(15 days)
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.
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.
The provided document describes the acceptance criteria and study for the Airlife® Bubble Humidifiers. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All materials 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. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the document. The document refers to "All materials used in the fabrication," implying that the testing was performed on the components of the device rather than a specific patient test set.
- Data Provenance: Not explicitly stated. The tests were performed in accordance with ISO 10993 Part-1 and "industry recognized test methods." The location or nature (retrospective/prospective clinical data) of any study involving human or animal subjects is not detailed, beyond the guinea pig maximization test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. This document pertains to the biological and material safety of a medical device, not diagnostic performance where expert ground truth would typically be established. The "ground truth" here is the acceptance of material safety based on established ISO standards and test results.
4. Adjudication method for the test set
- Not applicable/Not mentioned. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of the reported testing for this device.
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
- Not applicable. This document does not describe an MRMC study or any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document does not describe an algorithm or AI.
7. The type of ground truth used
- Biological Qualification Safety Tests: The ground truth for the safety and acceptability of the materials was established based on the results of standard biological qualification safety tests (cytotoxicity, skin irritation, and sensitization) as outlined in ISO 10993 Part-1 and "industry recognized test methods." The "ground truth" is adherence to these established safety standards.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML algorithm that would require a training set. The testing described relates to material validation.
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned, this question is not relevant to the provided text.
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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 Corporation1660 Iowa AvenueRiverside, CA 92507 |
|---|---|
| Regulatory Affairs Contact: | Sharon Robbins1500 Waukegan Road MPWMMcGaw 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 ofpolypropylene bottles with caps which arecomprised of high impact polystyrene. Thesehumidifiers are filled with sterile water andconnected to an oxygen source to add moistureto, and sometimes to warm, the breathinggases for administration to a patient. |
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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 isintended to add moisture to, and sometimes towarm, the breathing gases for administration toa patient |
|---|---|
| Substantial Equivalence: | The Airlife® Bubble Humidifiers aresubstantially equivalent to the Airlife® BubbleHumidifiers in that: |
| - the intended use is the same- the performance attributes are thesimilar | |
| Summary of testing: | All materials used in the fabrication of the Airlife®Humidifiers were evaluated through biologicalqualification safety tests as outlined in ISO 10993Part-1 "Biological Evaluation of Medical Devices".The biocompatibility tests performed werecytotoxicity, skin irritation and sensitization (guineapig maximization). These materials also weretested in accordance with industry recognized testmethods and were found to be acceptable for theintended use. |
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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.
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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
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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
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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 |
§ 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).