(286 days)
No
The device description focuses on physical components, sensors, and control mechanisms for heating and humidification. There is no mention of AI, ML, or complex data analysis for decision-making or prediction. The software is described as "major" level of concern, but this typically relates to safety and control logic, not AI/ML capabilities.
Yes
The device is intended to add moisture and warm breathing gases during mechanical ventilation, which directly affects the patient's physiological state and supports the therapeutic process of ventilation.
No
Explanation: The device is described as a humidifier intended to add moisture and warm breathing gases during mechanical ventilation. Its function is to modify the breathing gas, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly outlines hardware components such as a heating plate, temperature sensors, breathing tubes, and a float mechanism, indicating it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The HAMILTON-H900 humidifier and its associated breathing sets are designed to warm and humidify breathing gases delivered to patients during mechanical ventilation. They are directly involved in supporting the patient's respiratory function, not in analyzing biological samples.
- Intended Use: The intended use clearly states adding moisture and warming breathing gases during ventilation. There is no mention of analyzing any biological specimens.
- Device Description: The description focuses on the mechanics of heating and humidifying gases and the components involved in delivering those gases to the patient. There is no mention of any analytical or diagnostic function.
Therefore, based on the provided information, the HAMILTON-H900 humidifier and breathing sets are medical devices used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 for patients > 10 kg.
HAMILTON-BC8022: The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
HAMILTON-BC4022: The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
HAMILTON-BC8010: The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
HAMILTON-BC4010: The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
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-BC8022 / HAMILTON-BC8010: The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
HAMILTON-BC4022 / HAMILTON-BC4010: The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
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
HAMILTON-H900: patients > 10 kg
HAMILTON-BC8022, HAMILTON-BC4022: adult and pediatric patients > 10 kg
HAMILTON-BC8010, HAMILTON-BC4010: infants > 10 kg
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)
Electrical Safety and Electromagnetic Compatibility: Electrical safety and EMC testing were conducted on the HAMILTON-H900 and HAMILTON-BCseries breathing circuits. The devices comply with the IEC 60601-1 standard for safety, the IEC 60601-1-2 standard for EMC, and the ISO 8185 standard for respiratory gas humidifiers.
Mechanical Testing: Mechanical safety testing was conducted on the HAMILTON-H900. The system complies with the IEC 60601-1 standard for safety. Additional mechanical tests were conducted on the HAMILTON-BC-series breathing circuits. The breathing circuits comply with the ISO 5367 standard for breathing tubes intended for use with anaesthetic apparatus and ventilators, and the ISO 5356-1 standard for conical connectors.
Software Verification and Validation Testing: Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. The results of the software verification and validation testing demonstrate that all specified requirements have been implemented correctly and completely.
Biocompatibility: Biocompatibility testing and evaluation was performed on relevant parts of the breathing circuit. The evaluation was performed in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", and the FDA quidance document "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, 2013." The battery of tests included the following tests:
- Cytotoxicity
- Sensitization & Irritation
- Systemic Toxicity
- Genotoxicity Testing
- Implantation Testing
- Extractables and Leachables
Additional Testing: A Human Factors / Usability Study was conducted and the HAMILTON-H900 humidifier was found to be in conformance with the Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices, 2016". Additional testing on the HAMILTON-H900 device was conducted according to IEC 60601-1-8, IEC 60601-1-6, and IEC 62304 standards. The test results show that the device performs adequately for its intended use.
Summary: Based on the nonclinical performance as documented, the HAMILTON-H900 and the HAMILTON-BC breathing circuits were found to have an adequate performance profile that is similar to the predicate devices.
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.
K913368, K983112, K122432, K103767
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 & Human Services. The logo consists of a stylized eagle with three heads facing right, representing health, human services, and the USA. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Hamilton Medical AG Steffen Boden Quality Engineer/ Regulatory Affairs Via Crusch 8, Bonaduz, CH 7402, Grisons Switzerland
Re: K152029
Trade/Device Name: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010. Hamilton-BC4010 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: March 21, 2016 Received: March 24, 2016
Dear Mr. Boden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number: K152029
HAMILTON-H900 Device Name: HAMILTON-BC8022, HAMILTON-BC8010 HAMILTON-BC4022, HAMILTON-BC4010
Intended Use HAMILTON-H900
The HAMILTON-H900 humidifier is 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 kq.
Intended Use HAMILTON-BC8022
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
Intended Use HAMILTON-BC4022
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of adult and pediatric patients > 10 kg.
Intended Use HAMILTON-BC8010
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.
Intended Use HAMILTON-BC4010
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.
| Prescription
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter | |
| (21 CFR 801 Subpart C) | Use |
Use
3
Image /page/3/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
510(k) Summary - K152029
l. Submitter
Hamilton Medical AG Via Crusch 8 7402 Bonaduz Switzerland
| Establishment 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: | May 03, 2016 |
II. Device(s)
| (Trade) Name of Device(s): | HAMILTON-H900 |
|---|---|
| Common or Usual Name: | Humidifier for Respiratory Gas |
| Classification Name: | Respiratory gas humidifier (21 CFR § 868.5450) |
| Regulatory Class: | II |
| Product Code: | BTT |
| (Trade) Name of Device(s): | HAMILTON-BC8022, HAMILTON-BC8010
HAMILTON-BC4022, HAMILTON-BC4010 |
|----------------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Heated Breathing Circuit Set, with water chamber |
| Classification Name: | Breathing system heater (21 CFR § 868.5270) |
| Regulatory Class: | II |
| Product Code: | BZE |
4
Image /page/4/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a stylized "H" in a circle. Below the logo is the tagline "Intelligent Ventilation since 1983".
.............................................................................................................................................................................. Predicate Device(s)
Predicate Device - for Humidifier
Fisher & Paykel MR700 / MR720 / MR730 Respiratory Humidifier, K913368
Fisher & Paykel MR850 Respiratory Humidifier, K983112
Predicate Devices - for Heated Breathing Circuits
Fisher & Paykel RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits, K122432 RT265 and RT266 Dual Heated Infant Breathing Circuits, K103767
References Devices - for Heated Breathing Circuits
Plastiflex Healthcare Hybernite Rainout Control System, K100104
IV. Device Description
HAMILTON-H900
The HAMILTON-H900 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-BC8022 / HAMILTON-BC8010
The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
5
Image /page/5/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a blue circle with a white "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
HAMILTON-BC4022 / HAMILTON-BC4010
The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
V. Indications for Use / Intended Use
Intended Use HAMILTON-H900
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.
Intended Use HAMILTON-BC8022
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
Intended Use HAMILTON-BC4022
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
Intended Use HAMILTON-BC8010
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
Intended Use HAMILTON-BC4010
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.
VI. Comparison of Technological Characteristics with the Predicate Device(s)
The Intended Use statements for the HAMILTON-H900 and HAMILTON-BC-series breathing circuits are substantially equivalent to the predicate devices; the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both the subject and predicate devices have the same Indications for use for respiratory gas conditioning.
6
Image /page/6/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. There is a stylized "H" in a circle to the right of the word "HAMILTON". Below the logo is the tagline "Intelligent Ventilation since 1983".
The proposed devices and the predicates were evaluated against selected applicable standards, and the technological characteristics and performance specifications of the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits are substantially equivalent to those of the predicate devices. The differences do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the devices relative to the predicates.
Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BCseries breathing circuits to have adequate performance. The HAMILTON-H900 humidifier and HAMILTON-BC-series breathing circuits are considered to be substantially equivalent to currently marketed predicate devices that have been previously cleared by the FDA.
| Characteristic used
for comparison | HAMILTON-H900 | F&P MR730
(Primary predicate device) | F&P MR850
(Secondary predicate device) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152029 | K913368 | K983112 |
| Device Name | HAMILTON-H900
Respiratory Gas Humidifier | MR700 / MR720 / MR730
Respiratory Humidifier | MR850 Respiratory Humidifier |
| Classification No. &
Product code | 868.5450
BTT | 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. | To warm and add moisture to
gases delivered to patients
requiring mechanical ventilation
or positive pressure breathing
assistance via an endotracheal
tube or face mask. | The MR850 humidifier is
intended to add moisture to, and
to warm, the breathing gases for
administration to a patient.
Gases available for medical use
do not contain sufficient
moisture and may damage or
irritate the respiratory tract, or
desiccate secretions of patients
whose supraglottic airways
have been bypassed.
This may be indicated for
patients requiring mechanical
ventilation, positive pressure
breathing assistance, or general
medical gases. These gases
may be delivered by face mask
or through bypassing the upper
airways, for example use of an
endotracheal tube. |
| Environment | Hospital use by trained
personnel | Hospital use by trained
personnel | Hospital use by trained
personnel |
| Type of ventilation | invasive and noninvasive | 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 | Manual Mode
Standby Mode | 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 | Up to 80 L/min | Non-invasive - up to 120 L/min
Invasive - up to 60 L/min |
| Maximum operating
duration | Continuously | Continuously | Continuously |
| Accuracy displayed
temperature | Displayed Range: 10°C to 60°C - Accuracy Range: 10°C to 60°C
(±1°C) - Accuracy Range: 30°C to 41°C
(±0.5°C) | Displayed Range: 5.0°C to 80.0 °C
Accuracy Range: 25°C to 45°C
(±0.3°C) | Displayed Range: 10°C to 70 °C
Accuracy Range: 25°C to 45°C
(±0.3°C) |
| Resolution of
displayed
temperature | 0.1 °C | 0.1 °C | 0.1 °C |
| Airway temperature | Invasive mode: 33°C - 43°C | 29.5 °C to max 41 °C | Invasive mode: 33°C - 43°C |
| Characteristic used
for comparison | HAMILTON-H900 | F&P MR730
(Primary predicate device) | F&P MR850
(Secondary predicate device) |
| | | | |
| Disabling heater
wires | Yes; - expiratory tube is disabled
when using Single Limb Circuits - temperature alarm can disable
all heating wires | Yes:
can be disabled manually - temperature alarm can disable
all heating wires | Yes:
can be disabled manually - temperature alarm can disable
all heating wires |
| 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 | - humidity of > 33 mg/L with a
gas flow of up to 60 L/min | invasive mode: - humidity of > 33 mg/L with a
gas flow of up to 60 L/min
Noninvasive mode: - humidity of > 10 mg/L with a
gas flow of up to 120 L/min |
| Invasive /
noninvasive mode | Invasive / Noninvasive mode - auto mode and
- manual mode available | Mode cannot be selected
- only manual mode
available | Invasive / Noninvasive mode
only auto mode available |
| Alarm display | Indicators for: - Chamber Temperature
- Heater Wire
- Humidity Alarm
- Patient-end Probe (Y-Piece)
- water level (Low / High)
- device inclination
- tube detection / recognition /
connection, - chamber insertion | Amber LED indicators for:
- Temperature Probe
- Heater Wire
- Humidity Alarm
- Chamber Probe
- Patient-end Probe
Red LED indicator for: - See Manual (red LED). | Amber LED indicators for:
- Temperature Probe,
- Heater Wire
- Humidity Alarm
- Chamber Probe
- Patient-end Probe
- Water Out |
| Maximum power | 283 VA (230 V version) /
293 VA (115 V version) /
268 VA (100 V version) | 230 V / 1.0 A max
127 V / 1.9 A max
115 V / 2.0 A max
100 V / 2.4 A max | 230 V / 1.0 A max
127 V / 1.8 A max
115 V / 2.0 A max
100 V / 2.4 A max |
| Power heated tube | at 22V
60 W (dual limb)
30 W (single limb) | Internal voltage not specified
60 W | at 22 V
60 W |
| Power heating plate | 150 W ± 5 % | 150 W | 150 W |
| Heating plate
overheat protector | $130°C ± 4°C$ | $118 ± 6 °C$ | $118 ± 6 °C$ |
| Max gas input
temperature | $31°C$ | $29.5°C$ | $31°C$ |
| Max water input
temperature | $37°C$ | $37°C$ | $37°C$ |
| Chamber insertion
detection | HAMILTON-H900 is able to
detect if a chamber is inserted | No chamber detection available | No chamber detection available |
| Water level detection | High and Low water level can
be detected via optical sensors
reaching into the water. - Low water level: 5 minutes
alarm delay - high water level: immediate
alarm | No water level detection
available | Only insufficient water in the
chamber is detected by
measuring the amount of power
used to obtain the chamber
temperature - Up to 15 minutes to generate
an alarm |
| Breathing circuit
recognition | Via electrical connectors inside
the breathing tubes | No breathing circuit recognition | 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 | 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) | Class I (in accordance with IEC
60601-1) |
| Applied part | Type BF | Type B | Type BF |
| Characteristic used | HAMILTON-H900 | F&P MR730 | F&P MR850 |
| for comparison | | (Primary predicate device) | (Secondary predicate device) |
| Standards /
Performance | - IEC 60601-1 - IEC 60601-1-2
- IEC 60601-1-4
- IEC 60601-1-8
- ISO 8185:2007
- ISO 10993
- MILSTD 461F
- ISO 14971
- IEC 62304
- IEC 62366
- ISO 5356-1
- ISO 5367 | - CSA-C22.2 No.125
- UL2601
- IEC60601-1, AS3200.1
- EN 60601-1 | - AS/NZS 3200.1.0
- CAN/CSA-22.2 No.601.1
- UL60601-1
- IEC 60601-1
- EN 60601-1 |
Table 1: Comparison table of humidifier characteristics and specifications
7
Image /page/7/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circle with a stylized "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
8
Image /page/8/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. Below the logo is the text "Intelligent Ventilation since 1983".
Table 2: HAMILTON-BC8022 and HAMILTON-BC4022 Comparison table of humidifier breathing circuits characteristics and specifications
| Characteristic used
for comparison | HAMILTON-BC8022 /
HAMILTON-BC4022 | Predicate Device:
F&P RT380 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152029 | K122432 |
| Device name | HAMILTON-BC8022
HAMILTON-BC4022 | RT380 |
| Description | HAMILTON-BC8022, breathing circuit set, dual
limb, heated with water chamber
HAMILTON-BC4022, breathing circuit set, single
limb, heated with water chamber | Dual Limb Adult Breathing Circuit Kit with
Evaqua 2 Technology |
| Classification No. &
Product code | 868.5270,
BZE | 868.5270,
BZE |
| Intended use | The HAMILTON-BC8022 breathing set is
intended to be used together with compatible
Hamilton Medical respiratory gas humidifiers
during invasive and noninvasive mechanical
ventilation of adult and pediatric patients > 10
kg.
The HAMILTON-BC4022 breathing set is
intended to be used together with compatible
Hamilton Medical respiratory gas humidifiers
during invasive and noninvasive mechanical
ventilation of adult and pediatric patients > 10 kg | The RT380 and RT385 'Adult Evaqua 2' dual-
heated breathing circuits are intended as
conduits of breathing gas for ventilation of adult
patients, and to maintain the temperature of
humidified inspired gas. |
| Indications for use | invasive and noninvasive ventilation | Patients requiring respiratory support |
| Compatibility with
other devices | Hamilton Medical compatible humidifier such as
HAMILTON-H900 | Compatible with 700 series and MR 850
humidifiers (specification sheet) |
| Environment | during invasive and noninvasive mechanical
ventilation, hospital use by trained personnel | Intensive Care environment in conjunction with
life support equipment |
| Target / Patient
population | Adult and pediatric patients requiring mechanical
ventilation or positive pressure breathing
assistance | Adult patients requiring respiratory support. |
| Compressible volume | 1600 ml (BC8022)
1000 ml (BC4022) | 1600 ml |
| maximum chamber
operating pressure | 20 kPa | 8 kPa (specification sheet) |
| Length | - inspiration 1.95m
- expiration 1.95m | - inspiration 1.5m
- expiration 1.5m |
| Inner diameter | 19 mm | 22 mm |
| Flow range | 4 to 120 L/min - invasive max. 60 L/min
- noninvasive max. 120 L/min | - invasive 60 L/min
- noninvasive 120 L/min (MR850) |
| Rated flow | 2 cmH2O @ 85 L/min (BC8022)
2 cmH2O @ 125 L/min (BC4022) | 40 l/ min, ≤ 0.2 kPa |
| Flow resistance | BC8022 (@ 30L/min)
Inspiration: 0.3 cmH2O
Expiration: 0.15 cmH20
BC4022 (@ 30L/min)
Inspiration: 0.2 cmH2O (inkl. chamber) | RT380 @ 30 L/min
Inspiration: 0.91 cmH20
Expiration: 0.23 cmH20 |
9
Image /page/9/Picture/1 description: The image shows the logo for Hamilton Medical. The words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, blue font. Below the logo, the words "Intelligent Ventilation since 1983" are written in a smaller, lighter blue font.
| Characteristic used
for comparison | HAMILTON-BC8022 /
HAMILTON-BC4022 | Predicate Device:
F&P RT380 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Gas leakage | 4L/min) |
| Classification No. &
Product code | 868.5270,
BZE | 868.5270,
BZE |
| 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 dual-heated breathing circuits are intended
as conduits of breathing gas for ventilation of
infant patients, and to maintain the temperature
of humidified inspired gas. The RT265 is used
for flow rates greater than 4 L/min, and the
RT266 is for flow rates between 0.3 and 4 L/min. |
| Indications for use | invasive and noninvasive ventilation | facemask or through bypassing the upper
airways |
| Compatibility with
other devices | Hamilton Medical compatible humidifier such as
HAMILTON-H900 | Compatible with MR 850 humidifiers, not
compatible with MR810 humidifiers |
| Where used | during invasive and noninvasive mechanical
ventilation, hospital use by trained personnel | Intensive Care environment in conjunction with
life support equipment |
| Target / Patient
population | Infants > 10 kg requiring mechanical ventilation
or positive pressure breathing assistance | Infant |
| Compressible volume | 800 ml (BC8010)
600 ml (BC4010) | 760 ml |
| Maximum chamber
operating pressure | 20 kPa | 8 kPa |
10
Image /page/10/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on top of the word "MEDICAL". Below the logo is the text "Intelligent Ventilation since 1983".
| Characteristic used
for comparison | HAMILTON-BC8010 /
HAMILTON-BC4010 | Predicate Device:
F&P RT265 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Length | - Inspiration total length: 1.65 m
(heated section 1.3m, unheated section 0.35m)
- Expiration: 1.65m | - Inspiration total length: 1.5 m
(heated section 1.1m , unheated section 0.4m) - Expiration: 1.5m (IFU) |
| Inner diameter | 12 mm | 11.0mm |
| Flow Range | 1 to 30 L/min | For flow rates > 4 L/min |
| Rated flow | 2 cmH2O @ 16 L/min (BC8010)
2 cmH2O @ 29 L/min (BC4010) | 2 cmH2O @ 13 L/min |
| Flow resistance | BC8010 (@ 15 L/min)
Inspiration: 1.0 cmH2O
Expiration: 0.8 cmH2O | RT265 @ 15 L/min
Inspiration 2.42 cmH2O
Expiration 1.32 cmH2O |
| | BC8010 (@ 2.5 L/min)
Inspiration 0.05 cmH20
Expiration 0.04 cmH2O | RT265 @ 2.5 L/min
Inspiration 0.11 cmH2O
Expiration 0.08 cmH2O |
| | BC4010 (@ 15 L/min)
Inspiration 0.75 cmH20 | |
| | BC4010 (@ 2.5 L/min)
Inspiration 0.05 cmH2O | |
| Gas leakage | - 15 mL/min (BC8010) - 4.0 mL/min (BC4010) |