(290 days)
No
The summary explicitly states the device utilizes the "same algorithm as the Transcend Auto for respiratory event detection and therapy," and there is no mention of AI or ML in the description or performance studies.
Yes
The device is clearly indicated for the "treatment of adults... with Obstructive Sleep Apnea (OSA)", which is a therapeutic purpose.
No
The device is described as providing positive airway pressure to support treatment of Obstructive Sleep Apnea (OSA) and adjusting pressure based on monitored breathing, indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components such as a blower, differential pressure sensor, internal pneumotach, integrated heated humidifier with water reservoir, filter media, battery, USB cable, heater cartridge, wick, reservoir, power supply, and power cord. While it contains software, it is an integral part of a physical medical device system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Transcend 365 miniCPAP Auto System provides positive airway pressure to treat Obstructive Sleep Apnea (OSA). It works by delivering air to the patient's airway, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for supporting the treatment of OSA in adults by providing positive airway pressure. There is no mention of analyzing any biological specimens.
- Device Description: The description details the mechanical and electrical components involved in generating and delivering air pressure and humidification. It does not describe any components or processes related to analyzing biological samples.
Therefore, the Transcend 365 miniCPAP Auto System falls under the category of a respiratory therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.
Product codes
BZD
Device Description
The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications:
- Integrated CPAP and humidification system .
- . Modifications from predicate Transcend Auto device
- Graphic LCD interface vs LED in predicate o
- Housing design O
- Updated air inlet filter o
- Use of a standard 22-mm connection port for air hose attachment O
- Integrated heated humidifier with water reservoir attached with magnets o
- Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ●
- o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate)
- Similar to PARI Hydrate V (K072982); same supplier (Vapore) o
- Allows for a smaller water reservoir and footprint o
The Transcend 365 is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway.
The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets.
It includes the following components and accessories, which are all single patient reusable:
- . Filter Media
- P10 Battery ●
- Transcend 365 miniCPAP Unit .
- USB cable* ●
- Heater Cartridge .
- Wick
- Reservoir .
- Power supply PSA3 ●
- US 2-prong power cord
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults over 66 pounds (30 kg)
Intended User / Care Setting
home and hospital/institutional use.
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)
The following performance data were used in support of the substantial equivalence determination.
- . Biocompatibility Assessment: The device is categorized as tissue contact of permanent (>30 days) duration. Evaluation and testing were conducted in accordance with the following standards and guidance documents:
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
- . FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization
- . 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 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
- . ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs)
- . ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
- Electrical Safety and Electromagnetic Compatibility: Testing was conducted on the . Transcend 365 device. The system complies with the following standards for electrical safety and EMC:
- . IEC 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – requirements and tests
- . IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for safety – Collateral standard: Usability
- . IEC 60601-1-11: Medical electrical equipment Part 1-11: Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 80601-2-70: Medical electrical equipment Part 2-70: Particular requirements . for basic safety and essential performance of sleep apnoea breathing therapy equipment
- . ISO 80601-2-74: Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- IEC 62133: Secondary cells and batteries containing alkaline or other non-acid . electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from then, for use in portable applications
- UL 2054 Household and Commercial Batteries .
- . RTCA/DO-160G:2010, Section 21, Emissions for Category M Equipment
- ISO 8185: Respiratory tract humidifiers for medical use Particular requirements . for respiratory humidification systems
- Software Verification and Validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software in this device is considered a moderate level of concern.
- Mechanical and Acoustic Testing: component cycling, pressure regulation, auto adjust ● functionality, sound power levels, flow, altitude testing, expiratory pressure relief, humidifier reservoir gas leakage, 20-degree spill test, out-of-water detection, humidifier runtime, and humidifier output
Results of tests and assessments did not raise new safety or efficacy questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Transcend Auto (K132127), Transcend Heated Humidifier (K131388)
Reference Device(s)
PARI Hydrate V (K072982)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
November 30, 2018
Somnetics International, Inc. % Melinda Swanson Regulatory Consultant Bluebird Consulting, LLC 100 NE 2nd St. #340 Minneapolis, Minnesota 55413
Re: K180388
Trade/Device Name: Transcend 365 miniCPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: October 26, 2018 Received: October 30, 2018
Dear Melinda Swanson:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180388
Device Name Transcend 365 miniCPAP Auto System
Indications for Use (Describe)
The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.
| 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
510(k) Number: K180388
Date Prepared: November 13, 2018
| Submitter/Manufacturer | Somnetics International, Inc.
33 5th Ave NW, Suite 500
New Brighton, MN 55112
Establishment Registration # 3008770104 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent | Melinda Swanson
Regulatory Consultant
Telephone: 612-308-4500
Email: melinda@bluebirddevice.com |
| Trade Name | Transcend 365 miniCPAP Auto System |
| Common/Usual Name | Non-continuous ventilator |
| Classification | Ventilator, Non-continuous (Respirator)
21 CFR 868.5905, Class II |
| Product Code | BZD |
| Predicate Devices | Somnetics International, Inc.:
Transcend Auto (K132127) Transcend Heated Humidifier (K131388) Neither predicate device has been subject to a recall |
| Reference Device | PARI Innovative Manufacturers, Inc.
PARI Hydrate V (K072982) |
Device Description
The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications:
- Integrated CPAP and humidification system .
- . Modifications from predicate Transcend Auto device
- Graphic LCD interface vs LED in predicate o
- Housing design O
4
- Updated air inlet filter o
- Use of a standard 22-mm connection port for air hose attachment O
- Integrated heated humidifier with water reservoir attached with magnets o
- Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ●
- o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate)
- Similar to PARI Hydrate V (K072982); same supplier (Vapore) o
- Allows for a smaller water reservoir and footprint o
The Transcend 365 is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway.
The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets.
It includes the following components and accessories, which are all single patient reusable:
- . Filter Media
- P10 Battery ●
- Transcend 365 miniCPAP Unit .
- USB cable* ●
- Heater Cartridge .
- Wick
- Reservoir .
- Power supply PSA3 ●
- US 2-prong power cord
Indications for Use
The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The
5
device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.
Both the subject and the predicate devices have the same intended use for the treatment of OSA. The Indications for Use statement for the Transcend 365 is not identical to the predicates; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness relative to the predicate.
Comparison of Technological Characteristics with the Predicate Device
At a high level, the Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The subject and predicate device share the same intended use, same operating principal, and are manufactured and packaged with similar processes. The substantial equivalence comparison is provided below.
| Substantial Equivalence Comparison | |||||
|---|---|---|---|---|---|
| Transcend 365 | |||||
| miniCPAP Auto | Primary | ||||
| Predicate: | |||||
| Transcend Auto | Predicate: | ||||
| Transcend | |||||
| Heated | |||||
| Humidifier | Reference | ||||
| PARI Hydrate | |||||
| V | Comparison | ||||
| Regulatory Classification | |||||
| 510(k) Number | NA | K132127 | K131388 | K072982 | NA |
| Product Code | BZD | BZD | BTT | BTT | Identical to Primary |
| Predicate | |||||
| Regulation | |||||
| Number | 868.5905 | 868.5905 | 868.5450 | 868.540 | Identical to Primary |
| Predicate | |||||
| Regulation Name | Ventilator, non- | ||||
| continuous | |||||
| (respirator) | Ventilator, non- | ||||
| continuous | |||||
| (respirator) | Respiratory gas | ||||
| humidifier | Respiratory | ||||
| gas humidifier | Identical to Primary | ||||
| Predicate | |||||
| Intended Use and Indications for Use | |||||
| Indications for | |||||
| Use | The 'Transcend | ||||
| 365 miniCPAP | |||||
| Auto System' | |||||
| provides | |||||
| positive airway | |||||
| pressure to | The Transcend | ||||
| Auto provides | |||||
| positive airway | |||||
| pressure for | |||||
| treatment of | |||||
| obstructive sleep | The Transcend | ||||
| Heated | |||||
| Humidifier is | |||||
| indicated for | |||||
| the | |||||
| humidification | The Hydrate V | ||||
| is a | |||||
| Respiratory | |||||
| Gas Humidifier | |||||
| which provides | |||||
| heated | Identical Intended | ||||
| Use: Intended to treat | |||||
| patients with OSA | |||||
| with an option for | |||||
| Substantial Equivalence Comparison | |||||
| Transcend 365 | |||||
| miniCPAP Auto | Primary | ||||
| Predicate: | |||||
| Transcend Auto | Predicate: | ||||
| Transcend Heated | |||||
| Humidifier | Reference | ||||
| PARI Hydrate V | Comparison | ||||
| support | |||||
| treatment of | |||||
| adults over 66 | |||||
| pounds (30 kg) | |||||
| with Obstructive | |||||
| Sleep Apnea | |||||
| (OSA). The | |||||
| device is | |||||
| intended for | |||||
| home and | |||||
| hospital/ | |||||
| institutional use. | |||||
| The integrated | |||||
| humidifier | |||||
| provides | |||||
| humidification of | |||||
| air delivered | |||||
| from the | |||||
| Transcend 365 | |||||
| devices. The use | |||||
| of the humidifier | |||||
| is optional. | apnea (OSA) in | ||||
| adults weighing | |||||
| over 66 pounds | |||||
| (30 kg). The | |||||
| device is | |||||
| intended for | |||||
| home and | |||||
| hospital/ | |||||
| institutional use. | of the air | ||||
| delivered from | |||||
| a compatible | |||||
| Transcend | |||||
| positive airway | |||||
| pressure | |||||
| therapy device. | |||||
| The Humidifier | |||||
| is intended for | |||||
| single patient | |||||
| re-use in the | |||||
| home | |||||
| environment | |||||
| and in a | |||||
| hospital/institu | |||||
| tional | |||||
| environment. | |||||
| The Humidifier | |||||
| is for use only | |||||
| as | |||||
| recommended | |||||
| by a physician. | evaporated | ||||
| water content | |||||
| to dry | |||||
| breathing | |||||
| gases using | |||||
| Capillary Force | |||||
| Vaporization | |||||
| technology. A | |||||
| breathing | |||||
| circuit is used | |||||
| to deliver the | |||||
| heated and | |||||
| humidified gas | |||||
| to the patient. | providing | ||||
| humidification. |
Indication for Use:
Similar to predicate
devices. Slight
modification to
incorporate the
intended use of the
integrated humidifier. |
| Pressure Delivery | Fixed | Yes | Yes | NA | Identical feature to
primary predicate |
| | Auto-adjust | Yes | Yes | NA | Identical feature to
primary predicate |
| Algorithm | Auto-adjust | Yes | Yes | NA | Algorithm is identical
to primary predicate |
| | AHI
Measurement | Yes | Yes | NA | Algorithm is identical
to primary predicate |
| | Ramp | Yes | Yes | NA | Algorithm is identical
to primary predicate |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend
Heated
Humidifier | Reference
PARI Hydrate
V | Comparison |
| Expiratory
Pressure Relief | Yes | Yes | NA | NA | Algorithm is identical
to primary predicate |
| Drying Mode | Yes | Yes | NA | NA | identical feature to
primary predicate |
| Humidifier | | | | | |
| Integrated | Yes | No | No | NA | Similar. Both subject
and predicate devices
have a method to
attach a humification
system. |
| Humidification
Method | Capillary Force
VaporizationTM
Technology | NA | Pass over
humidification
through use of a
heater plate | Capillary Force
VaporizationTM
Technology | Similar to predicate;
Devices have a
method for providing
heated humidified air
in accordance with
industry standard
(ISO 8185). Capillary
Force Vaporization
Technology is found in
the reference device
PARI Hydrate V
(K072982) |
| Humidifier/PAP
Connection | Humidifier is
connected to
PAP via magnets | PAP is slide fit
into slots in top
of humidifier | PAP is slide fit
into slots in top
of humidifier | NA | Similar. Devices have
a mechanism for
securing the PAP and
humidifier
components together
as verified by
component cycling
testing. Change does
not impact safety or
effectiveness. |
| Humidifier
Settings | 0-10 | NA | 0-5 | Designed to
automatically
match the gas
flow rate to | Similar. Both devices
deliver a range of
humidity based on
setting level and are |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend
Heated
Humidifier | Reference
PARI Hydrate
V | Comparison |
| | | | | provide 100%
RH. Can be
physician
adjusted to
deliver lower
RH. | adjusted by the
patient for comfort.
Change does not
impact safety or
effectiveness. |
| Warm-up Time | NA | NA | Up to 1 hour
depending on
heat setting | NA | The subject and
predicate device heat
water using different
methods. The subject
device does not have a
warm up time, so this
does not affect safety
or effectiveness. The
reference device does
not have a warm up
time and uses the
same method to heat
water |
| Maximum
Heater Plate
Temperature | NA, device does
not include a
heater plate | NA, device does
not include a
heater plate | 55C | NA, device
does not
include a
heater plate | The subject and
predicate device heat
water using different
methods. The subject
device does not have a
heater plate, so this
does not affect safety
or effectiveness. |
| Water Reservoir
Volume | 195 ml to fill line | NA | 325 ml to fill
line | Up to 2 L | Similar to predicate.
Humidifier contains
water for 8 hours |
| Physical Characteristics | | | | | |
| Dimensions | 7.8 in X 3.8 in X
4.5 in | 6.1 in X 3.5 in X
2.8 in | 9 in X 5.5 in X
4.7 in | 12.5 in X 6.0 in
X 8.0 in | Dimensions are
smaller than predicate
humidifier which
forms the footprint of
the combined |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend Heated
Humidifier | Reference
PARI Hydrate V | Comparison |
| Weight | 1.7 lbs | Less than 1 lb | 2.2 lb empty;
3.1 lbs with
water to max fill
line | 6.8 lbs | Weight is less than
combined weight of
combined predicate
devices when used
together. No impact
on safety and
effectiveness. |
| Redesigned
Enclosure | Yes | No | No | NA | Similar. Made of same
flame-retardant
materials (VO rating).
Enclosure design does
not impact safety or
effectiveness as
demonstrated by
performance testing. |
| Air Filter | Reusable/
replaceable inlet
filter updated to
include ease of
replacement. | Reusable/
replaceable inlet
filter | NA | Unknown | Similar. Air filter
update does not
impact safety or
effectiveness as
demonstrated by
cycling testing and
other performance
testing. The device
uses identical filter
media. |
| Connection Port | Compatible with
commercially
available 22 mm
breathing hoses | Universal hose
adaptor required
for compatibility
with
commercially
available 22 mm
breathing hoses | NA | Delivery tubes
and nasal
cannula | Similar. Devices are
compatible with
commercially
available 22 mm
breathing hoses
(compliant with ISO
5356-1). Does not
impact safety or
effectiveness |
| Substantial Equivalence Comparison | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend Heated
Humidifier | Reference
PARI Hydrate V | Comparison |
| User Interface | Color LCD menu driven user interface | Power button 2 LEDs Push button to activate blower and ramp | Power button 3 LEDs Setting adjustment knob | Keypad control | Similar. Changes are not significant and do not impact safety or effectiveness as confirmed by usability testing (60601-1-6) |
| Accessories
Provided with
Device | None | Provided with standard 6 ft hose and universal hose adaptor. | Supplied with an industry standard 6 ft hose.
Compatible with commercially available 22 mm hoses and masks | Provided with a patient cable and power cord | Similar. All devices are compatible with a 22 mm air hose |
| Biocompatible | New heater materials. Yes; assessed and tested for biocompatibility according to ISO 10993 and 18562 | Yes; assessed for biocompatibility according to ISO 10993 | Yes; assessed for biocompatibility according to ISO 10993 | 510k summary does not indicate biocompat-ibility status | Testing and risk assessment confirm the biocompatibility of the new materials and device. Changes do not impact safety or effectiveness |
| Reuse/Cleaning/Sterility | | | | | |
| Multi-patient
Use | No | Yes, following instructions for cleaning and replacing parts | No | Yes, following instructions for cleaning of the unit and patient cable.
The humidification unit, water lines, and nasal cannula are for | Subject device and predicate humidifier are for single patient use only. Does not affect safety or effectiveness. |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend
Heated
Humidifier | Reference
PARI Hydrate
V | Comparison |
| | | | | single patient
use | |
| Cleaning/
Disinfection | Distilled water
using mild
detergent | Distilled water
using a mild
detergent | Distilled water
using a mild
detergent | The unit and
patient cable
may be wiped
with an alcohol
solution and a
clean towel. | Identical |
| Sterility | Components and
accessories are
not provided
sterile or
intended to be
sterilized | Components and
accessories are
not provided
sterile or
intended to be
sterilized | Components
and accessories
are not
provided sterile
or intended to
be sterilized | Unknown | Identical |
| Therapy
Pressure | $4-20 cm H_2O$ | $4-20 cm H_2O$ | Determined by
compatible PAP
device | Unknown | Identical to Primary
Predicate |
| Pressure
Regulation | $\pm 1 cm H_2O$ or
10%, whichever
is greater | $\pm 1 cm H_2O$ or
10%, whichever
is greater | Determined by
compatible PAP
device | Unknown | Identical to Primary
Predicate |
| Ramp Feature | 0-45 min +25%
time variance | 0-45 min +25%
time variance | NA | Unknown | Identical to Primary
Predicate |
| Ramp Time | 0 – 45 min | 0 – 45 min | NA | Unknown | Identical to Primary
Predicate |
| Data Storage
Download | Stored on device
and transferred
via USB to
computer with
desktop
software | Stored on device
and transferred
via USB to
computer with
desktop software | Not applicable | Unknown | Identical to Primary
Predicate. Devices use
identical desktop
software |
| Degree of
Protection
Against Water
Ingress | IP22 | IP21 | IP21 | IPX1 | Similar. IP22 is a
more rigorous test
than IP21. Does not |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend
Heated
Humidifier | Reference
PARI Hydrate
V | Comparison |
| | | | | | impact safety or
effectiveness. |
| Operating Conditions | | | | | |
| Operating
Altitude | 0 to 8,000 ft | 0 to 8,000 ft | 0 - 8000 ft | Atmospheric
pressure
700hPa to
1060 hPa | Identical |
| Operating
Temperature | 5° C (41° F) to
35° C (95° F) | 5° C (41° F) to
35° C (95° F) | 5° C (41° F) to
35° C (95° F) | 20° C to 29° C | Identical |
| Operating
Humidity | 10 - 80%
relative
humidity, non-
condensing | 10 - 80% relative
humidity, non-
condensing | 10 - 80%
relative
humidity, non-
condensing | 30 % - 75% | Identical |
| Shipping and Storage Conditions | | | | | |
| Shipping/Storag
e Temperature | -20° C (-4° F) to
60° C (140° F) | -20° C (-4° F) to
60° C (140° F) | -20° C (-4° F) to
60° C (140° F) | -40° C to 70°C | Identical |
| Shipping/Storag
e Humidity | 10 - 90%
relative
humidity, non-
condensing | 10 - 90% relative
humidity, non-
condensing | 10 - 90%
relative
humidity, non-
condensing | 10% to 100% | Identical |
| Electrical | | | | | |
| Power | 100-240 VAC,
50/60 Hz | 100-240 VAC,
50/60 Hz | 100-240 VAC,
50/60 Hz | 100-240 VAC,
50/60 Hz | Identical |
| Power supply | PSA3 | PSA2 | 2-prong power
cord | G.33 power
cord | The predicate devices
were powered
separately. The
power supply has
been upgraded to
provide enough power
to operate the PAP
and humidifier.
Testing confirms this |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365
miniCPAP Auto | Primary
Predicate:
Transcend Auto | Predicate:
Transcend
Heated
Humidifier | Reference
PARI Hydrate
V | Comparison |
| | | | | | modification does not
impact safety or
effectiveness. |
| Optional Power
Supplies | Battery: 10 cell,
18.0 VDC, 5,200
mAH | Batteries:
4 cell: 14.4 VDC,
2600 mAH or 8
cell: 14.4 VDC,
5200 mAH
Solar battery
charger
Mobile Power
Adapter | No | No | Similar to primary
predicate. A larger
battery is required to
power the CPAP with
integrated humidifier.
The subject device
does not include a
solar battery charger
or mobile power
adaptor as optional
accessories. Does not
affect safety or
effectiveness since
they are not necessary
for device use. |
| IEC 60601
Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Class II, Type
BF | Identical |
| RTCA DO-160
Section 21
Category M | Yes | Yes | Yes | Unknown | Identical |
| Sound Power
Level | 46.2 dBA | 34.6 dBA | 29.1 dBA | Unknown | Similar. Tested
according to 80601-2-
70. Device emitted a
sound power level of
46.2 dBA meeting
acceptance criteria. |
6
7
8
9
10
11
12
13
Performance Data
The following performance data were used in support of the substantial equivalence determination.
14
- . Biocompatibility Assessment: The device is categorized as tissue contact of permanent (>30 days) duration. Evaluation and testing were conducted in accordance with the following standards and guidance documents:
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
- . FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization
- . 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 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
- . ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs)
- . ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
- Electrical Safety and Electromagnetic Compatibility: Testing was conducted on the . Transcend 365 device. The system complies with the following standards for electrical safety and EMC:
- . IEC 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – requirements and tests
- . IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for safety – Collateral standard: Usability
- . IEC 60601-1-11: Medical electrical equipment Part 1-11: Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
15
- ISO 80601-2-70: Medical electrical equipment Part 2-70: Particular requirements . for basic safety and essential performance of sleep apnoea breathing therapy equipment
- . ISO 80601-2-74: Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- IEC 62133: Secondary cells and batteries containing alkaline or other non-acid . electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from then, for use in portable applications
- UL 2054 Household and Commercial Batteries .
- . RTCA/DO-160G:2010, Section 21, Emissions for Category M Equipment
- ISO 8185: Respiratory tract humidifiers for medical use Particular requirements . for respiratory humidification systems
- Software Verification and Validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software in this device is considered a moderate level of concern.
- Mechanical and Acoustic Testing: component cycling, pressure regulation, auto adjust ● functionality, sound power levels, flow, altitude testing, expiratory pressure relief, humidifier reservoir gas leakage, 20-degree spill test, out-of-water detection, humidifier runtime, and humidifier output
Results of tests and assessments did not raise new safety or efficacy questions.
Conclusion
The Transcend 365 is substantially equivalent to the predicate Transcend Auto (K132127) and Transcend Heated Humidifier (K131388). The subject and predicate devices are used for the treatment of obstructive sleep apnea. They are equivalent in terms of technology and intended use. Risk assessments, biocompatibility evaluation, software evaluation, electromagnetic compatibility and electrical safety, mechanical and acoustic testing, including compliance with recognized standards, demonstrate that any differences do not raise new questions of safety or effectiveness. The Transcend 365 is, therefore, substantially equivalent to the predicate devices.