(211 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard medical device (endotracheal tube) and does not mention any AI/ML components or functionalities.
No.
The device is used for airway management, specifically oral intubation and drainage, which is a supportive function rather than directly treating a disease or condition. While essential for patient care, it does not fit the typical definition of a therapeutic device designed to cure, mitigate, or prevent disease.
No
The device is described as an Endotracheal Tube with Evacuation Lumen, intended for "Oral intubation and drainage of the subglottic space for airway management." Its description focuses on its material, physical features (lumens, connector, curve, tip, radiopaque line), and performance studies relate to physical standards (e.g., dimensions, cuff inflation). There is no mention of it being used to detect, diagnose, monitor, or predict any medical condition, disease, or health status.
No
The device description clearly outlines a physical medical device made of Polyvinylchloride with lumens, a cuff, and a connector, indicating it is hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for Oral intubation and drainage of the subglottic space for airway management." This describes a procedure performed directly on a patient's body for therapeutic and management purposes.
- Device Description: The description details a physical tube used for intubation and drainage, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform such analysis.
This device is a medical device used for airway management, specifically an endotracheal tube with an evacuation lumen.
N/A
Intended Use / Indications for Use
The Well Lead Endotracheal Tube with Evacuation Lumen is intended for Oral intubation and drainage of the subglottic space for airway management.
Product codes (comma separated list FDA assigned to the subject device)
FMC73 BTR, BTR, BSY
Device Description
Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subglottic space
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)
The results from non - clinical data were provided for the Endotracheal Tubes with Evacuation lumen according to EN1782:1998 and ISO 5361-1:1999, in each of the tests the results fell within the required limits of the standard. The following testing was performed:
- Surface Finish Dimensions Testing (I.D, O,D Overall Length) Connector Testing Cuff Heniation Cuff Resting Diameter Tube Inflation Radius of curvature Angle of bevel Security of the construction of the evacuation lumen Shaft of the evacuation lumen
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
Traditional 510(k) Summary
2 6 2011
(as required by 807.92(c))
Regulatory Correspondent:
AJW Technology Consultants Inc 962 Allegro Lane Apollo Beach, FL 33572 John O'Brien jobrien@ajwtech.com 813-645-2855 813-677-4787
Submitter of 510(k):
WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE, HUALONG, PAN YU GUANGZHOU, 511434, CHINA
Phone: 86- 20-84758878 Fax : 86- 20-84758224
Contact Person:
Han Guang Yuan
510(k) Preparation Date:
12/27/2010.
Device Name:
Trade Name: Well Lead Endotracheal Tube with Evacuation Lumen Common Name: Endotracheal Tube with Evacuation Lumen Classification Name: Tube, tracheal (w/wo connector) (21 CFR 878.5730, Product Code FMC73 BTR)
Predicate Device:
K042683-WELL LEAD ENDOTRACHEAL TUBE K090352-Taperguard Evac TM Endotracheal Tubes
Device Description:
Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.
Traditional 510(k) for Well Lead Endotracheal Tubes with Evacuation Lumen
L
1
Intended Use:
The Well Lead Endotracheal Tube with Evacuation Lumen is intended for Oral intubation and drainage of the subglottic space for airway management.
Substantial Equivalence:
Well Lead Medical Instruments claims the proposed device is substantially equivalent to the devices previously cleared by FDA, K042683 and K090352.
The Well Lead Endotracheal Tubes with Evacuation Lumen maintain the similar intended use as the predicate device. It is a device inserted into the trachea to facilitate breathing.
The Well Lead Endotracheal Tubes with Evacuation Lumen and the predicate device consist of the same fundamental technology.
The Well Lead Endotracheal Tubes with Evacuation Lumen differ from the predicate device K042683 in that it has a Evacuation Lumen for evacuation for drainage of the subglottic space.
The Well Lead Endotracheal Tubes with Evacuation Lumen differ from the predicate device K090352 in that the cuff is in different shape.
The Well Lead Endotracheal Tubes with Evacuation Lumen in clinical application will be identical to the use of predicate device K090352. None of the changes in any way affect the operation or usability of the tube or cuff.
Summary of Non-Clinical Data
The results from non - clinical data were provided for the Endotracheal Tubes with Evacuation lumen according to EN1782:1998 and ISO 5361-1:1999, in each of the tests the results fell within the required limits of the standard. The following testing was performed:
- Surface Finish Dimensions Testing (I.D, O,D Overall Length) Connector Testing Cuff Heniation Cuff Resting Diameter Tube Inflation Radius of curvature Angle of bevel Security of the construction of the evacuation lumen Shaft of the evacuation lumen
Traditional 510(k) for Well Lead Endotracheal Tubes with Evacuation Lumen
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and two snakes intertwined.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Well Lead Medical Company, Limited C/O Mr. John O'Brien Regulatory Affairs Specialist AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
AUG 2 6 2011
Re: K110269
Trade/Device Name: Well Lead Endotracheal Tube with Evacuation Lumen Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR, BSY Dated: August 4, 2011 Received: August 22, 2011
Dear Mr. O'Brien:
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.
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Page 2 - Mr. O'Brien
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. 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): K110269
Device Name: Well Lead Endotracheal Tube with Evacuation Lumen
Indications for use:
The device is intended for Oral intubation and drainage of the subglottic space for airway management.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Traditional 510(k) for Well Lead Endotracheal Tubes
510(k) Number: