(88 days)
The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients.
It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.
The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP Heated Tubing (THERMALITE) is a heated tube that connects between a continuous positive airway pressure (CPAP) machine and the patient's interface, typically a CPAP mask. The THERMALITE is compatible with the Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers.
The THERMALITE has a unique design that helps prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form. This condition of condensation is commonly known as "rainout," and is usually the result of temperature and humidity differentials between the device versus the surrounding air.
The THERMALITE is available in a three (3) or two (2) wire configuration.
The provided text is a 510(k) Premarket Notification for a medical device called "THERMALITE CPAP Heated Tubing." It details the device's characteristics, indications for use, comparison to a predicate device, and a summary of performance testing. However, it does not contain specific acceptance criteria values or detailed study results in the format typically requested for AI/ML device performance.
Therefore, many of the requested items cannot be fully answered with the provided text. I will answer what is available and indicate where information is missing.
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed based on international standards and guidance documents. It states that "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards and guidance documents" and "Test results indicated that the Exceleron THERMALITE complies with internal requirements, applicable Standards, and the guidance documents." However, it does not provide specific numerical acceptance criteria (e.g., "temperature must be within X +/- Y °C") or the exact reported performance values (e.g., "observed temperature was Z °C").
Acceptance Criteria and Reported Device Performance (as far as available in the text):
| Test Category | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-18, ISO 18562-1, ISO 18562-2, ISO 18562-3, and FDA guidance for biocompatibility evaluation (tests for cytotoxicity, sensitization, irritation, emissions of particulate matter, volatile organic compounds, extractables and leachables). | "Test results indicated that the indirect patient-contact materials in the Exceleron THERMALITE complies with the applicable Standards and guidance documents." |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-11. | "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 and FDA guidance for EMC of medical devices. | "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards and guidance documents." |
| Performance Testing (Bench) | Compliance with internal requirements, IEC 60601-1-6, IEC 62366-1, ISO 5356-1, ISO 5367, ISO 80601-2-70, ISO 80601-2-74, and ISTA Procedure 3A. | "Test results indicated that the Exceleron THERMALITE complies with internal requirements, applicable Standards, and the guidance documents." The purpose of the device is to provide "warmed and/or humidified breathing gases" and "prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form." The predicate device description mentions "air passing through the tubing is warmed to or above the dew point (of the air existing the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit 41 °C. The raising of the gas temperature does not exceed." This implies a performance target but no specific results for the subject device are given beyond general compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "test results" and "verification and validation activities" but does not detail the sample sizes for these tests or the data provenance. These are bench tests on the device itself, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is a heated tubing for CPAP machines, not an AI/ML diagnostic or therapeutic device requiring expert interpretation of results or establishment of ground truth from clinical data. The "ground truth" for this type of device is established through engineering and performance specifications and testing against those specifications and relevant international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic data requiring adjudication.
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
This question is not applicable. This is a physical medical device (heated tubing), not a software/AI device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, compliance with international standards (e.g., ISO, IEC), and internal requirements for safety and performance (e.g., biocompatibility limits, electrical safety thresholds, EMC limits, and performance parameters for heating and humidification as defined in the standards). It is not derived from clinical expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. See #8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
August 2, 2024
Exceleron Medical % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr. NE Saint Petersburg, Florida 33704
Re: K241268
Trade/Device Name: THERMALITE CPAP Heated Tubing Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: May 4, 2024 Received: May 6, 2024
Dear Paul Dryden:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241268
Device Name THERMALITE CPAP Heated Tubing
Indications for Use (Describe)
The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients.
It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.
| 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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(in accordance with 21 CFR 807.92)
| Date: | 30 July 2024 |
|---|---|
| Sponsor: | Exceleron Medical, LLC5000 Township ParkwaySaint Paul, MN 55110 USA |
| Keith Roberts - CEOPhone: +1 (877) 834-9279 | |
| Submission Correspondent: | Paul DrydenProMedic, LLCPhone: +1 (239) 307-6061 |
| Trade Name: | THERMALITE® CPAP Heated Tubing |
| Common andClassification Name: | Breathing System, Heater |
| ClassificationRegulation: | 21 CFR §868.5270 |
| Product Code: | BZE |
| Predicate: | K140424Philips Heated CPAP Tube |
| Device Description: | The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP HeatedTubing (THERMALITE) is a heated tube that connects between a continuouspositive airway pressure (CPAP) machine and the patient's interface, typically aCPAP mask. The THERMALITE is compatible with the Philips RespironicsDreamStation 1 and DreamStation 2 heated humidifiers.The THERMALITE has a unique design that helps prevent condensate fromforming within the heated air stream during CPAP therapy by controlling theairflow temperature, creating an environment to maintain water in its vaporform. This condition of condensation is commonly known as "rainout," and isusually the result of temperature and humidity differentials between the deviceversus the surrounding air.The THERMALITE is available in a three (3) or two (2) wire configuration. |
| Indications for Use: | The THERMALITE® CPAP Heated Tubing is a heated wire breathing tubeintended to provide warmed and/or humidified breathing gases before theyenter a patient's airway. It is indicated for single-patient reuse in the home andin clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adultpatients.It is compatible with the Philips Respironics DreamStation 1 and DreamStation2 heated humidifiers. |
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| Manufacturer / Device | Cleared | Reason for Inclusion | Regulation ( Product Code) |
|---|---|---|---|
| Primary PredicatePhilips Respironics ReusableHeated Tubing | K140424 | Same indications for use andsame or similar technology. | 21 CFR §868.5270 (BZE) |
| ReferencePhilips Respironics DreamStation 2 System whichincludes heated tubing | K200480 | Same indications for use andsame or similar technology. | 21 CFR 868.5905 (BZD)But contains heated tubing asan accessory |
Table - Primary Predicate and Reference Devices
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| Characteristics | Primary PredicatePhilips Respironics ReusableHeated Tubing (K140424) | ReferencePhilips RespironicsReusable Heated Tubing(K200480) | Exceleron Medical HeatedCPAP Tube (3 wire design) -Subject Device | Exceleron Medical HeatedCPAP Tube (2 wiredesign) - Subject Device | Discussion ofDifferences |
|---|---|---|---|---|---|
| Indications for Use | The Philips RespironicsReusable Heated Tubing is aheated wire breathing tubeintended to provide warmedand/or humidified breathinggases before they enter apatient's airway. It is indicatedfor single-patient reuse in thehome and multi-patient use inclinical settings, such ashospitals, institutions, sleeplaboratories, and sub- acutecare facilities. It may be usedwith non-invasive ventilationfor patients weighing over 10kg (22lbs).It is compatible with thePhilips Respironics SystemOne Heated Humidifier andPhilips Respironics A-SeriesSystem One HeatedHumidifier. | The heated tube is used, alongwith the heated humidifier, tocontrol the providedhumidification. This isaccomplished by controllingthe temperature of the air inorder to ensure that it does notcool down prior to reachingthe mask. | The Exceleron Heated CPAPTube is a heated wirebreathing tube intended toprovide warmed and/orhumidified breathing gasesbefore they enter a patient'sairway. It is indicated forsingle-patient reuse in thehome and in clinical settings,such as hospitals, institutions,sleep laboratories, and sub-acute care facilities. It may beused with non-invasiveventilation for adult patients.It is compatible with thePhilips Dreamstation 1(K140424) and Dreamstation2(K200480) HeatedHumidifiers | The Exceleron HeatedCPAP Tube is a heated wirebreathing tube intended toprovide warmed and/orhumidified breathing gasesbefore they enter a patient'sairway. It is indicated forsingle-patient reuse in thehome and in clinicalsettings, such as hospitals,institutions, sleeplaboratories, and sub-acutecare facilities. It may beused with non-invasiveventilation for adult patients.It is compatible with thePhilips Dreamstation 1 andDreamstation 2 HeatedHumidifiers. | Similar.Subjectdevicesrestricted to:· Singlepatientreuse.Adult patients. |
| Compatibilitywith Humidifiers,StandardConnectors andHumidificationChambers | The tubing has a proprietaryconnector with two lockingtabs that makes it compatiblewith the Philips RespironicsSystem One Humidifier(K113068) and PhilipsRespironics A-Series SystemOne Heated Humidifier(K121623). | The tubing has a proprietaryconnector with two lockingtabs that makes it compatiblewith the Dreamstation 2 machine. | The tubing has a proprietaryconnector with two lockingtabs that make it compatiblewith the RespironicsDreamstation Series(Dreamstation 1 andDreamstation 2 CPAPmachine (K200480)) | The tubing has a proprietaryconnector with two lockingtabs that make itcompatible with theRespironics DreamstationSeries (Dreamstation 1 andDreamstation 2 CPAPmachine (K200480)) | Similar.Compatibilitywith a subset ofthe devices withwhich thepredicate iscompatible. |
| Anatomical Site | Non-invasive | Non-invasive | Non-invasive | Non-invasive | Same. |
| Characteristics | Primary PredicatePhilips Respironics ReusableHeated Tubing (K140424) | ReferencePhilips RespironicsReusable Heated Tubing(K200480) | Exceleron Medical HeatedCPAP Tube (3 wire design) –Subject Device | Exceleron Medical HeatedCPAP Tube (2 wiredesign) – Subject Device | Discussion ofDifferences |
| PatientPopulation | Patients weighing over 10 kg(22lbs). | Patients weighing more than 66lb (30 kg) | Adult patients | Adult patients | Similar. Deviceis used with asubset of thepredicatedevice's |
| Environment ofUse | Home and hospital | Home and hospital | Home and hospital | Home and hospital | Same. |
| OperatingPrinciple | During use a voltage is appliedand a current flows through theheating wires, encapsulated inthe tubing. Due to the wireresistance, heat is dissipatedthrough the wall of the tubeconstruction into the air flow inthe lumen of the tubing. As aresult, the air passing throughthe tubing is warmed reducingor eliminating watercondensation and/or pooling ofwater in the breathing circuit. | Due to the wire resistance, heatis dissipated through the wallof the tube construction intothe air flow in the lumen of thetubing. As a result, the airpassing through the tubing iswarmed to or above the dewpoint (of the air existing thehumidifier) reducing oreliminating water condensationand/or pooling of water in thebreathing circuit 41 °C.The raising of the gastemperature does not exceed | During use a voltage is appliedand a current flows through theheating wires, encapsulated inthe tubing. Due to the wireresistance, heat is dissipatedthrough the wall of the tubeconstruction into the air flow inthe lumen of the tubing. As aresult, the air passing throughthe tubing is warmed reducingor eliminating watercondensation and/or pooling ofwater in the breathing circuit. | During use a voltage isapplied and a current flowsthrough the heating wires,encapsulated in the tubing.Due to the wire resistance,heat is dissipated through thewall of the tube constructioninto the air flow in the lumenof the tubing. As a result, theair passing through the tubingis warmed reducing oreliminating watercondensation and/or poolingof water in the breathingcircuit. | Same. |
| Characteristics(continued) | Philips Respironics ReusableHeated Tubing (K140424) | Philips RespironicsReusable Heated Tubing(K200480) | Exceleron Heated CPAP Tube(3 wire design) – ProposedDevice | Exceleron Medical HeatedCPAP Tube (2 awire design) -Proposed Device | Discussion ofDifferences |
| Technology | The power is generated by thehumidifier and due to the wireresistance in the device, heat isdissipated through the wall ofthe tube construction into the airflow in the lumen of the tubing.An in-circuit integrated NegativeTemperature Coefficientthermistor (NTC) at the mask-end senses the temperature of thepassing air flow. The resistancecharacteristics of the NTCchanges with temperature andregulates the current through theheated wires and therebyregulates the temperature of thebreathed air. | The power is generated by thehumidifier and due to the wireresistance in the device, heat isdissipated through the wall ofthe tube construction into theair flow in the lumen of thetubing. An in-circuit integratedNegative TemperatureCoefficient thermistor (NTC) atthe mask-end senses thetemperature of the passing airflow. The resistancecharacteristics of the NTCchanges with temperature andregulates the current through theheated wires and therebyregulates the temperature of thebreathed air. | The power is generated by thehumidifier and due to the wireresistance in the device, heat isdissipated through the wall of thetube construction into the air flowin the lumen of the tubing. An in-circuit integrated NegativeTemperature Coefficientthermistor (NTC) at the mask-endsenses the temperature of thepassing air flow. The resistancecharacteristics of the NTCchanges with temperature andregulates the current through theheated wires and thereby regulatesthe temperature of the breathedair. | The power is generated by thehumidifier and due to the wireresistance in the device, heat isdissipated through the wall of thetube construction into the air flowin the lumen of the tubing. An in-circuit integrated NegativeTemperature Coefficientthermistor (NTC) at the machineend. The machine will sense theresistance of the thermistor andwill determine the amount ofvoltage to apply to the heaters toachieve the tubing temperature. | Same with theonly difference onthe 2 wire designis the NTC is atthe machine endand provides thesame voltageregulation through the heated wires asboth predicate 3wire designs. |
| Dimensions/specs | Length: 1.83 mmTubing Inner Diameter: 15mm version and 22 mmversionPatient Fitting – 22 mmMachine Fitting - Proprietaryto the humidifier | Length: 1.83 mmTubing Inner Diameter: 15mm version and 22 mmversionPatient Fitting – 22 mmMachine Fitting -Proprietary to the humidifier | Length: 1.83 meter InnerTubing Inner Diameter: 15 mmPatient Fitting – 22 mmMachine Fitting – Proprietary tothe humidifier | Length: 1.83 meter InnerTubing Inner Diameter: 15 mmPatient Fitting – 22 mmMachine Fitting – Proprietaryto the humidifier | Proposeddevice is thesimilar to the15 mmpredicateversions. |
| Characteristics | Primary PredicatePhilips Respironics ReusableHeated Tubing (K140424) | ReferencePhilips RespironicsReusable Heated Tubing(K200480) | Exceleron Medical HeatedCPAP Tube (3 wire design) -Subject Device | Exceleron Medical HeatedCPAP Tube (2 wiredesign) – Subject Device | Discussion ofDifferences |
| Reusable | Single-patient reuse in thehome and multi-patient use inclinical setting | Single patient reuse. | Single patient reuse. | Single patient reuse. | Similar.Proposed deviceis labeled thesame for homeuse and forsingle use onlyin a clinical |
| Power Source | Humidifier controlled | Humidifier controlled | Humidifier controlled | Humidifier controlled | Same. |
| Standards ofConformity /Performance | ISO 5367IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 8185 | ISO 5367IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-70ISO 80601-2-74 | ISO 5367IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-70ISO 80601-2-74 | ISO 5367IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-70ISO 80601-2-74 | Similar.Proposeddevice hasappliedrelevantstandards. |
| Biocompatibility | ISO 10993,tests for: Cytotoxicity,sensitization, irritation,genotoxicity, implantation,extractables and leachables. | ISO 10993-1ISO 18562-1ISO 18562-2ISO 18562-3ISO 18562-4tests for: emissions of particulatematter, emissions of volatileorganic compounds (VOCs) | ISO 10993-1ISO 18562-1ISO 18562-2ISO 18562-3ISO 10993-18tests for: Cytotoxicity,sensitization, irritation,emissions of particulate matter,emissions of volatile organiccompounds (VOCs),extractables and leachables. | ISO 10993-1ISO 18562-1ISO 18562-2ISO 18562-3ISO 10993-18tests for: Cytotoxicity,sensitization, irritation,emissions of particulatematter, emissions of volatileorganic compounds (VOCs),extractables and leachables. | Similar |
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Summary of Performance Testing:
| Biocompatibility | The indirect patient-contact materials in the Exceleron THERMALITE were tested for biocompatibility compliance in accordance with the following Standards and guidance documents:ISO 10993-1: 2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. ISO 10993-18: 2020, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process. ISO 18562-1: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process. ISO 18562-2: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter. ISO 18562-3: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," 04 Sep 20. Test results indicated that the indirect patient-contact materials in the Exceleron THERMALITE complies with the applicable Standards and guidance documents. |
|---|---|
| Electrical Safety | The Exceleron THERMALITE was tested for patient safety in accordance with the following Standards: IEC 60601-1: 2005, Am1: 2012, Am2: 2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60601-1-11: 2020, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Test results indicated that the Exceleron THERMALITE complies with the applicable Standards |
| ElectromagneticCompatibility | The Exceleron THERMALITE was tested for EMC in accordance with thefollowing Standards and guidance documents:IEC 60601-1-2: 2020, Medical Electrical Equipment, Part 1: Part 1-2:General Requirements for Safety – Collateral Standard: ElectromagneticCompatibility-Requirements and Tests. Electromagnetic Compatibility (EMC) of Medical Devices, 06 Jun 22. Test results indicated that the Exceleron THERMALITE complies with theapplicable Standards and guidance documents. |
| Performance Testing –Bench | The Exceleron THERMALITE was tested for performance in accordance withinternal requirements, applicable Standards, and guidance documents. IEC 60601-1-6: 2020, Medical electrical equipment: Generalrequirements for basic safety and essential performance – collateralstandard: Usability. IEC 62366-1: 2020, Medical devices – Application of usabilityengineering to medical devices. ISO 5356-1: 2015, Anaesthetic and respiratory equipment - Conicalconnectors – Part 1: Cones and sockets. ISO 5367: 2014, Anaesthetic and respiratory equipment -- Breathing setsand connectors. |
| Performance Testing –Bench | The Exceleron THERMALITE was tested for performance in accordance withinternal requirements, applicable Standards, and guidance documents. ISO 80601-2-70: 2020, Medical electrical equipment - Part 2-70:Particular requirements for the basic safety and essential performance ofsleep apnoea breathing therapy equipment. ISO 80601-2-74: 2017, Medical electrical equipment - Part 2-74:Particular requirements for basic safety and essential performance ofrespiratory humidifying equipment. ISTA Procedure 3A – 2018, Parcel Delivery System Shipments 150 lb (70kg) or Less. Test results indicated that the Exceleron THERMALITE complies withinternal requirements, applicable Standards, and the guidance documents. |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the Exceleron THERMALITE. Theresults of these activities demonstrate that the Exceleron THERMALITE is assafe and as effective as the predicate device when used in accordance with itsintended use and labeling.Therefore, the Exceleron THERMALITE is considered substantiallyequivalent to the predicate device. |
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§ 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).