(49 days)
Not Found
None
No
The summary does not contain any keywords or descriptions related to AI or ML, nor does it mention image processing or performance studies typically associated with AI/ML-powered devices.
No.
The device's intended use is to assist verification of endotracheal tube placement and assess tracheal intubation, which is a diagnostic or assistive function, not a therapeutic intervention.
Yes
The device is described as assisting "verification of placement of the endotracheal tube in the trachea" and an "adjunct to assess tracheal intubation," which indicates it is used to determine a patient's condition to aid in diagnosis or treatment.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist verification of placement of the endotracheal tube in the trachea." This is a procedure performed directly on a patient's body (in vivo), not on a sample taken from the body (in vitro).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information about a patient's health status based on sample analysis
The device's function is related to a medical procedure performed on the patient's airway, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
Product codes
73 BTR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Mr. Sanjay Parikh Ambu Inc. 611 N. Hammonds Ferry Road Linthicum, MD 21090
K981891 Re: Ambu Esophageal Intubation Detector (Bulb version and Syringe version) Requlatory Class: II (two) Product Code: 73 BTR Dated: May 20, 1998 Received: May 29, 1998
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 to 895. A substantially equivalent determination assumes compliance 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 requlations.
1
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 diaqnostic 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,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Esophageal Intubation Detector
Intended Use
BULB VERSION
ESOPHAGEAL INTUBATION DETECTOR (BULB) INDICATION FOR USE
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
Mark Reiner
(Division Sign-On)
on of Cardiovascular, Respiratory,
eurological Devices
5.K: Number K981891
3
Esophageal Intubation Detector
Intended Use
SYRINGE VERSION
ESOPHAGEAL INTUBATION DETECTOR (SYRINGE) INDICATION FOR USE
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
e kame
(Division Sign-Off) Division of Cardiovascula and Neurological Device 510(k) Number