(135 days)
No
The summary describes a heated humidifier for PAP therapy and does not mention any AI or ML capabilities. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
No.
The device humidifies air for a therapeutic device but is not explicitly stated to be therapeutic itself.
No
The device is a humidifier designed to humidify air for PAP therapy. Its intended use and description focus on humidification, not on diagnosing medical conditions.
No
The device description explicitly states it is a "Heated Humidifier," which is a physical hardware component designed to humidify air. The performance studies also include tests related to physical characteristics, electrical safety, and other hardware-specific parameters.
Based on the provided information, the Transcend Heated Humidifier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to humidify air delivered during positive airway pressure therapy. This is a therapeutic function, not a diagnostic one.
- Device Description: The description reinforces its role in humidifying air for therapy.
- Anatomical Site: The airway is the target for the humidified air, not a sample being analyzed for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the device's physical and functional performance (electrical safety, humidification output, temperature, etc.), not on diagnostic accuracy or clinical outcomes related to a diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Transcend Heated Humidifier does not fit this definition.
N/A
Intended Use / 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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home environment and in a hospital/institutional environment. For use only as recommended by a physician.
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 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.
The Transcend Heated Humidifier was tested and shown to be compliant with the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ISO 8185:2007, ISO 10993-1, ISO 14971.
Key results from performance comparison to predicate:
- Inspiratory / Expiratory Pressure Drop: 0.375 cmH₂O at 50 L/min. Subject device meets requirements of ISO 8185.
- Gas Leak at Max Operating Pressure: 4.85 L/min. Subject device meets requirements of ISO 8185.
- Sound power level at 10 cm H₂O static pressure: 37 dB. Subject device meets requirements of ISO 8185.
- Maximum Heater Plate Temperature: 131 °F. Subject device meets requirements of ISO 8185.
- Maximum output humidity: >95%. Similar to predicate (95%).
- Maximum gas temperature: 77 °F. Subject device meets requirements of ISO 8185.
- Water Capacity: 325 ml. Similar to predicate (400 ml). Devices are intended to have enough water to last a minimum of 8 hours (equivalent to a full night of sleep).
- IEC 60601-1 Classification: Type BF. Subject device is compliant with ISO 8185 Section 6.8.2-14 which states the device should be either BF or CF.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ResMed HumidAire 2iTM, K080797
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 500
New Brighton, MN 55112 |
|------------------------------|------------------------------------------------------------------------------------------------------|
| Establishment Registration # | 3008770104 |
| Contact Person | Melinda Swanson
Regulatory Consultant
Telephone: 651-621-1800
Email: mswanson@somnetics.com |
| Trade Name | Transcend Heated Humidifier |
| Common/Usual Name | Respiratory Humidifier |
| Classification | 21 CFR 868.5450, product code BTT
Humidifier, 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.
1
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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: Electromagnetic |
| compatibility - Requirements and tests | |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral Standard: Usability | |
| IEC 60601-1-11 | Medical Electrical Equipment – Collateral Standard: Requirements for |
| home health care environment | |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use -- Particular requirements |
| for 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 Heated | ||
| Humidifier | ResMed Ltd | ||
| HumidAire 2iTM | Comparison | ||
| 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. | The HumidAire 2i is | ||
| indicated for the | |||
| humidification of the air | |||
| delivered from a ResMed | |||
| compatible CPAP therapy | |||
| device. | |||
| The HumidAire 2i is | |||
| intended for single patient | |||
| re-use in the home | |||
| environment and multi- | |||
| patient re-use in a hospital / | |||
| institutional environment. | |||
| The HumidAire 2i is for use | |||
| only as recommended by a | |||
| physician. | Similar. The Transcend | ||
| Heated Humidifier is | |||
| intended for use only by a | |||
| single patient. | |||
| Intended Population of Use | Adult | Adult | Identical |
| Summary of Predicate Comparisons | |||
| Characteristic | Transcend Heated | ||
| Humidifier | ResMed LtdTM | ||
| HumidAire 2iTM | Comparison | ||
| Compatible Devices | Transcend PAP device and | ||
| associated accessories | ResMed PAP device and | ||
| associated accessories | Similar. The humidifiers are | ||
| made to be used with | |||
| manufacturers' existing PAP | |||
| devices. | |||
| Dimensions | 9 in X 5.5 in X 4.7 in | 4.8 in X 7.2 in X 8.6 in | Similar. Overall dimensions |
| do not effect substantial | |||
| equivalence determination. | |||
| Weight | 2.2 lbs | 2 lb | Similar. Overall weight does |
| not affect substantial | |||
| equivalence determination. | |||
| Disinfection | None | Should be disinfected when | |
| used between patients. | The Transcend Heated | ||
| Humidifier is for single | |||
| patient re-use only. | |||
| Cleaning | Distilled water using a mild | ||
| detergent. | Warm water using a mild | ||
| detergent. | Identical | ||
| Sterilization | Not sterilized | Not sterilized | Identical |
| Biocompatible | Yes | Yes | 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 | 1-6 | Similar. Both devices deliver |
| a range of humidity based | |||
| on setting level. | |||
| Inspiratory / Expiratory | |||
| Pressure Drop | 0.375 cmH₂O at 50 L/min | Not reported | Subject device meets |
| requirements of ISO 8185. | |||
| Gas Leak at Max Operating | |||
| Pressure | 4.85 L/min | Not reported | Subject device meets |
| requirements of ISO 8185. | |||
| Sound power level at 10 cm | |||
| H₂O static pressure | 37 dB | Not reported | Subject device meets |
| requirements of ISO 8185. | |||
| Maximum Heater Plate | |||
| Temperature | 131 °F | 167 °F | Subject device meets |
| requirements of ISO 8185. | |||
| Maximum output humidity | >95% | 95% | Similar |
| Maximum gas temperature | 77 °F | Not reported | Subject device meets |
| requirements of ISO 8185. | |||
| Water Capacity | 325 ml | 400 ml | Similar. Devices are |
| intended to have enough | |||
| water to last a minimum of | |||
| 8 hours (equivalent to a full | |||
| night of sleep) | |||
| Operating Temperature | +41°F to +95°F | +41°F to +104°F | Similar. Operating |
| temperature is based on | |||
| compatible PAP device. | |||
| Operating Humidity | 10 - 80% relative humidity, | ||
| non-condensing | 10-95% relative humidity, | ||
| non-condensing | Similar. Operating humidity | ||
| is based on compatible PAP | |||
| device. | |||
| Summary of Predicate Comparisons | |||
| Characteristic | Transcend Heated | ||
| Humidifier | ResMed Ltd | ||
| HumidAire 2i™ | Comparison | ||
| Shipping/Storage | |||
| Temperature | -4° F to +140° F | -4°F to +140°F | Identical |
| Gas inlet temperature | |||
| range | +41°F to +95°F | +41°F to +104°F | Similar. Inlet temperature is |
| based on compatible PAP | |||
| device. | |||
| 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 compliant |
| with ISO 8185 Section 6.8.2- | |||
| 14 which states the device | |||
| should be either BF or CF. | |||
| Electromagnetic | |||
| compatibility | Compliant with IEC 60601- | ||
| 1-2 | Compliant with IEC 60601- | ||
| 1-2 | Identical | ||
| ISO 8185 compliant | Yes | Unknown - not stated in | |
| 510k summary or Users | |||
| Manual | Consensus standards can be | ||
| used to determine | |||
| substantial equivalence to a | |||
| legally marketed device. |
2
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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Somnetics International Inc.
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.
5
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.
6
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
7
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