(91 days)
Not Found
No
The description focuses on the physical heating mechanism of the tubing and does not mention any AI or ML components for control or analysis.
No.
The device is a heated breathing circuit designed to prevent condensation in CPAP systems by warming breathing gases, rather than directly treating a medical condition.
No
The device is a heated breathing circuit intended to humidify breathing gases and reduce condensation, not to diagnose medical conditions.
No
The device description explicitly states it is a "heated tubing system consisting of a heated tube and power supply," which are hardware components.
Based on the provided text, the Hybernite Rainout Control System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Hybernite's Function: The Hybernite Rainout Control System is a heated breathing circuit that warms and humidifies breathing gases before they enter the patient's airway. Its purpose is to prevent condensation in the breathing circuit.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. It directly interacts with the air being delivered for breathing.
Therefore, the Hybernite Rainout Control System falls under the category of a medical device used for respiratory support, not an IVD.
N/A
Intended Use / 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 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.
Product codes
BZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
home or sleep-lab setting
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Submitter: Plastiflex Healthcare .
510(k) Summary
.
| Submitter Name: | Plastiflex Group NV
Division: Plastiflex Healthcare
rik.langerock@plastiflex.com | APR 1 4 2010 |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Address: | Beverlosesteenweg 99
3583 Paal-Beringen
Belgium | |
| Establishment
Registration 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 AND
SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
K041900 F&P HC 600 CPAP HUMIDIFIER including the Thermosmart® heated
tubing | |
| Device Description and
Statement of Intended
Use | 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 | |
1
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.
2
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
3
Submitter:
Plastiflex Healthcare
Summary Comparison with Predicate Devices
| Feature | Reusable | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | New | K071958 | K041900 | Compatible with | ||||||||
| multiple | ||||||||||||
| humidifiers | ||||||||||||
| (standard | ||||||||||||
| connectors) | 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. | circuits may be comprised of a dual limb or | |||||||||||
| single limb circuit. The purpose of the heated | ||||||||||||
| wire ventilator breathing circuits is to maintain or | ||||||||||||
| raise the gas temperature to or above the dew | ||||||||||||
| point reducing or eliminating water condensation | ||||||||||||
| and/or pooling of water in the breathing circuit. | humidifier. The purpose of the heated | |||||||||||
| wire breathing circuits is to maintain or | ||||||||||||
| raise the gas temperature to or above the | ||||||||||||
| dew point reducing or eliminating water | ||||||||||||
| condensation and/or pooling of water in | ||||||||||||
| the breathing circuit. | ||||||||||||
| Manufacturer | Plastiflex Healthcare | Smiths Medical | Fisher & Pykel Healthcare | Breathing gases | ||||||||
| specified | Yes | |||||||||||
| Cleaning Regime: Mild soap and water after | ||||||||||||
| use | Disposable | |||||||||||
| For use with the Thera-Heat TM Heated | ||||||||||||
| Humidifier | Yes | |||||||||||
| Cleaning Regime: Mild soap and water | ||||||||||||
| after use | ||||||||||||
| For use with the HC 600 CPAP | ||||||||||||
| Humidifier. | ||||||||||||
| Classification # & | ||||||||||||
| Product Code | 868.5270, | |||||||||||
| BZE | 868.5270, | |||||||||||
| BZE (for heated tubing) | BZD | |||||||||||
| Tubing not separately coded! | Standard | |||||||||||
| breathing circuit | ||||||||||||
| polymeric | ||||||||||||
| materials | Yes, Universal | General Breathing Gases | Air & Supplemental Oxygen | |||||||||
| 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 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. | An adult ventilator Heated Breathing Circuit is | |||||||||||
| intended to warm breathing gases before they | ||||||||||||
| enter a patient's airway when used with the | ||||||||||||
| Thera-Heat TM Heated Humidifier. The circuit | ||||||||||||
| acts as a conduit to warm the gases between | ||||||||||||
| the humidification chamber and the patient | ||||||||||||
| during mechanical ventilation or positive | ||||||||||||
| pressure breathing assistance for use with | ||||||||||||
| invasive and non invasive breathing systems | "Includes a heated breathing tube | |||||||||||
| connected to the device, reducing | ||||||||||||
| condensation or "rain-out" to form in the | ||||||||||||
| tube." |
The device (humidifier) is used to assist
with patient breathing while sleeping for
the purpose of treating Obstructive Sleep
Apnea (OSA). This is done by the
delivery of Continuous Positive Airway
Pressure (CPAP) in order to prevent
airway obstruction. The addition of
heated respiratory humidification to the
device relieves the drying and irritating
effects on the patient airways which
usually arises from use of a CPAP
system. The device is for use on adult
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
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 | After the gas is warmed and humidified in the
humidification chamber it is delivered through
the breathing circuit to the patient. Heating of
the breathing tube is provided and controlled by
the heated humidifier. The heated wire breathing | After the gas is warmed and humidified in
the humidification chamber it is delivered
through the breathing circuit to the
patient. Heating of the breathing tube is
provided and controlled by the heated | Heating Wire | Separate | Incorporated | Incorporated | | | | | |
| Active Controller | Encased | Exposed in the lumen of the tubing | Encased | | | | | | | | | |
| Standards of
Conformity/
Performance | No | Yes | Yes | | | | | | | | | |
| | ISO 5367 Breathing tubes intended for use
with anaesthetic apparatus and ventilators
ISO 5356-1, Anaesthetic and respiratory
equipment - Conical connectors: Part 1:
Cones and sockets.
ISO 8185 Respiratory humidification
systems- requirements (as applicable to
breathing tubes).
IEC 60601-1: Medical electrical equipment -
Part 1: General requirements for basic safety
and essential performance | Individual standards for the heated breathing
tube not specified.
IEC 60601-1, IEC60601-2 EMC Standards
IEC 60601-1-4 Software compliance.
ISO 8185 Respiratory humidification systems-
requirements
ASTM 1609 Humidifiers for Medical Use | Individual standards for the heated
breathing tube not specified.
IEC 60601-1, IEC60601-2 EMC
Standards
ISO 8185 Respiratory humidification
systems- requirements
ASTM 1609 Humidifiers for Medical Use | | | | | | | | | |
Section 5.0: 510(k) Summary
4
Submitter:
Plastiflex Healthcare
Section 5.0: 510(k) Summary
ର/6
5
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.
6
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
7
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