(189 days)
EME Infant Flow System Driver
Not Found
No
The summary describes a hardware device that delivers air and oxygen for CPAP. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or control. The performance studies section focuses on material safety, not algorithmic performance.
Yes
The device is intended to provide CPAP to treat newborns and infants with RDS or recovering from RDS, indicating a therapeutic purpose.
No
The device is a therapeutic device that delivers Continuous Positive Airway Pressure (CPAP); it does not perform any diagnostic function.
No
The device description explicitly states "The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen..." indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AirLife™ nCPAP System Driver is a device that delivers a mixture of air and oxygen to provide respiratory support directly to the patient. It does not analyze any biological samples.
- Intended Use: The intended use is to provide CPAP for treating newborns and infants with RDS, which is a direct treatment/support function, not a diagnostic one based on analyzing samples.
Therefore, based on the provided information, the AirLife™ nCPAP System Driver is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen to provide the prescribed level of CPAP through a circuit and generator. Either a prong or mask is attached to the generator as a patient interface. The generator is held to the infant's nose by a fixation device.
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
newborns and infants
Intended User / Care Setting
hospitals
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™ Infant Nasal Continuous Positive Airway Pressure (nCPAP) Driver 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.
EME Infant Flow System Driver
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
K 051226
NOV 1 7 2005
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver
| Sponsor: | Cardinal Health 1430 Waukegan Road MPWM McGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | April 2005 |
| Common Name: | AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver |
| Classification: | Class II per 21CFR § 868.5905 |
| Predicate Device: | EME Infant Flow System Driver |
| Description: | The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen to provide the prescribed level of CPAP through a circuit and generator. Either a prong or mask is attached to the generator as a patient interface. The generator is held to the infant's nose by a fixation device. |
000012
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Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is made up of several curved lines that intersect each other. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver
Intended Use: The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS. Substantial Equivalence: AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is substantially equivalent to the EME Infant Flow System Driver in that: - the intended use is the same - the performance attributes are similar Summary of testing: All materials used in the fabrication of the AirLife™ Infant Nasal Continuous Positive Airway Pressure (nCPAP) Driver 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.
000013
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles three wavy lines or ribbons, which are meant to represent the human services provided by the department. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2005
Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085
Re: K051226
Trade/Device Name: AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 8, 2005 Received: November 9, 2005
Dear Ms. Nichols:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Nichols
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Ruane
fa
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847,578,6610 AX: 847.785.2506
Indication for Use
510(k) Number (if known):
Device Name:
Indications For Use:
AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver
The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The Counter Use _ (21 CFR Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aim Sarlson
(Division Sign-Off)
Division of Anesihesiology, General Hospital,
Division Ocentral Devices (Jivision Sign-C Division of Anesthesionaly)
Dental Devices Infection Control. Dental Devices
510(k) Number:__
000011