(297 days)
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.
The Hybernite RT is a breathing system heater according to 21 CFR§ 868.5270. A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway. The Device family "Hybernite RT" is the name for dual wire passive heated breathing circuits optimized for patient category and application. The Hybernite RT is optimized for 3 patient categories, adult, paediatric and neonatal. Within each patient category there is a dual limb and single limb version to accommodate the specific clinical application as tabulated below; the device is intended to act as a conduit for the breathing gasses delivered from the ventilator to the humidifier, from the humidifier to the patient and if applicable from the patient to the ventilator. The product family of Hybernite RT is defined as the combination of non- heated and heated breathing tubes intended to deliver the desire air temperature at the patient port when used in combination with a Humidifier. The Hybernite RT tubing has a range of tubing dimensions (Internal diameter from 10 mm to 22 mm and length from 0.3 meter to 2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element. All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification. The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated. The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to the Hybernite RT. All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors. The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.
The provided document is a 510(k) summary for the Hybernite RT, a heated breathing circuit. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical data and testing conducted.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance that would typically be found in an AI/diagnostic device submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices through compliance with established standards and comparable performance characteristics for a breathing system heater.
The performance characteristics evaluated are:
| Acceptance Criteria (Implied) | Reported Device Performance (Hybernite RT) |
|---|---|
| Material Safety (Biocompatibility) | ISO 10993 compliant; tests for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation, Extractables and leachables. (No risks identified for any patient populations). |
| Device Performance (Breathing Circuit) | Meets design and performance functional requirements. Comparative performance testing with Intersurgical Predicate utilizing Fisher & Paykel MR 850 Heated Humidifier showed equivalence in specified performance characteristics. |
| - Resistance to flow | ISO 5367 compliant |
| - Compliance (mlpa), Tube Volume | ISO 5367 compliant |
| - Gas temperature (Max) | The raising of the gas temperature does not exceed 40°C. |
| Electrical Safety | IEC 60601-1 (Basic safety and essential performance, Electrical, Basic safety and essential performance, Mechanical) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Basic safety and essential performance, EMC) |
| Usability | Subjected to a usability study according to IEC 62366, which demonstrated the utility of the device and user interface for its intended use and environment. |
| Specific Standards Compliance | ISO 5367 (Breathing tubes), ISO 5356-1 (Conical connectors), ISO 8185. |
| Substantial Equivalence to Predicate Device | Demonstrates substantial equivalence and does not raise new safety and effectiveness issues. Shares same intended use, operating principle, basic heated wire breathing circuit design elements, performance characteristics, and applicable standards compliance with predicates. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/diagnostic algorithm using patient data. The testing described is primarily for engineering and safety performance of the physical device.
- Performance Testing: "Comparative performance testing has been done for the Hybernite RT and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated Humidifier." No specific sample size (e.g., number of circuits, number of test runs) is provided, nor is the provenance of this testing (e.g., conducted internally, by a third-party lab, country of origin).
- Biocompatibility Testing: "All materials utilized in the Hybernite RT circuits have been evaluated according to tests outlined in ISO 10993-1." This involves material samples, not a patient test set.
- Usability Study: "The device has been subject to a usability study according to IEC 62366." The number of participants or details of the study are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The device is a heated breathing circuit, and its performance and safety are evaluated against engineering standards and physiological parameters (e.g., temperature, flow resistance), not by expert interpretation of medical images or diagnostic data. Therefore, there is no "ground truth" in the sense of expert consensus on diagnostic findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, there is no test set requiring expert adjudication for ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a physical medical device (heated breathing circuit), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no human-in-the-loop performance study or MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the typical sense for an AI/diagnostic device. For this physical device, "ground truth" for performance is established by objective measurements against harmonized standards (e.g., ISO, IEC) and internal specifications. For instance, temperature measurements are compared against a maximum allowable temperature (40°C), and resistance to flow is measured and compared against ISO 5367 requirements. Biocompatibility is assessed through standardized tests on materials.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set or AI component.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Plastiflex Healthcare Division of Plastiflex Group NV c/o Patsy J. Trisler Regulatory Consultant for Plastiflex Group Belgium Qserve Group, US, Inc. PO Box 940 Charlestown, New Hampshire 03603
Re: K151461
Trade/Device Name: Hybernite RT Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: February 15, 2016 Received: February 16, 2016
Dear Patsy J. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
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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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 HealthcareDivision of Plastiflex Group NV |
| Submitter Address: | Frederic.arien@plastiflex.comBeverlosesteenweg 993583 Paal-BeringenBelgium |
| EstablishmentRegistration Number | 3008331339 |
| Phone Number: | +32 (0) 11 43 58 00 |
| Fax Number: | + 32 (0) 11 43 41 69 |
| Contact Person: | Frédéric Ariën, Project Manager |
| Date Prepared: | 10 February 2016; updated 23 March 2016 |
| Device Trade Name: | Hybernite RT |
| Common Name | Heated Breathing Tube |
| Classification Name,Number &Product Code: | Breathing system heater,868.5270,BZE |
| Predicate Device:Reference Device: | K092129 INTERSURGICAL HEATED WIRE BREATHING SYSTEMK100104 PLASTIFLEX HEALTHCARE HYBERNITE RAINOUTCONTROL SYSTEM |
| Device Description: | Description: The Hybernite RT is a breathing system heater according to21 CFR§ 868.5270. A breathing system heater is identified by the Foodand Drug Administration (FDA) as a therapeutic device that is intendedto warm breathing gases before they enter a patient's airway.The Device family "Hybernite RT" is the name for dual wire passiveheated breathing circuits optimized for patient category and application.The Hybernite RT is optimized for 3 patient categories, adult, paediatricand neonatal. Within each patient category there is a dual limb andsingle limb version to accommodate the specific clinical application astabulated below; the device is intended to act as a conduit for thebreathing gasses delivered from the ventilator to the humidifier, from thehumidifier to the patient and if applicable from the patient to theventilator.The product family of Hybernite RT is defined as the combination ofnon- heated and heated breathing tubes intended to deliver the desireair temperature at the patient port when used in combination with aHumidifier. The Hybernite RT tubing has a range of tubing dimensions(Internal diameter from 10 mm to 22 mm and length from 0.3 meter to |
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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 connectiontubeHeated inspiratory limbHeated expiratory limb |
| Hybernite RT 1100 | Adult | Single limb | Non heated connectiontubeHeated inspiratory limb |
| Hybernite RT 2000 | Paediatric | Dual limb | Non heated connectiontubeHeated inspiratory limbHeated expiratory limb |
| Hybernite RT 2100 | Paediatric | Single limb | Non heated connectiontubeHeated inspiratory limb |
| Hybernite RT 3000 | Neonatal | Dual limb | Non heated connectiontubeHeated inspiratory limb.Build up out an inspiratoryheated tube and unheatedincubator tube.Heated expiratory limb |
| Hybernite RT 3100 | Neonatal | Single limb | Non heated connectiontubeHeated inspiratory limb.Build up out an inspiratoryheated tube and unheatedincubator 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 newissues of safety and effectiveness | |||
|---|---|---|---|
| Non-clinical data | Testing carried out on the Hybernite RT indicates that it meets designand performance functional requirements. The device has been testedaccording to the appropriate ISO and IEC standards includinginternational electrical standards for safety (IEC 60601-1 Basic safetyand essential performance, Electrical, Basic safety and essentialperformance, Mechanical) and performance and test standards forelectromagnetic immunity (IEC 6060-2 Basic safety and essentialperformance, EMC). Tests include Resistance to flow, Compliance,Compressible Volume, and Wire resistance. Performance and safetyrequirements from particular standards for heated breathing tubes: ISO5367, Breathing tubes intended for use with anesthetic apparatus andventilators, and the universal connectors ISO 5356-1, Anaesthetic andrespiratory equipment - Conical connectors: Part 1: Cones and socketshave also been conducted. | ||
| Comparative performance testing has been done for the Hybernite RTand Intersurgical Predicate utilizing the Fisher & Paykel MR 850 HeatedHumidifier, for which both devices have demonstrated compatibility; interms of the specified performance characteristics both devices wereconsidered to be equivalent. | |||
| All materials utilized in the Hybernite RT circuits have been evaluatedaccording 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 IEC62366. The Usability study demonstrated the utility of the device, theuser interface, for the intended use and in the environment in which it isused. | ||
| Conclusion | The information discussed above demonstrates that the new HyberniteRT is substantially equivalent to the predicate device, and the newdevice does not raise any new issues of safety and effectiveness. |
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| Feature | Hybernite RT | IntersurgicalHeated WireBreathing System#1 Predicate | Hybernite RainoutControl SystemReference Device | Impact onSafetyEffectiveness? |
|---|---|---|---|---|
| 510(k) Number | K151461 | K092129 | K100104 | None |
| Manufacturer | Plastiflex Healthcare | IntersurgicalIncorporated | Plastiflex Healthcare | None |
| CFR RegulationNumber | 868.5270, Breathingsystem heater.(a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient'sairway. The devicemay include atemperaturecontroller. | 868.5270, Breathingsystem heater.(a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient'sairway. The devicemay include atemperaturecontroller. | 868.5270, Breathingsystem heater.(a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient'sairway. The devicemay include atemperaturecontroller. | None |
| Product Code | BZE - heaterbreathing systemw/wo controller | BZE - heaterbreathing systemw/wo controller | BZE - heaterbreathing systemw/wo controller | None |
| Classification | Class II,performancestandards | Class II,performancestandards | Class II, performancestandards | None |
| ClassificationPanel | Anesthesiology | Anesthesiology | Anesthesiology | None |
| Intended Use | The Hybernite RTheated breathingcircuits are intendedto carry warmed/moistened gas fromthe humidifier to thepatient's airways.The Hybernite RTbreathing tubes areindicated for patientpopulations fromneonates to adults.They may be usedin the home orhospitalenvironments.They are for singlepatient use only. | Breathing systemheaters are definedas a device that isintended to warmbreathing gasesbefore they enter apatient's airways. | The HyberniteRainout ControlSystem is a heatedbreathing circuitintended to providewarmed and/orhumidified breathinggases beforeentering the patientairway. TheHybernite device isintended forincorporation intoCPAP (continuouspositive airwaypressure) devicesand is intended to actas a conduit for thebreathing gassesdelivered from thehumidifier to thepatient. After the gasis warmed andhumidified in thehumidifier, it isdelivered through the | None |
| Anatomical Site | ||||
| Invasive and Non-invasive | Any patient using a heated humidifier:implies bothinvasive and non-invasive therapies | heated tubing to thepatient. The purposeof the Hybernite is tomaintain or raise thegas temperature to orabove the dew point(of the air exiting thehumidifier) reducingor eliminating watercondensation and/orpooling of water inthe breathing circuit,and problemsassociated with such.The Hybernite isintended to be usedin the home or sleeplab by a singlepatient. It can also beused in conjunctionwith supplementalOxygen and isindicated for use innon-invasiveventilation. | Non-invasive | |
| PatientPopulation | Neo-natal, pediatric, adult | Any patient using aheated humidifier | Adult | |
| Environment ofUse | Home and Hospital | Hospital Setting | Home, Sleep Lab | |
| Mode of Action | When a voltage isapplied, a currentflows through theheating wires. Dueto the wireresistance, heat isdissipated throughthe wall of the tubeconstruction into theair flow in the lumenof the tubing. As aresult, the airpassing through thetubing is warmedreducing oreliminating watercondensation and/orpooling of water inthe breathing circuit. | Applied voltagethrough heatingwires | When a voltage isapplied, a currentflows through theheating wires. Due tothe wire resistance.heat is dissipatedthrough the wall ofthe tube constructioninto the air flow in thelumen of the tubing.As a result, the airpassing through thetubing is warmed toor above the dewpoint (of the airexiting the humidifier)reducing oreliminating watercondensation and/orpooling of water inthe breathing circuit. | |
| None | None.(Hybernite RTsubject to ausability study) | |||
| None.(Hybernite RTsubject to ausability study). | ||||
| None |
Summary Technical Characteristics Comparison Table the Hybernite RT with the Legally Marketed Predicate
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| Energyused/delivered | Due to the wireresistance, heat isdissipated throughthe wall of the tubeconstruction into theair flow in the lumenof the tubing.The raising of thegas temperaturedoes not exceed40°C. | Rising of thedelivered gastemperature from 37to 40°C increasesits enthalpy | Due to the wireresistance, heat isdissipated throughthe wall of the tubeconstruction into theair flow in the lumenof the tubing. As aresult, the air passingthrough the tubing iswarmed to or abovethe dew point (of theair exiting thehumidifier) reducingor eliminating watercondensation and/orpooling of water inthe breathing circuitThe raising of the gastemperature does notexceed 40°C | None |
|---|---|---|---|---|
| Reusable | No, Disposable.Single patient useonly. | Not specified | YesCleaning Regime:Mild soap and waterafter use | None |
| Sterility | Not sterile | Not Sterile | Not Sterile | None |
| Compatibilitywith multiplehumidifiers,standardconnectors,andhumidificationchambers | Compatible withF&P MR850humidifier, standardconnectors, F&PMR290humidificationchamber | Compatible withF&P MR850humidifier, standardconnectors, 2310humidificationchamber(substantiallyequivalent to F&PMR 290 Compatiblewith MR850humidifier) | Yes, Universal | None |
| Breathinggases specified | Not specified | Not specified | Air & SupplementalOxygen | None |
| Standardbreathingcircuitpolymericmaterials | Yes | Yes | Yes | None |
| Power Source | Humidifier controlled | Humidifiercontrolled | Separate | None |
| Heating Wire | Encased | Encased | Encased | None |
| ActiveController | No, humidifiercontrolled | No, humidifiercontrolled | No, humidifiercontrolled | None |
| Standards ofConformity/Performance | ISO 5367ISO 5356ISO 8185ISO 10993IEC 60601-1IEC 60601-1-2IEC 62366 | ISO 5367ISO 5356ISO 8185ISO 10993IEC 60601-1IEC 60601-1-2 | ISO 5367ISO 5356ISO 8185ISO 10993IEC 60601-1 | None |
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| Compliance(mlpa)Resistance toflow (mb)2Tube Volume | ISO 5367 compliant | ISO 5367 compliant | ISO 5367 Compliant | None |
|---|---|---|---|---|
| Biocompatibilty | ISO 10993, testsfor:Cytotoxicity,Sensitization,Irritation,Genotoxicity,Implantation,Extractables andleachables | ISO 10993, testsfor:Cytotoxicity,Sensitization,Irritation,Genotoxicity,Implantation | ISO 10993, tests for:Cytotoxicity,Sensitization,Irritation,Genotoxicity,Implantation | None.Hybernite RT ismanufacturedunder the sameconditions andusing the sameprocess, andmaterials as theReferencedevice.Hybernite RThas alsocompleted E&Ltesting and riskassessment.No risksidentified forany of thepatientpopulations. |
| Usability | Usability testingconducted to IEC62366 | None | None | None |
§ 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).