The tracheal tubes are disposable and are supplied sterile. The tracheal tubes are available in a number of sizes/variants. All variants are primarily made from polyvinyl chloride. The tracheal tube without cuff is composed of a tubular body and a standard connector, and the cuffed tube is composed of tubular body, cuff, oneway valve, pilot balloon, inflating tube and standard connector. All variants have a Murphy eye. As the device functions in airway management/gas transport for anesthesia or resuscitation, it is required to be flexible and resistant to kinking. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed.

AI/ML Overview

This document is a 510(k) Premarket Notification Submission for a Disposable Tracheal Tube. It outlines the device's indications for use, comparison to predicate devices, and performance data to support its substantial equivalence. The document is a regulatory submission filing and not a study report. Therefore, much of the requested information, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, and details about clinical or comparative effectiveness studies, is either not applicable or not provided in the scope of this regulatory submission.

Here's a breakdown of the information that can be extracted and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Reference)	Reported Device Performance (Testing Results)
Material Properties:
Biocompatibility (ISO 10993-1, FDA Blue Book Memo #G95-1)	Met requirements for:
- Cytotoxicity	- Cytotoxicity (Passed)
- Sensitization	- Sensitization (Passed)
- Irritation	- Irritation (Passed)
Functional/Performance:
Essential performance and safety requirements (ISO 5361:2012)	Met requirements of ISO 5361:2012
Continuous wave resistance of the shaft (ISO 11990-1:2011)	Met requirements of ISO 11990-1:2011
Kinking resistance (Shore hardness 88A)	Designed with Shore hardness 88A (Ensures effective intubation)
Radio-opacity (identification via X-ray)	Embedded radio-opaque line
Disposable and sterile	Supplied sterile

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

Sample Size: Not specified. The document only states that "testing results demonstrate that the proposed devices meet the requirements of the standards listed above" for performance and biocompatibility. This refers to laboratory testing, not a clinical test set with human subjects for performance evaluation.
Data Provenance: The device manufacturer, Suzhou Weikang Medical Apparatus Co., Ltd., is located in China. The testing would have been conducted by or for this manufacturer, likely in China or by accredited labs. The document does not specify the country of origin of the raw test data but implicitly it originates from the manufacturer's testing efforts. The testing is for premarket notification, implying developmental/verification testing, not necessarily a "retrospective or prospective" study in the clinical sense.

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

Not Applicable. For a medical device like a tracheal tube, "ground truth" is established by adherence to recognized international standards and bench testing protocols as specified (e.g., ISO 5361, ISO 11990-1, ISO 10993). There isn't a "ground truth" established by experts in the context of diagnostic accuracy, but rather by objective physical and biological tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where human interpretation is involved and consensus is needed for a "ground truth" label. For physical device performance and biocompatibility testing, the results are objectively measured against predefined standard criteria.

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 a disposable tracheal tube, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant to this product.

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

Not Applicable. As stated above, this is not an AI algorithm but a physical medical device. No standalone algorithm performance was evaluated.

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

Performance Standards and Biocompatibility Test Results: For this device, the "ground truth" is defined by the requirements outlined in international standards (ISO 5361:2012, ISO 11990-1:2011) for physical performance, and the results of specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation) conducted according to ISO 10993-1. These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not Applicable. As no training set is relevant for this device, no ground truth needed to be established for it.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2014

Suzhou Weikang Medical Apparatus Co., Ltd. c/o Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyum District Guangzhou, Guangdong 510420 CHINA

Re: K140228

Trade/Device Name: Disposable Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 12, 2014 Received: November 14, 2014

Dear Mr. Gu:

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. Gu

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image contains a logo with a stylized letter "W" in dark gray, surrounded by a green circle. To the right of the "W", there is Chinese text followed by the word "Weikang" in black, sans-serif font. The logo appears to represent a company or organization named "Weikang", possibly in the medical or healthcare field, given the Chinese characters present.

510(k) Premarket Notification Submission

510(k) Number (if known): K140228

Disposable Tracheal Tube Device Name:

Indications for Use:

Disposable tracheal tube is intended for oral or nasal intubation and for airway management.

Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use___ AND/OR (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)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: l. SUBMITTER

Suzhou Weikang Medical Apparatus Co., Ltd.

No.89 Wangmi Street, Suzhou New District, Suzhou, 215129, China

Tel: 0086-512-66627328

Fax: 0086-512-66650996

Primary Contact Person: Mike Gu

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6232 1333
	Fax: (+86) 20-8633 0253
Secondary Contact Person:	Wu Wenhe
	Quality Director
	Suzhou Weikang Medical Apparatus Co., Ltd.
Date Prepared:	21 January, 2014
II. DEVICE
Name of Device:	Disposable tracheal tube
Common/Usual Name:	Tracheal tube
Classification Names:	Tracheal tube, 21 CFR 868.5730
Regulation Class:	II
Product Code:	BTR
III. PREDICATE

DEVICE

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Traditional 510(k) Submission_ Disposable tracheal tube

Weikang is claiming substantial equivalence to the following medical devices:

Well Lead Endotracheal Tube – K042683

Well Lead Reinforced Endotracheal Tubes-K073383

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

. The tracheal tubes are disposable and are supplied sterile. The tracheal tubes are available in a number of sizes/variants. All variants are primarily made from polyvinyl chloride. The tracheal tube without cuff is composed of a tubular body and a standard connector, and the cuffed tube is composed of tubular body, cuff, oneway valve, pilot balloon, inflating tube and standard connector. All variants have a Murphy eye. As the device functions in airway management/gas transport for anesthesia or resuscitation, it is required to be flexible and resistant to kinking. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed.

V. INDICATIONS FOR USE

Disposable tracheal tube is intended for oral or nasal intubation and for airway management.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The disposable tracheal tubes are made from biocompatible, non-toxic polyvinyl chloride material. The lumen is embedded with radio-opaque line to assist locating the device when the patient is X-ray viewed. The tracheal tube is designed with a Shore hardness of 88A to resist kinking and to ensure effective intubation.

The disposable tracheal tubes employ the same technology as its predicate devices Well Lead Endotracheal Tube (K042683) and Well Lead Reinforced Endotracheal Tubes (K073383).

The following technological differences exist between the subject and predicate devices:

Size of tracheal tubes used for airway management.
Same material but similar hardness degree;

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Traditional 510(k) Submission_ Disposable tracheal tube

Though these technological elements are slightly different, both the subject and predicate device meet the requirements of ISO 5361:2012 Standard.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Performance testing:

Essential performance and safety requirements and continuous wave resistance of the shaft of the tube are evaluated according to the following standard respectively:

. ISO 5361:2012
ISO 11990-1: 2011 ●

The testing results demonstrate that the proposed devices meet the requirements of the standards listed above.

Biocompatibility testing:

The biocompatibility evaluation for the disposable tracheal tubes was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
. Sensitization
. Irritation

The probe is considered as external communicating device in contact with tissue with cumulative contact up to 24 hours.

Animal and clinical study

The subject of this premarket submission, disposable tracheal tubes, does not require clinical

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Traditional 510(k) Submission_ Disposable tracheal tube

studies to support substantial equivalence.

CONCLUSIONS VIII.

The non-clinical data support the safety of the device and the performance testing results demonstrate that the disposable tracheal tubes should perform as intended in the specified use conditions. Suzhou Weikang Medical Apparatus Co., Ltd considers the disposable tracheal tubes do not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 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).