(142 days)
The device is intended for oral or nasal intubation and for airway management.
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.
The provided text is a 510(k) summary for an Endotracheal Tube, seeking clearance from the FDA. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way a medical device performance study typically would. Instead, it relies on substantial equivalence to predicate devices.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by ISO Standard and Predicate Equivalence) | Reported Device Performance |
|---|---|
| Dimension (conformance with ISO 5361:1999(E)) | Conformed |
| Design (conformance with ISO 5361:1999(E)) | Conformed |
| Material (medical grade PVC, conformance with ISO 5361:1999(E)) | Conformed |
| Sterility (conformance with ISO 5361:1999(E)) | Conformed |
| Packaging (conformance with ISO 5361:1999(E)) | Conformed |
| General Purpose (oral or nasal intubation, airway management) | Met by Intended Use |
| Substantial Equivalence to specified predicate devices | Claimed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a formal performance study with a specific number of devices tested. The submission relies on conformance to an ISO standard and comparison to predicate devices, inferring that the design and manufacturing process meet these criteria. It doesn't detail a specific test sample size for an investigative study.
- Data Provenance: N/A for a specific test set. The submission itself is from China (Well Lead Medical Instruments Ltd, Guangzhou City, China). The basis for comparison is market-cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This device clearance is based on substantial equivalence to predicate devices and conformance to an international standard (ISO 5361:1999(E)), not on a clinical or performance study requiring expert ground truth establishment for a test set. The FDA's review and clearance process involves their own experts, but not in the context of establishing ground truth for a specific device efficacy or diagnostic accuracy study.
4. Adjudication method for the test set
- N/A. No specific test set requiring adjudication in this context.
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
- N/A. This is a physical medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- N/A. Not applicable for this type of device clearance. Instead of ground truth, the submission relies on:
8. The sample size for the training set
- N/A. Not applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established
- N/A. Not applicable. There is no AI training set for this physical device.
Summary based on the provided text:
The clearance for the Well Lead Endotracheal Tube (K042683) was based on demonstrating substantial equivalence to predicate devices and conformance to the ISO 5361:1999(E) standard for dimensions, design, material, sterility, and packaging. This is typical for Class II physical medical devices where a new clinical performance study is not required if the device is sufficiently similar to existing devices on the market. The text does not describe a clinical study with specific acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic or therapeutic device requiring de novo authorization or a PMA.
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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.
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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.
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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
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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 |
§ 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).