CONCHASMART BREATHING CIRCUIT

K140556 · Teleflex, Inc. · BTT · Sep 24, 2014 · Anesthesiology

Device Facts

• Record ID: K140556
• Device Name: CONCHASMART BREATHING CIRCUIT
• Applicant: Teleflex, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2

Intended Use

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 Story

ConchaSmart and ISO-GARD breathing circuits serve as conduits for respiratory gases between adult patients and ventilators; integrated heated wires connect to Hudson RCI Neptune Heated Humidifier. Heated wires maintain set patient temperature; minimize condensation within 22mm corrugated tubing. Used in professional healthcare environments; operated by respiratory care clinicians. Clinicians configure system using provided adaptors/connectors. Device benefits patient by ensuring consistent gas delivery temperature and reducing moisture accumulation in circuit. Disposable design; 30-day useful life.

Clinical Evidence

Bench testing only. Compliance testing to ISO 5367 (breathing tubes) and ISO 5356-1 (conical connectors). Biocompatibility testing performed including cytotoxicity, sensitization, irritation, genotoxicity, and implantation. Compatibility testing with Hudson RCI Neptune Heated Humidifier and 30-day useful life validation completed.

Technological Characteristics

Corrugated tubing (22mm diameter) containing integrated heated wires. Materials: Clearblend (wye), Polypropylene/Engage (tubing). Connectivity: Compatible with Hudson RCI Neptune Heated Humidifier. Standards: ISO 5367, ISO 5356-1. Disposable, 30-day useful life.

Indications for Use

Indicated for adult patients in professional healthcare facilities requiring respiratory gas delivery via a ventilator circuit with integrated heated wires to maintain temperature and minimize condensation.

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

• Hudson RCI Heated Wire Circuit (K031383)

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

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.

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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 [phone] or [phone] 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 [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

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

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# 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)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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

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<br>Characteristics | Hudson Heated Wire<br>Breathing Circuits<br>(K031383) | Proposed ISO-GARD and<br>ConchaSmart breathing<br>circuits |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Hudson Heated Wire Ventilator<br>Circuit is intended as a conduit for<br>respiratory gas between a patient<br>and a ventilator, and includes heated<br>wires for use with a Concha Column<br>Humidifier; the heated wires are<br>intended to minimize condensation<br>in the ventilator tubing. | The ConchaSmart breathing circuit<br>is intended as a conduit for<br>respiratory gas between a patient<br>and a ventilator and includes heated<br>wire(s) for use with the Hudson RCI<br>Neptune Heated Humidifier. The<br>heated wires are intended to aid in<br>maintaining the set patient<br>temperature and minimize<br>condensation in the breathing<br>circuit. |
| Intended Use | Act as a conduit for gas delivery to a<br>patient. | Same |
| Environment of<br>Use | Professional Healthcare<br>Environments | Same |
| Patient<br>Population | Adult | Same |
| Compatible<br>Humidifiers | All Hudson ConchaTherm Heated<br>Humidifiers | Hudson RCI Neptune Heated<br>Humidifier |
| Disposable vs.<br>Reusable | Disposable | Same |
| Simulated Use | Not labeled for useful life | Labeled for 30 day useful life |

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| Comparative<br>Characteristics | Hudson Heated Wire<br>Breathing Circuits<br>(K031383) | Proposed ISO-GARD and<br>ConchaSmart breathing<br>circuits |
|--------------------------------|-------------------------------------------------------|------------------------------------------------------------|
| Standards | Tested to some sections of ISO 5367 | Compliant to ISO 5367 and ISO<br>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.