(253 days)
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Not Found
No
The summary describes a mechanical device for securing endotracheal tubes and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is described as a retention system for endotracheal tubes, not as a device used to treat a disease or condition.
No
The device is described as a "retention system" for securing endotracheal tubes, which is a supportive function, not a diagnostic one. It does not mention any capabilities for detecting, identifying, or monitoring medical conditions.
No
The device description and intended use clearly describe a physical system for securing endotracheal tubes, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Bridle Retention System" for securing endotracheal tubes. This is a mechanical device used to physically hold a medical tube in place within the body.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples or providing diagnostic information. Its function is purely supportive and mechanical.
Therefore, the AMT Endotracheal Tube Bridle Retention System falls under the category of a general medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AMT Endotracheal Tube Bridle Retention System is indicated for use in the adult population for securing medically applied oral endotracheal tubes ranging in size from 5 to 10 mm in diameter. Target areas of use include intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
Product codes
KNT, CBH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult population
Intended User / Care Setting
intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
§ 868.5770 Tracheal tube fixation device.
(a)
Identification. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24,2014
AMT Bridle™Endotracheal Tube Bridle Retention System Mr. Joshua Meinke Ouality Assurance, Regulatory Supervisor 8000 Katherine Boulevard St. Paul, Minnesota 55102
Re: K140097
Trade/Device Name: AMT Endotracheal Tube Bridle Retention System Regulation Number: CFR 21 876.5980 Regulatory Class: II Product Code: KNT, CBH Dated: August 21, 2014 Received: August 24, 2014
Dear Mr. Meinke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
Erin Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION - 4
c. – INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K140097
Trade Name: AMT Endotracheal Tube Bridle Retention System Common Name: Tracheal Tube Fixation Device
Indications For Use:
The AMT Endotracheal Tube Bridle Retention System is indicated for use in the adult population for securing medically applied oral endotracheal tubes ranging in size from 5 to 10 mm in diameter. Target areas of use include intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |