(171 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard medical device (endobronchial tube) and does not mention any AI/ML capabilities or related performance metrics.
No
The device is used to isolate a lung for surgical procedures (ventilation or anesthesia) rather than to treat a disease or condition.
No
The device, an endobronchial tube, is used to isolate a lung for surgical procedures, ventilation, or anesthesia, which are therapeutic or supportive actions, not diagnostic.
No
The device description clearly states it is a physical tube made of Polyvinylchloride with cuffs and connectors, indicating it is a hardware device.
No, 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. These tests are performed outside of the body.
- Well Lead Endobronchial Tube Function: The Well Lead Endobronchial Tube is a device that is inserted into the patient's body (specifically, the airway) to physically isolate and ventilate a lung during surgery or anesthesia. It is a therapeutic and procedural device, not a diagnostic test performed on a sample.
The description clearly states its use is for "isolating the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia." This is a direct intervention on the patient's body, not a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The Well Lead Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Product codes
CBI
Device Description
The Well Lead Endobronchial Tube is made of Polyvinylchloride and is available in sizes 28fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
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
All testing that is required by the required standards has been performed. None clinical testing was performed and included standards such as ISO 5361, ISO 16628 and ISO 10993-1. The Well Lead Medical Instruments Endobronchial Tubes have been found to fall within the required limits of the testing. The test results can be found in both the Biocompatibility Testing (Section 13) and the Performance Testing (Section 14) of this submission.
The Well Lead Medical Instruments Endobronchial Tubes have been found to fall within the required limits of the testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY (as required by 807.92(c))
MAR 1 1 2010
!
| Regulatory Correspondent: | Regulatory and Marketing Services Inc
962 Allegro Lane
Apollo Beach, FL 33572
Arthur Ward
award@ajwtech.com/awconsltng@aol.com
813-645-2855
813-677-4787 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Well LEAD Medical Device Instruments Ltd.
A4-1# Jinhu Industrial Estate
Hualong, Panyu
Guangzhou City, China 511434
Han Guang Yuan
info@welllead.com.cn |
| Date of Summary: | 3/11/2010 |
| Trade/Proprietary Name: | Well LEAD Endobronchial Tubes |
| Classification Name: | Endobronchial Tubes |
| Product Code: | CBI |
| Intended Use: | The Well Lead Endobronchial Tube is used to
isolate the left or right lung of a patient for surgery,
one lung ventilation or one lung anesthesia. |
| Device Description: | The Well Lead Endobronchial Tube is made of
Polyvinylchloride and is available in sizes 28fr to
41fr. They are designated as double lumen tube
with 2 cuffs and separate 15mm connectors for
isolating and ventilating one lung during surgical
procedures. The tubes contain an x-ray opaque line
that runs through the tube making them detectable
by x-ray. |
| Predicate Device: | K771219 - Mallinckrodt Bronch-Cath
K051522 - Fuji Double Lumen Bronch Tube |
1
Substantial Equivalence:
Well Lead Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K771219. Well Lead Medical Instruments claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 10 of this submission. These differences have no effect on safety and effectiveness.
All testing that is required by the required standards has been performed. None clinical testing was performed and included standards such as ISO 5361, ISO 16628 and ISO 10993-1. The Well Lead Medical Instruments Endobronchial Tubes have been found to fall within the required limits of the testing. The test results can be found in both the Biocompatibility Testing (Section 13) and the Performance Testing (Section 14) of this submission. Therefore we have concluded that the Well Lead Endobronchial Tubes are substantially equivalent.
Performance Testing:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Well LEAD Medical Device Instruments Limited C/O Dr. Arthur J. Ward Regulatory Correspondent Regulatory and Marketing Services, Incorporated 962 Allergo Lane Apollo Beach, Florida 33572
MAR 1 1 2010
Re: K092886
Trade/Device Name: Well Lead Endobronchial Tubes Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: March 3, 2010 Received: March 9, 2010
Dear Dr. Ward:
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.
3
Page 2 - Dr. Ward
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,
h fo
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): 16992886
Device Name: Well Lead Endobronchial Tubes
The Well Lead Endobronchial Tube is used to isolate the left or the Indications for Use: right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
L. Schurlotterno
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092886
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Well Lead Medical Traditional 510k Endobronchial Tubes
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