The ConchaTherm® Neptune™ is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits.

The ConchaTherm® Neptune™ can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anesthesia gases to help maintain patient body temperature.

Device Description

The ConchaTherm® Neptune™ is designed to provide heat and moisture to the medical gases delivered to a patient via continuous flow, invasive ventilation or non-invasive ventilation. The ConchaTherm® Neptune™ heated humidifier is the main component of the Teleflex Medical ConchaTerm Humidification system, which allow gas to be delivered to a patient using various interfaces.

The ConchaTherm® Neptune™ heated humidification system consists of the ConchaTherm® Neptune™ heated humidifier, the CONCHA-COLUMN® humidifier cartridge, CONCHA sterile water reservoir, a Hudson RCI dual temperature probe, and either a non-heated wire breathing circuit or a Hudson RCI 21-volt heated-wire breathing circuit. The servo-controlled heated humidifier continuously monitors the proximal airway temperature and regulates the heat supplied to the column by the heating element, and if used, the heated-wire circuit.

AI/ML Overview

This is a 510(k) summary for a medical device, the ConchaTherm® Neptune™ Heated Humidifier. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The document states that the device was evaluated for compliance with several international and national standards related to medical electrical equipment safety, electromagnetic compatibility, and humidifiers for medical use. These standards would contain performance requirements that the device must meet to be compliant. However, the specific acceptance criteria values and the reported device performance against those values are not provided in this summary.

Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance from the provided text. The document also does not contain information about sample sizes for test sets, data provenance, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Based on the provided text, here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this document. The document states compliance with standards (IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC/EN 60601-1-2, ISO 8185), but not the specific performance metrics or their values.

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

Not provided in this document. The summary states "performance testing" was done, but gives no details on sample size or data origin.

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

Not applicable/Not provided. This device is a hardware humidifier, not an AI/diagnostic software, so "ground truth" in the context of expert consensus on data is not relevant to this type of device submission. Performance is typically assessed against physical standards and engineering specifications.

4. Adjudication method for the test set:

Not applicable/Not provided. See point 3.

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:

Not applicable. This is a hardware device, not an AI software.

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

Not applicable. This is a hardware device.

7. The type of ground truth used:

Engineering specifications and compliance with voluntary performance standards. This is implied by the mention of ISO 8185 for humidification systems and IEC/EN standards for electrical safety and EMC. These standards define measurable physical and electrical performance parameters.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

In summary, while the document indicates that performance testing was conducted according to standards for a medical device, it does not provide the granular details of acceptance criteria or study results that would typically be associated with an AI/ML or diagnostic device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a medical device. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is in black and white.

eleflex Medical Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA 866-246-6990 Phone: 919-361-3914 Fax: www.teleflex.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 2 3 2007

The ConchaTherm® Neptune™ Heated Humidifier

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

Teleflex Medical Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-361-3927 919-361-4061 Fax:

B. Contact Person

Elizabeth (Betty) Landon Sr. Regulatory Affairs Specialist

C. Date Prepared

April 23, 2007

D. Device Name

Trade Name: The ConchaTherm® Neptune™ heated humidifier

Common Name: Humidification System

Classification Name: Respiratory Gas Humidifier (21 CFR 868.5450, Product Code BTT)

E. Device Description

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Image /page/1/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is black and consists of the word "Teleflex" in a bold, sans-serif font. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern.

Teleflex Medical Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 866-246-6990 Fax: 919-361-3914 www.teleflex.com

F. Indications for Use

The ConchaTherm® Neptune™ can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature.

G. Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical ConchaTherm IV® (K923946) and the Fisher & Paykel MR850 (K033710). The determination of substantial equivalence for this device was based on a detailed device description, performance testing, and conformance with voluntary performance standards.

H. Summary of Testing

The ConchaTherm® Neptune™ heated humidifier has been tested and evaluated for compliance with the Standard for Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety (IEC/EN 60601-1). Medical Electrical Equipment. Part 1: General Requirements for Safety, Collateral Standard, CAN/CSA C22.2 No. 601.1-M90 (IEC/EN 60601-1); Standard for Electromagnetic Compatibility and Tests (IEC/EN 60601-1-2) and Humidifiers for Medical Use-General Requirements for Humidification Systems (ISO 8185).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Landon Senior Regulatory Affairs Specialist Teleflex Medical 2917 Weck Drive Research Triangle Park, North Carolina 27709

APR 2 3 2007

Re: K063758

Trade/Device Name: ConchaTherm® Neptune™ Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: March 16, 2007 Received: March 19, 2007

Dear Ms. Landon:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Landon

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Thorne

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K063758

Device Name: The ConchaTherm® Neptune™

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cullh

Page 1 of

Anesthesiology, General Hospital, on Control Demes

:(K) Number: K06375-8

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).