Hybernite RT

K151461 · Plastiflex Group NV · BZE · Mar 24, 2016 · Anesthesiology

Device Facts

• Record ID: K151461
• Device Name: Hybernite RT
• Applicant: Plastiflex Group NV
• Product Code: BZE · Anesthesiology
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Hybernite RT is a dual-wire passive heated breathing circuit; functions as a conduit for breathing gases delivered from a ventilator to a humidifier, then to the patient. Device consists of single-limb, single-lumen smooth-bore tubing with two embedded heater wires; wires are physically separated from the lumen. When voltage is applied by an external humidifier, current flows through wires; heat dissipates through tube walls into the airflow to warm gases and prevent condensation/pooling. Device includes flow and temperature probe ports for connection to humidifier sensors; humidifier regulates power. Used in hospital or home environments; operated by clinicians or patients. Benefits include reduced condensation in breathing circuits. Single patient use.

Clinical Evidence

No clinical data required. Bench testing included resistance to flow, compliance, compressible volume, and wire resistance per ISO 5367 and ISO 5356-1. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Biocompatibility evaluated per ISO 10993-1. Usability study conducted per IEC 62366.

Technological Characteristics

Heated breathing circuit with embedded heater wires; spiral tube construction. Materials ISO 10993 compliant. Dimensions: 10-22mm ID, 0.3-2.4m length. Power source: external humidifier-controlled. Connectivity: standard male/female connectors for ventilators/masks. Standards: ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, IEC 62366. Non-sterile.

Indications for Use

Indicated for patient populations from neonates to adults requiring warmed/moistened gas delivery via breathing circuits in home or hospital environments.

Regulatory Classification

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.

Predicate Devices

• INTERSURGICAL HEATED WIRE BREATHING SYSTEM (K092129)

Reference Devices

• PLASTIFLEX HEALTHCARE HYBERNITE RAINOUT CONTROL SYSTEM (K100104)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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)

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# 510(k) Summary

| 510(k) Summary | K151461 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Plastiflex Healthcare<br>Division of Plastiflex Group NV |
| Submitter Address: | [e-mail]<br>Beverlosesteenweg 99<br>3583 Paal-Beringen<br>Belgium |
| Establishment<br>Registration Number | 3008331339 |
| Phone Number: | [phone] |
| 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,<br>Number &<br>Product Code: | Breathing system heater,<br>868.5270,<br>BZE |
| Predicate Device:<br>Reference Device: | K092129 INTERSURGICAL HEATED WIRE BREATHING SYSTEM<br>K100104 PLASTIFLEX HEALTHCARE HYBERNITE RAINOUT<br>CONTROL SYSTEM |
| Device Description: | Description: The Hybernite RT is a breathing system heater according to<br>21 CFR§ 868.5270. A breathing system heater is identified by the Food<br>and Drug Administration (FDA) as a therapeutic device that is intended<br>to warm breathing gases before they enter a patient's airway.<br>The Device family "Hybernite RT" is the name for dual wire passive<br>heated breathing circuits optimized for patient category and application.<br>The Hybernite RT is optimized for 3 patient categories, adult, paediatric<br>and neonatal. Within each patient category there is a dual limb and<br>single limb version to accommodate the specific clinical application as<br>tabulated below; the device is intended to act as a conduit for the<br>breathing gasses delivered from the ventilator to the humidifier, from the<br>humidifier to the patient and if applicable from the patient to the<br>ventilator.<br>The product family of Hybernite RT is defined as the combination of<br>non- heated and heated breathing tubes intended to deliver the desire<br>air temperature at the patient port when used in combination with a<br>Humidifier. The Hybernite RT tubing has a range of tubing dimensions<br>(Internal diameter from 10 mm to 22 mm and length from 0.3 meter to |

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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<br>tube<br>Heated inspiratory limb<br>Heated expiratory limb |
| Hybernite RT 1100 | Adult | Single limb | Non heated connection<br>tube<br>Heated inspiratory limb |
| Hybernite RT 2000 | Paediatric | Dual limb | Non heated connection<br>tube<br>Heated inspiratory limb<br>Heated expiratory limb |
| Hybernite RT 2100 | Paediatric | Single limb | Non heated connection<br>tube<br>Heated inspiratory limb |
| Hybernite RT 3000 | Neonatal | Dual limb | Non heated connection<br>tube<br>Heated inspiratory limb.<br>Build up out an inspiratory<br>heated tube and unheated<br>incubator tube.<br>Heated expiratory limb |
| Hybernite RT 3100 | Neonatal | Single limb | Non heated connection<br>tube<br>Heated inspiratory limb.<br>Build up out an inspiratory<br>heated tube and unheated<br>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

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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).

●

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

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

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

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| Energy<br>used/delivered | Due to the wire<br>resistance, heat is<br>dissipated through<br>the wall of the tube<br>construction into the<br>air flow in the lumen<br>of the tubing.<br>The raising of the<br>gas temperature<br>does not exceed<br>40°C. | Rising of the<br>delivered gas<br>temperature from 37<br>to 40°C increases<br>its enthalpy | Due to the wire<br>resistance, heat is<br>dissipated through<br>the wall of the tube<br>construction into the<br>air flow in the lumen<br>of the tubing. As a<br>result, the air passing<br>through the tubing is<br>warmed to or above<br>the dew point (of the<br>air exiting the<br>humidifier) reducing<br>or eliminating water<br>condensation and/or<br>pooling of water in<br>the breathing circuit<br>The raising of the gas<br>temperature does not<br>exceed 40°C | None |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Reusable | No, Disposable.<br>Single patient use<br>only. | Not specified | Yes<br>Cleaning Regime:<br>Mild soap and water<br>after use | None |
| Sterility | Not sterile | Not Sterile | Not Sterile | None |
| Compatibility<br>with multiple<br>humidifiers,<br>standard<br>connectors,<br>and<br>humidification<br>chambers | Compatible with<br>F&P MR850<br>humidifier, standard<br>connectors, F&P<br>MR290<br>humidification<br>chamber | Compatible with<br>F&P MR850<br>humidifier, standard<br>connectors, 2310<br>humidification<br>chamber<br>(substantially<br>equivalent to F&P<br>MR 290 Compatible<br>with MR850<br>humidifier) | Yes, Universal | None |
| Breathing<br>gases specified | Not specified | Not specified | Air & Supplemental<br>Oxygen | None |
| Standard<br>breathing<br>circuit<br>polymeric<br>materials | Yes | Yes | Yes | None |
| Power Source | Humidifier controlled | Humidifier<br>controlled | Separate | None |
| Heating Wire | Encased | Encased | Encased | None |
| Active<br>Controller | No, humidifier<br>controlled | No, humidifier<br>controlled | No, humidifier<br>controlled | None |
| Standards of<br>Conformity/<br>Performance | ISO 5367<br>ISO 5356<br>ISO 8185<br>ISO 10993<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 62366 | ISO 5367<br>ISO 5356<br>ISO 8185<br>ISO 10993<br>IEC 60601-1<br>IEC 60601-1-2 | ISO 5367<br>ISO 5356<br>ISO 8185<br>ISO 1099…