(18 days)
Not Found
Not Found
No
The summary describes a transport incubator and does not mention any AI or ML capabilities.
No
A transport incubator is a device used to provide a controlled environment for neonates during transport. While it aids in maintaining the health of the infant, its primary function is supportive and protective, not directly therapeutic. Therapeutic devices are typically defined as those that treat or cure a disease or condition.
No
Explanation: The device is a transport incubator for neonatal infants, used for transportation and care, not for diagnosing medical conditions.
No
The device is described as a "transport incubator," which is a physical hardware device used for transporting infants. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transport neonatal infants. This is a direct patient care function, not a diagnostic test performed on samples taken from the body.
- Device Description: While "Not Found" is listed, the intended use clearly describes a physical device for transporting infants.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This transport incubator does not fit that description.
N/A
Intended Use / Indications for Use
The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.
Product codes
FPL
Device Description
Not Found
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
neonatal infants
Intended User / Care Setting
personnel trained in neonatal care, transport in ambulances or aircraft
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)
Not Found
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.
Not Found
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
Not Found
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
Ms. Amy Pieper Director of Regulatory Affairs International Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754
Rc: K081399
Trade/Device Name: Aviator Transport Incubator Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: May 14, 2008 Received: May 19, 2008
Dear Ms. Pieper:
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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Pagc 2 - Ms. Pieper
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 vour 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) 276-0115. 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,
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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Special 510(k): Device Modification Aviator Transport Incubator May 14, 2008
INDICATIONS FOR USE STATEMENT
Applicant's Name:
International Biomedical, Ltd.
510(k) Number:
Device Name:
Aviator Transport Incubator
Indications for Use:
The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K481399 510(k) Number: