HYBERNITE RAINOUT CONTROL SYSTEM

K100104 · Plastiflex Group NV · BZE · Apr 14, 2010 · Anesthesiology

Device Facts

• Record ID: K100104
• Device Name: HYBERNITE RAINOUT CONTROL SYSTEM
• Applicant: Plastiflex Group NV
• Product Code: BZE · Anesthesiology
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 heated tubing to the patient. The purpose of the Hybernite Rainout Control System 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 indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. Hybernite is indicated for non-invasive ventilation.

Device Story

Hybernite Rainout Control System is a heated breathing circuit; consists of a single-limb, single-lumen smooth-bore tube with two embedded heater wires. Device connects to standard CPAP/humidifier outlets. Principle of operation: voltage applied to embedded wires dissipates heat through tube wall into gas lumen; maintains gas temperature at or above dew point to prevent condensation (rainout). Operated by patient in home or sleep-lab. Power supplied by independent AC power source via integrated connector. Benefits: reduces water pooling in circuit; improves patient comfort during non-invasive ventilation. Healthcare providers use the system to manage humidity delivery; output is warmed/humidified gas flow.

Clinical Evidence

Bench testing only. Device met functional requirements and international electrical safety/performance standards, including IEC 60601-1, ISO 5367 (breathing tubes), and ISO 5356-1 (conical connectors). No clinical data required.

Technological Characteristics

Single-limb, single-lumen smooth-bore polymeric tube; two embedded heater wires (single loop form) physically separated from lumen. Independent AC power supply. Standard cuffs (ISO 5356-1). Complies with IEC 60601-1 and ISO 5367.

Indications for Use

Indicated for single adult patients in home or sleep-lab settings requiring non-invasive ventilation or CPAP therapy; compatible with supplemental oxygen.

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

• THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS (K071958)
• F&P HC 600 CPAP HUMIDIFIER (K041900)

Submission Summary (Full Text)

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K100104

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Submitter: Plastiflex Healthcare .

# 510(k) Summary

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| Submitter Name: | Plastiflex Group NV<br>Division: Plastiflex Healthcare<br>[e-mail] | APR 1 4 2010 |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Address: | Beverlosesteenweg 99<br>3583 Paal-Beringen<br>Belgium | |
| Establishment<br>Registration Number | Not yet obtained | |
| Phone Number: | [phone] | |
| Fax Number: | + 32 (0) 11 43 41 69 | |
| Contact Person: | Mr. Rik Langerock, Marketing Manager | |
| Date Prepared: | January 2010 | |
| Device Trade Name: | Hybernite Rainout Control System | |
| Common Name | Heated Breathing Tube | |
| Classification Name,<br>Number &<br>Product Code: | Breathing system heater,<br>868.5270,<br>BZE | |
| Predicate Devices: | K071958 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND<br>SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS<br>K041900 F&P HC 600 CPAP HUMIDIFIER including the Thermosmart® heated<br>tubing | |
| Device Description and<br>Statement of Intended<br>Use | Description: The Device family "Hybernite Rainout Control System" is the name<br>for a heated tubing system consisting of a heated tube and power supply. The<br>heated tubing comprises a single limb single lumen smooth bore tube containing<br>2 heater wires that are embedded in the tubing construction. The heating wires<br>are physically separated from the lumen of the tubing. When a voltage is applied,<br>a current flows through the heating wires. Due to the wire resistance, heat is<br>dissipated through the wall of the tube construction into the air flow in the lumen<br>of the tubing. As a result, the air passing through the tubing is warmed to or<br>above the dew point (of the air exiting the humidifier) reducing or eliminating<br>water condensation and/or pooling of water in the breathing circuit and the<br>problems associated with such condensation. The Hybernite heated breathing<br>tube has standard cuffs on both the machine-end cuff and mask-end cuff. As | |

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such, the Hybernite heated breathing tube can be connected to heated humidifiers and flow generators that have standard male outlet connectors. Intended Use: 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 heated tubing to the patient. The purpose of the Hybernite Rainout Control System 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 indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. Hybernite is indicated for non-invasive ventilation. Summary of The heated tubing consists of a single limb single lumen smooth interior tube Technological 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 Characteristics 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. The device is equipped with an independent power supply i.e. requiring an additional power socket for the lead plug (AC power cord). The power supply is connected to the tube via an integrated connector in the tubing. The lead can be disconnected from the tubing to allow efficient cleaning of the tubing. The device is made of polymeric materials which have been selected on their suitability for medical purpose. A table comparing the Hybernite Rainout Control System to the predicate devices is attached. Non-clinical data Testing carried out on the Hybernite indicates that it meets design and performance functional requirements. It meets the requirements of international electrical standards for safety and performance, IEC 60601-1, and 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 are in compliance with ISO 5356-1, Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets. Clinical data was not required for this submission Clinical data The information discussed above demonstrates that the Hybernite Rainout Conclusion Control System is as safe, as effective, and performs as well as or better than the predicate devices. Declarations This summary includes only information that is also covered in the body of the 510(k).

o This summary does not contain any puffery or unsubstantiated labeling claims.

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This summary does not contain any raw data, i.e., contains only summary 0 data.

- This summary does not contain any trade secret or confidential commercial 0 information.
- This summary does not contain any patient identification information. 0

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Submitter:
Plastiflex Healthcare

# Summary Comparison with Predicate Devices

| Feature | | | | Reusable | | | | | | | | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| 510(k) Number | New | K071958 | K041900 | Compatible with<br>multiple<br>humidifiers<br>(standard<br>connectors) | passing through the tubing is warmed to or<br>above the dew point (of the air exiting the<br>humidifier) reducing or eliminating water<br>condensation and/or pooling of water in the<br>breathing circuit. | circuits may be comprised of a dual limb or<br>single limb circuit. The purpose of the heated<br>wire ventilator breathing circuits is to maintain or<br>raise the gas temperature to or above the dew<br>point reducing or eliminating water condensation<br>and/or pooling of water in the breathing circuit. | humidifier. The purpose of the heated<br>wire breathing circuits is to maintain or<br>raise the gas temperature to or above the<br>dew point reducing or eliminating water<br>condensation and/or pooling of water in<br>the breathing circuit. | | | | | |
| Manufacturer | Plastiflex Healthcare | Smiths Medical | Fisher & Pykel Healthcare | Breathing gases<br>specified | Yes<br>Cleaning Regime: Mild soap and water after<br>use | Disposable<br>For use with the Thera-Heat TM Heated<br>Humidifier | Yes<br>Cleaning Regime: Mild soap and water<br>after use<br>For use with the HC 600 CPAP<br>Humidifier. | | | | | |
| Classification # &<br>Product Code | 868.5270,<br>BZE | 868.5270,<br>BZE (for heated tubing) | BZD<br>Tubing not separately coded! | Standard<br>breathing circuit<br>polymeric<br>materials | Yes, Universal | General Breathing Gases | Air & Supplemental Oxygen | | | | | |
| Intended Use | The Hybernite Rainout Control System is a<br>heated breathing circuit intended to provide<br>warmed and/or humidified breathing gases<br>before entering the patient airway. The<br>Hybernite device is intended for incorporation<br>into CPAP (continuous positive airway<br>pressure) devices and is intended to act as a<br>conduit for the breathing gasses delivered<br>from the humidifier to the patient. After the<br>gas is warmed and humidified in the<br>humidifier, it is delivered through the heated<br>tubing to the patient. The purpose of the<br>Hybernite is to maintain or raise the gas<br>temperature to or above the dew point (of the<br>air exiting the humidifier) reducing or<br>eliminating water condensation and/or<br>pooling of water in the breathing circuit, and<br>problems associated with such. The<br>Hybernite is intended to be used in the home<br>or sleep lab by a single patient. It can also be<br>used in conjunction with supplemental<br>Oxygen and is indicated for use in non-<br>invasive ventilation. | An adult ventilator Heated Breathing Circuit is<br>intended to warm breathing gases before they<br>enter a patient's airway when used with the<br>Thera-Heat TM Heated Humidifier. The circuit<br>acts as a conduit to warm the gases between<br>the humidification chamber and the patient<br>during mechanical ventilation or positive<br>pressure breathing assistance for use with<br>invasive and non invasive breathing systems | "Includes a heated breathing tube<br>connected to the device, reducing<br>condensation or "rain-out" to form in the<br>tube."<br><br>The device (humidifier) is used to assist<br>with patient breathing while sleeping for<br>the purpose of treating Obstructive Sleep<br>Apnea (OSA). This is done by the<br>delivery of Continuous Positive Airway<br>Pressure (CPAP) in order to prevent<br>airway obstruction. The addition of<br>heated respiratory humidification to the<br>device relieves the drying and irritating<br>effects on the patient airways which<br>usually arises from use of a CPAP<br>system. The device is for use on adult<br>patients at home or in the steep lab. | Power Source | Air & Supplemental Oxygen | Yes | Yes | | | | | |
| Mode of Action | When a voltage is applied, a current flows<br>through the heating wires. Due to the wire<br>resistance, heat is dissipated through the wall<br>of the tube construction into the air flow in the | After the gas is warmed and humidified in the<br>humidification chamber it is delivered through<br>the breathing circuit to the patient. Heating of<br>the breathing tube is provided and controlled by<br>the heated humidifier. The heated wire breathing | After the gas is warmed and humidified in<br>the humidification chamber it is delivered<br>through the breathing circuit to the<br>patient. Heating of the breathing tube is<br>provided and controlled by the heated | Heating Wire | Separate | Incorporated | Incorporated | | | | | |
| Active Controller | Encased | Exposed in the lumen of the tubing | Encased | | | | | | | | | |
| Standards of<br>Conformity/<br>Performance | No | Yes | Yes | | | | | | | | | |
| | ISO 5367 Breathing tubes intended for use<br>with anaesthetic apparatus and ventilators<br>ISO 5356-1, Anaesthetic and respiratory<br>equipment - Conical connectors: Part 1:<br>Cones and sockets.<br>ISO 8185 Respiratory humidification<br>systems- requirements (as applicable to<br>breathing tubes).<br>IEC 60601-1: Medical electrical equipment -<br>Part 1: General requirements for basic safety<br>and essential performance | Individual standards for the heated breathing<br>tube not specified.<br>IEC 60601-1, IEC60601-2 EMC Standards<br>IEC 60601-1-4 Software compliance.<br>ISO 8185 Respiratory humidification systems-<br>requirements<br>ASTM 1609 Humidifiers for Medical Use | Individual standards for the heated<br>breathing tube not specified.<br>IEC 60601-1, IEC60601-2 EMC<br>Standards<br>ISO 8185 Respiratory humidification<br>systems- requirements<br>ASTM 1609 Humidifiers for Medical Use | | | | | | | | | |

# Section 5.0: 510(k) Summary

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Submitter:
Plastiflex Healthcare

Section 5.0: 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

# APR 1 4 2010

Plastiflex Group NV C/O Mr. William Greenrose President Oserve America, Incorporated 220 River Road Claremont, New Hampshire 03743

Re: K100104

> Trade/Device Name: Hybernite Rainout Control System Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE Dated: January 11, 2010 Received: January 14, 2010

Dear: Mr. Greenrose:

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.

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## Page 2 - Mr. Greenrose

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, 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): Unknown Device Name: Hybernite Rainout Control System

Indications For Use:

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 heated tubing to the patient. The purpose of the Hybenite Rainout Control System 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 Rainout Control System is indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. The Hybernite Rainout Control System is indicated for non-invasive ventilation.

Prescription Use YES AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign Off) | Page 1 of 1 |

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

4100104 510(k) Number:

Section 4.0

CONFIDENTIAL