The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.

AI/ML Overview

The provided document is a 510(k) summary for the Well Lead Tracheostomy Tubes, which was cleared in 2005. It describes the device, its intended use, and its equivalence to a predicate device.

However, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance through a clinical or performance study involving human readers or algorithmic standalone performance. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies for safety and effectiveness.

Here’s a breakdown of the information requested, based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO 5366-1 and ISO 5366-3)	Reported Device Performance
Conformance to ISO 5366-1 (Dimensions, Design, Material, Sterility, Packaging)	The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1.
Conformance to ISO 5366-3 (Dimensions, Design, Material, Sterility, Packaging)	The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-3.
Appropriate hardness of the tube	The tracheostomy tubes have such good performances as the tube with appropriate hardness.
Big capacity and low pressure cuff	The tracheostomy tubes have such good performances as the cuff with big capacity and low pressure.
Smooth tube	The tracheostomy tubes have such good performances as smooth tube.
Excellent biocompatibility	The tracheostomy tubes have such good performances as excellent biocompatibility.
Same dimensions and design as predicate device (Rusch Tracheofix Set)	The device has the same dimensions and design as the predicate device (Section 9 – not provided in the excerpt).

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of data. The performance claims are based on conformance to international standards (ISO 5366-1 and ISO 5366-3) and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. See above. Ground truth, in the context of clinical studies for AI/algorithms, is not relevant to this type of device submission which focuses on physical and material specifications.

4. Adjudication method for the test set

Not applicable / Not provided. See above.

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 / Not provided. This device is a physical medical instrument (tracheostomy tube), not an AI/software-as-a-medical-device (SaMD) that would assist human readers or perform diagnostic interpretations.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This device is a physical medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. For this type of device, "ground truth" would relate to its physical and material properties meeting specified engineering and biocompatibility standards rather than diagnostic accuracy. The provided text indicates conformance to ISO standards and biocompatibility.

8. The sample size for the training set

Not applicable / Not provided. This submission does not involve an AI algorithm with a training set.

9. How the ground truth for the training set was established

Not applicable / Not provided. This submission does not involve an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an engineering and materials conformance study against established international standards and comparison to a predicate device, rather than a clinical trial or an AI performance study.

The document states:
"The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3."
Additionally, claims are made about "good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility."
Finally, "The device has the same dimensions and design as the predicate device (Section 9)."

This implies that the manufacturer conducted internal testing and verification to ensure their device met the physical, material, and performance specifications outlined in the ISO standards and matched the predicate device’s characteristics. The FDA's 510(k) clearance is a determination of "substantial equivalence" based on this documentation, verifying that the new device is as safe and effective as a legally marketed predicate device.

Summary

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K0512684

FEB 1 7 2005

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	Well Lead Medical Instruments LtdJinhu Industrial Estate, Hualong, Panyu,Guangzhou City, China 511434
	Phone: +8620 84752978Fax: +8620 84758224
Contact Person:	Huan Guang Yuan, han@welllead.com.cn
Date of Summary:	October 1, 2004
Trade/Proprietary Name:	Well Lead Tracheostomy Tubes
Classification Name:	Tracheostomy Tube
Product Code:	BTO
Predicate Device:	Rusch Tracheofix Set, Cuffed and Uncuffed - K021764
Intended Use:	The device is a single patient disposable tracheostomytube for airway management of tracheostomotizedpatients.

Device Description:

Device Performance:

The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3.

Device Comparison: The device has the same dimensions and design as the predicate device (Section 9).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Public Health Service

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K042684

Trade/Device Name: Well Lead Tracheostomy Tube Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: January 3, 2005 Received: January 6, 2005

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your secure mined 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 merslate commerce priors that have been reclassified in accordance with the provisions of Amendinents, or to actrices and motic 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 provisions of an annual 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 classified (500 additional controls. Existing major regulations affecting (1 MA), it may of subject to tach of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsther announcements 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 I least that FDA has made a determination that your device complies with other requirements Incall that I DX mas made a actessiand regulations administered by other Federal agencies. of the Act of ally I oderal title Act sequirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), laceling (21 CFR Pat 820) regulation (21 CFR Part 820); and if requirents as sectionic product radiation 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) I mis letter will anow Jourse of Journalial equivalence of your device to a premairer notification and 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 and Compliance at (240) 276-0120. 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 maj obtain of Small 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,

Solita H. Michio 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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Indications for Use

K042684 510(k) Number (if known):

Device Name: Well Lead Tracheostomy Tubes

Indications for Use: The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.

Prescription Use (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)

liii Julion

Page 1 of 1

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042684

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.