(15 days)
Not Found
Not Found
No
The device description and performance studies focus on material biocompatibility and the basic function of adding moisture to breathing gases. There is no mention of AI, ML, or any computational analysis of data.
No
Explanation: The device adds moisture to breathing gases but does not directly treat a medical condition or disease.
No
The device's intended use is to add moisture and sometimes warm breathing gases for administration to a patient, which is a therapeutic function, not a diagnostic one. It doesn't analyze patient data or identify a medical condition.
No
The device description explicitly states it is comprised of polypropylene bottles and caps, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for adding moisture and warmth to breathing gases administered to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details the physical components and how it functions to humidify breathing gases. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays
The device is a medical device used for patient care, but its function is related to gas conditioning for respiration, not in vitro analysis for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
73 BTT
Device Description
The Airlife Bubble Humidifiers are comprised of polypropylene bottles with caps which are comprised of high impact polystyrene. These humidifiers are filled with sterile water and connected to an oxygen source to add moisture to, and sometimes to warm, the breathing gases for administration to a patient.
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
Not Found
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)
All materials used in the fabrication of the Airlife® Humidifiers were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, skin irritation and sensitization (guinea pig maximization). These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
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.
Airlife® Bubble Humidifiers.
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
MAY 1 3 1999
K9914841
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The word is slightly slanted to the right, giving it a dynamic appearance.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Bubble Humidifiers
| Manufacturer: | Allegiance Healthcare Corporation
1660 Iowa Avenue
Riverside, CA 92507 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
1500 Waukegan Road MPWM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | March, 1999 |
| Common Name: | Airlife® Bubble Humidifiers |
| Classification: | Class II per 21CFR § 868.5450 |
| Predicate Device: | Airlife® Bubble Humidifiers. |
| Description: | The Airlife Bubble Humidifiers are comprised of
polypropylene bottles with caps which are
comprised of high impact polystyrene. These
humidifiers are filled with sterile water and
connected to an oxygen source to add moisture
to, and sometimes to warm, the breathing
gases for administration to a patient. |
1
Image /page/1/Picture/0 description: The image contains the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Bubble Humidifiers
| Intended Use: | 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 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Airlife® Bubble Humidifiers are
substantially equivalent to the Airlife® Bubble
Humidifiers in that: |
| | - the intended use is the same
- the performance attributes are the
similar |
| Summary of testing: | All materials used in the fabrication of the Airlife®
Humidifiers were evaluated through biological
qualification safety tests as outlined in ISO 10993
Part-1 "Biological Evaluation of Medical Devices".
The biocompatibility tests performed were
cytotoxicity, skin irritation and sensitization (guinea
pig maximization). These materials also were
tested in accordance with industry recognized test
methods and were found to be acceptable for the
intended use. |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Ms. Sharon Robbins Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787
Re : K991484 Airlife® Bubble Humidifiers Regulatory Class: II (two) Product Code: 73 BTT Dated: April 26, 1999 Received: April 28, 1999
Dear Ms. Robbins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Sharon Robbins
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image contains the word "Allegiance" in a stylized font. To the left of the word is a graphic that resembles a plus sign made up of small dots. The word is in bold, and the font is slightly italicized.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500
FAX: 847.785.2461
Page 1 of 1
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| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name: | Airlife® Bubble Humidifiers |
| Indications For Use: | 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | ✓ |
| or | |
| Over-The Counter Use | _____ |
19
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K991484 |