(106 days)
EME Infant Flow System
Not Found
No
The description focuses on the mechanical delivery of CPAP and does not mention any computational or algorithmic components that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as providing continuous positive airway pressure to newborns and infants with compromised respiratory systems, which is a therapeutic intervention aimed at improving their respiratory function.
No.
The device is described as providing continuous positive airway pressure for treatment, not for diagnosing a condition.
No
The device description explicitly lists hardware components such as a generator, prongs, masks, headgear/fixation device, and a driver.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for delivering air and oxygen to the patient's nose. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.
- Anatomical Site: The anatomical site is the nose, which is the point of application for the therapeutic intervention, not a site for collecting samples for analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device, consisting of a generator, prongs, masks and a headgear/fixation device, is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.
Product codes
BZD
Device Description
The Cardinal infant nCPAP system consists of a Generator, Prongs, Masks, and a headgear/fixation device. A 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 straps connected to a headgear/fixation device. This product is a single patient use, non-sterile prescriptive 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
hospital environment
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) System 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)
EME Infant Flow System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The text "CardinalHealth" is in a sans-serif font and is black.
AUG 3 2005
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 Infant Nasal Continuous Positive Airway Pressure (nCPAP) System
| 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 Infant Nasal Continuous Positive
Airway Pressure (nCPAP) System |
| Classification: | Class II per 21CFR §868.5905 |
| Predicate Device: | EME Infant Flow System |
| Description: | The Cardinal infant nCPAP system
consists of a Generator, Prongs, Masks,
and a headgear/fixation device. A 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
straps connected to a headgear/fixation
device. This product is a single patient
use, non-sterile prescriptive device. |
1
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 four curved lines that intersect each other. 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 (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System
This device, consisting of a generator, prongs, Intended Use: masks and a headgear/fixation device, is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.
Airlife Infant Nasal Continuous Positive Substantial Equivalence: Airway Pressure (nCPAP) System is substantially equivalent to the EME Infant Flow System in that:
-
the intended use is the same
-
the performance attributes are similar
All materials used in the fabrication of the Airlife Summary of testing: Infant Nasal Continuous Positive Airway Pressure (nCPAP) System 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.
000094
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 - 2005
Ms. Sharon Nichols Regulatory Affairs Manager . . . . Cardinal Health 1430 Waukegan Road, Building KB McGraw Park, Illinois 60085
4-2
Re: K050994
Trade/Device Name: Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 7, 2005 Received: July 8, 2005
Dear Ms. Nichols:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed young and have determined the device is substantially equivalent (for the receiced above and not in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersule commerce prior so prior so been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouchar I Vou, I vagy ... You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 (1 WAY), It may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device announcements concernents concerning your device in the Federal Register.
3
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. or are ret or any 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 and insting (2 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet forms 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 promative actived 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), if you dontact 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 maj count 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,
Syritie Y. Michin Oms.
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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Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
تعمل تي ته تع
Indications for Use
510(k) Number (if known): K050994 Airlife Infant Nasal Continuous Device Name: Positive Airway Pressure (nCPAP) System This device, consisting of a Indications for Use: generator, prongs, masks and a headgear/fixation device is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.
AND/OR Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cure Muiconi
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
000045