(171 days)
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.
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.
The document provided is a 510(k) summary for the Well LEAD Endobronchial Tubes. It highlights the substantial equivalence of the device to previously cleared devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria through clinical performance.
Based on the provided text, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
The document states: "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."
This indicates that the acceptance criteria are defined by the required limits set forth in the referenced ISO standards. However, the specific quantitative acceptance criteria (e.g., maximum leak rate, specific material strength values) and the exact performance metrics achieved are not provided in the summary. The summary only gives a general statement that the device met these "required limits."
Therefore, a table with specific acceptance criteria and reported device performance cannot be fully constructed from the provided text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document explicitly states: "None clinical testing was performed."
- Sample size for test set: Not applicable, as no clinical testing was performed.
- Data provenance: Not applicable, as no clinical testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as no clinical testing with ground truth establishment was performed. The evaluation relied on non-clinical performance and biocompatibility testing against established standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical testing requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an endobronchial tube, not an AI-assisted diagnostic device, and no MRMC study was mentioned or required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm, and the evaluation was based on non-clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for non-clinical testing would be the defined acceptable ranges and properties within the referenced ISO standards.
8. The sample size for the training set:
Not applicable, as no machine learning or AI component is described.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning or AI component is described.
Summary of what can be inferred about acceptance criteria and "study" from the provided text:
The "study" that proves the device meets acceptance criteria consists of non-clinical performance testing and biocompatibility testing against recognized international standards.
- Acceptance Criteria Source: ISO 5361 (Anesthetic and respiratory equipment - Tracheal tubes and connectors), ISO 16628 (Tracheal tubes and other connection devices - Cuffs - Test methods for resistance to pressure and deflation), and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
- Device Performance: The Well Lead Medical Instruments Endobronchial Tubes were found to "fall within the required limits of the testing." This is a qualitative statement indicating compliance.
- Type of Study: Non-clinical (bench testing) and biocompatibility testing.
- Clinical Data: Explicitly stated as "None clinical testing was performed."
- Basis for Equivalence: Substantial equivalence was claimed based on equivalent intended use, manufacturing materials, operating principles, and physical operational specifications compared to predicate devices (K771219 - Mallinckrodt Bronch-Cath and K051522 - Fuji Double Lumen Bron Tube).
In essence, for this specific device, the FDA cleared it based on demonstrating adherence to established non-clinical performance standards and substantial equivalence to existing devices, without requiring human clinical trials or AI-related performance studies.
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510(k) SUMMARY (as required by 807.92(c))
MAR 1 1 2010
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| Regulatory Correspondent: | Regulatory and Marketing Services Inc962 Allegro LaneApollo Beach, FL 33572Arthur Wardaward@ajwtech.com/awconsltng@aol.com813-645-2855813-677-4787 |
|---|---|
| Submitter of 510(k): | Well LEAD Medical Device Instruments Ltd.A4-1# Jinhu Industrial EstateHualong, PanyuGuangzhou City, China 511434Han Guang Yuaninfo@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 toisolate 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 ofPolyvinylchloride and is available in sizes 28fr to41fr. They are designated as double lumen tubewith 2 cuffs and separate 15mm connectors forisolating and ventilating one lung during surgicalprocedures. The tubes contain an x-ray opaque linethat runs through the tube making them detectableby x-ray. |
| Predicate Device: | K771219 - Mallinckrodt Bronch-CathK051522 - Fuji Double Lumen Bronch Tube |
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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:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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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§ 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).