The bubble humidifier is a device that is intended to add moisture to breathing gases for administration to a patient. The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

Device Description

The Salter Labs Bubble Humidifier (High Flow) is an empty, disposable, non-sterile device that is intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (High Flow) is provided with a 6 PSI safety valve and can operate within flow rates of 6 to 15 LPM. The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks and cannulas, and use of optional oxygen tubing and water traps. The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle and houses the different interface connectors, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located inside the humidifier bottle that is designed to uniformly disperse the gas throughout the water. The 360° diffuser ports also provide quiet operation and minimize system backpressure. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The jar is permanently marked with minimum/maximum water levels.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Salter Lab Bubble Humidifier (High Flow), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Performance	Acceptance Criteria (Salter Labs Bubble Humidifier)	Reported Device Performance (Salter Labs Bubble Humidifier)
Humidifier Output (Operating Gas Flow Rates)	At least 10mgH2O/L when operating within flow rates of 6 to 15 LPM, in accordance with ASTM F1690 (Clause 49.1).	Met. The device "still produces a humidifier output of at least 10mgH2O/L in accordance with ASTM F1690 (Clause 49.1)" at operating gas flow rates of 6 to 15 LPM.
Pressure Relief Valve	6 PSI	Met. The device "is provided with a 6 PSI safety valve." The comparison table also lists "6 PSI."
Audible Notification of Occlusion	Yes	Met. The device includes "an audible pressure relief mechanism to notify the user of a downstream occlusion." The comparison table lists "Yes."
Materials of Construction (Biocompatibility)	Complies with ISO 10993, “Biological Evaluation of Medical Devices” for biocompatibility.	Met. "Testing was performed in accordance with ISO 10993, 'Biological Evaluation of Medical Devices' for biocompatibility." The Conclusion states, "All acceptance criteria from testing were met."
General Requirements for Active Humidification Systems	Complies with applicable clauses of ASTM F1690-96 (Reapproved 2004), “Standard Specification for Humidifiers for Medical Use-Part 1: General Requirements for Active Humidification Systems” for safety and performance.	Met. "Testing was performed in accordance with ASTM F1690-96 (Reapproved 2004), 'Standard Specification for Humidifiers for Medical Use-Part 1: General Requirements for Active Humidification Systems' for safety and performance." The Conclusion states, "All acceptance criteria from testing were met."
Latex Free	Product is not made with natural rubber latex.	Met. "This product is not made with natural rubber latex - Yes."
Bottle Capacity	Not explicitly stated as an acceptance criterion but the device's capacity is 350 ml. The predicate (AirLife® Bubble Humidifier) has a 370 ml capacity.	350 ml
Used with Oxygen Concentrators, Gas Cylinders and Wall Outlets	Yes	Met. "Yes"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a specific "sample size for the test set" or the "country of origin of the data" or whether the testing was "retrospective or prospective." The non-clinical testing appears to be a series of laboratory tests performed on the device itself against established standards.

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)

This information is not applicable to a physical medical device like a humidifier, where performance is measured against technical specifications and industry standards rather than being subject to expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to the non-clinical testing of a physical medical device against performance standards.

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

This information is not applicable. The device is a bubble humidifier, not an AI-powered diagnostic tool requiring human reader studies.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements, specifically:

ASTM F1690-96 (Reapproved 2004), "Standard Specification for Humidifiers for Medical Use-Part 1: General Requirements for Active Humidification Systems" for safety and performance and humidifier output.
ISO 10993, "Biological Evaluation of Medical Devices" for biocompatibility.
The 6 PSI pressure relief valve specification.
The presence of an audible occlusion notification.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

Summary

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5.	510(k) Summary	K113542
Date:	August 6, 2011
Contact:	Salter Labs100 W. Sycamore RoadArvin, CA 93203
	Michael ShoupVice President Quality/RegulatoryPhone: 800-421-0024Fax: 661-854-3850Email: mshoup@salterlabs.com
	Trade Name:	Salter Lab Bubble Humidifier (High Flow)
	Common Name:	Bubble Humidifier (High Flow) Model #7900
	Classification Name:	Respiratory gas humidifier
	Classification:	21 CFR 868.5450 Respiratory gas humidifier, Class II
	Product Code:	BTT

Predicate Devices:

Predicate510(k)	Device Name	Intended Use	ClearanceDate	Company
K991484	AirLife® BubbleHumidifier(Model 002006)	Humidifiers are defined as adevice that is intended to addmoisture to, and sometimes towarm, the breathing gases foradministration to a patient.	May 13, 1999	CareFusion(cleared asAllegiance)
K041963	AmericanBantexHumidifierBottle, 6 PSI(Model B9001)	The American BantexHumidifier is intended for usewith Oxygen Concentrators ina patients home, physiciansoffice or hospital/institutionalenvironment. The humidifierincreases the moisture contentof the airstream gases foradministration to the patient.	Oct. 20, 2004	American BantexCorporation

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Device Description:	The Salter Labs Bubble Humidifier (High Flow) is an empty,disposable, non-sterile device that is intended to humidifybreathing gas prior to delivery to a patient. The Salter LabsBubble Humidifier (High Flow) is provided with a 6 PSI safetyvalve and can operate within flow rates of 6 to 15 LPM. Thedevice is used with various breathing gas sources (i.e., oxygenconcentrators, gas cylinders and wall outlets) and providesconnection for delivery of humidified breathing gas via facemasks and cannulas, and use of optional oxygen tubing andwater traps.
	The device is made of a humidifier bottle which is used to holdwater during use, a lid which seals the humidifier bottle andhouses the different interface connectors, an audible pressurerelief mechanism to notify the user of a downstream occlusionand a diffuser located inside the humidifier bottle that isdesigned to uniformly disperse the gas throughout the water.The 360° diffuser ports also provide quiet operation andminimize system backpressure. Both the bottle and lid areconstructed to be easy to grip and reduce the chance of crossthreading. The jar is permanently marked withminimum/maximum water levels.
Intended Use/IndicationFor Use:	The bubble humidifier is a device that is intended to addmoisture to breathing gases for administration to a patient.The bubble humidifier is indicated for use with oxygenconcentrators or gas sources in homecare, hospital, extendedcare facilities and hospice environments. The bubblehumidifier is a non-sterile device indicated for single-patientusage. The device is indicated for patients who requirehumidification of high flow supplemental breathing gases.
TechnologicalCharacteristics:	Salter Bubble Humidifier (High Flow) is substantiallyequivalent to the predicate device with regards to design,materials, performance and intended use. The difference is inthe operating gas flow rates of 6 to 15 LPM that still producesa humidifier output of at least 10mgH2O/L in accordance withASTM F1690 (Clause 49.1).

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NA A A L A M I T A M IS C A F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F

Feature/Performance	Salter Labs .	American Bantex	CareFusion(Allegiance)AirLife®
Model #	7900	B9001	2006
Method of Humidification	Gas bubblesthrough thediffuser submergedin a user-filled,waterreservoir/bottle andenters the patientbreathing gascircuit	Same	Same
Gas Flow Range	6 - 10 LPMConcentrator,6 - 15 LPM WallSource	Not Specified	Not Specified
Pressure Relief Value	.6 PSI	.6 PSI	.6 PSI
Audible Notification ofOcclusion	Yes	Yes	Yes
Materials of Construction	ABSPVCPPBrass	ABSPVCPPBrass	High Impact PSPPBrass
This product is not madewith natural rubber latex	Yes	Not Specified	Label states “LatexFree”
Bottle Capacity	350 ml	Not Specified	370 ml
Used with OxygenConcentrators, GasCylinders and Wall Outlets	Yes	Yes	Not Specified
Complies with applicableclauses of ASTM F1690-96(2004) and ISO 10993-1:2000 (Biocompatibility)	Yes	Not Specified, nodeclaration ofconformity to thisstandard	Not Specified, nodeclaration ofconformity to thisstandard

Assessment of Non-Clinical Testing

Non-clinical testing of the Salter Bubble Humidifier (High Flow) has been performed against requirements for performance, physical attributes, environmental conditions, materials and safety, and to provide objective evidence that the device's intended use is met. As applicable to the requirements, testing was performed in accordance with ISO

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	10993, “Biological Evaluation of Medical Devices” for
	biocompatibility and ASTM F1690-96 (Reapproved 2004),
	“Standard Specification for Humidifiers for Medical Use-Part
	1: General Requirements for Active Humidification Systems’
	for safety and performance. All acceptance criteria from
	testing were met.
Conclusion:	The Salter Bubble Humidifier (High Flow) has been verifiedand validated against design requirements, user needs andintended uses. Based on this testing and the comparison ofdesign, materials, performance and intended use, the SalterBubble Humidifier (High Flow) raises no new questionsconcerning safety and effectiveness, and is thus substantiallyequivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Salter Labs, Arvin Facility C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747

FEB 1 0 2012

Re: K113542

Trade/Device Name: Salter Lab Bubble Humidifier (High Flow) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: January 25, 2012 Received: January 26, 2012

Dear Mr. Conry:

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. Conry

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,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Bubble Humidifier (High Flow)

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4. Indications for Use

510(k) Number (if known): New 510(k)

Device Name:	Salter Lab Bubble Humidifier (High Flow)
Indications for Use:	The bubble humidifier is a device that is intended to addmoisture to breathing gases for administration to a patient.
	The bubble humidifier is indicated for use with oxygenconcentrators or gas sources in homecare, hospital, extendedcare facilities and hospice environments. The bubblehumidifier is a non-sterile device indicated for single-patientusage. The device is indicated for patients who requirehumidification of high flow supplemental breathing gases.

Prescription Use _ X_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

L. Schultze

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).