(211 days)
The device is intended for Oral intubation and drainage of the subglottic space for airway management.
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.
The provided text describes a 510(k) submission for a medical device, the "Well Lead Endotracheal Tube with Evacuation Lumen," and its substantial equivalence to predicate devices. However, this submission does not contain the kind of detailed study information (like a comparative effectiveness study with human readers, specific performance metrics, ground truth establishment, or sample sizes for training/test sets) that would be relevant for an AI/ML powered device.
The study described is a non-clinical performance evaluation against established standards for endotracheal tubes. Therefore, I cannot fully complete the requested table and information, as much of it pertains to AI/ML device evaluations which are not present in this document.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with EN1782:1998 | Results fell within required limits of the standard |
| Compliance with ISO 5361-1:1999 | Results fell within required limits of the standard |
| Surface Finish Dimensions Testing (I.D, O.D, Overall Length) | Results fell within required limits of the standard |
| Connector Testing | Results fell within required limits of the standard |
| Cuff Herniation | Results fell within required limits of the standard |
| Cuff Resting Diameter | Results fell within required limits of the standard |
| Tube Inflation | Results fell within required limits of the standard |
| Radius of curvature | Results fell within required limits of the standard |
| Angle of bevel | Results fell within required limits of the standard |
| Security of the construction of the evacuation lumen | Results fell within required limits of the standard |
| Shaft of the evacuation lumen | Results fell within required limits of the standard |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This was a non-clinical performance test against engineering standards, not a study involving patient data or a "test set" in the AI/ML context. The submission doesn't specify the number of devices tested for each parameter.
- Data Provenance: Not applicable in the context of patient data. The non-clinical tests were conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of non-clinical device testing, which focuses on adherence to engineering standards.
4. Adjudication method for the test set
- Not applicable. There was no need for adjudication as the testing involved objective measurements against established standard limits.
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
- No, a MRMC comparative effectiveness study was not done. This device is an endotracheal tube, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- The "ground truth" for this submission was the established engineering and performance specifications defined by the EN1782:1998 and ISO 5361-1:1999 standards for endotracheal tubes. The device's physical and functional characteristics were measured and compared against these predefined limits.
8. The sample size for the training set
- Not applicable. There is no AI/ML component, so no training set was used.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML component, so no training set or its ground truth establishment is relevant.
Summary of the study that proves the device meets the acceptance criteria:
The study was a series of non-clinical performance tests conducted on the Well Lead Endotracheal Tube with Evacuation Lumen. These tests evaluated various physical and functional attributes of the device, such as surface finish, dimensions, connector integrity, cuff characteristics (herniation, resting diameter, inflation), tube curvature, bevel angle, and the security of the evacuation lumen construction.
The device was tested according to EN1782:1998 and ISO 5361-1:1999 standards. The results of all these tests reportedly fell within the required limits of the respective standards, thereby demonstrating the device's compliance and substantial equivalence to legally marketed predicate devices. This type of testing is standard for demonstrating the safety and performance of medical devices like endotracheal tubes, which are subject to specific material and functional requirements.
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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
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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
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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
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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:
§ 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).