(130 days)
No
The summary describes a disposable humidifier cartridge, an accessory to a heated humidifier. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies section also indicates no performance testing was required, which would be unusual for a device incorporating complex AI/ML algorithms.
No
The device provides heated humidification but does not inherently treat a disease or condition; it is an accessory used with a humidifier and ventilator for patient comfort and support.
No
The device provides heated humidification, which is a therapeutic function, not a diagnostic one. It assists with patient care rather than identifying or monitoring a medical condition.
No
The device description clearly states it is a "single use, disposable humidifier cartridge," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide heated humidification for patients using a humidifier and ventilator circuits. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is described as a disposable humidifier cartridge, an accessory to a heated humidifier. This aligns with a respiratory support device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
Product codes
BTT
Device Description
The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.
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
Neonatal, Infant, Pediatric, Adult
Intended User / Care Setting
Not Found
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
The change in sterility does not impact the performance characteristic of the device; therefore, no performance testing was required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K132017, K131957, K131895, K110019, K063758, K131912
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2014
Teleflex Medical Amanda Webb Senior Regulation Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K141940
Trade/Device Name: Concha Smart Column Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: II Product Code: BTT Dated: October 27, 2014 Received: October 29, 2014
Dear Amanda Webb:
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin | Keith -S
Erin I. Keith, M.S 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)
Device Name ConchaSmart Column
Indications for Use (Describe)
When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
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 OF SAFETY AND EFFECTIVENESS
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8050 919-433-4996 Fax:
B. Contact Person
Amanda Webb Senior Regulatory Affairs Specialist
C. Date Prepared
July 14, 2014
D. Device Name
| Trade Name: | ConchaSmart Column |
|---|---|
| Common Name: | Respiratory Gas Humidifier |
| Product Code: | BTT |
| Regulation Number: | 868.5450 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
E. Predicate Device
This submission demonstrates substantial equivalence to the Fisher and Paykel MR290 Autofeed Humidification Chamber K131957.
F. Device Description
The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.
G. Indications for Use
When used with the a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
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| Comparative
Characteristics | Fisher and Paykel MR290
Autofeed Humidification
Chamber K131957 | ConchaSmart Column | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | When used with Fisher and Paykel
heated humidifiers cleared in
K132017, K131957, K131895, and
K110019 the MR290 provides heated
humidification for patients with and
without an artificial airway in place. | When used with a Neptune Heated
Humidifier and Hudson RCI
ventilator circuits, the ConchaSmart
Column provides heated
humidification for patients with and
without an artificial airway in place. | |
| | Patient
Population | Neonatal, Infant, Pediatric, Adult | Neonatal, Infant, Pediatric, Adult |
| | Humidification
Therapies | Invasive, Non-Invasive, High Flow
Nasal Cannula Therapy | Invasive, Non-Invasive, High Flow
Nasal Cannula Therapy |
| Humidity
Output | ISO 8185:2007 | ISO 8185:2007 | |
| | Subglottic mode: (≥33mg H2O /L) | Subglottic mode: (≥33mg H2O /L) | |
| | Supraglottic mode: (≥10mg H2O /L) | Supraglottic mode: (≥10mg H2O /L) | |
| | ISO 8185:2007 | ISO 8185:2007 | |
| Enthalpy Limit |