SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

K113542 · Salter Labs, Arvin Facility · BTT · Feb 10, 2012 · Anesthesiology

Device Facts

• Record ID: K113542
• Device Name: SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
• Applicant: Salter Labs, Arvin Facility
• Product Code: BTT · Anesthesiology
• Decision Date: Feb 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Non-sterile, disposable bubble humidifier; adds moisture to breathing gases. Input: breathing gas from oxygen concentrators, cylinders, or wall outlets. Operation: gas passes through diffuser submerged in water reservoir; 360° diffuser ports disperse gas, minimize backpressure, and ensure quiet operation. Output: humidified breathing gas delivered via face masks or cannulas. Includes 6 PSI safety valve and audible pressure relief mechanism for downstream occlusion notification. Used in homecare, hospital, extended care, and hospice environments; operated by clinicians or patients. Benefits: prevents airway drying during high-flow oxygen therapy.

Clinical Evidence

Bench testing only. Device verified and validated against design requirements, user needs, and intended use. Testing performed per ISO 10993 for biocompatibility and ASTM F1690-96 (2004) for safety and performance. All acceptance criteria met.

Technological Characteristics

Materials: ABS, PVC, PP, Brass. Sensing/Actuation: Mechanical bubble diffusion; 6 PSI pressure relief valve; audible occlusion alarm. Form factor: 350 ml bottle with lid and interface connectors. Connectivity: None. Sterilization: Non-sterile. Standards: ASTM F1690-96 (2004), ISO 10993-1:2000.

Indications for Use

Indicated for patients requiring humidification of high flow supplemental breathing gases delivered via oxygen concentrators or gas sources in homecare, hospital, extended care, or hospice settings. Single-patient use only.

Regulatory Classification

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.

Predicate Devices

• AirLife® Bubble Humidifier (Model 002006) (K991484)
• American Bantex Humidifier Bottle, 6 PSI (Model B9001) (K041963)

Submission Summary (Full Text)

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| 5. | 510(k) Summary | K113542 |
|----------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Date: | August 6, 2011 | |
| Contact: | Salter Labs<br>100 W. Sycamore Road<br>Arvin, CA 93203 | |
| | Michael Shoup<br>Vice President Quality/Regulatory<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| | 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:

| Predicate<br>510(k) | Device Name | Intended Use | Clearance<br>Date | Company |
|---------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------|
| K991484 | AirLife® Bubble<br>Humidifier<br>(Model 002006) | Humidifiers are defined as a<br>device that is intended to add<br>moisture to, and sometimes to<br>warm, the breathing gases for<br>administration to a patient. | May 13, 1999 | CareFusion<br>(cleared as<br>Allegiance) |
| K041963 | American<br>Bantex<br>Humidifier<br>Bottle, 6 PSI<br>(Model B9001) | The American Bantex<br>Humidifier is intended for use<br>with Oxygen Concentrators in<br>a patients home, physicians<br>office or hospital/institutional<br>environment. The humidifier<br>increases the moisture content<br>of the airstream gases for<br>administration to the patient. | Oct. 20, 2004 | American Bantex<br>Corporation |

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| Device Description: | The Salter Labs Bubble Humidifier (High Flow) is an empty,<br>disposable, non-sterile device that is intended to humidify<br>breathing gas prior to delivery to a patient. The Salter Labs<br>Bubble Humidifier (High Flow) is provided with a 6 PSI safety<br>valve and can operate within flow rates of 6 to 15 LPM. The<br>device is used with various breathing gas sources (i.e., oxygen<br>concentrators, gas cylinders and wall outlets) and provides<br>connection for delivery of humidified breathing gas via face<br>masks and cannulas, and use of optional oxygen tubing and<br>water traps. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is made of a humidifier bottle which is used to hold<br>water during use, a lid which seals the humidifier bottle and<br>houses the different interface connectors, an audible pressure<br>relief mechanism to notify the user of a downstream occlusion<br>and a diffuser located inside the humidifier bottle that is<br>designed to uniformly disperse the gas throughout the water.<br>The 360° diffuser ports also provide quiet operation and<br>minimize system backpressure. Both the bottle and lid are<br>constructed to be easy to grip and reduce the chance of cross<br>threading. The jar is permanently marked with<br>minimum/maximum water levels. |
| Intended Use/Indication<br>For Use: | The bubble humidifier is a device that is intended to add<br>moisture to breathing gases for administration to a patient.<br>The bubble humidifier is indicated for use with oxygen<br>concentrators or gas sources in homecare, hospital, extended<br>care facilities and hospice environments. The bubble<br>humidifier is a non-sterile device indicated for single-patient<br>usage. The device is indicated for patients who require<br>humidification of high flow supplemental breathing gases. |
| Technological<br>Characteristics: | Salter Bubble Humidifier (High Flow) is substantially<br>equivalent to the predicate device with regards to design,<br>materials, performance and intended use. The difference is in<br>the operating gas flow rates of 6 to 15 LPM that still produces<br>a humidifier output of at least 10mgH2O/L in accordance with<br>ASTM 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<br>(Allegiance)<br>AirLife® |
|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Model # | 7900 | B9001 | 2006 |
| Method of Humidification | Gas bubbles<br>through the<br>diffuser submerged<br>in a user-filled,<br>water<br>reservoir/bottle and<br>enters the patient<br>breathing gas<br>circuit | Same | Same |
| Gas Flow Range | 6 - 10 LPM<br>Concentrator,<br>6 - 15 LPM Wall<br>Source | Not Specified | Not Specified |
| Pressure Relief Value | .6 PSI | .6 PSI | .6 PSI |
| Audible Notification of<br>Occlusion | Yes | Yes | Yes |
| Materials of Construction | ABS<br>PVC<br>PP<br>Brass | ABS<br>PVC<br>PP<br>Brass | High Impact PS<br>PP<br>Brass |
| This product is not made<br>with natural rubber latex | Yes | Not Specified | Label states “Latex<br>Free” |
| Bottle Capacity | 350 ml | Not Specified | 370 ml |
| Used with Oxygen<br>Concentrators, Gas<br>Cylinders and Wall Outlets | Yes | Yes | Not Specified |
| Complies with applicable<br>clauses of ASTM F1690-96<br>(2004) and ISO 10993-1:<br>2000 (Biocompatibility) | Yes | Not Specified, no<br>declaration of<br>conformity to this<br>standard | Not Specified, no<br>declaration of<br>conformity to this<br>standard |

## 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 verified<br>and validated against design requirements, user needs and<br>intended uses. Based on this testing and the comparison of<br>design, materials, performance and intended use, the Salter<br>Bubble Humidifier (High Flow) raises no new questions<br>concerning safety and effectiveness, and is thus substantially<br>equivalent 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 [phone] or [phone] 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

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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 add<br>moisture to breathing gases for administration to a patient. |
| | The bubble humidifier is indicated for use with oxygen<br>concentrators or gas sources in homecare, hospital, extended<br>care facilities and hospice environments. The bubble<br>humidifier is a non-sterile device indicated for single-patient<br>usage. The device is indicated for patients who require<br>humidification 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: _______________________________________________________________________________________________________________________________________________________________

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