(230 days)
Not Found
Not Found
No
The summary describes a manual resuscitator and contains no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as a "Resuscitator," which is used for "ventilation," indicating a therapeutic purpose to assist in breathing.
No
Explanation: The device is described as a resuscitator intended for ventilation, which is a therapeutic rather than a diagnostic function. It does not mention identifying or characterizing disease or injury.
No
The device is described as a "Neonate Silicone Resuscitator," which is a physical medical device used for ventilation. There is no mention of software as the primary or sole component.
Based on the provided information, the Ambu Neonate Silicone Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ventilation of neonates and infants. This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used for respiratory support.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ambu Neonate Silicone Resuscitator is a therapeutic device used to assist breathing.
N/A
Intended Use / Indications for Use
The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).
Product codes
73 BTM
Device Description
Ambu Neonate Silicone Resuscitator
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
neonate and infants
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the edge. In the center of the circle is a symbol consisting of three parallel lines that curve and taper to a point, resembling a stylized bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2000
Mr. Sanjay Parikh Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, MD 21090-1356
Re: K993278 Ambu Neonate Silicone Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 9, 2000 March 10, 2000 Received:
Dear Mr. Parikh:
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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory 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.
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Page 2 - Mr. Sanjay Parikh
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 regulation 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
sincerely yours,
Mark n Melkum
James E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993278 510(k) Number (if known):
Dovice Namo: Ambu Neonate Silicone Resuscitator
Indications For Use:
The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Melkerson
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
(Optior al Format 3-10-98)
PRESCRIPTION USE
510(k) Number .
OVER - THE- COUNTER USE