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.

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.

AI/ML Overview

The document describes the acceptance criteria and performance of the Comfort Flo Humidification System, primarily focusing on its substantial equivalence to a predicate device (K131912).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test Objective	Reported Device Performance
Shelf life / Useful life testing	PASS
- Pre- and Post-aging Visual Inspection	Met
- Length per ISO 5367	Met
- Connection strength testing	Met
- Maximum Temperature / Minimum flow testing	Met
- ISO 8185 Section 101 (Useful life testing)	Met
- Rainout control	Met
Enthalpy related to flow variations, Resistance to Flow, Resistance to Flow with a bend, Leakage, Humidity Output, Enthalpy related to use and system errors, Warm Up Time and Temperature Tracking (as per 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

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "The proposed Corrugated Comfort Flo Heated Wire Breathing Circuit" and "the proposed device," implying that testing was conducted on samples of the new design.
Data Provenance: The document does not specify the country of origin of the data. The testing appears to be "bench testing" or "laboratory testing" based on the nature of the tests (ISO standards, physical and functional performance). It is prospective in the sense that the testing was performed on the new device (or samples thereof) to demonstrate its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the described testing involves objective physical and functional performance criteria against established ISO standards, rather than subjective expert assessment or "ground truth" derived from human interpretation.

4. Adjudication method for the test set:

This information is not applicable. The testing involves objective measurements and adherence to specified performance parameters defined by ISO standards. Therefore, an adjudication method for human interpretation is not relevant.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems that assist human interpretation of medical images, which is not the nature of the Comfort Flo Humidification System.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone algorithm-only performance study was not done. This device is a medical apparatus (humidification system), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of the Comfort Flo Humidification System is based on International Organization for Standardization (ISO) standards and specific engineering/performance requirements. This includes:
- ISO 8185:2007 - Respiratory tract humidifiers for medical use
- ISO 5356-1:2004 - Anaesthetic and respiratory equipment -- Conical connectors
- ISO 5367:2000 - Breathing tubes
- ISO 10993 series - Biological evaluation of medical devices (for biocompatibility)
- Specific functional parameters like visual inspection, length, connection strength, temperature/flow, rainout control, enthalpy, resistance to flow, leakage, humidity output, warm-up time, and temperature tracking.

8. The sample size for the training set:

This information is not applicable. The Comfort Flo Humidification System is a physical medical device, not an AI/machine learning model that requires a training set. The term "training set" is typically used in the context of developing AI algorithms.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as #8. No training set or associated ground truth was relevant for this device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K162242

Device Name Comfort Flo Humidification System

Indications for Use (Describe)

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

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

ComparativeCharacteristics	Comfort Flo HumidificationSystemK131912	Proposed Comfort FloHumidification System
IntendedUse/Indicationsfor Use	To provide a continuous flow ofheated and humidified gas tospontaneously breathing patients.	The Comfort Flo HumidificationSystem provides a continuous flow ofheated and humidified gas tospontaneously breathing patients. Itis indicated for single use byneonate/infant, pediatric, and adultpatients in professional healthcareenvironments.
Environment ofUse	Professional healthcare environment(ex. Hospital)	Professional healthcare environment(ex. Hospital)
PatientPopulation	Neonate/infant, pediatric, Adult	Neonate/infant, pediatric, Adult
Gas SourceCompatibility	Non-Ventilator (continuous flowsystem)	Non-Ventilator (continuous flowsystem)
CompatibleHumidifiers	ConchaTherm Neptune HeatedHumidifier	ConchaTherm Neptune HeatedHumidifier
CompatibleColumns	ConchaSmart Column	ConchaSmart Column
HumidificationMethod	Paper wick within the sterile ConchaColumn. Water fills the bottom of thecolumn and is absorbed up the wickwhich is directly in the air flow. Thecolumn is warmed to increase waterand air temperature to aid thecreation and absorption of watervapor into the airstream.	Paper wick within the sterile ConchaColumn. Water fills the bottom of thecolumn and is absorbed up the wickwhich is directly in the air flow. Thecolumn is warmed to increase waterand air temperature to aid the creationand absorption of water vapor into theairstream.
Gas Delivery	Inspiratory limb only	Inspiratory limb only
Water Type	Sterile water sold separately	Sterile water sold separately
Enthalpy	Per ISO 8185:2007Thermal overshoot to the patientconnection port limited to an energyequivalent to 43°C and 100% relativehumidity when averaged over any 30second period	Per ISO 8185:2007Thermal overshoot to the patientconnection port limited to an energyequivalent to 43°C and 100% relativehumidity when averaged over any 30second period
Disposable vs.Reusable	Disposable, single use	Disposable, single use
Sterility	Gamma sterilized ConchaSmartcolumn. Circuit and all otheraccessories are non-sterile	Non-sterile
Patient InterfaceType	Nasal Cannula (sold separately, notpart of this 510(k))	Nasal Cannula (sold separately, notpart of this 510(k))
Comfort FloHumidificationSystemComponents	● Heated Wire Breathing Circuit● ConchaSmart Column● Various Class 1 Exempt devices	● Heated Wire Breathing Circuit● ConchaSmart Column● Various Class 1 Exempt devices
ComparativeCharacteristics	Comfort Flo HumidificationSystemK131912	Proposed Comfort FloHumidification System
Heated WireBreathing 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 corrugatedPolypropylene/Engage tubing(catalog# 2415 and 2416)	15 mm ID corrugatedPolypropylene/Engage tubing(catalog# 2415 and 2416)
Simulated Use	Circuit, column, and nasal cannulaassembly operate at 37°C (+/- 2°C)for up to 37 days with visiblecondensation, without loss offunctional integrity.	Circuit, column, and nasal cannulaassembly operate at 37°C (+/- 2°C)for up to 21 days with visiblecondensation, without loss offunctional integrity.
Humidity Output	System delivers gas conditioned ator near 37°C and 10mg/l of humidityto the patient interface from 1 to 60LPM.	System delivers gas conditioned at ornear 37°C and 10mg/l of humidity tothe patient interface from 1 to 60 LPM.
Condensation(rainout)	System controls amount ofcondensation in the circuit using theheated wire settings of theConchaTherm Neptune HeatedHumidifier from 1 to 60 LPM.	System controls amount ofcondensation in the circuit using theheated wire settings of theConchaTherm Neptune HeatedHumidifier from 1 to 60 LPM.
Shelf Life	5 year shelf life on the CorrugatedComfort Flo Kits (catalog# 2415 and2416)	1 year shelf life on the CorrugatedComfort Flo Kits (catalog# 2415 and2416)
Useful Life	30 Days	21 Days
	Polypropylene	Polypropylene (different blend)
	PVC	PVC
	Polypropylene	Polypropylene
	Polystyrene	Polystyrene
Breathing CircuitMaterials	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.

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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 lifetesting	The proposed Corrugated Comfort Flo HeatedWire Breathing Circuit, when used with theHudson RCI Neptune Heated Humidifier mustperform as intended when subject to the followingtest 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 toflow variations,Resistance to Flow,Resistance to Flowwith a bend, andLeakage, HumidityOutput, Enthalpyrelated to use andsystem errors, WarmUp Time andTemperature Tracking	The proposed Corrugated Comfort Flo HeatedWire Breathing Circuit, when used with theHudson RCI Neptune Heated Humidifier mustperform as intended post accelerated aging anduseful life testing when subject to the testmethods from the following applicable sections ofISO 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.

Regulation Number and Section

§ 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).