Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.

The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output.

Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality.

Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.

AI/ML Overview

The provided text describes the 510(k) Summary for the Hudson RCI® AquaPak® Prefilled Humidifier. The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative characteristics and non-clinical performance testing. However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study proving the device meets those criteria, particularly for a medical AI/ML device.

Here's an analysis of what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Technology and Features" for the proposed device and predicate devices, which can be interpreted as performance specifications or criteria. It also mentions "Non-clinical Comparative Performance Testing" but doesn't explicitly state quantitative acceptance criteria for each test or detailed results.

Device Feature/Test	Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance (Directly Stated)
Flow rate	1.5 – 10 LPM (for predicate comparison)	1.5 – 10 LPM
Audible notification of occlusion	5 – 30 psi (for predicate comparison)	5 – 30 psi
Humidity output	At least 10mg H2O/L (for predicate comparison)	At least 10mg H2O/L
Cannula Pop-Off, Bottle Burst, Occlusion Test	Does not burst, relieve valve performs as expected	Determines strength of tubing connector, reservoir does not burst when nares are occluded and the relieve valve performs as expected
Spitting Test	Will not spit or flood the tubing	Determines the expected outcome that the humidifier will not spit or flood the tubing at the maximum flow rate of 10 LPM
Humidification Output Test	N/A (determined rate of humidification)	Determines the rate of humidification at which the liquid is humidified and emitted in milligrams per liter
Packaging Integrity Tests	N/A (determines integrity)	Determines the integrity of the packaged device against known shipping tests
Ink Adherence Tests	N/A (determines adherence properties)	Determines ink adherence properties of the printed film used in packaging the device

Missing Information for Acceptance Criteria: The document describes the type of tests performed and the principle of the tests, but it lacks specific quantitative acceptance criteria (e.g., "Cannula Pop-Off strength must be > X Newtons") and the quantitative results (e.g., "Cannula Pop-Off strength was Y Newtons, which passed"). The "Reported Device Performance" column largely reflects the purpose of the test rather than the actual outcome against specific criteria.

2. Sample Sizes and Data Provenance

This document describes a physical medical device (humidifier), not an AI/ML device. Therefore, concepts like "test set," "training set," "data provenance," and "country of origin" as typically applied to AI/ML models are not directly applicable.

Test Set/Training Set: Not applicable in the context of this traditional medical device. No data sets are mentioned for model training or testing.
Data Provenance: Not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of device and study. The "ground truth" for a humidifier's performance would be derived from physical measurements and engineering specifications, not expert consensus on interpretations.

4. Adjudication Method

Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments, often in diagnostic imaging by multiple readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device where human reader performance with and without AI would be compared.

6. Standalone Performance

The non-clinical performance testing summarized in Section K (Packaging Integrity, Ink Adherence, Cannula Pop-Off, Bottle Burst, Occlusion, Spitting, Humidification Output) represents the standalone performance evaluation of the device as an engineering product. However, the details of these studies, including specific protocols, sample sizes for each test, and quantitative results against pre-defined acceptance limits, are not provided in this summary document.

7. Type of Ground Truth Used

For the non-clinical comparative performance testing, the "ground truth" would be objective physical measurements and engineering standards (e.g., pressure readings, humidity measurements in mg H2O/L, observation of spitting/flooding). The document indicates that some tests referenced standards (ISTA 2A, ASTM F2252) while others did not ("N/A").

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device.

Summary of What the Document Provides regarding "Acceptance Criteria" and "Study":

The document provides a high-level summary of non-clinical bench testing conducted to demonstrate that the Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to predicate devices and will perform as intended.

Acceptance Criteria (Implied): The implied acceptance criteria for the new device are that its performance (flow rate, occlusion notification, humidity output) is comparable to the predicate devices and meets its own stated specifications, and that it passes specific functional and integrity tests (e.g., no spitting/flooding, package integrity, ink adherence).
Study: The "study" referenced is a series of "Bench Testing" activities focused on:
- Packaging Integrity (referencing ISTA 2A)
- Ink Adherence (referencing ASTM F2252)
- Cannula Pop-Off, Bottle Burst, Occlusion Test
- Spitting Test
- Humidification Output Test

The document states that these tests were performed to "verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Humidifier will perform as intended."

Missing Detailed Information:
The K141353 summary is intentionally concise and does not include the full study reports. To fully answer your question with explicit acceptance criteria, detailed results, and sample sizes for each bench test, one would need to refer to the complete study reports submitted to the FDA, which are not part of this summary document. The information provided is sufficient for a 510(k) summary (demonstrating substantial equivalence) but not for a detailed scientific publication of a study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2014

Teleflex Medical, Inc. Mr. James A. Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K141353

Trade/Device Name: Hudson RCI® AquaPak® Prefilled Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: June 30, 2014 Received: July 2, 2014

Dear Mr. Cochie:

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. Cochie

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 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 Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141353

Device Name Hudson RCI® AquaPak® Prefilled Humidifier

Indications for Use (Describe) The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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Anya C. Harry -S 2014.07.31 12:36:04 -04'00'

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Section 24 - 510(k) Summary

510(k) SUMMARY

Hudson RCI® AquaPak® Prefilled Humidifiers

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

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 919-433-4996 Fax:

B. Contact Person

James Cochie Sr. Regulatory Affairs Specialist

C. Date Prepared

July 31, 2014

D. Device Name

Trade Name: Hudson RCI® AquaPak® Prefilled Humidifier

Common Name: Humidifier

Classification Name: Humidifier, Respiratory Gas (Direct Patient Interface), CFR -868.5450, Class II

E. Device Description

Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.

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Section 24 – 510(k) Summary

Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.

F. Indications for Use

The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.

G. Target Population

This device is intended for use on any patient connected to ventilation devices

H. Environments of Use

This device is intended for hospital, sub-acute facilities, long-term care facilities and in a home care environment.

This product is single use only.

I. Contraindications

There are no known contraindications.

J. Comparative Characteristics

The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device:

ComparativeCharacteristics	Proposed Device:Hudson RCI®AquaPak® PrefilledHumidifier	Predicate Device:Hudson RCI®AquaPak® PrefilledHumidifier	Predicate Device:CareFusion Airlife®Prefilled Humidifier
Manufacturer	Teleflex Medical,Inc.	Teleflex Medical,Inc.	CareFusion
510(k) Number	TBD	K780562 – PrefilledHumidifierK833974 –Humidifier Adaptor	K853146
Indications for Use	The Hudson RCI®AquaPak® PrefilledHumidifier addshumidity to apatient's breathinggases.	The Hudson RCI®AquaPak® PrefilledHumidifier addshumidity to apatient's breathinggases.	The CareFusionAirlife® PrefilledHumidifiers providea cost-effectivesolution for sterilewater inhalation.
			(www.caefusion.com)
Principle of Operation	Gas bubbles through built-in diffuser in reservoir	Gas bubbles through built-in diffuser in reservoir	Gas bubbles through reservoir
Gas source	50 Psi oxygen regulated via a flow meter	50 Psi oxygen regulated via a flow meter	50 Psi oxygen regulated via a flow meter
Technology and Features	Flow rate: 1.5 – 10 LPMAudible notification of occlusion: 5 – 30 psiHumidity output: At least 10mg H2O/L	Flow rate: 1.5 – 10 LPMAudible notification of occlusion: 5 – 30 psiHumidity output: At least 10mg H2O/L	Flow rate: 4 LPM for audible notificationAudible notification of occlusion: Not specifiedHumidity output: Not specified
Sterilization	Adaptor – Non-sterileSterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill	Adaptor – Gamma IrradiationSterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill	Adaptor – Non-sterileSterile Water/Saline Reservoirs – Steam or dry heat
Single Use	Yes	Yes	Adaptor - Single Patient UseSterile Water/Saline Reservoirs – Single Use
Shelf Life	Adaptors – N/A Sterile Water/Saline – 2 years from date of manufacture	Adaptors – 5 years from date of manufactureSterile Water/Saline – 2 years from date of manufacture	Adaptors - N/A Sterile Water/Saline – 2 years from date of manufacture
Packaging	Adaptor Top web: Coated High Density Polyethylene (HDPE)Adaptor Bottom web: Surlyn Amcor C-060	Adaptor Top web: TyvekAdaptor Bottom film: Surlyn Amcor C-060Bottle – Sealed	Adaptor - Heat sealed polybagBottle - Sealed polypropylene
	Bottle - Sealedpolypropylene	polypropylene

Teleflex Medical, Inc.

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Section 24 – 510(k) Summary

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Section 24 - 510(k) Summary

K. Non-clinical Comparative Performance Testing

Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RC1® AquaPak® Prefilled Humidifier will perform as intended.

TestPerformed	Reference to Standard (ifapplicable)	Principle of Test
PackagingIntegrity Tests	ISTA 2A	Determines the integrity of the packageddevice against known shipping tests
Ink AdherenceTests	ASTM F2252	Determines ink adherence properties ofthe printed film used in packaging thedevice
Cannula Pop-Off, BottleBurst,Occlusion Test	N/A	Determines strength of the tubingconnector, the reservoir does not burstwhen nares are occluded and the relievevalve performs as expected to relievepressure
Spitting Test	N/A	Determines the expected outcome thatthe humidifier will not spit or flood thetubing at the maximum flow rate of 10LPM
HumidificationOutput Test	N/A	Determines the rate of humidification atwhich the liquid is humidified andemitted in milligrams per liter

L. Substantial Equivalence

The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under 510(k) K780562 and K833974. The differences between the proposed Hudson RCI® AquaPak® Prefilled Humidifier and the predicate devices are minor (sterile to non-sterile packaging) and raise no new issues of safety and efficacy. The proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the currently marketed predicate devices.

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).