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.

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.

AI/ML Overview

Here's an analysis of the provided text in relation to acceptance criteria and study details, presented as requested:

Device Name: ConchaSmart and ISO-GARD Breathing Circuits
Regulation Name: Respiratory Gas Humidifier
Product Code: BTT

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison format that is typical for diagnostic tools. Instead, it focuses on compliance with standards and compatibility.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 5367 (Breathing tubes intended for use with anaesthetic apparatus and ventilators)	The proposed devices were tested to ensure compliance to ISO 5367.
Compliance with ISO 5356-1 (Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets)	The proposed devices were tested to ensure compliance to ISO 5356-1.
Compatibility with the Hudson RCI Neptune Heated Humidifier	Testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier.
Useful life of 30 days	Testing was performed to ensure a useful life of 30 days.
Biocompatibility of patient contacting materials (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation)	Cytotoxicity, sensitization, irritation, genotoxicity, and implantation testing were performed to demonstrate biocompatibility of the patient contacting materials.

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

The document does not provide specific sample sizes for the testing described. It broadly states that "testing was performed."

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) summary, the testing would have been conducted by the manufacturer (Teleflex Medical, Incorporated, USA) to support their submission.

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

This information is not provided in the document. The testing described (compliance with ISO standards, compatibility, useful life, biocompatibility) typically relies on laboratory measurements and established protocols rather than expert clinical interpretation for "ground truth" in the way it might be for a diagnostic AI device.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. The testing involved objective measurements and compliance checks against established standards, not human expert adjudication of subjective results.

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 information is not applicable and not provided in the document. The device is a breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this device.

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

This information is not applicable and not provided in the document. The device is a physical breathing circuit, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation in this context refers to established international standards (ISO 5367, ISO 5356-1), manufacturer specifications (compatibility with Hudson RCI Neptune Heated Humidifier, 30-day useful life), and biocompatibility testing protocols for patient-contacting materials. It is not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic device.

8. The sample size for the training set

This information is not applicable and not provided in the document. The device is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable and not provided in the document, as there is no "training set" for this type of device.

Summary

{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)

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.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{4}------------------------------------------------

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.

ComparativeCharacteristics	Hudson Heated WireBreathing Circuits(K031383)	Proposed ISO-GARD andConchaSmart breathingcircuits
Indications forUse	The Hudson Heated Wire VentilatorCircuit is intended as a conduit forrespiratory gas between a patientand a ventilator, and includes heatedwires for use with a Concha ColumnHumidifier; the heated wires areintended to minimize condensationin the ventilator tubing.	The ConchaSmart breathing circuitis intended as a conduit forrespiratory gas between a patientand a ventilator and includes heatedwire(s) for use with the Hudson RCINeptune Heated Humidifier. Theheated wires are intended to aid inmaintaining the set patienttemperature and minimizecondensation in the breathingcircuit.
Intended Use	Act as a conduit for gas delivery to apatient.	Same
Environment ofUse	Professional HealthcareEnvironments	Same
PatientPopulation	Adult	Same
CompatibleHumidifiers	All Hudson ConchaTherm HeatedHumidifiers	Hudson RCI Neptune HeatedHumidifier
Disposable vs.Reusable	Disposable	Same
Simulated Use	Not labeled for useful life	Labeled for 30 day useful life

{5}------------------------------------------------

ComparativeCharacteristics	Hudson Heated WireBreathing Circuits(K031383)	Proposed ISO-GARD andConchaSmart breathingcircuits
Standards	Tested to some sections of ISO 5367	Compliant to ISO 5367 and ISO5356-1
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.

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).