(162 days)
Not Found
No
The summary describes a humidification system with standard components and testing, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients, which suggests a therapeutic intervention to aid respiration or provide comfort.
No
The device's intended use is to provide heated and humidified gas to patients, which is a therapeutic function, not a diagnostic one. It does not mention detecting, monitoring, or diagnosing any medical condition.
No
The device description explicitly lists hardware components such as a Heated Wire Breathing Circuit and a ConchaSmart Column, indicating it is not solely software.
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 and supportive function, not a diagnostic one.
- Device Description: The description focuses on delivering respiratory gases and working with a humidifier. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The Comfort Flo Humidification System is a medical device used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatic, and adult patients in professional healthcare environments.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the Neptune Heated Humidifier with ConchaSmart Technology for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.
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
neonate/infant, pediatic, and adult patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed on the proposed device:
- ISO 8185:2007 - Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems, applicable sections
- ISO 5356-1:2004 - Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets, applicable sections
- ISO 5367:2000 (Section 4.4, and Annexes D and E, per ISO 8185) Breathing tubes intended for use with anaesthetic apparatus and ventilators, applicable sections
- Biocompatibility:
- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
- ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2002 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
- Shelf life
- Useful life
Summary of Non-Clinical Testing:
- Shelf life / Useful life testing: The proposed Corrugated Comfort Flo Heated Wire Breathing Circuit, when used with the Hudson RCI Neptune Heated Humidifier must perform as intended when subject to the following test methods: Pre- and Post-aging Visual Inspection Length per ISO 5367 Connection strength testing Maximum Temperature / Minimum flow testing ISO 8185 Section 101 Useful life testing Rainout control. Result: PASS.
- Enthalpy related to flow variations, Resistance to Flow, Resistance to Flow with a bend, and Leakage, Humidity Output, Enthalpy related to use and system errors, Warm Up Time and Temperature Tracking: The proposed Corrugated Comfort Flo Heated Wire Breathing Circuit, when used with the Hudson RCI Neptune Heated Humidifier must perform as intended post accelerated aging and useful life testing when subject to the test methods from the following applicable sections of ISO 8185: Section 51.103 Section 56.101.2 and 56.101.3 Section 101 Section 51.103 with faults from 3.6 bb Section 6.8.2 a) 14. Result: PASS.
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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing 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
January 19, 2017
Teleflex Medical, Inc. Brian Gall Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K162242 Trade/Device Name: Comfort Flo Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: December 16, 2016 Received: December 19, 2016
Dear Mr. Gall:
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162242
Device Name Comfort Flo Humidification System
Indications for Use (Describe)
The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatic, and adult patients in professional healthcare environments.
| 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
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-228-4350 919-361-3939 Fax:
B. Contact Person
Brian Gall Senior Regulatory Affairs Specialist
C. Date Prepared
16 December 2016
D. Device Name
| Trade Name: | Comfort Flo Humidification System |
|---|---|
| Classification 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 devices:
- Comfort Flo Humidification System K131912 ●
F. Device Description
The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the Neptune Heated Humidifier with ConchaSmart Technology for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.
G. Indications for Use
The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatric, and adult patients in professional healthcare environments.
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H. Technological Characteristics Comparison to the predicate
| Comparative
Characteristics | Comfort Flo Humidification
System
K131912 | Proposed Comfort Flo
Humidification System |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | To provide a continuous flow of
heated and humidified gas to
spontaneously breathing patients. | The Comfort Flo Humidification
System provides a continuous flow of
heated and humidified gas to
spontaneously breathing patients. It
is indicated for single use by
neonate/infant, pediatric, and adult
patients in professional healthcare
environments. |
| Environment of
Use | Professional healthcare environment
(ex. Hospital) | Professional healthcare environment
(ex. Hospital) |
| Patient
Population | Neonate/infant, pediatric, Adult | Neonate/infant, pediatric, Adult |
| Gas Source
Compatibility | Non-Ventilator (continuous flow
system) | Non-Ventilator (continuous flow
system) |
| Compatible
Humidifiers | ConchaTherm Neptune Heated
Humidifier | ConchaTherm Neptune Heated
Humidifier |
| Compatible
Columns | ConchaSmart Column | ConchaSmart Column |
| Humidification
Method | Paper wick within the sterile Concha
Column. Water fills the bottom of the
column and is absorbed up the wick
which is directly in the air flow. The
column is warmed to increase water
and air temperature to aid the
creation and absorption of water
vapor into the airstream. | Paper wick within the sterile Concha
Column. Water fills the bottom of the
column and is absorbed up the wick
which is directly in the air flow. The
column is warmed to increase water
and air temperature to aid the creation
and absorption of water vapor into the
airstream. |
| Gas Delivery | Inspiratory limb only | Inspiratory limb only |
| Water Type | Sterile water sold separately | Sterile water sold separately |
| Enthalpy | Per ISO 8185:2007
Thermal overshoot to the patient
connection port limited to an energy
equivalent to 43°C and 100% relative
humidity when averaged over any 30
second period | Per ISO 8185:2007
Thermal overshoot to the patient
connection port limited to an energy
equivalent to 43°C and 100% relative
humidity when averaged over any 30
second period |
| Disposable vs.
Reusable | Disposable, single use | Disposable, single use |
| Sterility | Gamma sterilized ConchaSmart
column. Circuit and all other
accessories are non-sterile | Non-sterile |
| Patient Interface
Type | Nasal Cannula (sold separately, not
part of this 510(k)) | Nasal Cannula (sold separately, not
part of this 510(k)) |
| Comfort Flo
Humidification
System
Components | ● Heated Wire Breathing Circuit
● ConchaSmart Column
● Various Class 1 Exempt devices | ● Heated Wire Breathing Circuit
● ConchaSmart Column
● Various Class 1 Exempt devices |
| Comparative
Characteristics | Comfort Flo Humidification
System
K131912 | Proposed Comfort Flo
Humidification System |
| Heated Wire
Breathing Circuit | 10 mm ID smooth bore PVC tubing
(catalog# 2010 and 2414) | 10 mm ID smooth bore PVC tubing
(catalog# 2010 and 2414) |
| Tubing | 15 mm ID corrugated
Polypropylene/Engage tubing
(catalog# 2415 and 2416) | 15 mm ID corrugated
Polypropylene/Engage tubing
(catalog# 2415 and 2416) |
| Simulated Use | Circuit, column, and nasal cannula
assembly operate at 37°C (+/- 2°C)
for up to 37 days with visible
condensation, without loss of
functional integrity. | Circuit, column, and nasal cannula
assembly operate at 37°C (+/- 2°C)
for up to 21 days with visible
condensation, without loss of
functional integrity. |
| Humidity Output | System delivers gas conditioned at
or near 37°C and 10mg/l of humidity
to the patient interface from 1 to 60
LPM. | System delivers gas conditioned at or
near 37°C and 10mg/l of humidity to
the patient interface from 1 to 60 LPM. |
| Condensation
(rainout) | System controls amount of
condensation in the circuit using the
heated wire settings of the
ConchaTherm Neptune Heated
Humidifier from 1 to 60 LPM. | System controls amount of
condensation in the circuit using the
heated wire settings of the
ConchaTherm Neptune Heated
Humidifier from 1 to 60 LPM. |
| Shelf Life | 5 year shelf life on the Corrugated
Comfort Flo Kits (catalog# 2415 and
2416) | 1 year shelf life on the Corrugated
Comfort Flo Kits (catalog# 2415 and
2416) |
| Useful Life | 30 Days | 21 Days |
| | Polypropylene | Polypropylene (different blend) |
| | PVC | PVC |
| | Polypropylene | Polypropylene |
| | Polystyrene | Polystyrene |
| Breathing Circuit
Materials | Silicone | Silicone |
| | Cyclohexanone | Cyclohexanone |
| | Engage | Engage (different blend) |
| | Cyclohexane / Styrene Butadiene
(adhesive) | Cyclohexane / Styrene Butadiene
(adhesive) |
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The following are the primary differences in the proposed Comfort Flo Humidification System:
- . The Indications for Use Statement has been updated per to better align with 21 CFR 814.20(b)(3)(i). There are no changes to the content or meaning of the Indications for Use from the predicate to the proposed device.
- The ConchaSmart column (part of the Comfort Flo Humidification System) included in the ● predicate device was sterilized by gamma radiation. The circuit and other accessories were non-sterile. The ConchaSmart column was made non-sterile in submission K141940. The proposed Comfort Flo Humidification system is completely non-sterile.
6
- . The shelf life and useful life of the predicate are different from the proposed device. The proposed shelf life and useful life are based on test data.
- There are two new materials in the proposed Heated Wire Breathing Circuit ● has undergone all necessary biocompatibility and performance tests
I. Performance Data
The following testing was performed on the proposed device.
- . ISO 8185:2007 - Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems, applicable sections ISO 5356-1:2004 - Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets, applicable sections
- ISO 5367:2000 (Section 4.4, and Annexes D and E, per ISO 8185) Breathing tubes ● intended for use with anaesthetic apparatus and ventilators, applicable sections
- . Biocompatibilitv
- o ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- o ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: o Tests for irritation and skin sensitization
- ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: O Sample preparation and reference materials
- o ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2002 Biological evaluation of medical devices -- Part 18: o Chemical characterization of materials
- Shelf life ●
- . Useful life
J. Summary of Non-Clinical Testing
| Test Description | Test Objective | Results |
|---|---|---|
| Shelf life / Useful life | ||
| testing | The proposed Corrugated Comfort Flo Heated | |
| Wire Breathing Circuit, when used with the | ||
| Hudson RCI Neptune Heated Humidifier must | ||
| perform as intended when subject to the following | ||
| test methods: | ||
| Pre- and Post-aging Visual Inspection Length per ISO 5367 Connection strength testing Maximum Temperature / Minimum flow testing ISO 8185 Section 101 Useful life testing Rainout control | PASS |
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| Test Description | Test Objective | Result |
|---|---|---|
| Enthalpy related to | ||
| flow variations, | ||
| Resistance to Flow, | ||
| Resistance to Flow | ||
| with a bend, and | ||
| Leakage, Humidity | ||
| Output, Enthalpy | ||
| related to use and | ||
| system errors, Warm | ||
| Up Time and | ||
| Temperature Tracking | The proposed Corrugated Comfort Flo Heated | |
| Wire Breathing Circuit, when used with the | ||
| Hudson RCI Neptune Heated Humidifier must | ||
| perform as intended post accelerated aging and | ||
| useful life testing when subject to the test | ||
| methods from the following applicable sections of | ||
| ISO 8185: | ||
| Section 51.103 Section 56.101.2 and 56.101.3 Section 101 Section 51.103 with faults from 3.6 bb Section 6.8.2 a) 14 | PASS |
K. Conclusion
The proposed Comfort Flo Humidification System is substantially equivalent to the predicate devices listed above in that the indications for use, the intended use, and fundamental scientific technology remain unchanged. The difference between the predicate device and the proposed device is the material of construction of the corrugated tubing on the Comfort Flo Heated Wire Breathing Circuit. The tubing material is being changed to a different grade of the same material. The proposed device was tested with equivalent biocompatibility and performance testing as the predicate, and met all of the acceptance criteria.
The device data and test results demonstrate that the device is substantially equivalent to the predicate device.