(59 days)
Not Found
No
The summary describes a gas delivery system with a heated circuit, column, and nasal cannula. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is designed to provide heated and humidified gas for spontaneously breathing patients, which is a therapeutic function to aid respiration and prevent complications from dry gas. The "Intended Use / Indications for Use" explicitly states this purpose.
No
The device's description and intended use focus on delivering heated and humidified gas for respiratory support, not on diagnosing medical conditions or diseases.
No
The device description clearly outlines multiple hardware components including a heated circuit, a Concha® Column, and a nasal cannula patient interface.
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 and humidified gas to spontaneously breathing patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a gas delivery system used in conjunction with a humidifier. This aligns with respiratory support, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to deliver a therapeutic gas mixture to the patient's respiratory system.
N/A
Intended Use / Indications for Use
The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.
Indications For Use:
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
Product codes
BTT
Device Description
The COMFORT FLO™ Humidification System is a gas delivery system.This system is designed to deliver heated and humidified respiratory gases to spontaneously breathing adult, pediatric, infant, and/or neonatal patients. This delivery system will be used in conjunction with the ConchaTherm Heated Humidifier product line.
The COMFORT FLO™ Humidification System consists of a heated circuit, a Concha® Column, and a nasal cannula patient interface. All components of the COMFORT FLO™ Humidification System are non-sterile with the exception of the gamma-sterilized Concha® Column.
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
adult, pediatric, infant, and/or neonatal patients.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions to demonstrate that all components can operate at or near 100% Relative Humidity, 37°C, and a rate of 1 to 40 LPM for up to 14 days without loss of functional integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031383, K010402, K923946, K033710
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letters 'Ko', followed by the numbers '61736'. The handwriting is in black ink and the background is white. The letters and numbers are connected, giving the impression of a single word or code.
847-572-8001
AUG 1 8 2006 Teleflex Medical Group Headquarters 2345 Waukegan Road, Suite 120 Bannockburn, IL 60015 USA Phone: 847-572-8027
Fax:
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS COMFORT FLO™ Humidification System
A. Name. Address. Phone and Fax Number of Applicant
Teleflex Medical 2345 Waukegan Road Suite 120 Bannockburn, IL 60015
B. Contact Person
Lori Hays Senior Manager, Regulatory Affairs
C. Date Prepared
August 9, 2006
D. Device Name
Trade Name: COMFORT FLO™ Humidification System
Common Name: Humidification System
Classification Name: Respiratory Gas Humidifier
Product Code: BTT
Regulation Number: 21 CFR 868.5450
Class: Il
E. Device Description
The COMFORT FLO™ Humidification System is a gas delivery system.This system is designed to deliver heated and humidified respiratory gases to spontaneously breathing adult, pediatric, infant, and/or neonatal patients. This delivery system will be used in conjunction with the ConchaTherm Heated Humidifier product line.
The COMFORT FLO™ Humidification System consists of a heated circuit, a Concha® Column, and a nasal cannula patient interface. All components of the COMFORT
A Division of Telex incorporated
beere | KMedic | Pilling | SURGICAL SERVICES | RUSCH | WECK | C Yevolutions
1
FLO™ Humidification System are non-sterile with the exception of the gamma-sterilized Concha® Column.
F. Intended Use
The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.
G. Substantial Equivalence
The COMFORT FLO™ Humidification System is substantially equivalent to the components of the currently marketed Hudson RCI Breathing Circuits (K031383 and K010402), Hudson RCI ConchaTherm IV Heated Molecular Humidifier (K923946) and Fisher & Paykel MR850 Respiratory Humidifier (K033710). These systems have the following similarities:
-
- Can be used with a heated wire assembly.
-
- Intended to deliver heated humidified gas to patients.
The major differences between the COMFORT FLO™ Humidification System and the currently marketed Hudson RCI Breathing Circuits (K031383 and K010402), Hudson RCI ConchaTherm IV Heated Molecular Humidifier (K923946) and Fisher & Paykel MR850 Respiratory Humidifier (K033710) are as follows:
-
- The COMFORT FLO™ Humidification System will be sold with the oxygen accessory kit. These components are not sold with the currently marketed system.
-
- The COMFORT FLO™ Humidification System will contain a temperature probe wire clip not found on the currently marketed system.
-
- The COMFORT FLO™ Humidification System will contain a Concha® Column which has the check valves removed to help normalize the pressure in the water bottle with the pressure in the circuit.
H. Summary of Testing
The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions to demonstrate that all components can operate at or near 100% Relative Humidity, 37°C, and a rate of 1 to 40 LPM for up to 14 days without loss of functional integrity.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three overlapping profiles suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
Teleflex Medical C/O Mr. Neil E. Devine Responsible Third Party Official Tntertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K061736
ﺮ ﮐﯽ ﮨﺮ
Trade/Device Name: COMFORT FLO™ Humidification System Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: August 3, 2006 Received: August 4, 2006
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clrs
Chin-Lien, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: COMFORT FLO™ Humidification System
Indications For Use:
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
Aur Suliom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K061136