(396 days)
Not Found
No
The device description and intended use describe a standard endotracheal tube with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
An endotracheal tube is primarily a device for airway management and mechanical ventilation, not for treating a disease or condition in a therapeutic sense. It facilitates breathing rather than curing or ameliorating a medical condition.
No
The device description clearly states its purpose is for "oral or nasal intubation and for airway management," which are therapeutic or management functions, not diagnostic. There are no mentions of detecting, monitoring, or identifying medical conditions.
No
The device description clearly outlines physical components like the tube body, connector, cuff, inflating tube, pilot balloon, and valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for oral or nasal intubation and for airway management." This describes a device used in vivo (within the body) to manage the airway, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details the physical components of an endotracheal tube, which is a medical device used to establish and maintain an airway. It doesn't mention any components or processes related to testing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, this device is a medical device used for airway management, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Endotracheal tube is intented for oral or nasal intubation and for airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve. Tracheat tube with a radius of curvature. a line for x-radial through the body. All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.
Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
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): 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.
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
§ 868.5730 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
K080105
p. 1 of 2
510(K) SUMMARY
[as required by 807.92(c)]
- A. 510k Number:
B. Applicant:
Company name: Chilecom Medical Devices Co., Ltd. Address: 106 Boyi Road, Boluo County, Guangdong, China
Tel: +86-752-6282030
Fax: +86-752-6289386
E-mail: chilecom@163.com
C. Proprietary and Established Names: Chilecom Medical Devices Co., Ltd.
- · D. Regulatory Information
- Classification: Class II Device 1.
- Common Name: Tracheal tube ﻨﺎ
-
- Product Code: BTR (21 CFR 868.5730)
- Proprietary name: Endotracheal tube বা
E. Intended use
:
Endotracheal tube is intented for oral or nasal intubation and for airway management.
F. Device Description
Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve。Tracheat tube with a radius of curvature.。 a line for x-radial through the body.。 All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.
Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only
FEB 1 3 2009
1
G. Substantial Equivalence Information
-
- Predicate device name
Predicate Device 1 - K042683 / Tracheal tube, Well lead endotracheal tube
- Predicate device name
2. Comparison with predicate
The Chilecom Tracheal tube device described in this 510K is very similar in terms of design, materials and indications for use to three predicate devices already approved and marketed. There are no new safety concerns when compared to the already available predicate devices. For these reasons, we feel the Chilecom Tracheal tube fulfills all criteria to be found substantially equivalent to the predicate devices and should be cleared for marketing.
- H. Standard / Guidance Document Referenced (if applicable) ISO 5361:1999 Anaesthetic and respiratory equipment—Tracheal tubes and connectors
- -Sterility
-Sterilized by EO gas
-Sterile method: refer to validation report
-Self-life: 3 years
-Single use only.
Performance Characteristics (If/when applicable) J.
- See the Exhibits.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with three legs.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chilecom Medical Devices Company, Limited C/o Mr. Brandon Choi PATS Corporation 155 Flemington Court La Mirada, California 90638
FEB 1 3 2009
K080105 Re:
Trade/Device Name: Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: October 28, 2008 Received: January 21, 2009
Dear Mr. Choi:
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.
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 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.
3
Page 2 - Mr. Choi
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Anant for CRM
Signature of Applicant, M.D.
Ginette Y. Michaud, M.D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Endotracheal Tube
Indications for Use: Endotracheal tubes is intended for oral or nasal intubation and for airway management.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) -
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Zn Mzi
(Division Sign-U) ز (Division Sign-Of.)
Division of Anesthasiningy General Hospitzl Division of Anton Contact, Dentes Dovides
Infection Control, Dental, Dental, Dentes
510(k) Number: _______________________________________________________________________________________________________________________________________________________________