Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of a heated breathing circuit, with no mention of AI or ML. The control of heating is explicitly stated to be regulated by the humidifier based on sensor readings.

Therapeutic

Yes
The "Device Description" explicitly states, "A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway."

Diagnostic

No

The "Hybernite RT" is described as a breathing system heater intended to warm breathing gases, not to diagnose a medical condition. It functions as a conduit for gases and a heating element.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like heated tubing, wires, and connectors, and the performance studies focus on physical characteristics and material biocompatibility, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Hybernite RT heated breathing circuits are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to carry warmed/moistened gas to the patient's airways for therapeutic purposes (warming breathing gases). This is a direct interaction with the patient's respiratory system.
Device Description: The device is described as a "breathing system heater" and is classified under 21 CFR § 868.5270, which is for therapeutic devices. It functions as a heating element for the air being delivered to the patient.
Lack of Diagnostic Function: The description explicitly states that the Hybernite RT does not have sensing functionality. While it connects to sensors on the humidifier, its role is to receive power and heat the air, not to analyze biological samples or provide diagnostic information.
No Mention of Biological Samples: The device's function is related to the delivery of gases, not the collection or analysis of biological samples (like blood, urine, tissue, etc.), which is a key characteristic of IVD devices.

In summary, the Hybernite RT is a therapeutic device used to modify the temperature of breathing gases delivered to a patient, not a device used to perform tests on biological samples to diagnose or monitor a medical condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments. They are for single patient use only.

Product codes (comma separated list FDA assigned to the subject device)

BZE

Device Description

The Hybernite RT is a breathing system heater according to 21 CFR§ 868.5270. A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway. The Device family "Hybernite RT" is the name for dual wire passive heated breathing circuits optimized for patient category and application. The Hybernite RT is optimized for 3 patient categories, adult, paediatric and neonatal. Within each patient category there is a dual limb and single limb version to accommodate the specific clinical application as tabulated below; the device is intended to act as a conduit for the breathing gasses delivered from the ventilator to the humidifier, from the humidifier to the patient and if applicable from the patient to the ventilator. The product family of Hybernite RT is defined as the combination of non- heated and heated breathing tubes intended to deliver the desire air temperature at the patient port when used in combination with a Humidifier. The Hybernite RT tubing has a range of tubing dimensions (Internal diameter from 10 mm to 22 mm and length from 0.3 meter to 2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element. All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification.

The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated. The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to the Hybernite RT. All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors. The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's airways, Invasive and Non-invasive

Indicated Patient Age Range

neonates to adults

Intended User / Care Setting

home or hospital environments

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)

Non-clinical data: Testing carried out on the Hybernite RT indicates that it meets design and performance functional requirements. The device has been tested according to the appropriate ISO and IEC standards including international electrical standards for safety (IEC 60601-1 Basic safety and essential performance, Electrical, Basic safety and essential performance, Mechanical) and performance and test standards for electromagnetic immunity (IEC 6060-2 Basic safety and essential performance, EMC). Tests include Resistance to flow, Compliance, Compressible Volume, and Wire resistance. Performance and safety requirements from particular standards for heated breathing tubes: ISO 5367, Breathing tubes intended for use with anesthetic apparatus and ventilators, and the universal connectors ISO 5356-1, Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets have also been conducted.
Comparative performance testing has been done for the Hybernite RT and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated Humidifier, for which both devices have demonstrated compatibility; in terms of the specified performance characteristics both devices were considered to be equivalent.
All materials utilized in the Hybernite RT circuits have been evaluated according to tests outlined in ISO 10993-1.

Usability: The device has been subject to a usability study according to IEC 62366. The Usability study demonstrated the utility of the device, the user interface, for the intended use and in the environment in which it is used.

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.

K092129

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.

K100104

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).

Summary

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 human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

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

March 24, 2016

Plastiflex Healthcare Division of Plastiflex Group NV c/o Patsy J. Trisler Regulatory Consultant for Plastiflex Group Belgium Qserve Group, US, Inc. PO Box 940 Charlestown, New Hampshire 03603

Re: K151461

Trade/Device Name: Hybernite RT Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: February 15, 2016 Received: February 16, 2016

Dear Patsy J. Trisler:

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

1

Page 2 - Patsy J. Trisler

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 the quality systems (QS) 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

510(k) Number (if known) K151461

Device Name

Hybernite RT

Indications for Use (Describe)

The Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments.

They are for single patient use only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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3

510(k) Summary

510(k) Summary	K151461
Submitter Name:	Plastiflex Healthcare
Division of Plastiflex Group NV
Submitter Address:	Frederic.arien@plastiflex.com
Beverlosesteenweg 99
3583 Paal-Beringen
Belgium
Establishment
Registration Number	3008331339
Phone Number:	+32 (0) 11 43 58 00
Fax Number:	+ 32 (0) 11 43 41 69
Contact Person:	Frédéric Ariën, Project Manager
Date Prepared:	10 February 2016; updated 23 March 2016
Device Trade Name:	Hybernite RT
Common Name	Heated Breathing Tube
Classification Name,
Number &
Product Code:	Breathing system heater,
868.5270,
BZE
Predicate Device:
Reference Device:	K092129 INTERSURGICAL HEATED WIRE BREATHING SYSTEM
K100104 PLASTIFLEX HEALTHCARE HYBERNITE RAINOUT
CONTROL SYSTEM
Device Description:	Description: The Hybernite RT is a breathing system heater according to
21 CFR§ 868.5270. A breathing system heater is identified by the Food
and Drug Administration (FDA) as a therapeutic device that is intended
to warm breathing gases before they enter a patient's airway.
The Device family "Hybernite RT" is the name for dual wire passive
heated breathing circuits optimized for patient category and application.
The Hybernite RT is optimized for 3 patient categories, adult, paediatric
and neonatal. Within each patient category there is a dual limb and
single limb version to accommodate the specific clinical application as
tabulated below; the device is intended to act as a conduit for the
breathing gasses delivered from the ventilator to the humidifier, from the
humidifier to the patient and if applicable from the patient to the
ventilator.
The product family of Hybernite RT is defined as the combination of
non- heated and heated breathing tubes intended to deliver the desire
air temperature at the patient port when used in combination with a
Humidifier. The Hybernite RT tubing has a range of tubing dimensions
(Internal diameter from 10 mm to 22 mm and length from 0.3 meter to

4

2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element.

All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification.

Breathing circuit	Patient category	Application	Components
Hybernite RT 1000	Adult	Dual limb	Non heated connection
tube
Heated inspiratory limb
Heated expiratory limb
Hybernite RT 1100	Adult	Single limb	Non heated connection
tube
Heated inspiratory limb
Hybernite RT 2000	Paediatric	Dual limb	Non heated connection
tube
Heated inspiratory limb
Heated expiratory limb
Hybernite RT 2100	Paediatric	Single limb	Non heated connection
tube
Heated inspiratory limb
Hybernite RT 3000	Neonatal	Dual limb	Non heated connection
tube
Heated inspiratory limb.
Build up out an inspiratory
heated tube and unheated
incubator tube.
Heated expiratory limb
Hybernite RT 3100	Neonatal	Single limb	Non heated connection
tube
Heated inspiratory limb.
Build up out an inspiratory
heated tube and unheated
incubator tube.

The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated.

The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to

5

the Hybernite RT.

All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors

The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.

The Hybernite RT heated breathing circuits are intended to carry Indications for Use Statement: warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments. They are for single patient use only.

Summary of Technological Characteristics and Comparison to Predicate devices

The heated tubing consists of a single limb single lumen smooth interior tube containing 2 heater wires that are embedded in the tubing construction of which the tube is formed having a supporting structure; the tube is spiral and the wire has a single loop form. The heating wires are physically separated from the lumen of the tubing. As such, there is no direct contact between the heating wires and the air flow, which contributes significantly to the safety of the device. After the gas is warmed and humidified in the humidifier, it is delivered through the heated tubing to the patient. The purpose of the Hybernite RT is to maintain or raise the gas temperature to the desired patient port temperature. The desired patient port temperature is set, monitored and regulated by the humidifier.

A table comparing the Hybernite RT to the Predicate #1 and Reference device is provided below.

The Hybernite RT circuits have the following similarities to the predicate and reference devices:

Has the same intended use .
. Uses the same operating principle
. Incorporates the same basic heated wire breathing circuit design elements for use with ventilators including physical interfaces.
. Has the same basic performance characteristics
. Complies with the applicable electrical, mechanical, chemical and performance standards, and comparison of the data shows similar values for the kev performance characteristics.
. Is manufactured using the same manufacturing process (Reference device)
. Incorporates the same materials (Reference device) and is ISO 10993 compliant

The differences between the Hybernite RT and predicate device are:

The Indications for the Hybernite includes:
- Use in the patient population to include neonates up to adults.
- . Use in the home, as well as hospital environments, and
- . Single patient use.
. A Usability Study and additional Biocompatibility testing were performed for the Hybernite RT because of the expanded indications (patient population and inclusion of home use).

●

6

| | The new device as designed and manufactured does not raise any new
issues of safety and effectiveness | | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Non-clinical data | Testing carried out on the Hybernite RT indicates that it meets design
and performance functional requirements. The device has been tested
according to the appropriate ISO and IEC standards including
international electrical standards for safety (IEC 60601-1 Basic safety
and essential performance, Electrical, Basic safety and essential
performance, Mechanical) and performance and test standards for
electromagnetic immunity (IEC 6060-2 Basic safety and essential
performance, EMC). Tests include Resistance to flow, Compliance,
Compressible Volume, and Wire resistance. Performance and safety
requirements from particular standards for heated breathing tubes: ISO
5367, Breathing tubes intended for use with anesthetic apparatus and
ventilators, and the universal connectors ISO 5356-1, Anaesthetic and
respiratory equipment - Conical connectors: Part 1: Cones and sockets
have also been conducted. | | |
| | Comparative performance testing has been done for the Hybernite RT
and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated
Humidifier, for which both devices have demonstrated compatibility; in
terms of the specified performance characteristics both devices were
considered to be equivalent. | | |
| | All materials utilized in the Hybernite RT circuits have been evaluated
according to tests outlined in ISO 10993-1. | | |
| | Further details are provided in the Table below. | | |
| Clinical data | Clinical data was not required for this submission. | | |
| Usability | The device has been subject to a usability study according to IEC
62366. The Usability study demonstrated the utility of the device, the
user interface, for the intended use and in the environment in which it is
used. | | |
| Conclusion | The information discussed above demonstrates that the new Hybernite
RT is substantially equivalent to the predicate device, and the new
device does not raise any new issues of safety and effectiveness. | | |

7

| Feature | Hybernite RT | Intersurgical
Heated Wire
Breathing System
#1 Predicate | Hybernite Rainout
Control System
Reference Device | Impact on
Safety
Effectiveness? |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K151461 | K092129 | K100104 | None |
| Manufacturer | Plastiflex Healthcare | Intersurgical
Incorporated | Plastiflex Healthcare | None |
| CFR Regulation
Number | 868.5270, Breathing
system heater.
(a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's
airway. The device
may include a
temperature
controller. | 868.5270, Breathing
system heater.
(a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's
airway. The device
may include a
temperature
controller. | 868.5270, Breathing
system heater.
(a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's
airway. The device
may include a
temperature
controller. | None |
| Product Code | BZE - heater
breathing system
w/wo controller | BZE - heater
breathing system
w/wo controller | BZE - heater
breathing system
w/wo controller | None |
| Classification | Class II,
performance
standards | Class II,
performance
standards | Class II, performance
standards | None |
| Classification
Panel | Anesthesiology | Anesthesiology | Anesthesiology | None |
| Intended Use | The Hybernite RT
heated breathing
circuits are intended
to carry warmed/
moistened gas from
the humidifier to the
patient's airways.
The Hybernite RT
breathing tubes are
indicated for patient
populations from
neonates to adults.
They may be used
in the home or
hospital
environments.
They are for single
patient use only. | Breathing system
heaters are defined
as a device that is
intended to warm
breathing gases
before they enter a
patient's airways. | The Hybernite
Rainout Control
System is a heated
breathing circuit
intended to provide
warmed and/or
humidified breathing
gases before
entering the patient
airway. The
Hybernite device is
intended for
incorporation into
CPAP (continuous
positive airway
pressure) devices
and is intended to act
as a conduit for the
breathing gasses
delivered from the
humidifier to the
patient. After the gas
is warmed and
humidified in the
humidifier, it is
delivered through the | None |
| | Anatomical Site | | | |
| | Invasive and Non-invasive | Any patient using a heated humidifier:
implies both
invasive and non-invasive therapies | heated tubing to the
patient. The purpose
of the Hybernite is to
maintain or raise the
gas temperature to or
above the dew point
(of the air exiting the
humidifier) reducing
or eliminating water
condensation and/or
pooling of water in
the breathing circuit,
and problems
associated with such.
The Hybernite is
intended to be used
in the home or sleep
lab by a single
patient. It can also be
used in conjunction
with supplemental
Oxygen and is
indicated for use in
non-invasive
ventilation. | Non-invasive |
| Patient
Population | Neo-natal, pediatric, adult | Any patient using a
heated humidifier | | Adult |
| Environment of
Use | Home and Hospital | Hospital Setting | | Home, Sleep Lab |
| Mode of Action | When a voltage is
applied, a current
flows through the
heating wires. Due
to the wire
resistance, heat is
dissipated through
the wall of the tube
construction into the
air flow in the lumen
of the tubing. As a
result, the air
passing through the
tubing is warmed
reducing or
eliminating water
condensation and/or
pooling of water in
the breathing circuit. | Applied voltage
through heating
wires | | When a voltage is
applied, a current
flows through the
heating wires. Due to
the wire resistance.
heat is dissipated
through the wall of
the tube construction
into the air flow in the
lumen of the tubing.
As a result, the air
passing through the
tubing is warmed to
or above the dew
point (of the air
exiting the humidifier)
reducing or
eliminating water
condensation and/or
pooling of water in
the breathing circuit. |
| | | | None | None.
(Hybernite RT
subject to a
usability study) |
| | | | | None.
(Hybernite RT
subject to a
usability study). |
| | | | | None |

Summary Technical Characteristics Comparison Table the Hybernite RT with the Legally Marketed Predicate

8

9

| Energy
used/delivered | Due to the wire
resistance, heat is
dissipated through
the wall of the tube
construction into the
air flow in the lumen
of the tubing.
The raising of the
gas temperature
does not exceed
40°C. | Rising of the
delivered gas
temperature from 37
to 40°C increases
its enthalpy | Due to the wire
resistance, heat is
dissipated through
the wall of the tube
construction into the
air flow in the lumen
of the tubing. As a
result, the air passing
through the tubing is
warmed to or above
the dew point (of the
air exiting the
humidifier) reducing
or eliminating water
condensation and/or
pooling of water in
the breathing circuit
The raising of the gas
temperature does not
exceed 40°C | None |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Reusable | No, Disposable.
Single patient use
only. | Not specified | Yes
Cleaning Regime:
Mild soap and water
after use | None |
| Sterility | Not sterile | Not Sterile | Not Sterile | None |
| Compatibility
with multiple
humidifiers,
standard
connectors,
and
humidification
chambers | Compatible with
F&P MR850
humidifier, standard
connectors, F&P
MR290
humidification
chamber | Compatible with
F&P MR850
humidifier, standard
connectors, 2310
humidification
chamber
(substantially
equivalent to F&P
MR 290 Compatible
with MR850
humidifier) | Yes, Universal | None |
| Breathing
gases specified | Not specified | Not specified | Air & Supplemental
Oxygen | None |
| Standard
breathing
circuit
polymeric
materials | Yes | Yes | Yes | None |
| Power Source | Humidifier controlled | Humidifier
controlled | Separate | None |
| Heating Wire | Encased | Encased | Encased | None |
| Active
Controller | No, humidifier
controlled | No, humidifier
controlled | No, humidifier
controlled | None |
| Standards of
Conformity/
Performance | ISO 5367
ISO 5356
ISO 8185
ISO 10993
IEC 60601-1
IEC 60601-1-2
IEC 62366 | ISO 5367
ISO 5356
ISO 8185
ISO 10993
IEC 60601-1
IEC 60601-1-2 | ISO 5367
ISO 5356
ISO 8185
ISO 10993
IEC 60601-1 | None |

10

| Compliance
(mlpa)
Resistance to
flow (mb)2

Tube Volume	ISO 5367 compliant	ISO 5367 compliant	ISO 5367 Compliant
Biocompatibilty	ISO 10993, tests
for:
Cytotoxicity,
Sensitization,
Irritation,
Genotoxicity,
Implantation,
Extractables and
leachables	ISO 10993, tests
for:
Cytotoxicity,
Sensitization,
Irritation,
Genotoxicity,
Implantation	ISO 10993, tests for:
Cytotoxicity,
Sensitization,
Irritation,
Genotoxicity,
Implantation	None.
Hybernite RT is
manufactured
under the same
conditions and
using the same
process, and
materials as the
Reference
device.
Hybernite RT
has also
completed E&L
testing and risk
assessment.
No risks
identified for
any of the
patient
populations.
Usability	Usability testing
conducted to IEC
62366	None	None	None