(109 days)
Not Found
Not Found
No
The 510(k) summary describes a standard endotracheal tube and does not mention any AI or ML components or functionalities.
No
An endotracheal tube is used for airway management, facilitating respiration or ventilation, but it does not directly treat a disease or condition in a therapeutic sense.
No
The device, an endotracheal tube, is used for airway management and establishing a seal in the trachea, which are therapeutic and supportive functions, not diagnostic.
No
The device is described as an "Endotracheal Tube," which is a physical medical device used for airway management. The summary does not mention any software component.
Based on the provided information, the AMSINO ® Endotracheal Tube is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for airway management by oral/nasal intubation of the trachea. This is a procedure performed directly on a patient's body to manage their airway.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or diagnostic purposes.
Therefore, the AMSINO ® Endotracheal Tube is a medical device used for a therapeutic/procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AMSINO ® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a scal between the tube and the trachea.
Product codes
BTR
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
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
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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)
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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.
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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)
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stylized wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2005
Mr. Ching Ching Seah, Ph.D Director of Regulatory Affairs · Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767
Re: K050785
Trade/Device Name: AMSINO™ Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: May 25, 2005 Received: May 31, 2005
Dear Dr. Seah:
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 Amendinents, of to arrived Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided 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 (1 Writ), it hay of each of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Dr. Seah
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that FDA nas made a decommances and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regarants, including, but not limited to: registration You must comply with and her her her brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laooiiisg (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (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 5 10(k) This letter will anow you to obgin mained of substantial equivalence of your device to a premarket notification. The PDF milians of sabssification 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), if you desire specific auvice for your de recolour and the regulation in the regulation prease contact the Other or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on the mational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Senute y. Michael Omd.
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
2
AMSINO
a participating program (1998). sa juternali in 'n'i
| 510(k) Number: (if known) | |
|---|---|
| Device Name: | AMSINO ® Endotracheal Tube |
| Indications for Use: | The AMSINO ® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a scal between the tube and the trachea. |
Indications for Use Statement
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
INCLE OF NOT WRITE VEEDED NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription/ Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
" -- 2 ··
Aure Suliom
(Division Sign-Off) (Livision Sign-On)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number:_
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