(203 days)
Not Found
No
The device description and performance studies focus on the physical components and their compatibility with existing equipment, with no mention of AI or ML capabilities.
No.
The device acts as a conduit for respiratory gas and helps minimize condensation and maintain temperature/humidity, but it does not treat or cure a medical condition. Its function is supportive within a respiratory system.
No
The device is described as a conduit for respiratory gas and its function is to minimize condensation and maintain temperature and humidity, not to diagnose a condition.
No
The device description explicitly mentions "corrugated tubing (22 mm in diameter) which house the heated wires" and "various adaptors and connectors," indicating physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "conduit for respiratory gas between a patient and includes heated wire(s)". It's used to deliver respiratory gas and manage humidity and temperature.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely related to the delivery and conditioning of respiratory gases.
Therefore, the Conchasmart and ISO-GARD Breathing Circuits fall under the category of respiratory support devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ConchaSmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
Product codes
BTT
Device Description
ConchaSmart and ISO-GARD breathing circuits provide a conduit for respiratory gases between the patient and the ventilator/Hudson RCI Neptune Heated Humidifier. The heated wires inside the breathing circuits are used to minimize condensation in the circuit and to aid in maintaining the designated humidity and temperature of the respiratory gas. ConchaSmart and ISO-GARD breathing circuits are intended for use with adult patient populations in professional healthcare environments. These devices are made of corrugated tubing (22 mm in diameter) which house the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration.
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
Intended User / Care Setting
professional healthcare environments
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 proposed devices were tested to ensure compliance to ISO 5367 (Breathing tubes intended for use with anaesthetic apparatus and ventilators) and ISO 5356-1 (Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets). In addition, testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier and a useful life of 30 days. Cytotoxicity, sensitization, irritation, genotoxicity, and implantation testing were performed to demonstrate biocompatibility of the patient contacting materials. The device data and test results demonstrate that the device is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, abstract design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2014
Teleflex Medical, Incorporated Ms. Amanda Webb Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K140556
Trade/Device Name: ConchaSmart and ISO-GARD Breathing Circuits Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: August 27, 2014 Received: August 28, 2014
Dear Ms. 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.
1
Page 2 - Ms. Webb
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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140556
Device Name ConchaSmart and ISO-GARD Breathing Circuit
Indications for Use (Describe)
The Conchasmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healtheare facilities as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the breathing circuit.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, 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
September 24, 2014
D. Device Name
| Trade Name: | ConchaSmart and ISO-GARD Breathing Circuits |
|---|---|
| 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 following predicate device:
- . Hudson RCI Heated Wire Circuit – K031383
F. Device Description
ConchaSmart and ISO-GARD breathing circuits provide a conduit for respiratory gases between the patient and the ventilator/Hudson RCI Neptune Heated Humidifier. The heated wires inside the breathing circuits are used to minimize condensation in the circuit and to aid in maintaining the designated humidity and temperature of the respiratory gas. ConchaSmart and ISO-GARD breathing circuits are intended for use with adult patient populations in professional healthcare environments.
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510(k) Submission Section 10 - 510(k) Summary
These devices are made of corrugated tubing (22 mm in diameter) which house the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration.
G. Indications for Use
The ConchaSmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
H. Technological Characteristics Comparison to the predicate
The proposed Heated Wire Breathing Circuits are substantially equivalent to the predicate devices listed above in that the intended use and fundamental scientific technology remain unchanged. The following table summarizes the technological differences between the proposed and predicate devices.
| Comparative
Characteristics | Hudson Heated Wire
Breathing Circuits
(K031383) | Proposed ISO-GARD and
ConchaSmart breathing
circuits |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Hudson Heated Wire Ventilator
Circuit is intended as a conduit for
respiratory gas between a patient
and a ventilator, and includes heated
wires for use with a Concha Column
Humidifier; the heated wires are
intended to minimize condensation
in the ventilator tubing. | The ConchaSmart breathing circuit
is intended as a conduit for
respiratory gas between a patient
and a ventilator and includes heated
wire(s) for use with the Hudson RCI
Neptune Heated Humidifier. The
heated wires are intended to aid in
maintaining the set patient
temperature and minimize
condensation in the breathing
circuit. |
| Intended Use | Act as a conduit for gas delivery to a
patient. | Same |
| Environment of
Use | Professional Healthcare
Environments | Same |
| Patient
Population | Adult | Same |
| Compatible
Humidifiers | All Hudson ConchaTherm Heated
Humidifiers | Hudson RCI Neptune Heated
Humidifier |
| Disposable vs.
Reusable | Disposable | Same |
| Simulated Use | Not labeled for useful life | Labeled for 30 day useful life |
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| Comparative
Characteristics | Hudson Heated Wire
Breathing Circuits
(K031383) | Proposed ISO-GARD and
ConchaSmart breathing
circuits |
|--------------------------------|-------------------------------------------------------|------------------------------------------------------------|
| Standards | Tested to some sections of ISO 5367 | Compliant to ISO 5367 and ISO
5356-1 |
| Wye Material | Polypropylene | Clearblend |
| Tubing Material | Polyethylene/EVA | Polypropylene/Engage |
I. Performance Data
The proposed devices were tested to ensure compliance to ISO 5367 (Breathing tubes intended for use with anaesthetic apparatus and ventilators) and ISO 5356-1 (Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets). In addition, testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier and a useful life of 30 days. Cytotoxicity, sensitization, irritation, genotoxicity, and implantation testing were performed to demonstrate biocompatibility of the patient contacting materials.
J. Conclusion
The device data and test results demonstrate that the device is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.