(322 days)
No reference devices were used in this submission.
No
The summary describes a standard medical device (tracheal tube) and its physical properties and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for "airway management," which is a therapeutic intervention.
No
The disposable tracheal tube is intended for airway management and gas transport, not for diagnosing medical conditions. While it has a radio-opaque line for X-ray identification, this is for device placement confirmation, not for diagnosing disease.
No
The device description clearly states it is a physical tracheal tube made from polyvinyl chloride with various components like a cuff, valve, and pilot balloon. It also mentions a radio-opaque line for X-ray identification, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral or nasal intubation and for airway management." This is a direct intervention on the patient's airway for gas transport, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical device used for intubation and airway management. It does not describe reagents, instruments, or systems intended for use in vitro.
- Function: The device functions in "airway management/gas transport." This is a therapeutic or supportive function, not a diagnostic one.
- Testing: The performance testing focuses on physical properties (resistance, flexibility) and biocompatibility, which are relevant for a device that comes into contact with the body, not for an IVD.
- Predicate Devices: The predicate devices listed are also tracheal tubes, which are not IVDs.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to gain information about a patient's health status. This tracheal tube is a medical device used directly on the patient for a physiological function (airway management).
N/A
Intended Use / Indications for Use
Disposable tracheal tube is intended for oral or nasal intubation and for airway management.
Product codes
BTR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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)
3
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
4
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;
5
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
6
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.