming breathing gases during mechanical ventilation. This is a direct therapeutic intervention on the patient's respiratory system.
- Device Description: The description details how the device heats and humidifies gases delivered to the patient's airway. It involves heating water and controlling the temperature of the breathing circuit.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples from the body, not to directly treat or support bodily functions like breathing. This device is a respiratory support device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT, BZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric and neonatal patients
Intended User / Care Setting
qualified, trained personnel under the direction of a physician / intensive care ward or the recovery room (Hospital use)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance and nonclinical data 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-BC-series 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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 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 |
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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 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.
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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
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.
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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.
| 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 | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ---------------------------------------------------------------------------- |
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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 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 |