(245 days)
The Sunset Heated CPAP Tube 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 non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.
The Sunset Heated CPAP Tube warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Sunset Heated CPAP Tube has a proprietary connector with two locking tabs that makes it compatible with the Respironics System One and with the Respironics Dreamstation series.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Sunset Heated CPAP Tube":
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and study outcomes in the way a clinical trial or a more comprehensive performance study would. Therefore, much of the requested information (like specific numerical performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths) is not explicitly available in this type of regulatory submission.
However, I can extract the general categories of testing performed and the standards met, which imply the acceptance criteria.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria alongside reported device performance values. Instead, it indicates that the device was tested against and meets the requirements of various international and national performance and safety standards. This implies that the acceptance criteria are embedded within these standards.
General Categories of Bench Testing Performed:
| Acceptance Criteria (Implied by Standards Met) | Reported Device Performance Statement |
|---|---|
| Performance of sleep apnea breathing therapy equipment (per ISO 80601-2-70) | Device was tested and meets the requirements of ISO 80601-2-70. |
| Performance with interaction of respiratory humidifying equipment (per ISO 80601-2-74) | Device was tested and meets the requirements of ISO 80601-2-74. |
| Requirements for breathing sets and connectors (per ISO 5367) | Device was tested and meets the requirements of ISO 5367. (ISO 5367 compliant) |
| Electromagnetic compatibility (EMC) (per IEC 60601-1-2) | Device complies with IEC 60601-1-2. |
| Electrical safety testing (per ANSI/AAMI/ES 60601-1) | Device complies with ANSI/AAMI/ES 60601-1. |
| Mechanical safety testing | Bench testing was carried out, implying satisfactory results. (No specific standard cited for "mechanical safety testing" in the performance list, but covered by general safety standards) |
| Human Factors and Usability Engineering (per FDA Guidance) | Usability evaluation was conducted as per the guidance. (Implies satisfactory outcome) |
| Biocompatibility (per ISO 10993-1, ISO 18562 series) | Device meets the requirements of these biocompatibility standards. |
| Electrical & Mechanical safety in home healthcare (per IEC 60601-1-11) | Device complies with IEC 60601-1-11. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify numerical sample sizes for any test sets. The testing described (bench testing, usability testing, biocompatibility) is indicative of engineering and lab-based evaluations rather than patient studies. Therefore, data provenance in terms of country of origin or retrospective/prospective nature isn't applicable in the context typically understood for clinical data. The testing is non-clinical, likely conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of testing described (bench, safety, biocompatibility, usability) typically relies on expert engineers, testers, and potentially human factors specialists, but the document does not detail their numbers or qualifications, nor does it explicitly mention "ground truth" establishment in the context of expert consensus as one would for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is generally not applicable to the types of bench and safety testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or image interpretation where expert disagreement might arise.
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
An MRMC study was not done. This type of study is irrelevant for a heated CPAP tube, as it is a physical medical device, not an AI-based diagnostic or assistive technology for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the "Sunset Heated CPAP Tube" as it is a hardware device (a heated breathing tube), not an algorithm or software. It does not have an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench, safety, and biocompatibility testing, the "ground truth" implicitly refers to compliance with the specified international and national standards. For usability testing, the "ground truth" would be adherence to human factors principles and satisfactory user performance/feedback, but the specific validation method is not detailed beyond stating it was "conducted as per the Guidance."
8. The sample size for the training set
The concept of a "training set" is not applicable here, as the device is a hardware product, not a machine learning model.
9. How the ground truth for the training set was established
As there is no training set mentioned or implied, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2021
Sunset Healthcare Solutions, Inc. % Thomas Kroenke Application Correspondent Speed To Market, Inc. 2235 East Flamingo Road, Suite 201G, Las Vegas, NV 89119 USA
Re: K201418
Trade/Device Name: Sunset Heated CPAP Tube Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: December 22, 2020 Received: December 28, 2020
Dear Thomas Kroenke:
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. 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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201418
Device Name Sunset Heated CPAP Tube
Indications for Use (Describe)
The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidffed 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 non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| I SUBMITTER | |
|---|---|
| Submitter Name: | Sunset Healthcare Solutions. |
| Submitter Address: | 180 N. Michigan Ave, Suite 2000Chicago, IL 60601, US |
| Phone Number: | +1 312-533-2449 |
| Contact Person: | Greg Marler |
| Date Prepared: | January 28, 2021 |
| II. DEVICE | |
| Device Trade Name: | Sunset Heated CPAP Tube |
| Common Name | Breathing system, heater |
| Classification | 21 CFR 868.5270 |
| Product Code: | BZE |
| Review Panel: | Anesthesiology |
| III. PREDICATE DEVICE | K140424, Philips Respironics Reusable Heated Tubing,Respironics, Inc. |
| IV. DEVICE DESCRIPTION | |
| Description | The Sunset Heated CPAP Tube warms air, or breathablegas, as it travels to and from the respiratory patient along thebreathing circuit of a respiratory system. It reducescondensation that can form in breathing circuit.The Sunset Heated CPAP Tube has a proprietary connectorwith two locking tabs that makes it compatible with theRespironics System One and with the RespironicsDreamstation series. |
| Physical Description: | Sunset Heated CPAP Tube: length: 1.83 m, internal diameter 15mmOperating voltage: 3.3 VDCPower consumption: max 5A |
| V. INTENDED USE /INDICATION FOR USESTATEMENT | The Sunset Heated CPAP Tube is a heated wire breathingtube intended to provide warmed and/or humidified breathinggases before they enter a patient's airway. It is indicated forsingle-patient reuse in the home and in clinical settings, suchas hospitals, institutions, sleep laboratories, and sub-acutecare facilities. It may be used with non-invasive ventilation foradult patients. It is compatible with the Philips RespironicsSystem One Heated Humidifier and Philips RespironicsDreamstation Heated Humidifier. |
{4}------------------------------------------------
- VI. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICES
| TechnologicalCharacteristics: | Characteristics | Philips RespironicsReusable Heated Tubing(K140424) | Sunset HealthcareSolutionsHeated CPAP Tube(proposed device) | Discussion ofDifferences |
|---|---|---|---|---|
| Intended Use | The Philips RespironicsReusable Heated Tubingis a heated wire breathingtube intended to providewarmed and/or humidifiedbreathing gases beforethey enter a patient'sairway. It is indicated forsingle-patient reuse in thehome and multi-patientuse in clinical settings,such as hospitals,institutions, sleeplaboratories, and sub-acute care facilities. It maybe used with non-invasiveventilation for patientsweighing over 10 kg(22lbs).It is compatible with the | The Sunset Heated CPAPTube is a heated wirebreathing tube intended toprovide warmed and/orhumidified breathing gasesbefore they enter apatient's airway. It isindicated for single-patientreuse in the home and inclinical settings, such ashospitals, institutions,sleep laboratories, andsub-acute care facilities. Itmay be used with non-invasive ventilation foradult patients.It is compatible with the | Similar.Proposeddevice isrestricted to:• Singlepatientreuse.• Adultpatients. | |
| Philips RespironicsSystem One HeatedHumidifier and PhilipsRespironics A-SeriesSystem One HeatedHumidifier. | Philips RespironicsSystem One HeatedHumidifier and PhilipsRespironics DreamstationHeated Humidifier. | |||
| Compatibilitywith Humidifiers,StandardConnectors andHumidificationChambers | The tubing has aproprietary connector withtwo locking tabs thatmakes it compatible withthe Philips RespironicsSystem One Humidifier(K113068) and PhilipsRespironics A-SeriesSystem One HeatedHumidifier (K121623). | The tubing has aproprietary connector withtwo locking tabs thatmakes it compatible withthe Respironics Systemone (K113068) and withthe RespironicsDreamstation series. | Similar.Compatibilitywith a subsetof the deviceswith which thepredicate iscompatible. | |
| Anatomical Site | Non-invasive | Non-invasive | Same. | |
| PatientPopulation | Patients weighing over 10kg (22lbs). | Adult patients | Similar.Device is usedwith a subsetof thepredicatedevice'spopulation. | |
| Environment ofUse | Home and hospital | Home and hospital | Same. | |
| OperatingPrinciple | During use a voltage isapplied and a current flowsthrough the heating wires,encapsulated in the tubing.Due to the wire resistance,heat is dissipated throughthe wall of the tubeconstruction into the airflow in the lumen of thetubing. As a result, the airpassing through the tubingis warmed reducing oreliminating watercondensation and/orpooling of water in the tubing. | During use a voltage isapplied and a current flowsthrough the heating wires,encapsulated in the tubing.Due to the wire resistance,heat is dissipated throughthe wall of the tubeconstruction into the airflow in the lumen of thetubing. As a result, the airpassing through the tubingis warmed reducing oreliminating watercondensation and/orpooling of water in the tubing. | Same. | |
| Characteristics(continued) | Philips RespironicsReusable Heated Tubing(K140424) | Sunset HealthcareSolutionsHeated CPAP Tube(proposed device) | Discussion ofDifferences | |
| Technology | The power is generated bythe humidifier and due tothe wire resistance in thedevice, heat is dissipatedthrough the wall of thetube construction into theair flow in the lumen of thetubing. An in-circuitintegrated NegativeTemperature Coefficientthermistor (NTC) at themask-end senses thetemperature of the passingair flow. The resistancecharacteristics of the NTCchanges with temperatureand regulates the currentthrough the heated wiresand thereby regulates thetemperature of thebreathed air. | The power is generated bythe humidifier and due tothe wire resistance in thedevice, heat is dissipatedthrough the wall of thetube construction into theair flow in the lumen of thetubing. An in-circuitintegrated NegativeTemperature Coefficientthermistor (NTC) at themask-end senses thetemperature of the passingair flow. The resistancecharacteristics of the NTCchanges with temperatureand regulates the currentthrough the heated wiresand thereby regulates thetemperature of thebreathed air. | Same. | |
| Materials | Standard breathing circuitPolymeric materials | Standard breathing circuitPolymeric materials | Similar. | |
| Device Designand PhysicalProperties | Use of heated tubing onrespiratory systems is aproven technology and iswell accepted by themedical community | Use of heated tubing onrespiratory systems is aproven technology and iswell accepted by themedical community | Similar. | |
| Dimensions | Length: 1.83 meterInner Diameter: 15 mmversion and 22 mmversion | Length: 1.83 meterInner Diameter: 15 mm | Proposeddevice is thesimilar to the15 mmpredicateversion. | |
| Reusable | Single-patient reuse in thehome and multi-patientuse in clinical setting | Single patient reuse. | Similar.Proposeddevice islabeled thesame forhome use andfor single useonly in aclinical setting. | |
| Sterility | Non-sterile. | Non-sterile. | Same. | |
| BreathingGases Specified | Not specified | Not Specified | Same. | |
| Power Source | Humidifier controlled | Humidifier controlled | Same. | |
| Heating Wire | Encased | Encased | Similar. | |
| Active Controller | No, humidifier controlled | No, 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 | Similar.Proposeddevice hasappliedrelevantstandards. | |
| Compliance(mlpa)Resistance toFlow (mb)2 TubeVolume | ISO 5367 compliant | ISO 5367 compliant | Same. | |
| Characteristics(continued) | Philips RespironicsReusable Heated Tubing(K140424) | Sunset HealthcareSolutionsHeated CPAP Tube(proposed device) | Discussion ofDifferences | |
| Biocompatibility | ISO 10993tests for: Cytotoxicity,sensitization, irritation,genotoxicity, implantation,extractables andleachables. | ISO 10993-1ISO 18562-1ISO 18562-2ISO 18562-3ISO 18562-4tests for: emissions ofparticulate matter,emissions of volatileorganic compounds(VOCs) and leachables incondensate. | Similar.Proposeddevice hasappliedrelevantstandards. |
{5}------------------------------------------------
{6}------------------------------------------------
Summary of Performance Data And Design Controls:
Bench testing was carried out on the following characteristics:
- . Performance of sleep apnea breathing therapy equipment
- . Performance with interaction of respiratory humidifying equipment
- Requirements for breathing sets and connectors .
- . Electromagnetic compatibility (EMC)
- Electrical safety testing
- Mechanical safety testing ●
Usability Testing:
In addition to the above, usability evaluation was also conducted as per the Guidance for Industry and Food and Drug Administration Staff, Applying Human Factors and Usability Engineering to Medical Devices February 3, 2016.
Referenced Standards and Performance Testing:
The Sunset Heated CPAP Tube was tested and meets the requirements of following performance standards.
- ISO 5367, edition 5.0. Anaesthetic and respiratory . equipment -- Breathing sets and connectors
- ISO 80601-2-70, edition 1.0 Medical Electrical . Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnea Breathing Therapy Equipment
- ISO 80601-2-74. edition 1.0 Medical Electrical . Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of respiratory humidifying equipment
{7}------------------------------------------------
Summary of Performance Biocompatibility testing: The Sunset Heated CPAP Tube was tested on biological Data And Design Controls (continued): safety and meets the requirements of following biocompatibility standards:
- ISO 10993-1:2018: Biological Evaluation of Medical . Devices Part 1: Evaluation and testing within a risk management process
- . ISO 18562-1 First edition, Biocompatibility evaluation of breathing gas pathways in healthcare applications -Part 1: Evaluation and testing within a risk management process
- ISO 18562-2 First edition, Biocompatibility evaluation . of breathing gas pathways in healthcare applications -Part 2: Tests for emissions of particulate matter
- . ISO 18562-3 First edition, Biocompatibility evaluation of breathing gas pathways in healthcare applications -Part 3: Tests for emissions of volatile organic compounds
- ISO 18562-4 First edition, Biocompatibility evaluation . of breathing gas pathways in healthcare applications -Part 4: Tests for leachables in condensate
Electrical & Mechanical safety and electromagnetic compatibility (EMC)
Electrical & Mechanical safety and EMC testing were conducted on the Sunset Heated CPAP Tube. The device complies with the following safety standards:
- . ANSI/AAMI/ES 60601-1:2005/(R)2012, A1:2012 edition 3.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, edition 4.0 2014, Medical electrical . equipment - Part 1-2 General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11, edition 2.0 2015, 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
Comparison with the predicate device demonstrates that the VIII. CONCLUSION OF Sunset Heated CPAP Tube is substantially equivalent to the SUBSTANTIAL predicate device. The non-clinical data support the safety of EQUIVALENCE the device and the hardware verification and validation demonstrate that the Sunset Heated CPAP Tube should perform as intended in the specified use conditions.
§ 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).