(88 days)
No
The description focuses on the physical design and function of a heated tube to prevent condensation, with no mention of AI or ML algorithms for control or analysis.
No.
The device is a heated tubing for CPAP machines, intended to provide warmed and/or humidified breathing gases and prevent "rainout" during CPAP therapy. It does not treat or cure a disease but rather serves as an accessory to a therapeutic device (CPAP machine) to improve the delivery of therapy.
No
The device is a heated tubing for CPAP machines, intended to deliver warmed and/or humidified breathing gases, not to diagnose a medical condition.
No
The device description explicitly states it is a "heated tube" with a "heated wire" and discusses physical components and their interaction with temperature and humidity, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide warmed and/or humidified breathing gases to a patient's airway. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a heated tube that connects a CPAP machine to a mask. Its function is to prevent condensation in the air stream. This is a mechanical/environmental control function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The THERMALITE® CPAP Heated Tubing does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZE
Device Description
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.
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
single-patient reuse in the home and in 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)
- Biocompatibility: Tested for biocompatibility compliance in accordance with ISO 10993-1: 2018, ISO 10993-18: 2020, ISO 18562-1: 2017, ISO 18562-2: 2017, and ISO 18562-3: 2017. Test results indicated compliance.
- Electrical Safety: Tested for patient safety in accordance with IEC 60601-1: 2005, Am1: 2012, Am2: 2020, and IEC 60601-1-11: 2020. Test results indicated compliance.
- Electromagnetic Compatibility: Tested for EMC in accordance with IEC 60601-1-2: 2020. Test results indicated compliance.
- Performance Testing – Bench: Tested for performance in accordance with internal requirements, IEC 60601-1-6: 2020, IEC 62366-1: 2020, ISO 5356-1: 2015, ISO 5367: 2014, ISO 80601-2-70: 2020, ISO 80601-2-74: 2017, and ISTA Procedure 3A – 2018. Test results indicated compliance with internal requirements, applicable Standards, and guidance documents.
- Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Exceleron THERMALITE. The results of these activities demonstrate that the Exceleron THERMALITE is as safe and as effective as the predicate device when used in accordance with its intended use and labeling. Therefore, the Exceleron THERMALITE is considered substantially equivalent to the predicate device.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
0
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.
1
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
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
(in accordance with 21 CFR 807.92)
| Date: | 30 July 2024 |
|---|---|
| Sponsor: | Exceleron Medical, LLC |
| 5000 Township Parkway | |
| Saint Paul, MN 55110 USA | |
| Keith Roberts - CEO | |
| Phone: +1 (877) 834-9279 | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Phone: +1 (239) 307-6061 | |
| Trade Name: | THERMALITE® CPAP Heated Tubing |
| Common and | |
| Classification Name: | Breathing System, Heater |
| Classification | |
| Regulation: | 21 CFR §868.5270 |
| Product Code: | BZE |
| Predicate: | K140424 |
| Philips Heated CPAP Tube | |
| Device Description: | 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. | |
| Indications for Use: | 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 non-invasive ventilation for adult | |
| patients. | |
| It is compatible with the Philips Respironics DreamStation 1 and DreamStation | |
| 2 heated humidifiers. |
5
| Manufacturer / Device | Cleared | Reason for Inclusion | Regulation ( Product Code) |
|---|---|---|---|
| Primary Predicate | |||
| Philips Respironics Reusable | |||
| Heated Tubing | K140424 | Same indications for use and | |
| same or similar technology. | 21 CFR §868.5270 (BZE) | ||
| Reference | |||
| Philips Respironics Dream | |||
| Station 2 System which | |||
| includes heated tubing | K200480 | Same indications for use and | |
| same or similar technology. | 21 CFR 868.5905 (BZD) | ||
| But contains heated tubing as | |||
| an accessory |
Table - Primary Predicate and Reference Devices
6
(
| Characteristics | Primary Predicate
Philips Respironics Reusable
Heated Tubing (K140424) | Reference
Philips Respironics
Reusable Heated Tubing
(K200480) | Exceleron Medical Heated
CPAP Tube (3 wire design) -
Subject Device | Exceleron Medical Heated
CPAP Tube (2 wire
design) - Subject Device | Discussion of
Differences |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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
Philips Respironics System
One Heated Humidifier and
Philips Respironics A-Series
System One Heated
Humidifier. | The heated tube is used, along
with the heated humidifier, to
control the provided
humidification. This is
accomplished by controlling
the temperature of the air in
order to ensure that it does not
cool down prior to reaching
the mask. | The Exceleron 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 Dreamstation 1
(K140424) and Dreamstation
2(K200480) Heated
Humidifiers | The Exceleron 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 Dreamstation 1 and
Dreamstation 2 Heated
Humidifiers. | Similar.
Subject
devices
restricted to:
· Single
patient
reuse.
Adult patients. |
| 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 Dreamstation 2 machine. | The tubing has a proprietary
connector with two locking
tabs that make it compatible
with the Respironics
Dreamstation Series
(Dreamstation 1 and
Dreamstation 2 CPAP
machine (K200480)) | The tubing has a proprietary
connector with two locking
tabs that make it
compatible with the
Respironics Dreamstation
Series (Dreamstation 1 and
Dreamstation 2 CPAP
machine (K200480)) | Similar.
Compatibility
with a subset of
the devices with
which the
predicate is
compatible. |
| Anatomical Site | Non-invasive | Non-invasive | Non-invasive | Non-invasive | Same. |
| Characteristics | Primary Predicate
Philips Respironics Reusable
Heated Tubing (K140424) | Reference
Philips Respironics
Reusable Heated Tubing
(K200480) | Exceleron Medical Heated
CPAP Tube (3 wire design) –
Subject Device | Exceleron Medical Heated
CPAP Tube (2 wire
design) – Subject Device | Discussion of
Differences |
| Patient
Population | Patients weighing over 10 kg
(22lbs). | Patients weighing more than 66
lb (30 kg) | Adult patients | Adult patients | Similar. Device
is used with a
subset of the
predicate
device's |
| Environment of
Use | Home and hospital | Home and hospital | 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 breathing circuit. | Due to the wire resistance, heat
is dissipated through the wall
of the tube construction into
the air flow in the lumen of the
tubing. As a result, the air
passing through the tubing is
warmed to or above the dew
point (of the air 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 | 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 breathing circuit. | 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 breathing
circuit. | Same. |
| Characteristics
(continued) | Philips Respironics Reusable
Heated Tubing (K140424) | Philips Respironics
Reusable Heated Tubing
(K200480) | Exceleron Heated CPAP Tube
(3 wire design) – Proposed
Device | Exceleron Medical Heated
CPAP Tube (2 awire design) -
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. | 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 machine
end. The machine will sense the
resistance of the thermistor and
will determine the amount of
voltage to apply to the heaters to
achieve the tubing temperature. | Same with the
only difference on
the 2 wire design
is the NTC is at
the machine end
and provides the
same voltage
regulation through the heated wires as
both predicate 3
wire designs. |
| Dimensions/specs | Length: 1.83 mm
Tubing Inner Diameter: 15
mm version and 22 mm
version
Patient Fitting – 22 mm
Machine Fitting - Proprietary
to the humidifier | Length: 1.83 mm
Tubing Inner Diameter: 15
mm version and 22 mm
version
Patient Fitting – 22 mm
Machine Fitting -
Proprietary to the humidifier | Length: 1.83 meter Inner
Tubing Inner Diameter: 15 mm
Patient Fitting – 22 mm
Machine Fitting – Proprietary to
the humidifier | Length: 1.83 meter Inner
Tubing Inner Diameter: 15 mm
Patient Fitting – 22 mm
Machine Fitting – Proprietary
to the humidifier | Proposed
device is the
similar to the
15 mm
predicate
versions. |
| Characteristics | Primary Predicate
Philips Respironics Reusable
Heated Tubing (K140424) | Reference
Philips Respironics
Reusable Heated Tubing
(K200480) | Exceleron Medical Heated
CPAP Tube (3 wire design) -
Subject Device | Exceleron Medical Heated
CPAP Tube (2 wire
design) – Subject Device | Discussion of
Differences |
| Reusable | Single-patient reuse in the
home and multi-patient use in
clinical setting | Single patient reuse. | Single patient reuse. | Single patient reuse. | Similar.
Proposed device
is labeled the
same for home
use and for
single use only
in a clinical |
| Power Source | Humidifier controlled | Humidifier controlled | Humidifier controlled | 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 | ISO 5367
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-70
ISO 80601-2-74 | 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. |
| 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) | ISO 10993-1
ISO 18562-1
ISO 18562-2
ISO 18562-3
ISO 10993-18
tests for: Cytotoxicity,
sensitization, irritation,
emissions of particulate matter,
emissions of volatile organic
compounds (VOCs),
extractables and leachables. | ISO 10993-1
ISO 18562-1
ISO 18562-2
ISO 18562-3
ISO 10993-18
tests for: Cytotoxicity,
sensitization, irritation,
emissions of particulate
matter, emissions of volatile
organic compounds (VOCs),
extractables and leachables. | Similar |
7
8
9
(
10
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 |
| Electromagnetic
Compatibility | The Exceleron THERMALITE was tested for EMC in accordance with the
following Standards and guidance documents:
IEC 60601-1-2: 2020, Medical Electrical Equipment, Part 1: Part 1-2:
General Requirements for Safety – Collateral Standard: Electromagnetic
Compatibility-Requirements and Tests. Electromagnetic Compatibility (EMC) of Medical Devices, 06 Jun 22. Test results indicated that the Exceleron THERMALITE complies with the
applicable Standards and guidance documents. |
| Performance Testing –
Bench | The Exceleron THERMALITE was tested for performance in accordance with
internal requirements, applicable Standards, and guidance documents. IEC 60601-1-6: 2020, Medical electrical equipment: General
requirements for basic safety and essential performance – collateral
standard: Usability. IEC 62366-1: 2020, Medical devices – Application of usability
engineering to medical devices. ISO 5356-1: 2015, Anaesthetic and respiratory equipment - Conical
connectors – Part 1: Cones and sockets. ISO 5367: 2014, Anaesthetic and respiratory equipment -- Breathing sets
and connectors. |
| Performance Testing –
Bench | The Exceleron THERMALITE was tested for performance in accordance with
internal 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 of
sleep apnoea breathing therapy equipment. ISO 80601-2-74: 2017, Medical electrical equipment - Part 2-74:
Particular requirements for basic safety and essential performance of
respiratory humidifying equipment. ISTA Procedure 3A – 2018, Parcel Delivery System Shipments 150 lb (70
kg) or Less. Test results indicated that the Exceleron THERMALITE complies with
internal requirements, applicable Standards, and the guidance documents. |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the Exceleron THERMALITE. The
results of these activities demonstrate that the Exceleron THERMALITE is as
safe and as effective as the predicate device when used in accordance with its
intended use and labeling.
Therefore, the Exceleron THERMALITE is considered substantially
equivalent to the predicate device. |
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