(71 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
A therapeutic device is used to treat a disease or condition. This device only adds moisture to breathing gases; it does not treat a condition.
No
The device description indicates its purpose is to "add moisture to breathing gases for administration to a patient" and "humidify breathing gas prior to delivery to a patient," which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a bottle, lid, safety valve, and diffuser, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to add moisture to breathing gases for administration to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a device for humidifying breathing gas, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
- Performance Studies: The performance studies focus on the device's ability to humidify gas and meet safety and performance standards for medical humidifiers, not on diagnostic accuracy.
In summary, the device's purpose is to modify the breathing gas delivered to a patient, which falls under the category of a medical device used for treatment or support, not for in vitro diagnosis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Homecare, hospital, extended care facilities and hospice environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
| 5. | 510(k) Summary | K113542 |
|---|---|---|
| Date: | August 6, 2011 | |
| Contact: | Salter Labs | |
| 100 W. Sycamore Road | ||
| Arvin, CA 93203 | ||
| Michael Shoup | ||
| Vice President Quality/Regulatory | ||
| Phone: 800-421-0024 | ||
| Fax: 661-854-3850 | ||
| Email: 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:
| Predicate
510(k) | Device Name | Intended Use | Clearance
Date | Company |
|---------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------|
| K991484 | AirLife® Bubble
Humidifier
(Model 002006) | Humidifiers are defined as a
device that is intended to add
moisture to, and sometimes to
warm, the breathing gases for
administration to a patient. | May 13, 1999 | CareFusion
(cleared as
Allegiance) |
| K041963 | American
Bantex
Humidifier
Bottle, 6 PSI
(Model B9001) | The American Bantex
Humidifier is intended for use
with Oxygen Concentrators in
a patients home, physicians
office or hospital/institutional
environment. The humidifier
increases the moisture content
of the airstream gases for
administration to the patient. | Oct. 20, 2004 | American Bantex
Corporation |
1
| 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. |
| Intended Use/Indication
For 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. |
| Technological
Characteristics: | Salter Bubble Humidifier (High Flow) is substantially
equivalent to the predicate device with regards to design,
materials, performance and intended use. The difference is in
the operating gas flow rates of 6 to 15 LPM that still produces
a humidifier output of at least 10mgH2O/L in accordance with
ASTM F1690 (Clause 49.1). |
2
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 bubbles
through the
diffuser submerged
in a user-filled,
water
reservoir/bottle and
enters the patient
breathing gas
circuit | Same | Same |
| Gas Flow Range | 6 - 10 LPM
Concentrator,
6 - 15 LPM Wall
Source | Not Specified | Not Specified |
| Pressure Relief Value | .6 PSI | .6 PSI | .6 PSI |
| Audible Notification of
Occlusion | Yes | Yes | Yes |
| Materials of Construction | ABS
PVC
PP
Brass | ABS
PVC
PP
Brass | High Impact PS
PP
Brass |
| This product is not made
with natural rubber latex | Yes | Not Specified | Label states “Latex
Free” |
| Bottle Capacity | 350 ml | Not Specified | 370 ml |
| Used with Oxygen
Concentrators, Gas
Cylinders and Wall Outlets | Yes | Yes | Not Specified |
| Complies with applicable
clauses of ASTM F1690-96
(2004) and ISO 10993-1:
2000 (Biocompatibility) | Yes | Not Specified, no
declaration of
conformity to this
standard | Not Specified, no
declaration of
conformity to this
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
3
| 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 |
| and validated against design requirements, user needs and | |
| intended uses. Based on this testing and the comparison of | |
| design, materials, performance and intended use, the Salter | |
| Bubble Humidifier (High Flow) raises no new questions | |
| concerning safety and effectiveness, and is thus substantially | |
| equivalent to the predicate devices. |
.
:
4
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.
5
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
6
Bubble Humidifier (High Flow)
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1
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 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. |
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: _______________________________________________________________________________________________________________________________________________________________
1,