(290 days)
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 humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.
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
Here's a breakdown of the acceptance criteria and study information for the Transcend 365 miniCPAP Auto System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance numbers for the Transcend 365. Instead, it lists the various tests and assessments conducted and states that "Results of tests and assessments did not raise new safety or efficacy questions" and that the device "meets acceptance criteria." It also notes specific performance metrics for some features in the "Substantial Equivalence Comparison" table.
However, based on the provided comparison table and performance data section, we can infer some criteria and the device's meeting of those criteria:
| Feature/Test | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| Intended Use | Treatment of obstructive sleep apnea (OSA) in adults over 66 pounds (30 kg), with an option for humidification (similar to predicate devices). | "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." (Effectively, it meets the intended use of the predicates) |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, ISO 18562-1, -2, -3, -4, and FDA Guidance for biological evaluation. | "Evaluation and testing were conducted in accordance with the following standards and guidance documents: ISO 10993-1, -5, -10; FDA Guidance; ISO 18562-1, -2, -3, -4." "Testing and risk assessment confirm the biocompatibility of the new materials and device." "Results of tests and assessments did not raise new safety or efficacy questions." |
| Electrical Safety & EMC | Compliance with IEC 60601-1, -1-2, -1-6, -1-11, ISO 80601-2-70, ISO 80601-2-74, IEC 62133, UL 2054, RTCA/DO-160G (Section 21, Category M). | "The system complies with the following standards for electrical safety and EMC: IEC 60601-1, -1-2, -1-6, -1-11; ISO 80601-2-70, ISO 80601-2-74; IEC 62133; UL 2054; RTCA/DO-160G (Section 21, Category M)." "Results of tests and assessments did not raise new safety or efficacy questions." |
| Software Verification & Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a moderate level of concern. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software in this device is considered a moderate level of concern." "Results of tests and assessments did not raise new safety or efficacy questions." |
| Sound Power Level | Similar to predicate devices, and meeting acceptance criteria based on ISO 80601-2-70 (specific dBA unknown from document for predicate, but generally low noise for sleep therapy). | "46.2 dBA." "Tested according to 80601-2-70. Device emitted a sound power level of 46.2 dBA meeting acceptance criteria." (Predicate Transcend Auto: 34.6 dBA; Transcend Heated Humidifier: 29.1 dBA. While higher, it states it met acceptance criteria.) |
| Pressure Delivery (Therapy Pressure) | 4-20 cm H2O (Identical to primary predicate). | "4-20 cm H2O." "Identical to Primary Predicate." |
| Pressure Regulation | ± 1 cm H2O or 10%, whichever is greater (Identical to primary predicate). | "± 1 cm H2O or 10%, whichever is greater." "Identical to Primary Predicate." |
| Ramp Time | 0 – 45 min (Identical to primary predicate). | "0 – 45 min." "Identical to Primary Predicate." |
| IP Rating (Water Ingress Protection) | IP21 or higher (Predicate devices were IP21). | "IP22." "Similar. IP22 is a more rigorous test than IP21. Does not impact safety or effectiveness." |
| Humidifier Output (ISO 8185) | Providing heated humidified air in accordance with industry standard ISO 8185. | "Similar to predicate; Devices have a method for providing heated humidified air in accordance with industry standard (ISO 8185)." (Implies compliance) |
| Humidifier Run Time (with water reservoir) | Sufficient run time for typical sleep duration (predicate was 325 ml, lasting 8 hours). | "Humidifier contains water for 8 hours." (with 195 ml to fill line - effectively similar to predicate in duration despite smaller volume, likely due to Capillary Force Vaporization™ technology efficiency). |
| Mechanical/Reliability | Functional after component cycling, altitude testing, 20-degree spill test, out-of-water detection, and overall operational tests, without impacting safety or effectiveness. | Performed tests including "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." (Specific numerical results are not provided for each, but the overall statement implies meeting criteria). |
| Usability | Compliance with IEC 60601-1-6, ensuring changes to user interface do not impact safety or effectiveness. | "Changes are not significant and do not impact safety or effectiveness as confirmed by usability testing (60601-1-6)." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify sample sizes for specific test sets (e.g., patient data for algorithm testing). The performance data cited are primarily related to general device performance (biocompatibility, electrical safety, mechanical, software validation) rather than a clinical study involving patient data.
- Sample Size: Not explicitly stated for any clinical or patient-related test sets. The tests mentioned are largely bench-top, engineering, and compliance tests.
- Data Provenance: Not applicable in the context of clinical trials/patient data. The data provenance is from various engineering and laboratory testing according to international standards (e.g., ISO, IEC, UL, RTCA).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the summary, as the performance data submitted are primarily for engineering and regulatory compliance rather than clinical efficacy studies requiring expert reader ground truth. The device is a "non-continuous ventilator" (CPAP), whose core function for OSA treatment is well-established, and the submission focuses on demonstrating substantial equivalence to existing cleared devices rather than proving a new clinical efficacy claim through extensive clinical data/expert review.
4. Adjudication Method
Not applicable, as no clinical study requiring a ground truth established by expert adjudication is detailed in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is typically done for diagnostic or screening devices to compare human performance with and without AI assistance on a set of cases. The Transcend 365 is a therapeutic device (CPAP), and the submission focuses on its engineering performance and equivalence to predicate devices, not on physician interpretation or diagnostic aid effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance of the algorithm (e.g., for auto-adjust functionality and AHI measurement) was implicitly done. The document states:
- "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."
- Under "Substantial Equivalence Comparison," for "Algorithm," it explicitly states: "Algorithm is identical to primary predicate" for "Auto-adjust," "AHI Measurement," and "Ramp."
- "Mechanical and Acoustic Testing" included "auto adjust functionality" as a tested parameter.
This indicates that the algorithm's performance, being identical to a previously cleared predicate device, was evaluated, but likely through engineering tests simulating respiratory events rather than a new full-scale clinical trial. The "results of tests and assessments did not raise new safety or efficacy questions" applies to this functionality as well.
7. The Type of Ground Truth Used
For the integrated algorithm's performance (respiratory event detection and therapy adjustment), the ground truth would have been established during the original clearance of the predicate device (Transcend Auto, K132127). For a CPAP device, this typically involves:
- Polysomnography (PSG) data: For validating the accuracy of event detection (apneas, hypopneas) and pressure titration algorithms against direct physiological measurements.
- Bench-top simulation: Using standardized breathing simulation equipment and models to test the device's response to various respiratory patterns and ensure accurate pressure delivery and adjustment.
For non-algorithmic aspects (e.g., biocompatibility, electrical safety, mechanical durability), the ground truth is established by the specifications of the relevant international standards (ISO, IEC, UL, RTCA).
8. The Sample Size for the Training Set
The 510(k) summary provides no information on the sample size for a training set. This is consistent with the nature of the submission, which relies on the algorithm being identical to a previously cleared predicate. Any algorithm training would have occurred during the development of the predicate device (Transcend Auto).
9. How the Ground Truth for the Training Set Was Established
As above, the 510(k) summary provides no information on how the ground truth for an algorithm training set was established. This process would have been part of the original development and clearance of the predicate Transcend Auto (K132127). For sleep apnea algorithms, ground truth for training data would typically involve:
- Expert-scored polysomnography (PSG) studies: A large dataset of sleep study recordings where respiratory events (apneas, hypopneas, RERAs) are manually identified and classified by sleep disorder experts according to established scoring rules (e.g., AASM guidelines). This forms the "ground truth" labels for algorithm development and training.
- Standardized physiological signals: Using calibrated sensors and data from patients or simulations that accurately represent the physiological changes associated with sleep-disordered breathing.
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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
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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
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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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510(k) Summary
510(k) Number: K180388
Date Prepared: November 13, 2018
| Submitter/Manufacturer | Somnetics International, Inc.33 5th Ave NW, Suite 500New Brighton, MN 55112Establishment Registration # 3008770104 |
|---|---|
| SubmissionCorrespondent | Melinda SwansonRegulatory ConsultantTelephone: 612-308-4500Email: 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
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- 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
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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 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| Regulatory Classification | |||||
| 510(k) Number | NA | K132127 | K131388 | K072982 | NA |
| Product Code | BZD | BZD | BTT | BTT | Identical to PrimaryPredicate |
| RegulationNumber | 868.5905 | 868.5905 | 868.5450 | 868.540 | Identical to PrimaryPredicate |
| Regulation Name | Ventilator, non-continuous(respirator) | Ventilator, non-continuous(respirator) | Respiratory gashumidifier | Respiratorygas humidifier | Identical to PrimaryPredicate |
| Intended Use and Indications for Use | |||||
| Indications forUse | The 'Transcend365 miniCPAPAuto System'providespositive airwaypressure to | The TranscendAuto providespositive airwaypressure fortreatment ofobstructive sleep | The TranscendHeatedHumidifier isindicated forthehumidification | The Hydrate Vis aRespiratoryGas Humidifierwhich providesheated | Identical IntendedUse: Intended to treatpatients with OSAwith an option for |
| Substantial Equivalence Comparison | |||||
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:Transcend HeatedHumidifier | ReferencePARI Hydrate V | Comparison | |
| supporttreatment ofadults over 66pounds (30 kg)with ObstructiveSleep Apnea(OSA). Thedevice isintended forhome andhospital/institutional use.The integratedhumidifierprovideshumidification ofair deliveredfrom theTranscend 365devices. The useof the humidifieris optional. | apnea (OSA) inadults weighingover 66 pounds(30 kg). Thedevice isintended forhome andhospital/institutional use. | of the airdelivered froma compatibleTranscendpositive airwaypressuretherapy device.The Humidifieris intended forsingle patientre-use in thehomeenvironmentand in ahospital/institutionalenvironment.The Humidifieris for use onlyasrecommendedby a physician. | evaporatedwater contentto drybreathinggases usingCapillary ForceVaporizationtechnology. Abreathingcircuit is usedto deliver theheated andhumidified gasto the patient. | providinghumidification.Indication for Use:Similar to predicatedevices. Slightmodification toincorporate theintended use of theintegrated humidifier. | |
| Pressure Delivery | Fixed | Yes | Yes | NA | Identical feature toprimary predicate |
| Auto-adjust | Yes | Yes | NA | Identical feature toprimary predicate | |
| Algorithm | Auto-adjust | Yes | Yes | NA | Algorithm is identicalto primary predicate |
| AHIMeasurement | Yes | Yes | NA | Algorithm is identicalto primary predicate | |
| Ramp | Yes | Yes | NA | Algorithm is identicalto primary predicate | |
| Substantial Equivalence Comparison | |||||
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| ExpiratoryPressure Relief | Yes | Yes | NA | NA | Algorithm is identicalto primary predicate |
| Drying Mode | Yes | Yes | NA | NA | identical feature toprimary predicate |
| Humidifier | |||||
| Integrated | Yes | No | No | NA | Similar. Both subjectand predicate deviceshave a method toattach a humificationsystem. |
| HumidificationMethod | Capillary ForceVaporizationTMTechnology | NA | Pass overhumidificationthrough use of aheater plate | Capillary ForceVaporizationTMTechnology | Similar to predicate;Devices have amethod for providingheated humidified airin accordance withindustry standard(ISO 8185). CapillaryForce VaporizationTechnology is found inthe reference devicePARI Hydrate V(K072982) |
| Humidifier/PAPConnection | Humidifier isconnected toPAP via magnets | PAP is slide fitinto slots in topof humidifier | PAP is slide fitinto slots in topof humidifier | NA | Similar. Devices havea mechanism forsecuring the PAP andhumidifiercomponents togetheras verified bycomponent cyclingtesting. Change doesnot impact safety oreffectiveness. |
| HumidifierSettings | 0-10 | NA | 0-5 | Designed toautomaticallymatch the gasflow rate to | Similar. Both devicesdeliver a range ofhumidity based onsetting level and are |
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| provide 100%RH. Can bephysicianadjusted todeliver lowerRH. | adjusted by thepatient for comfort.Change does notimpact safety oreffectiveness. | ||||
| Warm-up Time | NA | NA | Up to 1 hourdepending onheat setting | NA | The subject andpredicate device heatwater using differentmethods. The subjectdevice does not have awarm up time, so thisdoes not affect safetyor effectiveness. Thereference device doesnot have a warm uptime and uses thesame method to heatwater |
| MaximumHeater PlateTemperature | NA, device doesnot include aheater plate | NA, device doesnot include aheater plate | 55C | NA, devicedoes notinclude aheater plate | The subject andpredicate device heatwater using differentmethods. The subjectdevice does not have aheater plate, so thisdoes not affect safetyor effectiveness. |
| Water ReservoirVolume | 195 ml to fill line | NA | 325 ml to fillline | Up to 2 L | Similar to predicate.Humidifier containswater for 8 hours |
| Physical Characteristics | |||||
| Dimensions | 7.8 in X 3.8 in X4.5 in | 6.1 in X 3.5 in X2.8 in | 9 in X 5.5 in X4.7 in | 12.5 in X 6.0 inX 8.0 in | Dimensions aresmaller than predicatehumidifier whichforms the footprint ofthe combined |
| Substantial Equivalence Comparison | |||||
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:Transcend HeatedHumidifier | ReferencePARI Hydrate V | Comparison | |
| Weight | 1.7 lbs | Less than 1 lb | 2.2 lb empty;3.1 lbs withwater to max fillline | 6.8 lbs | Weight is less thancombined weight ofcombined predicatedevices when usedtogether. No impacton safety andeffectiveness. |
| RedesignedEnclosure | Yes | No | No | NA | Similar. Made of sameflame-retardantmaterials (VO rating).Enclosure design doesnot impact safety oreffectiveness asdemonstrated byperformance testing. |
| Air Filter | Reusable/replaceable inletfilter updated toinclude ease ofreplacement. | Reusable/replaceable inletfilter | NA | Unknown | Similar. Air filterupdate does notimpact safety oreffectiveness asdemonstrated bycycling testing andother performancetesting. The deviceuses identical filtermedia. |
| Connection Port | Compatible withcommerciallyavailable 22 mmbreathing hoses | Universal hoseadaptor requiredfor compatibilitywithcommerciallyavailable 22 mmbreathing hoses | NA | Delivery tubesand nasalcannula | Similar. Devices arecompatible withcommerciallyavailable 22 mmbreathing hoses(compliant with ISO5356-1). Does notimpact safety oreffectiveness |
| Substantial Equivalence Comparison | Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:Transcend HeatedHumidifier | ReferencePARI 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) |
| AccessoriesProvided withDevice | 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-patientUse | 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 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| single patientuse | |||||
| Cleaning/Disinfection | Distilled waterusing milddetergent | Distilled waterusing a milddetergent | Distilled waterusing a milddetergent | The unit andpatient cablemay be wipedwith an alcoholsolution and aclean towel. | Identical |
| Sterility | Components andaccessories arenot providedsterile orintended to besterilized | Components andaccessories arenot providedsterile orintended to besterilized | Componentsand accessoriesare notprovided sterileor intended tobe sterilized | Unknown | Identical |
| TherapyPressure | $4-20 cm H_2O$ | $4-20 cm H_2O$ | Determined bycompatible PAPdevice | Unknown | Identical to PrimaryPredicate |
| PressureRegulation | $\pm 1 cm H_2O$ or10%, whicheveris greater | $\pm 1 cm H_2O$ or10%, whicheveris greater | Determined bycompatible PAPdevice | Unknown | Identical to PrimaryPredicate |
| Ramp Feature | 0-45 min +25%time variance | 0-45 min +25%time variance | NA | Unknown | Identical to PrimaryPredicate |
| Ramp Time | 0 – 45 min | 0 – 45 min | NA | Unknown | Identical to PrimaryPredicate |
| Data StorageDownload | Stored on deviceand transferredvia USB tocomputer withdesktopsoftware | Stored on deviceand transferredvia USB tocomputer withdesktop software | Not applicable | Unknown | Identical to PrimaryPredicate. Devices useidentical desktopsoftware |
| Degree ofProtectionAgainst WaterIngress | IP22 | IP21 | IP21 | IPX1 | Similar. IP22 is amore rigorous testthan IP21. Does not |
| Substantial Equivalence Comparison | |||||
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| impact safety oreffectiveness. | |||||
| Operating Conditions | |||||
| OperatingAltitude | 0 to 8,000 ft | 0 to 8,000 ft | 0 - 8000 ft | Atmosphericpressure700hPa to1060 hPa | Identical |
| OperatingTemperature | 5° C (41° F) to35° C (95° F) | 5° C (41° F) to35° C (95° F) | 5° C (41° F) to35° C (95° F) | 20° C to 29° C | Identical |
| OperatingHumidity | 10 - 80%relativehumidity, non-condensing | 10 - 80% relativehumidity, non-condensing | 10 - 80%relativehumidity, non-condensing | 30 % - 75% | Identical |
| Shipping and Storage Conditions | |||||
| Shipping/Storage Temperature | -20° C (-4° F) to60° C (140° F) | -20° C (-4° F) to60° C (140° F) | -20° C (-4° F) to60° C (140° F) | -40° C to 70°C | Identical |
| Shipping/Storage Humidity | 10 - 90%relativehumidity, non-condensing | 10 - 90% relativehumidity, non-condensing | 10 - 90%relativehumidity, 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 powercord | G.33 powercord | The predicate deviceswere poweredseparately. Thepower supply hasbeen upgraded toprovide enough powerto operate the PAPand humidifier.Testing confirms this |
| Substantial Equivalence Comparison | |||||
| Transcend 365miniCPAP Auto | PrimaryPredicate:Transcend Auto | Predicate:TranscendHeatedHumidifier | ReferencePARI HydrateV | Comparison | |
| modification does notimpact safety oreffectiveness. | |||||
| Optional PowerSupplies | Battery: 10 cell,18.0 VDC, 5,200mAH | Batteries:4 cell: 14.4 VDC,2600 mAH or 8cell: 14.4 VDC,5200 mAHSolar batterychargerMobile PowerAdapter | No | No | Similar to primarypredicate. A largerbattery is required topower the CPAP withintegrated humidifier.The subject devicedoes not include asolar battery chargeror mobile poweradaptor as optionalaccessories. Does notaffect safety oreffectiveness sincethey are not necessaryfor device use. |
| IEC 60601Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Class II, TypeBF | Identical |
| RTCA DO-160Section 21Category M | Yes | Yes | Yes | Unknown | Identical |
| Sound PowerLevel | 46.2 dBA | 34.6 dBA | 29.1 dBA | Unknown | Similar. Testedaccording to 80601-2-70. Device emitted asound power level of46.2 dBA meetingacceptance criteria. |
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Performance Data
The following performance data were used in support of the substantial equivalence determination.
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- . 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
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- 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.
§ 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).