(365 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
Explanation: A therapeutic device treats a condition, whereas this device is intended for emergency relief of an airway obstruction, which is a temporary measure, not a treatment.
No
The device is intended for emergency airway obstruction, indicating a therapeutic or supportive function rather than a diagnostic one.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "emergency airway obstruction in a non-clinical environment." This describes a physical intervention or device used directly on a patient to address a medical emergency.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The description clearly indicates a device used on a person, not a test performed on a sample from a person.
N/A
Intended Use / Indications for Use
The device is intended for emergency airway obstruction in a non-clinical environment.
The device is intended to be used for less than 24 hours.
Product codes
73 BWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway (implied)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
non-clinical 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)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" are arranged around the top of the circle. The eagle is facing to the right, and its wings are depicted with thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Mr. H. Clay Wilson, P.E. ffrench Pocket Emergency Airway, Inc. 1705 Calhoun Street New Orleans, Louisiana 70118
Re: K962312 * Key Chain Emergency Airway Regulatory Class: II (two) Product Code: 73 BWC Dated: May 29, 1997 Received: May 30, 1997
Dear Mr. Wilson:
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 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 2 inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 regulations.
1
Page 2 - Mr. H. Clay Wilson, P.E.
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. In manufac
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) 594-4646. 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/dsmamain.html".
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
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name:ffrench Pocket Emergency Airway
Indications For Use:
The device is intended for emergency airway obstruction in a non-clinical environment.
The device is intended to be used for less than 24 hours.
专
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
To A Wictastaran
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Nuniber_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)