(28 days)
Not Found
Not Found
No
The description focuses on the physical components and function of a breathing circuit heater, with no mention of AI or ML.
No.
The device is intended to warm breathing gases, which is a supportive function during medical procedures, not a direct therapeutic intervention for a disease or condition. It facilitates therapy but is not a therapy itself.
No
Explanation: The device is described as a breathing system heater intended to warm gases for patients, not to diagnose a condition.
No
The device description explicitly states it is comprised of disposable connectors, tubing, and heating wire assemblies, 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 is to warm breathing gases before they enter a patient's airway. This is a direct therapeutic or supportive function related to patient care, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The device consists of tubing, connectors, and heating elements. These are components of a breathing circuit, not equipment used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to the delivery of warmed breathing gases to the patient.
N/A
Intended Use / Indications for Use
Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.
Product codes (comma separated list FDA assigned to the subject device)
73 BZE
Device Description
The Airlife Heated Ventilator and Anesthesia Breathing Circuits are comprised of disposable connectors, tubing, and heating wire assemblies. The circuits are for infant, pediatric and adults.
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
infant, pediatric and adults
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® Heated Ventilator and Anesthesia Breathing Circuits were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". 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.
Isothermal Heated Ventilator and Anesthesia Breathing Circuits.
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
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
0
DEC 1 0 1999
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Heated Ventilator and Anesthesia Breathing Circuits
| 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: | September, 1999 |
| Common Name: | Airlife® Heated Ventilator and Anesthesia
Breathing Circuits |
| Classification: | Class II per 21CFR § 868. 5270 |
| Predicate Device: | Isothermal Heated Ventilator and Anesthesia
Breathing Circuits. |
| Description: | The Airlife Heated Ventilator and Anesthesia
Breathing Circuits are comprised of disposable
connectors, tubing, and heating wire
assemblies. The circuits are for infant, pediatric
and adults. |
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif 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® Heated Ventilator and Anesthesia Breathing Circuits
| Intended Use: | Breathing system heaters are defined as a device
that is intended to warm breathing gases before
they enter a patient's airway. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Airlife® Heated Ventilator and Anesthesia
Breathing Circuits are substantially equivalent to
the Isothermal Heated Ventilator and Anesthesia
Breathing Circuits 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®
Heated Ventilator and Anesthesia Breathing Circuits
were evaluated through biological qualification safety
tests as outlined in ISO 10993 Part-1 "Biological
Evaluation of Medical Devices". 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 & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Ms. Sharon Robbins Allegiance Heathcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787
Re: K993833 Airlife® Heated Ventilator and Anesthesia Breathing Circuits Requlatory Class: II (two) Product Code: 73 BZE November 10, 1999 Dated: Received: November 12, 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 requlatory 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 requlation 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,
Juano H Westerhausen for
elia M. Witten, Ph.D., M.D. Acting 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 bold, stylized font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in all capital letters, and the font is sans-serif.
Allegiance Healthcare Corporation 1500 Waukegan Road
McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Page 1 of 1
| 510(k) Number (if known): | Unknown K993833 |
|---|---|
| Device Name: | Airlife® Heated Ventilator and Anesthesia |
| Breathing Circuits | |
| Indications For Use: | Breathing system heaters are defined as a device |
| that is intended to warm breathing gases before | |
| they enter a patient's airway. |
(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) | X |
|---|---|
| or | |
| Over-The Counter Use |
25
| Division Sign-Off | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993833 |