(142 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and compliance with standards for a basic medical device (tracheal tube), with no mention of AI or ML.
No
The device is used for airway management and intubation, which are supportive functions, not therapeutic in themselves. While essential for patient care, the device itself doesn't treat a disease or condition.
No
The device is described as a tracheal tube for oral or nasal intubation and airway management, which are therapeutic and management functions, not diagnostic.
No
The device description explicitly states it is made from medical grade PVC and includes physical components like a connector 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 procedure performed directly on a patient to manage their airway, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "tracheal tube" made of PVC. This is a physical device used for a medical procedure, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for oral or nasal intubation and for airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
DEVICE PERFORMANCE: the dimension, design, material, sterility and packaging of well lead endotracheal tube are conformed with ISO 5361:1999(E)
DEVICES COMPARE: the device has the same dimensions and design as the predicate devices.
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.
Kendall - Pre-Amendment, RÜSCHELIT K961837, K993786, K961840, K931163, K93786
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
FEB 1 8 2005
510K SUMMARY FOR ENDOTRACHEAL TUBE
SUBMITTER NAME: Well Lead Medical Instruments Ltd
SUBMITTER ADDESS: Jinhu Industrial Estate, Hualong, Panyu, Guangzhou City, China
CONTACT PERSON: Huan Guang Yuan (vice general manager)
PHONE NUMBER: +8620 84752978
FAX NUMBER: +8620 84758224
EMAIL: han@welllead.com.cn
DATE PREPARED: July 16, 2004
TRADE NAME: well lead Endotracheal tube
COMMON NAME: ET-tube
CLASSIFICATION NAME: Tracheal tube
CLASSIFICATION: BTR
PREDICATE DEVICE: Well Lead is claiming substantial equivalence to the following medical device(s) -
DEVICE DESCRIPTION: The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.
INTENDED USE: The device is intended for oral or nasal intubation and for airway management.
DEVICE PERFORMANCE: the dimension, design, material, sterility and packaging of well lead endotracheal tube are conformed with ISO 5361:1999(E)
DEVICES COMPARE: the device has the same dimensions and design as the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing growth and vitality. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2005
Well Lead Medical Instruments Limited C/O Mr. Arthur J. Ward Regulatory Consultant AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K042683
Trade/Device Name: Well Lead Endotracheal Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: January 3, 2005 Reccived: January 6, 2005
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the inclications 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 merslate commonel proces that have been reclassified in accordance with the provisions of Amendina, or to do roug, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 If your device is olabilional controls. Existing major regulations affecting (1 Mrt), It may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be nouncements concerning your device in the Federal Register.
2
Page 2 - Mr. Ward
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease of advisor that 1 27 is issuaines on that your device complies with other requirements Incall that I DX mas made a statutes and regulations administered by other Federal agencies. of the Act of ally i ederal bate reguirements, including, but not limited to: registration 1 ou intist comply with and any, labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadion 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) IThis letter will anow you to begin mailing of substantial equivalence of your device to a premaired 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), rryou desire specific advise to your and (240) 276-__. Also, please note the regulation entitled, "Misbranding by reference 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 manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syitte Michain D.M.D.
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
3
Indication for Use
K042683 510(k) Number (if known): 510(R) Name: Endotracheal Tube Indication For Use:
、
。 …
.
The device 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 | |
| (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K042683 |