(106 days)
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.
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.
This document describes the Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System. It outlines its intended use and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in a performance study section.
Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
The document primarily focuses on:
- Device Description: Consists of a generator, prongs, masks, and a headgear/fixation device, delivering a mixture of air and oxygen to provide prescribed CPAP.
- Intended Use: To provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.
- Substantial Equivalence Claim: To the EME Infant Flow System, based on the same intended use and similar performance attributes.
- Summary of Testing: Materials used were evaluated through biological qualification safety tests (ISO 10993 Part-1) and tested according to industry-recognized methods, found acceptable for the intended use.
- Regulatory Information: Class II device (21CFR §868.5905), Product Code: BZD.
In summary, the provided text from the 510(k) summary focuses on establishing substantial equivalence through intended use, device description, and material safety testing. It does not include a performance study with acceptance criteria and reported device performance metrics in the format requested.
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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 Health1430 Waukegan Road MPWMMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | April 2005 |
| Common Name: | Airlife Infant Nasal Continuous PositiveAirway Pressure (nCPAP) System |
| Classification: | Class II per 21CFR §868.5905 |
| Predicate Device: | EME Infant Flow System |
| Description: | The Cardinal infant nCPAP systemconsists of a Generator, Prongs, Masks,and a headgear/fixation device. A driver(hardware) delivers a mixture of air andoxygen to provide the prescribed level ofCPAP through a circuit and generator.Either a prong or mask is attached to thegenerator as a patient interface. Thegenerator is held to the infant's nose bystraps connected to a headgear/fixationdevice. This product is a single patientuse, non-sterile prescriptive device. |
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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 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:
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the intended use is the same
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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. 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
§ 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).