CONCHASMART COLUMN

K141940 · Teleflex, Inc. · BTT · Nov 24, 2014 · Anesthesiology

Device Facts

• Record ID: K141940
• Device Name: CONCHASMART COLUMN
• Applicant: Teleflex, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Nov 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

Device Story

ConchaSmart Column is a single-use, disposable humidifier cartridge accessory for the Neptune Heated Humidifier. It functions as a respiratory gas humidifier for patients requiring invasive or non-invasive ventilation or high-flow nasal cannula therapy. The device is inserted into the Neptune Heated Humidifier to provide heated, humidified gas to the patient. It is intended for use in clinical settings by healthcare professionals. The device improves patient comfort and airway management by maintaining appropriate humidity levels in the respiratory circuit. It features specific performance characteristics including reduced dead space, lower compliance, and stringent leak specifications compared to the predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of performance specifications against the predicate device, demonstrating compliance with ISO 8185:2007 and ISO 10993 requirements.

Technological Characteristics

Single-use disposable cartridge. Materials meet ISO 10993 and G-95-1 requirements. Connectors are ISO 5356-1:2004 compliant (22 mm). Operates with Neptune Heated Humidifier. Non-sterile. 3-year shelf life. Performance specs: leakage ≤ 29 ml/min, compressible volume 190 ml, compliance 0.25 ml/cmH2O.

Indications for Use

Indicated for neonatal, infant, pediatric, and adult patients requiring heated humidification, with or without an artificial airway.

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

• Fisher and Paykel MR290 Autofeed Humidification Chamber (K131957)

Reference Devices

• Neptune Heated Humidifier (K063758)
• Neptune Heated Humidifier (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

November 24, 2014

Teleflex Medical Amanda Webb Senior Regulation Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K141940

Trade/Device Name: Concha Smart Column Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: II Product Code: BTT Dated: October 27, 2014 Received: October 29, 2014

Dear Amanda 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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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 vours.

# Erin | Keith -S

Erin I. Keith, M.S 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)

Device Name ConchaSmart Column

Indications for Use (Describe)

When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

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 OF SAFETY AND EFFECTIVENESS

#### A. Name, Address, Phone and Fax Number of Applicant

Teleflex 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

July 14, 2014

## D. Device Name

| Trade Name: | ConchaSmart Column |
|-----------------------|----------------------------|
| 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 Fisher and Paykel MR290 Autofeed Humidification Chamber K131957.

#### F. Device Description

The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.

#### G. Indications for Use

When used with the a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

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| Comparative<br>Characteristics | Fisher and Paykel MR290<br>Autofeed Humidification<br>Chamber K131957 | ConchaSmart Column | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | When used with Fisher and Paykel<br>heated humidifiers cleared in<br>K132017, K131957, K131895, and<br>K110019 the MR290 provides heated<br>humidification for patients with and<br>without an artificial airway in place. | When used with a Neptune Heated<br>Humidifier and Hudson RCI<br>ventilator circuits, the ConchaSmart<br>Column provides heated<br>humidification for patients with and<br>without an artificial airway in place. | |
| | Patient<br>Population | Neonatal, Infant, Pediatric, Adult | Neonatal, Infant, Pediatric, Adult |
| | Humidification<br>Therapies | Invasive, Non-Invasive, High Flow<br>Nasal Cannula Therapy | Invasive, Non-Invasive, High Flow<br>Nasal Cannula Therapy |
| Humidity<br>Output | ISO 8185:2007 | ISO 8185:2007 | |
| | Subglottic mode: (≥33mg H2O /L) | Subglottic mode: (≥33mg H2O /L) | |
| | Supraglottic mode: (≥10mg H2O /L) | Supraglottic mode: (≥10mg H2O /L) | |
| | ISO 8185:2007 | ISO 8185:2007 | |
| Enthalpy Limit | < 194 kJ/kg dry gas | < 194 kJ/kg dry gas | |
| Leakage | < 100 ml/min | ≤ 29 ml/min | |
| Compressible<br>Volume | 280 ml | 190 ml | |
| Compliance | 0.4ml/cmH2O | 0.25ml/cmH2O | |
| Connectors | ISO 5356-1:2004 compliant 22 mm<br>connectors | ISO 5356-1:2004 compliant 22 mm<br>connectors | |
| | Sterilization | Non-Sterile | Non-Sterile |
| Shelf Life | No Shelf Life | 3 year | |
| Materials | The materials were cleared as having<br>met ISO 10993 and G-95-1<br>requirements | The materials were cleared as having<br>met ISO 10993 and G-95-1<br>requirements | |

# H. Technological Characteristics Comparison to the predicate

As evidenced by the comparison table above the ConchaSmart Column is the same as the predicate device in many ways, the same intended use, the same operating principles, and the same scientific fundamental technology. The primary differences relate to performance specifications in which the ConchaSmart Column contains less dead space, less compliance, and more stringent leak specifications. In addition the ConchaSmart Column is labeled with a shelf life, whereas the MR290 is not.

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## I. Performance Data

The change in sterility does not impact the performance characteristic of the device; therefore, no performance testing was required.

# J. Conclusion

The data presented demonstrate that the device is as safe and as effective as the predicate device and therefore substantially equivalent.