(59 days)
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.
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.
The provided text describes the COMFORT FLO™ Humidification System and its 510(k) submission, including a summary of testing conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Target performance) | Reported Device Performance |
|---|---|
| All components operate at or near 100% Relative Humidity. | "all components can operate at or near 100% Relative Humidity" |
| All components operate at 37°C. | "all components can operate at... 37°C" |
| All components operate at a rate of 1 to 40 LPM. | "all components can operate at... a rate of 1 to 40 LPM" |
| Maintain functional integrity for up to 14 days. | "all components can operate... for up to 14 days without loss of functional integrity." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact number of units or test runs used for the evaluation. It mentions "The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions."
- Data Provenance (Country of Origin): Not explicitly stated, but the applicant (Teleflex Medical) is located in Bannockburn, IL, USA, and the FDA's address is Rockville, MD, USA. This suggests the testing was likely conducted in the USA or supervised by US entities.
- Retrospective or Prospective: The testing described is prospective, as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the study did not involve human interpretation or subjective assessment of data requiring expert consensus or ground truth in the way medical imaging or diagnostic algorithms would. The study focused on the functional performance of a medical device against objective physical parameters (humidity, temperature, flow rate, duration).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. The testing involved objective measurements of physical parameters, not subjective assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems with human readers. This submission is for a medical device (humidification system) with no AI component or human interpretative task.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as there is no algorithm or AI component mentioned in the device description or testing summary. The device's performance was evaluated as a standalone physical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the specified physical parameters/performance requirements for the device: 100% Relative Humidity, 37°C, 1 to 40 LPM flow rate, and maintenance of functional integrity for 14 days. Compliance was assessed against these objective, measurable conditions.
8. The sample size for the training set
This section is not applicable. The device is a physical medical system, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set mentioned or implied for this type of device.
{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
§ 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).