The RT380/RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended to deliver humidified breathing gases for administration to an adult patient. The RT385 differs only from the RT380 in that the RT385 is supplied with a ventilator pressure line and connector port. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidified gases via a heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways via an endotracheal tube.

The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of adult patients, and to maintain the temperature of humidified inspired gas.

Device Description

The RT380/RT385 'Adult Evaqua 2' dual heated breathing circuits are classified as 'Breathing System Heater' according to 21 CFR §868.5270.

The RT380/RT385 breathing circuits form part of a respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limbs minimise the formation of condensate.

The new adult breathing circuits (RT380/RT385) have been developed based on the cleared RT265/RT266 infant breathing circuit device. The RT380/RT385 are dual-heated adult breathing circuits that, like the predicate device (RT265/RT266), utilize corrugated polymer tubing, with a heater wire in both the inspiratory and expiratory limb.

The RT380 and RT385 have a water vapor permeable expiratory limb. Permeability allows water vapor to pass into the environment, minimizing the amount of condensate that might form within the expiratory limb and also minimizing the amount of humidity delivered to a ventilator.

The inspiratory and expiratory limbs of the RT380/RT385 are made using a foaming technique that creates tiny air bubbles in the tube wall. In the case of the inspiratory limb the air bubbles improve the limb thermal insulation properties and thus reduce condensate formation. In the case of the expiratory limb, the air bubbles allow a thick tube wall for robustness against physical damage without compromising the water vapor permeability.

The RT380 and RT385 use the same expiratory limb technology and construction ('Evaqua 2') as the RT265/RT266 expiratory limb, but in an adult sized circuit.

Duration of use for the RT380/RT385 has been verified and labeled for 14 days continuous use, compared with 7 days for the predicate device.

Both the RT380/RT385 and the RT265/RT266 predicate device have been verified and labeled for a shelf life of 5 years.

AI/ML Overview

The provided text describes verification tests that were performed to establish the safety and efficacy of the RT380 and RT385 breathing circuits. However, it does not explicitly state acceptance criteria or provide specific numerical performance results in a way that can be directly presented in a table as requested.

The document uses the phrase "Testing was performed to the same standards as used for the predicate device," implying that the acceptance criteria for the new devices are aligned with those previously established for the predicate device (RT265/RT266). Without access to the predicate device's specific acceptance criteria and detailed test results, a precise table cannot be generated.

Therefore, many sections of your request cannot be fully answered with the information provided in the input text.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated with numerical values. The text only mentions "Testing was performed to the same standards as used for the predicate device."
Reported Device Performance: No specific numerical performance metrics are provided. The document generally states that "Verification tests were performed to establish the safety and efficacy" and "The RT380 and RT385 are considered to be substantially equivalent to the RT265/RT266 breathing circuit."

Therefore, a table cannot be accurately constructed based on the provided text. An example of how it would look if the data were present is shown below, but it would contain "N/A" for direct values from this document.

Acceptance Criterion (e.g., Condensate Volume)	Target/Limit	Reported Device Performance (RT380/RT385)
Condensate Performance	(Not specified)	(Verified as safe/efficacious per predicate standards)
Humidity Performance	(Not specified)	(Verified as safe/efficacious per predicate standards)
Pneumatic Testing	(Not specified)	(Verified as safe/efficacious per predicate standards)
Single Fault Conditions	(Not specified)	(Verified as safe/efficacious per predicate standards)
Patient Leakage Current	(Not specified)	(Verified as safe/efficacious per predicate standards)
Enthalpy	(Not specified)	(Verified as safe/efficacious per predicate standards)
Connector Strength	(Not specified)	(Verified as safe/efficacious per predicate standards)
Duration of Use	≥14 days continuous use	14 days continuous use verified
Shelf Life	≥5 years	5 years verified
Biocompatibility	(Not specified)	(Verified as safe/efficacious per predicate standards)

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

Sample Size for Test Set: Not specified. The document states "Verification tests were performed," but no sample sizes (e.g., number of circuits tested) are given for any of the listed tests.
Data Provenance: Not specified. No country of origin is mentioned for the testing data, nor is it explicitly stated whether the study was retrospective or prospective. It is implied prospective, as they are "verification tests" for a new device.

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

This question is not applicable to this type of device (heated breathing circuits). "Ground truth" and "experts" are typically relevant for diagnostic AI/software devices where human interpretation is involved. For a physical medical device like this, performance is established through engineering and biological testing against predefined specifications.

4. Adjudication method for the test set:

Not applicable for the same reasons as #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 study pertains to a physical medical device, not an AI/software diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable in the conventional sense of expert consensus, pathology, or outcomes data for imaging/diagnostic devices. For this device, the "ground truth" for each test category (e.g., condensate performance, humidity performance) would be established by engineering specifications, regulatory standards, and established physical/chemical measurement methods. For instance, "condensate performance" would likely involve measuring the amount of condensate formed under controlled conditions against a predetermined maximum allowable amount.

8. The sample size for the training set:

Not applicable. This refers to a physical medical device and not a machine learning model that would require a training set.

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

Not applicable for the same reason as #8.

Summary

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5 510(k) Summary

DEC 0 6 2012

Website: www fohcare.com

Contact person	Robert Petry
Date prepared	06 August 2012
Trade name	RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits 1
Common name	Heated Breathing Circuit
Classification name	Breathing System HeaterClass II (21 CFR § 868.5270), product code BZE
Predicate device	K103767 Fisher & Paykel HealthcareRT265 and RT266 Dual Heated Infant Breathing Circuit 2

1 Referred to throughout this document as RT380/RT385

2 Referred to throughout this document as RT265/RT266

5.1 Description

The RT380/RT385 'Adult Evaqua 2' dual heated breathing circuits are classified as 'Breathing System Heater' according to 21 CFR §868.5270.

The RT380/RT385 breathing circuits form part of a respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the Heater wires in the inspiratory and expiratory limbs expired gas away from the patient. minimise the formation of condensate.

5.2 Intended use

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5.3 Indications for use

Technological characteristics comparison 5.4

The intended use of the RT380/RT385 is the same as that of the predicate device, differing only in the population indicated.

The RT380 and RT385 use the same expiratory limb technology and construction ('Evaqua 2') as the RT265/RT266 expiratory limb, but in an adult sized circuit.

Duration of use for the RT380/RT385 has been verified and labeled for 14 days continuous use, compared with 7 days for the predicate device.

Both the RT380/RT385 and the RT265/RT266 predicate device have been verified and labeled for a shelf life of 5 years.

Non-clinical tests 5.5

Verification tests were performed to establish the safety and efficacy of the RT380 and RT385. These included condensate performance, humidity performance, pneumatic testing, single fault conditions, patient leakage current, enthalpy, connector strength, duration of use testing, shelf life verification and biocompatibility. Testing was performed to the same standards as used for the predicate device.

5.6 Conclusion

The RT380 and RT385 are considered to be substantially equivalent to the RT265/RT266 breathing circuit. The comparison of features, performance, materials and intended use demonstrate that the RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are safe and effective for their intended purpose.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 6, 2012

Mr. Robert Petry Regulatory Affairs Specialist Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland, New Zealand 2013

Re: K122432 ·

Trade/Device Name: RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE Dated: November 5, 2012 Received: November 6, 2012

Dear Mr. Petry:

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 - Mr. Petry

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement 4

510(k) Number

K122 432

Device Name

Fisher & Paykel Healthcare RT380 and RT385 'Adult Evaqua 2' Dual Heated Breathing Circuits

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E.
Moyal

Digitally signed by Albert E. Moyal DN: <=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Albert E. Moyal, 0.9.2342.19200300.100.1.1=13000593331 Date: 2012,12.06 08:29:26 -05'00"

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:_K122432

4-1

Regulation Number and Section

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).