Comfort Flo Humidification System

K162242 · Teleflexmedical, Inc. · BTT · Jan 19, 2017 · Anesthesiology

Device Facts

• Record ID: K162242
• Device Name: Comfort Flo Humidification System
• Applicant: Teleflexmedical, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Comfort Flo Humidification System delivers heated, humidified respiratory gases to spontaneously breathing patients. System components include heated wire breathing circuit, ConchaSmart column, and accessories. Operates in conjunction with Neptune Heated Humidifier using ConchaSmart technology. Humidification achieved via paper wick within sterile ConchaSmart column; water absorbed by wick directly in airflow; column warmed to increase water/air temperature for vapor creation. Used in professional healthcare environments (hospitals) by clinicians. Output is conditioned gas (near 37°C, 10mg/l humidity) at flow rates 1-60 LPM. Heated wire circuit controls condensation (rainout). Benefits include respiratory support for patients requiring humidified gas. Device is disposable/single-use.

Clinical Evidence

Bench testing only. No clinical data. Testing included ISO 8185 (respiratory humidifiers), ISO 5356-1 (connectors), ISO 5367 (breathing tubes), and comprehensive biocompatibility (ISO 10993 series). Performance testing verified enthalpy, resistance to flow, leakage, humidity output, warm-up time, temperature tracking, and rainout control post-aging and throughout useful life.

Technological Characteristics

Materials: Polypropylene, PVC, Polystyrene, Silicone, Engage, Cyclohexanone, Cyclohexane/Styrene Butadiene adhesive. Sensing/Actuation: Heated wire circuit, paper wick humidification. Energy: Heated humidifier base. Form factor: Breathing circuit with 10mm/15mm ID tubing. Connectivity: Standalone system. Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for neonate/infant, pediatric, and adult patients requiring continuous flow of heated and humidified gas in professional healthcare environments. For use with spontaneously breathing patients.

Regulatory Classification

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.

Predicate Devices

• Comfort Flo Humidification System (K131912)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size: 16px;">☐</span> 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: [phone] 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<br>Characteristics | Comfort Flo Humidification<br>System<br>K131912 | Proposed Comfort Flo<br>Humidification System |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | To provide a continuous flow of<br>heated and humidified gas to<br>spontaneously breathing patients. | The Comfort Flo Humidification<br>System provides a continuous flow of<br>heated and humidified gas to<br>spontaneously breathing patients. It<br>is indicated for single use by<br>neonate/infant, pediatric, and adult<br>patients in professional healthcare<br>environments. |
| Environment of<br>Use | Professional healthcare environment<br>(ex. Hospital) | Professional healthcare environment<br>(ex. Hospital) |
| Patient<br>Population | Neonate/infant, pediatric, Adult | Neonate/infant, pediatric, Adult |
| Gas Source<br>Compatibility | Non-Ventilator (continuous flow<br>system) | Non-Ventilator (continuous flow<br>system) |
| Compatible<br>Humidifiers | ConchaTherm Neptune Heated<br>Humidifier | ConchaTherm Neptune Heated<br>Humidifier |
| Compatible<br>Columns | ConchaSmart Column | ConchaSmart Column |
| Humidification<br>Method | Paper wick within the sterile Concha<br>Column. Water fills the bottom of the<br>column and is absorbed up the wick<br>which is directly in the air flow. The<br>column is warmed to increase water<br>and air temperature to aid the<br>creation and absorption of water<br>vapor into the airstream. | Paper wick within the sterile Concha<br>Column. Water fills the bottom of the<br>column and is absorbed up the wick<br>which is directly in the air flow. The<br>column is warmed to increase water<br>and air temperature to aid the creation<br>and absorption of water vapor into the<br>airstream. |
| Gas Delivery | Inspiratory limb only | Inspiratory limb only |
| Water Type | Sterile water sold separately | Sterile water sold separately |
| Enthalpy | Per ISO 8185:2007<br>Thermal overshoot to the patient<br>connection port limited to an energy<br>equivalent to 43°C and 100% relative<br>humidity when averaged over any 30<br>second period | Per ISO 8185:2007<br>Thermal overshoot to the patient<br>connection port limited to an energy<br>equivalent to 43°C and 100% relative<br>humidity when averaged over any 30<br>second period |
| Disposable vs.<br>Reusable | Disposable, single use | Disposable, single use |
| Sterility | Gamma sterilized ConchaSmart<br>column. Circuit and all other<br>accessories are non-sterile | Non-sterile |
| Patient Interface<br>Type | Nasal Cannula (sold separately, not<br>part of this 510(k)) | Nasal Cannula (sold separately, not<br>part of this 510(k)) |
| Comfort Flo<br>Humidification<br>System<br>Components | ● Heated Wire Breathing Circuit<br>● ConchaSmart Column<br>● Various Class 1 Exempt devices | ● Heated Wire Breathing Circuit<br>● ConchaSmart Column<br>● Various Class 1 Exempt devices |
| Comparative<br>Characteristics | Comfort Flo Humidification<br>System<br>K131912 | Proposed Comfort Flo<br>Humidification System |
| Heated Wire<br>Breathing Circuit | 10 mm ID smooth bore PVC tubing<br>(catalog# 2010 and 2414) | 10 mm ID smooth bore PVC tubing<br>(catalog# 2010 and 2414) |
| Tubing | 15 mm ID corrugated<br>Polypropylene/Engage tubing<br>(catalog# 2415 and 2416) | 15 mm ID corrugated<br>Polypropylene/Engage tubing<br>(catalog# 2415 and 2416) |
| Simulated Use | Circuit, column, and nasal cannula<br>assembly operate at 37°C (+/- 2°C)<br>for up to 37 days with visible<br>condensation, without loss of<br>functional integrity. | Circuit, column, and nasal cannula<br>assembly operate at 37°C (+/- 2°C)<br>for up to 21 days with visible<br>condensation, without loss of<br>functional integrity. |
| Humidity Output | System delivers gas conditioned at<br>or near 37°C and 10mg/l of humidity<br>to the patient interface from 1 to 60<br>LPM. | System delivers gas conditioned at or<br>near 37°C and 10mg/l of humidity to<br>the patient interface from 1 to 60 LPM. |
| Condensation<br>(rainout) | System controls amount of<br>condensation in the circuit using the<br>heated wire settings of the<br>ConchaTherm Neptune Heated<br>Humidifier from 1 to 60 LPM. | System controls amount of<br>condensation in the circuit using the<br>heated wire settings of the<br>ConchaTherm Neptune Heated<br>Humidifier from 1 to 60 LPM. |
| Shelf Life | 5 year shelf life on the Corrugated<br>Comfort Flo Kits (catalog# 2415 and<br>2416) | 1 year shelf life on the Corrugated<br>Comfort Flo Kits (catalog# 2415 and<br>2416) |
| Useful Life | 30 Days | 21 Days |
| | Polypropylene | Polypropylene (different blend) |
| | PVC | PVC |
| | Polypropylene | Polypropylene |
| | Polystyrene | Polystyrene |
| Breathing Circuit<br>Materials | Silicone | Silicone |
| | Cyclohexanone | Cyclohexanone |
| | Engage | Engage (different blend) |
| | Cyclohexane / Styrene Butadiene<br>(adhesive) | Cyclohexane / Styrene Butadiene<br>(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.

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- . 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<br>testing | The proposed Corrugated Comfort Flo Heated<br>Wire Breathing Circuit, when used with the<br>Hudson RCI Neptune Heated Humidifier must<br>perform as intended when subject to the following<br>test methods:<br>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<br>flow variations,<br>Resistance to Flow,<br>Resistance to Flow<br>with a bend, and<br>Leakage, Humidity<br>Output, Enthalpy<br>related to use and<br>system errors, Warm<br>Up Time and<br>Temperature Tracking | The proposed Corrugated Comfort Flo Heated<br>Wire Breathing Circuit, when used with the<br>Hudson RCI Neptune Heated Humidifier must<br>perform as intended post accelerated aging and<br>useful life testing when subject to the test<br>methods from the following applicable sections of<br>ISO 8185:<br>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.