HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
Device Facts
| Record ID | K152029 |
|---|---|
| Device Name | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 |
| Applicant | Hamilton Medical AG |
| Product Code | BTT · Anesthesiology |
| Decision Date | May 3, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications 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-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 mechanical ventilation of adult and pediatric patients > 10 kg. The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive 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.
Device Story
HAMILTON-H900 is a respiratory gas humidifier for invasive/non-invasive ventilation; used in ICU/recovery by trained personnel. Device inputs include breathing gases passed through a humidifier chamber; system uses a heating plate for water and controlled heating within breathing circuits. Temperature sensors in the humidifier base and a probe in the breathing tube monitor gas temperature. Output is heated, humidified gas delivered to patient airway. Features include automatic breathing circuit recognition, water level detection via optical sensors, and an autofill mechanism. Healthcare providers use the device to prevent respiratory tract damage/desiccation from dry medical gases. Benefits include optimized gas conditioning for ventilated patients. System supports automatic and manual modes.
Clinical Evidence
Bench testing only. No clinical data. Performance validated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), mechanical testing (ISO 5367, ISO 5356-1), biocompatibility (ISO 10993), and human factors/usability engineering. Software verification and validation performed per FDA guidance.
Technological Characteristics
Humidifier with heating plate (150W) and heated breathing circuits. Materials biocompatible per ISO 10993. Sensing: temperature probes, optical water level sensors, circuit recognition via electrical connectors. Connectivity: standalone. Sterilization: non-sterile, ready for use. Software: major level of concern, IEC 62304 compliant.
Indications for Use
Indicated for adult, pediatric, and infant patients > 10 kg requiring invasive or non-invasive mechanical ventilation or positive pressure breathing assistance in intensive care or recovery settings.
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
- Fisher & Paykel MR700 / MR720 / MR730 Respiratory Humidifier (K913368)
- Fisher & Paykel MR850 Respiratory Humidifier (K983112)
- Fisher & Paykel RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits (K122432)
- RT265 and RT266 Dual Heated Infant Breathing Circuits (K103767)
Reference Devices
- Plastiflex Healthcare Hybernite Rainout Control System (K100104)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing health, human services, and the USA. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Hamilton Medical AG Steffen Boden Quality Engineer/ Regulatory Affairs Via Crusch 8, Bonaduz, CH 7402, Grisons Switzerland
Re: K152029
Trade/Device Name: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010. Hamilton-BC4010 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: March 21, 2016 Received: March 24, 2016
Dear Mr. Boden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
*Tejashri Purohit-Sheth, M.D.*
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## INDICATIONS FOR USE STATEMENT
510(k) Number: K152029
HAMILTON-H900 Device Name: HAMILTON-BC8022, HAMILTON-BC8010 HAMILTON-BC4022, HAMILTON-BC4010
#### Intended Use HAMILTON-H900
The HAMILTON-H900 humidifier is 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<br>(Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> X |
|---------------------------------------------|--------------------------------------------------------|
| AND/OR | |
| Over-The-Counter<br>(21 CFR 801 Subpart C) | Use <span style="text-decoration: underline;"> </span> |
Use
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Image /page/3/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
# 510(k) Summary - K152029
#### l. Submitter
Hamilton Medical AG Via Crusch 8 7402 Bonaduz Switzerland
| Establishment registration<br>number: | 3001421318 |
|---------------------------------------|-------------------------------------------------------------|
| Phone:<br>Fax: | +41 58 610 10 20<br>+41 58 610 00 20 |
| Contact person: | Mr. Steffen Boden,<br>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<br>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 |
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Image /page/4/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a stylized "H" in a circle. Below the logo is the tagline "Intelligent Ventilation since 1983".
#### .............................................................................................................................................................................. Predicate Device(s)
### Predicate Device - for Humidifier
Fisher & Paykel MR700 / MR720 / MR730 Respiratory Humidifier, K913368
Fisher & Paykel MR850 Respiratory Humidifier, K983112
### Predicate Devices - for Heated Breathing Circuits
Fisher & Paykel RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits, K122432 RT265 and RT266 Dual Heated Infant Breathing Circuits, K103767
### References Devices - for Heated Breathing Circuits
Plastiflex Healthcare Hybernite Rainout Control System, K100104
#### IV. Device Description
### HAMILTON-H900
The HAMILTON-H900 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.
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Image /page/5/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a blue circle with a white "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
### HAMILTON-BC4022 / HAMILTON-BC4010
The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
#### V. Indications for Use / Intended Use
### Intended Use HAMILTON-H900
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.
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Image /page/6/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. There is a stylized "H" in a circle to the right of the word "HAMILTON". Below the logo is the tagline "Intelligent Ventilation since 1983".
The proposed devices and the predicates were evaluated against selected applicable standards, and the technological characteristics and performance specifications of the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits are substantially equivalent to those of the predicate devices. The differences do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the devices relative to the predicates.
Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BCseries breathing circuits to have adequate performance. The HAMILTON-H900 humidifier and HAMILTON-BC-series breathing circuits are considered to be substantially equivalent to currently marketed predicate devices that have been previously cleared by the FDA.
| Characteristic used<br>for comparison | HAMILTON-H900 | F&P MR730<br>(Primary predicate device) | F&P MR850<br>(Secondary predicate device) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152029 | K913368 | K983112 |
| Device Name | HAMILTON-H900<br>Respiratory Gas Humidifier | MR700 / MR720 / MR730<br>Respiratory Humidifier | MR850 Respiratory Humidifier |
| Classification No. &<br>Product code | 868.5450<br>BTT | 868.5450<br>BTT | 868.5450<br>BTT |
| Indication for Use | The HAMILTON- H900<br>humidifier is intended to add<br>moisture and to warm breathing<br>gases during invasive and non-<br>invasive mechanical ventilation.<br>The intended area of use is the<br>intensive care ward or the<br>recovery room.<br>The HAMILTON- H900<br>humidifier is a medical device<br>intended for use by qualified,<br>trained personnel under the<br>direction of a physician and<br>within the limits of its stated<br>technical specifications for<br>patients > 10 kg. | To warm and add moisture to<br>gases delivered to patients<br>requiring mechanical ventilation<br>or positive pressure breathing<br>assistance via an endotracheal<br>tube or face mask. | The MR850 humidifier is<br>intended to add moisture to, and<br>to warm, the breathing gases for<br>administration to a patient.<br>Gases available for medical use<br>do not contain sufficient<br>moisture and may damage or<br>irritate the respiratory tract, or<br>desiccate secretions of patients<br>whose supraglottic airways<br>have been bypassed.<br>This may be indicated for<br>patients requiring mechanical<br>ventilation, positive pressure<br>breathing assistance, or general<br>medical gases. These gases<br>may be delivered by face mask<br>or through bypassing the upper<br>airways, for example use of an<br>endotracheal tube. |
| Environment | Hospital use by trained<br>personnel | Hospital use by trained<br>personnel | Hospital use by trained<br>personnel |
| Type of ventilation | invasive and noninvasive | invasive and noninvasive | invasive and noninvasive |
| Modes Of operation | Automatic Mode:<br>- Invasive & Noninvasive<br>Manual Mode:<br>- Invasive & Noninvasive<br>Standby Mode<br>Default mode:<br>- Invasive mode after power on | Manual Mode<br>Standby Mode | Automatic Mode:<br>- Invasive & Noninvasive<br>Manual Mode:<br>- Invasive & Noninvasive<br>Standby Mode<br>Default mode:<br>- Invasive mode after power on |
| Flow range | Non-invasive - up to 120 L/min<br>Invasive - up to 60 L/min | Up to 80 L/min | Non-invasive - up to 120 L/min<br>Invasive - up to 60 L/min |
| Maximum operating<br>duration | Continuously | Continuously | Continuously |
| Accuracy displayed<br>temperature | Displayed Range: 10°C to 60°C<br>- Accuracy Range: 10°C to 60°C<br>(±1°C)<br>- Accuracy Range: 30°C to 41°C<br>(±0.5°C) | Displayed Range: 5.0°C to 80.0 °C<br>Accuracy Range: 25°C to 45°C<br>(±0.3°C) | Displayed Range: 10°C to 70 °C<br>Accuracy Range: 25°C to 45°C<br>(±0.3°C) |
| Resolution of<br>displayed<br>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<br>for comparison | HAMILTON-H900 | F&P MR730<br>(Primary predicate device) | F&P MR850<br>(Secondary predicate device) |
| | | | |
| Disabling heater<br>wires | Yes;<br>- expiratory tube is disabled<br>when using Single Limb Circuits<br>- temperature alarm can disable<br>all heating wires | Yes:<br>can be disabled manually<br>- temperature alarm can disable<br>all heating wires | Yes:<br>can be disabled manually<br>- temperature alarm can disable<br>all heating wires |
| Humidity<br>performance | invasive mode:<br>- humidity of >33 mg H2O/L is<br>reached with a gas flow of up to<br>60 L/min and an ambient<br>temperature of 26°C<br>noninvasive mode:<br>- humidity of > 10 mg H2O/L<br>with a gas flow of up to 120<br>L/min and an ambient<br>temperature of 26°C | - humidity of > 33 mg/L with a<br>gas flow of up to 60 L/min | invasive mode:<br>- humidity of > 33 mg/L with a<br>gas flow of up to 60 L/min<br>Noninvasive mode:<br>- humidity of > 10 mg/L with a<br>gas flow of up to 120 L/min |
| Invasive /<br>noninvasive mode | Invasive / Noninvasive mode<br>- auto mode and<br>- manual mode available | Mode cannot be selected<br>- only manual mode<br>available | Invasive / Noninvasive mode<br>only auto mode available |
| Alarm display | Indicators for:<br>- Chamber Temperature<br>- Heater Wire<br>- Humidity Alarm<br>- Patient-end Probe (Y-Piece)<br>- water level (Low / High)<br>- device inclination<br>- tube detection / recognition /<br>connection,<br>- chamber insertion | Amber LED indicators for:<br>- Temperature Probe<br>- Heater Wire<br>- Humidity Alarm<br>- Chamber Probe<br>- Patient-end Probe<br>Red LED indicator for:<br>- See Manual (red LED). | Amber LED indicators for:<br>- Temperature Probe,<br>- Heater Wire<br>- Humidity Alarm<br>- Chamber Probe<br>- Patient-end Probe<br>- Water Out |
| Maximum power | 283 VA (230 V version) /<br>293 VA (115 V version) /<br>268 VA (100 V version) | 230 V / 1.0 A max<br>127 V / 1.9 A max<br>115 V / 2.0 A max<br>100 V / 2.4 A max | 230 V / 1.0 A max<br>127 V / 1.8 A max<br>115 V / 2.0 A max<br>100 V / 2.4 A max |
| Power heated tube | at 22V<br>60 W (dual limb)<br>30 W (single limb) | Internal voltage not specified<br>60 W | at 22 V<br>60 W |
| Power heating plate | 150 W ± 5 % | 150 W | 150 W |
| Heating plate<br>overheat protector | $130°C ± 4°C$ | $118 ± 6 °C$ | $118 ± 6 °C$ |
| Max gas input<br>temperature | $31°C$ | $29.5°C$ | $31°C$ |
| Max water input<br>temperature | $37°C$ | $37°C$ | $37°C$ |
| Chamber insertion<br>detection | HAMILTON-H900 is able to<br>detect if a chamber is inserted | No chamber detection available | No chamber detection available |
| Water level detection | High and Low water level can<br>be detected via optical sensors<br>reaching into the water.<br>- Low water level: 5 minutes<br>alarm delay<br>- high water level: immediate<br>alarm | No water level detection<br>available | Only insufficient water in the<br>chamber is detected by<br>measuring the amount of power<br>used to obtain the chamber<br>temperature<br>- Up to 15 minutes to generate<br>an alarm |
| Breathing circuit<br>recognition | Via electrical connectors inside<br>the breathing tubes | No breathing circuit recognition | Via electrical connectors inside<br>the breathing tubes |
| Single use / Reuse | Compatible with single use and<br>reusable breathing circuits | Compatible with single use and<br>reusable breathing circuits | Compatible with single use and<br>reusable breathing circuits |
| Classification | Class I (in accordance with IEC<br>60601-1) | Class I (in accordance with IEC<br>60601-1) | Class I (in accordance with IEC<br>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 /<br>Performance | - IEC 60601-1<br>- IEC 60601-1-2<br>- IEC 60601-1-4<br>- IEC 60601-1-8<br>- ISO 8185:2007<br>- ISO 10993<br>- MILSTD 461F<br>- ISO 14971<br>- IEC 62304<br>- IEC 62366<br>- ISO 5356-1<br>- ISO 5367 | - CSA-C22.2 No.125<br>- UL2601<br>- IEC60601-1, AS3200.1<br>- EN 60601-1 | - AS/NZS 3200.1.0<br>- CAN/CSA-22.2 No.601.1<br>- UL60601-1<br>- IEC 60601-1<br>- EN 60601-1 |
Table 1: Comparison table of humidifier characteristics and specifications
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Image /page/7/Picture/1 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circle with a stylized "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
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Image /page/8/Picture/1 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on the top line and "MEDICAL" on the second line. Below the logo is the text "Intelligent Ventilation since 1983".
### Table 2: HAMILTON-BC8022 and HAMILTON-BC4022 Comparison table of humidifier breathing circuits characteristics and specifications
| Characteristic used<br>for comparison | HAMILTON-BC8022 /<br>HAMILTON-BC4022 | Predicate Device:<br>F&P RT380 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K152029 | K122432 |
| Device name | HAMILTON-BC8022<br>HAMILTON-BC4022 | RT380 |
| Description | HAMILTON-BC8022, breathing circuit set, dual<br>limb, heated with water chamber<br>HAMILTON-BC4022, breathing circuit set, single<br>limb, heated with water chamber | Dual Limb Adult Breathing Circuit Kit with<br>Evaqua 2 Technology |
| Classification No. &<br>Product code | 868.5270,<br>BZE | 868.5270,<br>BZE |
| Intended use | The HAMILTON-BC8022 breathing set is<br>intended to be used together with compatible<br>Hamilton Medical respiratory gas humidifiers<br>during invasive and noninvasive mechanical<br>ventilation of adult and pediatric patients > 10<br>kg.<br>The HAMILTON-BC4022 breathing set is<br>intended to be used together with compatible<br>Hamilton Medical respiratory gas humidifiers<br>during invasive and noninvasive mechanical<br>ventilation of adult and pediatric patients > 10 kg | The RT380 and RT385 'Adult Evaqua 2' dual-<br>heated breathing circuits are intended as<br>conduits of breathing gas for ventilation of adult<br>patients, and to maintain the temperature of<br>humidified inspired gas. |
| Indications for use | invasive and noninvasive ventilation | Patients requiring respiratory support |
| Compatibility with<br>other devices | Hamilton Medical compatible humidifier such as<br>HAMILTON-H900 | Compatible with 700 series and MR 850<br>humidifiers (specification sheet) |
| Environment | during invasive and noninvasive mechanical<br>ventilation, hospital use by trained personnel | Intensive Care environment in conjunction with<br>life support equipment |
| Target / Patient<br>population | Adult and pediatric patients requiring mechanical<br>ventilation or positive pressure breathing<br>assistance | Adult patients requiring respiratory support. |
| Compressible volume | 1600 ml (BC8022)<br>1000 ml (BC4022) | 1600 ml |
| maximum chamber<br>operating pressure | 20 kPa | 8 kPa (specification sheet) |
| Length | - inspiration 1.95m<br>- expiration 1.95m | - inspiration 1.5m<br>- expiration 1.5m |
| Inner diameter | 19 mm | 22 mm |
| Flow range | 4 to 120 L/min<br>- invasive max. 60 L/min<br>- noninvasive max. 120 L/min | - invasive 60 L/min<br>- noninvasive 120 L/min (MR850) |
| Rated flow | 2 cmH2O @ 85 L/min (BC8022)<br>2 cmH2O @ 125 L/min (BC4022) | 40 l/ min, ≤ 0.2 kPa |
| Flow resistance | BC8022 (@ 30L/min)<br>Inspiration: 0.3 cmH2O<br>Expiration: 0.15 cmH20<br>BC4022 (@ 30L/min)<br>Inspiration: 0.2 cmH2O (inkl. chamber) | RT380 @ 30 L/min<br>Inspiration: 0.91 cmH20<br>Expiration: 0.23 cmH20 |
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Image /page/9/Picture/1 description: The image shows the logo for Hamilton Medical. The words "HAMILTON" and "MEDICAL" are stacked on top of each other in a bold, blue font. Below the logo, the words "Intelligent Ventilation since 1983" are written in a smaller, lighter blue font.
| Characteristic used<br>for comparison | HAMILTON-BC8022 /<br>HAMILTON-BC4022 | Predicate Device:<br>F&P RT380 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Gas leakage | < 50 mL/min @ 60 cmH20 (BC8022)<br>< 25 mL/min @ 60 cmH20 (BC4022) | < 11 mL/min |
| Compliance | <1 ml/cmH2O/m | 2.10 ml/cmH20 |
| Wire resistance | - Inspiration: 15.35 ±1.23 Ω<br>- expiration: 16.45 ±1.23 Ω | - Inspiratory 17.5 Ω<br>- Expiratory 22.6 Ω |
| Connector | - Interface connections conical according to ISO<br>5356-1<br>- Electrical connector part of breathing tube | Interface connections conical according to ISO<br>-<br>5356-1<br>- Electrical connector part of breathing tube |
| Breathing circuit<br>recognition | Tubes can be recognized with a Hamilton<br>Medical Humidifier | No tube recognition |
| Sterility | Non Sterile, Ready for use | Non Sterile, Ready for use |
| Single use / Reuse | Single Use | Single Use |
| Power heated tube | 31.53W inspiratory tube @100% power<br>(BC8022/BC4022)<br>29.39W expiratory tube @100% power<br>(BC8022) | 27.66W inspiratory tube @100% power<br>21.42W expiratory tube @1…
