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 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.

Device Description

The Device family "Hybernite Rainout Control System" is the name for a heated tubing system consisting of a heated tube and power supply. 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 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 the problems associated with such condensation. The Hybernite heated breathing tube has standard cuffs on both the machine-end cuff and mask-end cuff. As such, the Hybernite heated breathing tube can be connected to heated humidifiers and flow generators that have standard male outlet connectors.

AI/ML Overview

The Plastiflex Healthcare Hybernite Rainout Control System (K100104) is a heated breathing tube intended to provide warmed and/or humidified breathing gases for CPAP devices.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in a quantitative manner (e.g., specific thresholds for temperature maintenance or condensation reduction). Instead, it states that the device "meets design and performance functional requirements" and complies with relevant international standards.

Here's a summary of the implicit acceptance criteria based on the device's intended use and comparison with predicate devices, and the general statement of performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Requirement: Maintain or raise gas temperature to or above the dew point of air exiting the humidifier.	"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 and the problems associated with such condensation." and "Testing carried out on the Hybernite indicates that it meets design and performance functional requirements."
Functional Requirement: Reduce or eliminate water condensation and/or pooling in the breathing circuit.	"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 and the problems associated with such condensation." and "Testing carried out on the Hybernite indicates that it meets design and performance functional requirements."
Safety Standard Compliance: Electrical safety and essential performance (IEC 60601-1).	"It meets the requirements of international electrical standards for safety and performance, IEC 60601-1..."
Performance Standard Compliance: Breathing tubes for anesthetic apparatus and ventilators (ISO 5367).	"...and performance and safety requirements from particular standards for heated breathing tubes: ISO 5367..."
Universal Connector Compliance: Conical connectors (ISO 5356-1).	"...and the universal connectors are in compliance with ISO 5356-1..."
Biocompatibility/Material Suitability: Polymeric materials suitable for medical purposes.	"The device is made of polymeric materials which have been selected on their suitability for medical purpose."
Equivalence to Predicate Devices: As safe, effective, and performs as well as (or better than) predicate devices (K071958 and K041900) regarding intended use, mode of action, and applicable standards. The detailed comparison table in the submission implicitly serves as the criteria for substantial equivalence.	"The information discussed above demonstrates that the Hybernite Rainout Control System is as safe, as effective, and performs as well as or better than the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical or performance testing data with a defined sample size. The testing carried out seems to be primarily bench testing for functional requirements and compliance with standards. It does not mention clinical data or patient-specific data provenance (e.g., country of origin, retrospective/prospective). The document explicitly states: "Clinical data was not required for this submission."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Given that "Clinical data was not required for this submission" and the testing primarily involved compliance with engineering and performance standards (e.g., IEC, ISO), there is no mention of experts (like radiologists) establishing ground truth for a clinical test set. The "ground truth" for this device's performance is based on the adherence to established engineering and medical device standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is mentioned. The assessment is based on compliance testing against predefined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data was not required for this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a heated breathing tube, not an AI/algorithm-based diagnostic or therapeutic system. Its performance is inherent to its physical design, materials, and electrical heating mechanism.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

Engineering and Performance Standards: Compliance with international standards such as IEC 60601-1, ISO 5367, and ISO 5356-1.
Functional Requirements: Demonstrating the ability to warm air above the dew point and reduce condensation through bench testing.
Material Suitability: Selection of polymeric materials suitable for medical applications.
Substantial Equivalence: Comparison to legally marketed predicate devices, implying that their established safety and effectiveness serve as a benchmark.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/machine learning algorithm, this question is not relevant.

Summary

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K100104

Submitter: Plastiflex Healthcare .

510(k) Summary

Submitter Name:	Plastiflex Group NVDivision: Plastiflex Healthcarerik.langerock@plastiflex.com	APR 1 4 2010
Submitter Address:	Beverlosesteenweg 993583 Paal-BeringenBelgium
EstablishmentRegistration Number	Not yet obtained
Phone Number:	+32 (0) 11 43 58 00
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,Number &Product Code:	Breathing system heater,868.5270,BZE
Predicate Devices:	K071958 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL ANDSINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITSK041900 F&P HC 600 CPAP HUMIDIFIER including the Thermosmart® heatedtubing
Device Description andStatement of IntendedUse	Description: The Device family "Hybernite Rainout Control System" is the namefor a heated tubing system consisting of a heated tube and power supply. Theheated tubing comprises a single limb single lumen smooth bore tube containing2 heater wires that are embedded in the tubing construction. The heating wiresare 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 isdissipated through the wall of the tube construction into the air flow in the lumenof the tubing. As a result, the air passing through the tubing is warmed to orabove the dew point (of the air exiting the humidifier) reducing or eliminatingwater condensation and/or pooling of water in the breathing circuit and theproblems associated with such condensation. The Hybernite heated breathingtube 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 withmultiplehumidifiers(standardconnectors)	passing through the tubing is warmed to orabove the dew point (of the air exiting thehumidifier) reducing or eliminating watercondensation and/or pooling of water in thebreathing circuit.	circuits may be comprised of a dual limb orsingle limb circuit. The purpose of the heatedwire ventilator breathing circuits is to maintain orraise the gas temperature to or above the dewpoint reducing or eliminating water condensationand/or pooling of water in the breathing circuit.	humidifier. The purpose of the heatedwire breathing circuits is to maintain orraise the gas temperature to or above thedew point reducing or eliminating watercondensation and/or pooling of water inthe breathing circuit.
Manufacturer	Plastiflex Healthcare	Smiths Medical	Fisher & Pykel Healthcare	Breathing gasesspecified	YesCleaning Regime: Mild soap and water afteruse	DisposableFor use with the Thera-Heat TM HeatedHumidifier	YesCleaning Regime: Mild soap and waterafter useFor use with the HC 600 CPAPHumidifier.
Classification # &Product Code	868.5270,BZE	868.5270,BZE (for heated tubing)	BZDTubing not separately coded!	Standardbreathing circuitpolymericmaterials	Yes, Universal	General Breathing Gases	Air & Supplemental Oxygen
Intended Use	The Hybernite Rainout Control System is aheated breathing circuit intended to providewarmed and/or humidified breathing gasesbefore entering the patient airway. TheHybernite device is intended for incorporationinto CPAP (continuous positive airwaypressure) devices and is intended to act as aconduit for the breathing gasses deliveredfrom the humidifier to the patient. After thegas is warmed and humidified in thehumidifier, it is delivered through the heatedtubing to the patient. The purpose of theHybernite is to maintain or raise the gastemperature to or above the dew point (of theair exiting the humidifier) reducing oreliminating water condensation and/orpooling of water in the breathing circuit, andproblems associated with such. TheHybernite is intended to be used in the homeor sleep lab by a single patient. It can also beused in conjunction with supplementalOxygen and is indicated for use in non-invasive ventilation.	An adult ventilator Heated Breathing Circuit isintended to warm breathing gases before theyenter a patient's airway when used with theThera-Heat TM Heated Humidifier. The circuitacts as a conduit to warm the gases betweenthe humidification chamber and the patientduring mechanical ventilation or positivepressure breathing assistance for use withinvasive and non invasive breathing systems	"Includes a heated breathing tubeconnected to the device, reducingcondensation or "rain-out" to form in thetube."The device (humidifier) is used to assistwith patient breathing while sleeping forthe purpose of treating Obstructive SleepApnea (OSA). This is done by thedelivery of Continuous Positive AirwayPressure (CPAP) in order to preventairway obstruction. The addition ofheated respiratory humidification to thedevice relieves the drying and irritatingeffects on the patient airways whichusually arises from use of a CPAPsystem. The device is for use on adultpatients at home or in the steep lab.	Power Source	Air & Supplemental Oxygen	Yes	Yes
Mode of Action	When a voltage is applied, a current flowsthrough the heating wires. Due to the wireresistance, heat is dissipated through the wallof the tube construction into the air flow in the	After the gas is warmed and humidified in thehumidification chamber it is delivered throughthe breathing circuit to the patient. Heating ofthe breathing tube is provided and controlled bythe heated humidifier. The heated wire breathing	After the gas is warmed and humidified inthe humidification chamber it is deliveredthrough the breathing circuit to thepatient. Heating of the breathing tube isprovided and controlled by the heated	Heating Wire	Separate	Incorporated	Incorporated
Active Controller	Encased	Exposed in the lumen of the tubing	Encased
Standards ofConformity/Performance	No	Yes	Yes
	ISO 5367 Breathing tubes intended for usewith anaesthetic apparatus and ventilatorsISO 5356-1, Anaesthetic and respiratoryequipment - Conical connectors: Part 1:Cones and sockets.ISO 8185 Respiratory humidificationsystems- requirements (as applicable tobreathing tubes).IEC 60601-1: Medical electrical equipment -Part 1: General requirements for basic safetyand essential performance	Individual standards for the heated breathingtube not specified.IEC 60601-1, IEC60601-2 EMC StandardsIEC 60601-1-4 Software compliance.ISO 8185 Respiratory humidification systems-requirementsASTM 1609 Humidifiers for Medical Use	Individual standards for the heatedbreathing tube not specified.IEC 60601-1, IEC60601-2 EMCStandardsISO 8185 Respiratory humidificationsystems- requirementsASTM 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 (800) 638-2041 or (301) 796-7100 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)
(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

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).