(214 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the endotracheal tube, with no mention of AI or ML capabilities. The radiopaque line is a passive feature for visualization, not an AI/ML-driven analysis.
No.
A therapeutic device is one that treats a disease or condition. This device is used for airway management and intubation, which are supportive functions, not treatment of a disease itself.
No
The device is an endotracheal tube used for airway management and intubation. While a radiopaque line aids in confirming placement, its primary function is therapeutic (to convey gases) rather than diagnostic (identifying a medical condition or disease).
No
The device description clearly outlines a physical, sterile, single-use endotracheal tube made of medical-grade PVC with various physical components (tube shaft, cuff, inflation line, etc.). This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Yikang endotracheal tube is a medical device used for airway management by being inserted into the trachea. It facilitates breathing and ventilation.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is mechanical and related to maintaining an open airway.
- Intended Use: The intended use is for "oral or nasal intubation and for airway management," which is a direct intervention on the patient's body, not an analysis of a sample.
While the device uses a radiopaque line for placement verification via X-rays, this is a feature for imaging guidance, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The device is intended for oral or nasal intubation and for airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
Yikang endotracheal tube is a device intended for oral or nasal intubation and for airway management. It is a sterile and single use device, it is made from medical grade PVC. The Yikang endotracheal tube has cuffed and uncuffed, and is available in size I.D. 2.0mm through I.D. 10.0mm, and has a Murphy eye. It basically consists of tube shaft, cuff, inflation line, pilot balloon, one-way valve, and a male 15mm conical connector. A radiopaque line is incorporated into the full length of the tracheal tube.
When used tracheal tube is inserted through the trachea to convey gases to and from the trachea. Cuffed tracheal tube is intended to seal and protect aspiration of secretions, and to provide an unobstructed airway in patients during ventilation. A radiopaque line helps to determine proper placement of the tracheal tube with the characterization of visibility of tracheal tube in X-rays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Size I.D. 2.0mm through 4.5mm are intended for pediatric use (12 years old to less than 21years old), Size I.D. 5.0mm through 10.0mm are intended for adult use.
Intended User / Care Setting
Not Found
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 have been conducted on YiKang Endotracheal Tube per ISO5361: 2016, and all the testing results meet requirements of ISO5361: 2016 and defined acceptance criteria. Detailed testing conducted as follows:
- Cuff diameter
- Cuff herniation
- Cuff leakage
- Tube collapse
- Kink resistance
- Tracheal seal
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Jiangxi Yikang Medical Instrument Group Co., Ltd Nicholas Su Regulatory Affairs Specialist 188 Aihua Road, Jinxian County Nanchang, 331725 Cn
Re: K190213
Trade/Device Name: Yikang Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: August 2, 2019 Received: August 12, 2019
Dear Nicholas Su:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190213
Device Name Yikang Endotracheal Tube
| Indications for Use (Describe) | The device is intended for oral or nasal intubation and for airway management. |
|---|---|
| -------------------------------- | -------------------------------------------------------------------------------- |
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows a circular emblem with two distinct symbols inside. The symbol on the left resembles a stylized depiction of a plant or a cluster of leaves, while the symbol on the right appears to be a character from a non-Latin alphabet, possibly Chinese or Japanese. The emblem is rendered in black against a white background, giving it a clear and contrasting appearance.
No.188 LiduAihua Ave.. Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
510(k) Summary
(as requested by 21 CFR 807.92) K190213
| Submitter of 510(k): | Jiangxi Yikang Medical Instrument Group Co., Ltd |
|---|---|
| Address: | 188 Aihua Road,Jinxian County, Nanchang, Jiangxi, |
| China 331725 | |
| Phone: | +86 791 8563 2226 |
| Fax: | +86 791 8563 2226 |
Contact Person: Nicholas Su Regulatory Affairs Specialist E-mail: andy_smith@yeah.net
Date of summary: January 29, 2019
Proposed device:
| Trade Name: | Yikang Endotracheal Tube |
|---|---|
| Common Name: | Endotracheal Tube |
| Classification Name: | Tracheal tube |
| Product Code: | BTR |
| Panel: | 73(Anesthesiology) |
| Classification: | Class II |
| Regulation Number: | 868.5730 |
Legally Marketed Predicate Device:
| Trade Name: | Well Lead Endotracheal Tube |
|---|---|
| 510(k) Number: | K042683 |
| Submitter of 510(k)/holder: | Well lead Medical Instruments Ltd. |
Device Description:
Yikang endotracheal tube is a device intended for oral or nasal intubation and for airway management. It is a sterile and single use device, it is made from medical grade PVC. The Yikang endotracheal tube has cuffed and uncuffed, and is available in size I.D. 2.0mm through I.D. 10.0mm, and has a Murphy eye. It basically consists of tube shaft, cuff, inflation line, pilot balloon, one-way valve, and a male 15mm conical connector. A radiopaque line is incorporated into the full length of the tracheal tube.
When used tracheal tube is inserted through the trachea to convey gases to and from the trachea. Cuffed tracheal tube is intended to seal and protect aspiration of secretions, and to provide an unobstructed airway in patients during ventilation. A radiopaque line helps to
4
Image /page/4/Picture/0 description: The image shows a circular emblem that is divided into two halves. The left half contains a symbol that resembles a stylized plant or flower with three distinct sections at the top. The right half features a more complex symbol that appears to be a stylized character, possibly Chinese or Japanese, with vertical and horizontal strokes forming a grid-like structure. The emblem is presented in black and white, with the symbols standing out against the background.
No.188 LiduAihua Ave., Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
Comparison
Same
Same
Same
Similar
determine proper placement of the tracheal tube with the characterization of visibility of tracheal tube in X-rays.
Size I.D. 2.0mm through 4.5mm are intended for pediatric use (12 years old to less than 21years old), Size I.D. 5.0mm through 10.0mm are intended for adult use.
Intended Use:
The device is intended for oral or nasal intubation and for airway management.
Device Performance:
Testing results indicated that the product meets specified performance requirements, and complied with ISO5361:2016.
Comparison of Technological Characteristics:
Yikanq's endotracheal tube has the same technological characteristics as the predicate device. The design, material, form, fit, function and method of operation are similar.
| Substantial Equivalence | ||
|---|---|---|
| Element of | ||
| Comparison | Submission Device | Predicate Device |
| K042683 | ||
| Intended Use | The device is intended for | |
| oral or nasal intubation and | ||
| for airway management. | The device is intended for oral | |
| or nasal intubation and for | ||
| airway management. | ||
| Principle of | ||
| Operation | Normal | Normal |
| Type | Oral/nasal cuffed, Oral/nasal | |
| uncuffed, Nasal cuffed, Nasal | ||
| uncuffed, Oral cuffed, Oral | ||
| uncuffed. | Oral/nasal cuffed, Oral/nasal | |
| uncuffed, Nasal cuffed, Nasal | ||
| uncuffed, Oral cuffed, Oral | ||
| uncuffed. | ||
| Size | Oral/nasal cuffed (I.D 2.0-10.0) | Oral/nasal cuffed (I.D 5.0-10.0) |
| Oral/nasal uncuffed (I.D 2.0-10.0) | Oral/nasal uncuffed (I.D 2.0-10.0) | |
| Nasal cuffed (I.D 3.0-10.0) | Nasal cuffed (I.D 5.0-10.0) | |
| Nasal uncuffed (I.D 3.0-10.0) | Nasal uncuffed (I.D 2.0-10.0) | |
| Oral cuffed (I.D 3.0-10.0) | Oral cuffed (I.D 5.0-10.0) |
Substantial Equivalence
| Oral/nasal uncuffed (I.D 2.0-10.0) | Oral/nasal uncuffed (I.D 2.0-10.0) | Same | ||
|---|---|---|---|---|
| Nasal cuffed (I.D 3.0-10.0) | Nasal cuffed (I.D 5.0-10.0) | Similar | ||
| Nasal uncuffed (I.D 3.0-10.0) | Nasal uncuffed (I.D 2.0-10.0) | Similar | ||
| Oral cuffed (I.D 3.0-10.0) | Oral cuffed (I.D 5.0-10.0) | Similar | ||
| Oral uncuffed (I.D 3.0-10.0) | Oral uncuffed (I.D 2.0-10.0) | Similar | ||
| Tube | I.D | Oral/nasal cuffed ±5mm | Oral/nasal cuffed ±3mm | / |
| Length | 2.0 | 170 | / | Meet |
| 2.5 | 170 | / | requirements | |
| 3.0 | 190 | / | of | |
| 3.5 | 215 | / | ISO5361:2016 | |
| 4.0 | 215 | / | / | |
| 4.5 | 240 | / | / | |
| 5.0 | 265 | 245 | Similar, and | |
| 5.5 | 275 | 275 | meet | |
| 6.0 | 285 | 285 | requirements | |
| 6.5 | 305 | 295 | of | |
| 7.0 | 310 | 310 | ISO5361:2016. | |
| 7.5 | 315 | 315 | ||
| 8.0 | 330 | 330 | ||
| 8.5 | 330 | 330 | ||
| 9.0 | 330 | 330 | ||
| 9.5 | 330 | 330 | ||
| 10.0 | 330 | 330 | ||
| I.D | Oral/nasal uncuffed±5mm | Oral/nasal uncuffed ±3mm | / | |
| 2.0 | 170 | 140 | Similar, and | |
| 2.5 | 170 | 145 | meet | |
| 3.0 | 190 | 165 | requirements | |
| 3.5 | 215 | 185 | of | |
| 4.0 | 215 | 210 | ISO5361:2016. | |
| 4.5 | 240 | 225 | ||
| 5.0 | 265 | 245 | ||
| 5.5 | 275 | 275 | ||
| 6.0 | 285 | 285 | ||
| 6.5 | 305 | 295 | ||
| 7.0 | 310 | 310 | ||
| 7.5 | 315 | 315 | ||
| 8.0 | 330 | 330 | ||
| 8.5 | 330 | 330 | ||
| 9.0 | 330 | 330 | ||
| 9.5 | 330 | 330 | ||
| 10.0 | 330 | 330 | ||
| I.D | Nasal cuffed, ±5mm | Nasal cuffed, ±3mm | / | |
| 2.0 | / | / | / | |
| 2.5 | / | / | / | |
| 3.0 | 290 | / | Meet | |
| 3.5 | 290 | / | requirements | |
| 4.0 | 310 | / | of | |
| 4.5 | 310 | / | ISO5361:2016. | |
| 5.0 | 330 | 330 | Similar, and | |
| meet | ||||
| requirements | ||||
| of | ||||
| ISO5361:2016. | ||||
| 5.5 | 330 | 330 | ||
| 6.0 | 360 | 360 | ||
| 6.5 | 360 | 360 | ||
| 7.0 | 380 | 380 | ||
| 7.5 | 380 | 380 | ||
| 8.0 | 390 | 390 | ||
| 8.5 | 390 | 390 | ||
| 9.0 | 400 | 400 | ||
| 9.5 | 400 | 400 | ||
| 10.0 | 400 | 400 | ||
| I.D | Nasal uncuffed, ±5mm | Nasal uncuffed, ±3mm | / | |
| 2.0 | / | 140 | / | |
| 2.5 | / | 145 | / | |
| 3.0 | 190 | 165 | Similar, and | |
| meet | ||||
| requirements | ||||
| 3.5 | 215 | 185 | ||
| 4.0 | 215 | 210 | requirements | |
| of | ||||
| ISO5361:2016. | ||||
| 4.5 | 240 | 225 | ||
| 5.0 | 265 | 245 | ||
| 5.5 | 275 | 275 | ||
| 6.0 | 285 | 285 | ||
| 6.5 | 305 | 295 | ||
| 7.0 | 310 | 310 | ||
| 7.5 | 315 | 315 | ||
| 8.0 | 330 | 330 | ||
| 8.5 | 330 | 330 | ||
| 9.0 | 330 | 330 | ||
| 9.5 | 330 | 330 | ||
| 10.0 | 330 | 330 | ||
| I.D | Oral cuffed, ±5mm | Oral cuffed, ±3mm | / | |
| 2.0 | / | / | / | |
| 2.5 | / | / | / | |
| 3.0 | 170 | / | Meet | |
| 3.5 | 180 | / | requirements | |
| 4.0 | 190 | / | of | |
| 4.5 | 215 | / | ISO5361:2016. | |
| 5.0 | 225 | 230 | Similar, and | |
| 5.5 | 240 | 245 | meet | |
| 6.0 | 255 | 255 | requirements | |
| 6.5 | 265 | 265 | of | |
| 7.0 | 290 | 295 | ISO5361:2016. | |
| 7.5 | 310 | 300 | ||
| 8.0 | 325 | 310 | ||
| 8.5 | 335 | 320 | ||
| 9.0 | 350 | 335 | ||
| 9.5 | 350 | 350 | ||
| 10.0 | 350 | 350 | ||
| I.D | Oral uncuffed, ±5mm | Oral uncuffed, ±3mm | / | |
| 2.0 | / | 125 | / | |
| 2.5 | / | 135 | / | |
| 3.0 | 170 | 155 | Similar, and | |
| 3.5 | 180 | 175 | meet | |
| 4.0 | 190 | 200 | requirements | |
| 4.5 | 215 | 215 | of | |
| 5.0 | 225 | 230 | ISO5361:2016. | |
| 5.5 | 240 | 245 | ||
| 6.0 | 255 | 255 | ||
| 6.5 | 265 | 265 | ||
| 7.0 | 290 | 295 | ||
| 7.5 | 310 | 300 | ||
| 8.0 | 325 | 310 | ||
| 8.5 | 335 | 320 | ||
| 9.0 | 350 | 335 | ||
| 9.5 | 350 | 350 | ||
| 10.0 | 350 | 350 | ||
| Material | PVC | PVC | Same | |
| Performance | Conforms to ISO5361 | Conforms to ISO5361 | Same | |
| Biocompatibility | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Same | |
| Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 | Same | |
| Sterility | Sterile, SAL: 1X10-6 ETO Sterilization | Sterile, SAL: 1X10-6 ETO Sterilization | Same | |
| Single use | Yes | Yes | Same |
5
Image /page/5/Picture/0 description: The image shows a circular emblem with two distinct halves. The left half contains a character that appears to be composed of stacked, box-like shapes, while the right half features a more complex character with vertical and angled strokes. The emblem is primarily black against a white background, and the characters are stylized and possibly symbolic.
No.188 LiduAihua Ave., Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
6
Image /page/6/Picture/0 description: The image shows a circular emblem with Chinese characters inside. The emblem is divided into two halves, with each half containing a different character. The characters are written in a traditional style, and the emblem has a simple, clean design. The emblem is black and white.
No.188 LiduAihua Ave., Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
7
Image /page/7/Picture/0 description: The image shows a circular emblem with two distinct symbols within it. The symbol on the left appears to be composed of vertical lines and a curved shape at the top, while the symbol on the right features a more complex structure with both vertical and horizontal lines. The emblem is enclosed by a thick, dark border, and the symbols inside are also dark, creating a strong contrast against the lighter background.
No.188 LiduAihua Ave., Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
Discussion of Similarities and Differences
As indicated by above comparison table our Yikang Endotracheal Tube has same intended use, and similar design, material, technical characteristics, principle of operation and performance as predicate device, Well Lead Endotracheal Tube under K042683.
8
Image /page/8/Picture/0 description: The image shows a circular emblem with two distinct calligraphic characters. The emblem is divided vertically, with one character on each side. The characters are stylized and appear to be of East Asian origin, possibly Chinese or Japanese. The emblem has a traditional and symbolic feel.
No.188 LiduAihua Ave.. Jinxian County, Nanchang, Jiangxi, China 331725 Tel: +86-791-85632226 Fax: +86-791-85632226
The additional size endotracheal tubes (oral/nasal cuffed (I.D2.0-4.5), nasal cuffed(I.D 3.0-4.5), and oral cuffed (I.D 3.0-4.5)) of propose device when compared to predicate device all complied with the requirements specified by ISO5361: 2016, compliance testing indicated in section 18: performance testing of this submission. The tube length of the proposed device for every type and size was similar as the predicate device, and it met the tube length requirements specified by ISO5361: 2016. Therefore, the differences between our proposed device and legally market predicate device (additional size and tube length) did not raise different questions of safety or effectiveness.
Based on the comparison of intended use, design, material, operation principle, and performance, our YiKang Endotracheal Tube is substantial equivalent to its predicate device which approved by FDA under K042683.
Summary of Performance testing
Performance testing have been conducted on YiKang Endotracheal Tube per ISO5361: 2016, and all the testing results meet requirements of ISO5361: 2016 and defined acceptance criteria. Detailed testing conducted as follows:
- Cuff diameter ●
- Cuff herniation
- Cuff leakage ●
- Tube collapse
- Kink resistance
- Tracheal seal ●
Biocompatibility
The YiKang Endotracheal Tube passed biocompatibility testing of cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, and implantation per ISO10993-1.
Conclusion
Based on the information included in this premarket notification submission, and in accordance with 21 CFR Part 807 (E), Jianqxi Yikang Medical Instrument Group Co., LTD. concludes that the YiKang Endotracheal Tube is substantially equivalent to the predicate device cleared under K042683 without raising different questions of safety and effectiveness.