(135 days)
The Transcend Heated Humidifier is indicated for the humidification 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/institutional environment. The Humidifier is for use only as recommended by a physician.
The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.
The provided document describes the acceptance criteria and supporting studies for the Transcend Heated Humidifier, a medical device for humidifying air during positive airway pressure (PAP) therapy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Transcend Heated Humidifier are primarily based on compliance with recognized consensus standards and direct comparison to a predicate device (ResMed HumidAire 2i™). The document presents a comparison of various characteristics, some of which serve as performance criteria.
| Acceptance Criterion | Specifics/Standard | Reported Device Performance (Transcend Heated Humidifier) | Comparison to Predicate / Compliance |
|---|---|---|---|
| Standards Compliance | |||
| Electrical Safety | IEC 60601-1 | Compliant | Compliant |
| Electromagnetic Compatibility | IEC 60601-1-2 | Compliant with IEC 60601-1-2 | Identical (Predicate also compliant) |
| Usability | IEC 60601-1-6 | Not explicitly stated, but implied compliance through substantial equivalence | Implied compliance |
| Home Health Care Environment | IEC 60601-1-11 | Not explicitly stated, but implied compliance through substantial equivalence | Implied compliance |
| Respiratory Humidifiers | ISO 8185:2007 | Compliant (Stated for multiple parameters) | Confirmed compliance, predicate's compliance unknown |
| Biological Evaluation | ISO 10993-1 | Biocompatible: Yes | Identical |
| Risk Management | ISO 14971 | Implied compliance through risk assessments | Implied compliance |
| Performance Characteristics (compared to predicate or ISO 8185) | |||
| Indications for Use | Humidification of air for compatible Transcend PAP device, single patient re-use in home/hospital | The Transcend Heated Humidifier is indicated for the humidification 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/institutional environment. | Similar (Transcend is single-patient vs. predicate's multi-patient option). |
| Intended Population of Use | Adult | Adult | Identical |
| Compatible Devices | Transcend PAP device and associated accessories | Transcend PAP device and associated accessories | Similar (both are manufacturer-specific) |
| Disinfection | None (single patient re-use only) | Differs from predicate (which should be disinfected between patients) | |
| Cleaning | Distilled water using a mild detergent | Distilled water using a mild detergent | Identical |
| Sterilization | Not sterilized | Not sterilized | Identical |
| Pressure Regulation | Determined by compatible PAP device | Determined by compatible PAP device | Identical |
| Working Pressure Range | 4-20 cm H₂O | 4-20 cm H₂O | Identical |
| Humidifier Settings | 1-5 | Similar (Predicate has 1-6 settings) | |
| Inspiratory / Expiratory Pressure Drop | Meets ISO 8185 requirements | 0.375 cmH₂O at 50 L/min | Meets ISO 8185 |
| Gas Leak at Max Operating Pressure | Meets ISO 8185 requirements | 4.85 L/min | Meets ISO 8185 |
| Sound Power Level at 10 cm H₂O static pressure | Meets ISO 8185 requirements | 37 dB | Meets ISO 8185 |
| Maximum Heater Plate Temperature | Meets ISO 8185 requirements | 131 °F | Meets ISO 8185 (Predicate: 167°F) |
| Maximum Output Humidity | >95% | >95% | Similar (Predicate: 95%) |
| Maximum Gas Temperature | Meets ISO 8185 requirements | 77 °F | Meets ISO 8185 |
| Water Capacity | Enough water to last a minimum of 8 hours | 325 ml | Similar (Predicate: 400ml; both intended for 8+ hours) |
| Operating Temperature | Based on compatible PAP device | +41°F to +95°F | Similar (Predicate: +41°F to +104°F) |
| Operating Humidity | Based on compatible PAP device | 10 - 80% relative humidity, non-condensing | Similar (Predicate: 10-95% RH) |
| Shipping/Storage Temperature | -4° F to +140° F | Identical | |
| Gas Inlet Temperature Range | Based on compatible PAP device | +41°F to +95°F | Similar (Predicate: +41°F to +104°F) |
| Shipping/Storage Humidity | 10 - 90% relative humidity, non-condensing | Similar (Predicate: 15-95% RH) | |
| Power Supply | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Identical |
| IEC 60601-1 Classification | Type BF or CF (ISO 8185 section 6.8.2-14) | Type BF | Subject device is compliant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for particular performance tests. The studies conducted are described as "Device design was qualified through the following tests and assessments" which implies these were bench and lab-based tests, not human studies. Therefore, typical "sample sizes" (as in patient data) and "data provenance" (e.g., country of origin, retrospective/prospective) are not applicable in the context of this device's premarket submission, which focuses on engineering, safety, and performance characteristics rather than clinical diagnostic accuracy. The studies performed are:
- Electrical Safety
- Electromagnetic Compatibility
- Biocompatibility Assessment
- Cleaning Validation
- Software Validation
- Packaging and Shipping
- Performance: physical (cycling), resistance to flow, spillage, flow sensing, sound power level, humidification output, out of water shutdown, temperature, runtime, warm-up duration, and reservoir gas leak
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The device relies on physical and electrical performance data, and compliance with engineering standards (e.g., ISO 8185, IEC 60601-1). Ground truth is established by the specifications defined in these standards and by direct laboratory measurements, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus for ground truth. This submission focuses on engineering and performance testing, where outcomes are determined by objective measurements against predefined criteria.
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 done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Transcend Heated Humidifier is a therapeutic accessory, not a diagnostic device involving human interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable in the typical sense of AI algorithms. The "device" itself operates "standalone" in its function as a humidifier, based on its internal programming and hardware. However, it's not an AI algorithm in the context of data analysis or diagnostic support where a "human-in-the-loop" would be relevant. The software validation mentioned ensures the device's internal algorithms and controls function correctly, which is a standalone performance test.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on:
- Engineering Standards and Specifications: Metrics defined by standards such as ISO 8185 (e.g., maximum output humidity, pressure drop, gas leak, sound power level, temperatures).
- Predicate Device Characteristics: Direct comparison of physical, functional, and safety attributes against a legally marketed predicate device.
- Laboratory Measurements: Objective measurements of the device's performance against the specified criteria (e.g., humidification output, temperature, water capacity).
8. The Sample Size for the Training Set
This section is not applicable. This device is not an AI/machine learning model where a "training set" of data would be used to develop an algorithm. Its design and validation are based on traditional engineering principles and testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" in the context of this device.
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31388
SEP 2 6 2013
Somnetics International Inc.
Traditional 510(k) Premarket Submission
Transcend Heated Humidifier
5 510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number: K131388
Date Prepared: June 3, 2013
| Submitter/Manufacturer | Somnetics International, Inc.33 5th Ave NW, Suite 500New Brighton, MN 55112 |
|---|---|
| Establishment Registration # | 3008770104 |
| Contact Person | Melinda SwansonRegulatory ConsultantTelephone: 651-621-1800Email: mswanson@somnetics.com |
| Trade Name | Transcend Heated Humidifier |
| Common/Usual Name | Respiratory Humidifier |
| Classification | 21 CFR 868.5450, product code BTTHumidifier, Respiratory Gas, (Direct Patient Interface) |
| Product Code | BTT |
| Predicate Device | ResMed HumidAire 2iTM, K080797 |
Device Description
The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.
Indications for Use
The Transcend Heated Humidifier is indicated for the humidification 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/institutional environment. The Humidifier is for use only as recommended by a physician.
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Substantial Equivalence and Summary of Studies
The Transcend Heated Humidifier was tested and shown to be compliant with the following standards.
| Document Number | Title |
|---|---|
| IEC 60601-1 | Medical Electrical Equipment, Part 1: General Requirements for Safety,Ed. 3 |
| IEC 60601-1-2 | Medical Electrical Equipment – Collateral Standard: Electromagneticcompatibility - Requirements and tests |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral Standard: Usability |
| IEC 60601-1-11 | Medical Electrical Equipment – Collateral Standard: Requirements forhome health care environment |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use -- Particular requirementsfor respiratory humidification systems |
| ISO 10993-1 | Biological evaluation of medical devices |
| ISO 14971 | Medical devices -- Application of risk management to medical devices |
The Transcend Heated Humidifier is substantially equivalent to the predicate device based on comparisons of indications for use and technological characteristics.
| Summary of Predicate Comparisons | |||
|---|---|---|---|
| Characteristic | Transcend HeatedHumidifier | ResMed LtdHumidAire 2iTM | Comparison |
| Indications for use: | The Transcend HeatedHumidifier is indicated forthe humidification of the airdelivered from a compatibleTranscend positive airwaypressure therapy device.The Humidifier is intendedfor single patient re-use inthe home environment andin a hospital/institutionalenvironment. TheHumidifier is for use only asrecommended by aphysician. | The HumidAire 2i isindicated for thehumidification of the airdelivered from a ResMedcompatible CPAP therapydevice.The HumidAire 2i isintended for single patientre-use in the homeenvironment and multi-patient re-use in a hospital /institutional environment.The HumidAire 2i is for useonly as recommended by aphysician. | Similar. The TranscendHeated Humidifier isintended for use only by asingle patient. |
| Intended Population of Use | Adult | Adult | Identical |
| Summary of Predicate Comparisons | |||
| Characteristic | Transcend HeatedHumidifier | ResMed LtdTMHumidAire 2iTM | Comparison |
| Compatible Devices | Transcend PAP device andassociated accessories | ResMed PAP device andassociated accessories | Similar. The humidifiers aremade to be used withmanufacturers' existing PAPdevices. |
| Dimensions | 9 in X 5.5 in X 4.7 in | 4.8 in X 7.2 in X 8.6 in | Similar. Overall dimensionsdo not effect substantialequivalence determination. |
| Weight | 2.2 lbs | 2 lb | Similar. Overall weight doesnot affect substantialequivalence determination. |
| Disinfection | None | Should be disinfected whenused between patients. | The Transcend HeatedHumidifier is for singlepatient re-use only. |
| Cleaning | Distilled water using a milddetergent. | Warm water using a milddetergent. | Identical |
| Sterilization | Not sterilized | Not sterilized | Identical |
| Biocompatible | Yes | Yes | Identical |
| Pressure Regulation | Determined by compatiblePAP device. | Determined by compatiblePAP device. | Identical |
| Working pressure range | 4-20 cm H₂O | 4-20 cm H₂O | Identical |
| Humidifier Settings | 1-5 | 1-6 | Similar. Both devices delivera range of humidity basedon setting level. |
| Inspiratory / ExpiratoryPressure Drop | 0.375 cmH₂O at 50 L/min | Not reported | Subject device meetsrequirements of ISO 8185. |
| Gas Leak at Max OperatingPressure | 4.85 L/min | Not reported | Subject device meetsrequirements of ISO 8185. |
| Sound power level at 10 cmH₂O static pressure | 37 dB | Not reported | Subject device meetsrequirements of ISO 8185. |
| Maximum Heater PlateTemperature | 131 °F | 167 °F | Subject device meetsrequirements of ISO 8185. |
| Maximum output humidity | >95% | 95% | Similar |
| Maximum gas temperature | 77 °F | Not reported | Subject device meetsrequirements of ISO 8185. |
| Water Capacity | 325 ml | 400 ml | Similar. Devices areintended to have enoughwater to last a minimum of8 hours (equivalent to a fullnight of sleep) |
| Operating Temperature | +41°F to +95°F | +41°F to +104°F | Similar. Operatingtemperature is based oncompatible PAP device. |
| Operating Humidity | 10 - 80% relative humidity,non-condensing | 10-95% relative humidity,non-condensing | Similar. Operating humidityis based on compatible PAPdevice. |
| Summary of Predicate Comparisons | |||
| Characteristic | Transcend HeatedHumidifier | ResMed LtdHumidAire 2i™ | Comparison |
| Shipping/StorageTemperature | -4° F to +140° F | -4°F to +140°F | Identical |
| Gas inlet temperaturerange | +41°F to +95°F | +41°F to +104°F | Similar. Inlet temperature isbased on compatible PAPdevice. |
| Shipping/Storage Humidity | 10 - 90% relative humidity,non-condensing | 15 - 95% relative humidity,non-condensing | Similar |
| Power Supply | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Identical |
| IEC 60601-1 Classification | Type BF | Type CF | Subject device is compliantwith ISO 8185 Section 6.8.2-14 which states the deviceshould be either BF or CF. |
| Electromagneticcompatibility | Compliant with IEC 60601-1-2 | Compliant with IEC 60601-1-2 | Identical |
| ISO 8185 compliant | Yes | Unknown - not stated in510k summary or UsersManual | Consensus standards can beused to determinesubstantial equivalence to alegally marketed device. |
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Somnetics International Inc.
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Traditional 510(k) Premarket Submission
Transcend Heated Humidifier
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Somnetics International Inc.
Transcend Heated Humidifier Traditional 510(k) Premarket Submission
The device design was qualified through the following tests and assessments:
- . Electrical Safety
- . Electromagnetic Compatibility
- Biocompatibility Assessment .
- . Cleaning Validation
- . Software Validation
- Packaging and Shipping .
- Performance: physical (cycling), resistance to flow, spillage, flow sensing, sound . power level, humidification output, out of water shutdown, temperature, runtime, warm-up duration, and reservoir gas leak
These tests and assessments did not raise new safety or efficacy questions.
Conclusion
The Transcend Heated Humidifier is substantially equivalent to the HumidAire 2i (K080797). The subject and predicate devices are used in conjunction with CPAP devices to humidify air. They are equivalent in terms of technology and intended use. Risk assessments, biocompatibility evaluation, software, electromagnetic compatibility and electrical safety, bench testing, and compliance with recognized standards demonstrate that any differences do not raise new
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Transcend Heated Humidifier
Traditional 510(k) Premarket Submission
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questions of safety or effectiveness. The Transcend Heated Humidifier is, therefore, substantially equivalent to the predicate HumidAire 2i device.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2013
Somnetics International, Incorporated Ms. Melinda Swanson Regulatory Consultant 33 510 Avenue NW, Suite 500 NEW BRIGHTON MN 22112
Re: K131388
Trade/Device Name: Transcend Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Il Product Code: BTT Dated: August 22, 2013 Received: August 26, 2013
Dear Ms. 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 may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S
Kwame Ulmer M.S. Acting Division 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): どころは38
Device Name: Transcend Heated Humidifier
Indications for Use:
The Transcend Heated Humidifier is indicated for the humidification 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/institutional environment. The Humidifier is for use only as recommended by a physician.
Prescription Use _ X _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anya C. Harry -S
Division Sign-Off) wision of Anesthesiology, General Hospital .ection Control, Dental Devices
.i0(k) Number:_ K1313888
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).