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 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.

AI/ML Overview

The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.

However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.

1. A table of acceptance criteria and the reported device performance

The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (ConchaSmart Column)
Intended Use	Same as predicate (Fisher & Paykel MR290)	When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, provides heated humidification for patients with and without an artificial airway in place.
Patient Population	Neonatal, Infant, Pediatric, Adult	Neonatal, Infant, Pediatric, Adult
Humidification Therapies	Invasive, Non-Invasive, High Flow Nasal Cannula Therapy	Invasive, Non-Invasive, High Flow Nasal Cannula Therapy
Humidity Output	ISO 8185:2007	ISO 8185:2007
- Subglottic mode	≥33mg H2O /L	≥33mg H2O /L
- Supraglottic mode	≥10mg H2O /L	≥10mg H2O /L
Enthalpy Limit	< 194 kJ/kg dry gas	< 194 kJ/kg dry gas
Leakage	< 100 ml/min	≤ 29 ml/min
Compressible Volume	280 ml	190 ml
Compliance	0.4ml/cmH2O	0.25ml/cmH2O
Connectors	ISO 5356-1:2004 compliant 22 mm connectors	ISO 5356-1:2004 compliant 22 mm connectors
Sterilization	Non-Sterile	Non-Sterile
Shelf Life	No Shelf Life (implied)	3 year
Materials	Cleared as having met ISO 10993 and G-95-1 requirements	Cleared as having met ISO 10993 and G-95-1 requirements

Study Proving Device Meets Acceptance Criteria:
The document states: "The data presented demonstrate that the device is as safe and as effective as the predicate device and therefore substantially equivalent." The comparison table and the statement "The primary differences relate to performance specifications in which the ConchaSmart Column contains less dead space, less compliance, and more stringent leak specifications" implicitly serve as the proof of meeting comparable or improved "acceptance criteria" by comparing it to an already approved device. For the ConchaSmart Column, the leakage, compressible volume, and compliance values are improvements over the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a 510(k) submission for a non-AI physical medical device. The "test set" concept as it applies to AI/algorithm evaluation is not present. The document refers to "Performance Data" but explicitly states "The change in sterility does not impact the performance characteristic of the device; therefore, no performance testing was required." This implies that the performance data for the mechanical characteristics are likely based on design specifications and engineering evaluations, not a clinical trial or a test set as understood in AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. No test set requiring expert ground truth was mentioned for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set requiring adjudication was mentioned.

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
N/A. This is not an AI device, so no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The "ground truth" for this physical device's performance relies on engineering specifications, adherence to ISO standards (e.g., ISO 8185:2007 for humidity output, ISO 5356-1:2004 for connectors), and biocompatibility testing (ISO 10993, G-95-1).

8. The sample size for the training set
N/A. This is not an AI device, so there is no training set.

9. How the ground truth for the training set was established
N/A. This is not an AI device, so there is no training set or ground truth in that context.

Summary

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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 (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 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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FOR FDA USE ONLY

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

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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: 919-433-8050 919-433-4996 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

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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ComparativeCharacteristics	Fisher and Paykel MR290Autofeed HumidificationChamber K131957	ConchaSmart Column
Intended Use	When used with Fisher and Paykelheated humidifiers cleared inK132017, K131957, K131895, andK110019 the MR290 provides heatedhumidification for patients with andwithout an artificial airway in place.	When used with a Neptune HeatedHumidifier and Hudson RCIventilator circuits, the ConchaSmartColumn provides heatedhumidification for patients with andwithout an artificial airway in place.
	PatientPopulation	Neonatal, Infant, Pediatric, Adult	Neonatal, Infant, Pediatric, Adult
	HumidificationTherapies	Invasive, Non-Invasive, High FlowNasal Cannula Therapy	Invasive, Non-Invasive, High FlowNasal Cannula Therapy
HumidityOutput	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
CompressibleVolume	280 ml	190 ml
Compliance	0.4ml/cmH2O	0.25ml/cmH2O
Connectors	ISO 5356-1:2004 compliant 22 mmconnectors	ISO 5356-1:2004 compliant 22 mmconnectors
	Sterilization	Non-Sterile	Non-Sterile
Shelf Life	No Shelf Life	3 year
Materials	The materials were cleared as havingmet ISO 10993 and G-95-1requirements	The materials were cleared as havingmet ISO 10993 and G-95-1requirements

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.

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).