(245 days)
Not Found
No
The summary describes a heated CPAP tube that warms air and reduces condensation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on standard medical device safety and performance standards.
No
The device is a heated CPAP tube that provides warmed and/or humidified breathing gases. It aids in delivering therapy but is not a standalone therapeutic device itself.
No
Explanation: The device is a heated CPAP tube designed to warm and humidify breathing gases, not to diagnose medical conditions. Its primary function is therapeutic/supportive by providing warmed and/or humidified breathing gases.
No
The device description clearly states it is a "heated wire breathing tube" and describes its physical components and function in warming air, indicating it is a hardware device.
Based on the provided information, the Sunset Heated CPAP Tube is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Sunset Heated CPAP Tube clearly states its purpose is to provide warmed and/or humidified breathing gases before they enter a patient's airway and to warm air as it travels to and from the patient. It does not involve the analysis of any biological samples.
- The intended use and device description focus on delivering a therapeutic gas. The function is related to respiratory support and comfort, not diagnostic testing.
- The performance studies listed are related to the physical and electrical performance of the device and its interaction with other respiratory equipment. There are no mentions of studies related to analyzing biological samples or diagnostic accuracy.
Therefore, the Sunset Heated CPAP Tube falls under the category of a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BZE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-invasive
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Home and hospital (clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities)
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)
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:
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
Biocompatibility testing: The Sunset Heated CPAP Tube was tested on biological 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 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
Key results: Comparison with the predicate device demonstrates that the Sunset Heated CPAP Tube is substantially equivalent to the predicate device. The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Sunset Heated CPAP Tube should perform as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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) |
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3
510(k) Summary
| I SUBMITTER | |
|---|---|
| Submitter Name: | Sunset Healthcare Solutions. |
| Submitter Address: | 180 N. Michigan Ave, Suite 2000 |
| Chicago, 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 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. |
| Physical Description: | Sunset Heated CPAP Tube: length: 1.83 m, internal diameter 15mm
Operating voltage: 3.3 VDC
Power consumption: max 5A |
| V. INTENDED USE /
INDICATION FOR USE
STATEMENT | 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. |
4
- VI. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICES
| Technological
Characteristics: | Characteristics | Philips Respironics
Reusable Heated Tubing
(K140424) | Sunset Healthcare
Solutions
Heated CPAP Tube
(proposed device) | Discussion of
Differences |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | Intended Use | The Philips Respironics
Reusable 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 multi-patient
use in clinical settings,
such as hospitals,
institutions, sleep
laboratories, and sub-
acute care facilities. It may
be used with non-invasive
ventilation for patients
weighing over 10 kg
(22lbs).
It is compatible with the | 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 | Similar.
Proposed
device is
restricted to:
• Single
patient
reuse.
• Adult
patients. |
| | | Philips Respironics
System One Heated
Humidifier and Philips
Respironics A-Series
System One Heated
Humidifier. | Philips Respironics
System One Heated
Humidifier and Philips
Respironics Dreamstation
Heated Humidifier. | |
| | Compatibility
with Humidifiers,
Standard
Connectors and
Humidification
Chambers | The tubing has a
proprietary connector with
two locking tabs that
makes it compatible with
the Philips Respironics
System One Humidifier
(K113068) and Philips
Respironics A-Series
System One Heated
Humidifier (K121623). | The tubing has a
proprietary connector with
two locking tabs that
makes it compatible with
the Respironics System
one (K113068) and with
the Respironics
Dreamstation series. | Similar.
Compatibility
with a subset
of the devices
with which the
predicate is
compatible. |
| | Anatomical Site | Non-invasive | Non-invasive | Same. |
| | Patient
Population | Patients weighing over 10
kg (22lbs). | Adult patients | Similar.
Device is used
with a subset
of the
predicate
device's
population. |
| | Environment of
Use | Home and hospital | Home and hospital | Same. |
| | Operating
Principle | During use a voltage is
applied and a current flows
through the heating wires,
encapsulated in the tubing.
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 tubing. | During use a voltage is
applied and a current flows
through the heating wires,
encapsulated in the tubing.
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 tubing. | Same. |
| Characteristics
(continued) | Philips Respironics
Reusable Heated Tubing
(K140424) | Sunset Healthcare
Solutions
Heated CPAP Tube
(proposed device) | Discussion of
Differences | |
| Technology | The power is generated by
the humidifier and due to
the wire resistance in the
device, heat is dissipated
through the wall of the
tube construction into the
air flow in the lumen of the
tubing. An in-circuit
integrated Negative
Temperature Coefficient
thermistor (NTC) at the
mask-end senses the
temperature of the passing
air flow. The resistance
characteristics of the NTC
changes with temperature
and regulates the current
through the heated wires
and thereby regulates the
temperature of the
breathed air. | The power is generated by
the humidifier and due to
the wire resistance in the
device, heat is dissipated
through the wall of the
tube construction into the
air flow in the lumen of the
tubing. An in-circuit
integrated Negative
Temperature Coefficient
thermistor (NTC) at the
mask-end senses the
temperature of the passing
air flow. The resistance
characteristics of the NTC
changes with temperature
and regulates the current
through the heated wires
and thereby regulates the
temperature of the
breathed air. | Same. | |
| Materials | Standard breathing circuit
Polymeric materials | Standard breathing circuit
Polymeric materials | Similar. | |
| Device Design
and Physical
Properties | Use of heated tubing on
respiratory systems is a
proven technology and is
well accepted by the
medical community | Use of heated tubing on
respiratory systems is a
proven technology and is
well accepted by the
medical community | Similar. | |
| Dimensions | Length: 1.83 meter
Inner Diameter: 15 mm
version and 22 mm
version | Length: 1.83 meter
Inner Diameter: 15 mm | Proposed
device is the
similar to the
15 mm
predicate
version. | |
| Reusable | Single-patient reuse in the
home and multi-patient
use in clinical setting | Single patient reuse. | Similar.
Proposed
device is
labeled the
same for
home use and
for single use
only in a
clinical setting. | |
| Sterility | Non-sterile. | Non-sterile. | Same. | |
| Breathing
Gases 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 of
Conformity /
Performance | ISO 5367
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 8185 | ISO 5367
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-70
ISO 80601-2-74 | Similar.
Proposed
device has
applied
relevant
standards. | |
| Compliance
(mlpa)
Resistance to
Flow (mb)2 Tube
Volume | ISO 5367 compliant | ISO 5367 compliant | Same. | |
| Characteristics
(continued) | Philips Respironics
Reusable Heated Tubing
(K140424) | Sunset Healthcare
Solutions
Heated CPAP Tube
(proposed device) | Discussion of
Differences | |
| Biocompatibility | ISO 10993
tests for: Cytotoxicity,
sensitization, irritation,
genotoxicity, implantation,
extractables and
leachables. | ISO 10993-1
ISO 18562-1
ISO 18562-2
ISO 18562-3
ISO 18562-4
tests for: emissions of
particulate matter,
emissions of volatile
organic compounds
(VOCs) and leachables in
condensate. | Similar.
Proposed
device has
applied
relevant
standards. | |
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.