(428 days)
Not Found
No
The summary describes a physical medical device for airway management and monitoring, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing "active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV)" and a "main oxygen supply channel," indicating its use in managing airway and supplying oxygen for therapeutic purposes in respiratory distress.
Yes
The device description states, "It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube." Monitoring PetCO2 is a diagnostic function.
No
The device description and performance studies clearly indicate a physical medical device (nasal tube) with hardware components and associated testing (biocompatibility, sterilization, mechanical properties, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for airway management, supplying jet ventilation, providing oxygen, and monitoring CO2 status. These are all related to managing a patient's respiratory system directly.
- Device Description: The description reinforces its function as a nasopharyngeal airway for ventilation, oxygen supply, and CO2 monitoring.
- Lack of In Vitro Testing: The description of performance studies focuses on non-clinical tests related to the device's physical properties, biocompatibility, sterilization, and shelf-life. There is no mention of testing biological samples (blood, urine, tissue, etc.) to diagnose or monitor a disease or condition.
- Function: The device is used in vivo (within the patient's body) for direct physiological support and monitoring, not for analyzing samples in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
Product codes
BTR
Device Description
Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription Use
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISTA 2A, ASTM F1886 / F1886M-16, ASTM F88/F88M-15, ASTM F1929-15, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-6: 2016, ISO 10993-3:2014, ISO 10993-7:2008, USP , ISO 80369-7:2016, ISO 5356-1: 2015, ASTM F1573-95 (2000), ISO 18562-1:2017, ISO 18562-2:2017, ISO 18562-3:2017, ISO 10993-17:2002.
Connecter testing (ISO 5356-1:2015, ISO 80369-7:2016, ISO 80369-20:2015) were performed and conform to requirements.
Comparative tests for length, diameter, bevel angle, curvature, kink resistance and connectors were performed on the proposed device and predicate device. All results met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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.
July 21, 2022
Well Lead Medical Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K211543
Trade/Device Name: Wei Nasal Jet Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: June 20, 2022 Received: June 22, 2022
Dear Diana Hong:
We have reviewed vour 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
1
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 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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211543
Device Name Wei Nasal Jet Tube
WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211543
-
- Date of Preparation: 06/20/2022
-
- Sponsor Identification
Well Lead Medical Co., LTD.
C-4 Jinhu Industrial Estate Hualong, 511434 Panyu, Guangzhou, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3003903031
Contact Person: Jenny Zhu Position: RA Supervisor Tel: +86 20 84758878-8029 Email: jenny zhu@welllead.com.cn
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Wei Nasal Jet Tube Common Name: Nasopharyngeal airway
Regulatory Information
Classification Name: Tracheal Tube: Classification: II; Product Code: BTR Regulation Number: 21 CFR 868.5730; Review Panel: Anesthesiology;
Indication for Use:
WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
Device Description:
Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.
- Identification of Predicate Device
510 (k) Number: K040657 Product Name: Boussignac/ Vygon Endotracheal Tribe
5
6. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Regulation | |||
| No. | 21 CFR 868.5730 | 21 CFR 868.5730 | Same |
| Product Code | BTR | BTR | Same |
| Class | II | II | Same |
| Indication for | |||
| Use | WEI nasal jet tube is indication for | ||
| airway management, inserted | |||
| through nasal cavity. During and | |||
| after insertion, the Jet Tube can | |||
| supply jet ventilation intermittently. | |||
| When the Jet tube is not in use, the | |||
| main tube serves as the main oxygen | |||
| supply channel, and oxygen is | |||
| supplied through main tube. The | |||
| PetCO2 Monitor tube can connect to | |||
| CO2 monitoring machine to monitor | |||
| CO2 status. | The Bousxignac/iygon Endotracheal | ||
| Tube is indicated for airway | |||
| management. The insufflation canals | |||
| permit the delivery of intermittent jet | |||
| ventilation and the administration of | |||
| oxygen during tracheobronchial | |||
| suctioning procedures. They also | |||
| provide a supplemental means for | |||
| administering oxygen during | |||
| bronchoscopies. In these ventilatory | |||
| modes, the main lumen serves as a | |||
| channel for the elimination of expired | |||
| gases. When the insufflation port is | |||
| capped, the Boussignac/Vygon | |||
| Endotracheal Tube can function as a | |||
| standard tracheal tube with ventilation | |||
| occurring through the main lumen. The | |||
| Boussignac/iygon Endotracheal Tube is | |||
| intended for oral/nasal intubation. | |||
| The monitoring/irrigation lumens may | |||
| be used for monitoring airway pressure, | |||
| for irrigation of a patient's | |||
| tracheobronchial tree, to aid in the | |||
| removal of accumulated secretions, for | |||
| sampling tracheal gases, for | |||
| anesthetizing the trachea, or for | |||
| introducing suitable medication in | |||
| accordance with standard medical | |||
| practices. | Similar |
6
| PetCO2 Monitor Tube | Insufflation Access | ||
|---|---|---|---|
| Luer | Connecting Tube for | ||
| Cap of PetCO2 Monitor Tube | Monitoring/Irrigation Lumen | ||
| Cap of Jet Tube | Pilot Balloon | ||
| Connect | Valve for Cuff Inflation | ||
| Jet Tube | Cuff | ||
| 15 mm Connector | Beveled Tip | ||
| Size (mm) | I.D. 5.0, 6.0, 7.0 mm | Adult, Cuffed: I.D. 7.0, 7.5, 8.0 mm | |
| Pediatric, Uncuffed: I.D. 2.5, 3.0, 3.5 mm. | |||
| Intended | |||
| population | Adult | Adult, Pediatric | Different |
| Anatomical | |||
| Site | Nasal | Oral/Nasal | Different |
| Single Use | Single Use | Single Use | Same |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Patient Contact Material | Different | ||
| Main Tube | PVC and green pigment | Unknown | |
| PetCO2 | |||
| Monitor Tube | PVC | ||
| Luer | |||
| Connector | PC | ||
| Jet Tube | PVC and blue pigment | ||
| 15mm | |||
| Connector | PP | ||
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993 standards | |
| requirements | Same | ||
| Intracutaneous | |||
| Irritation | No Irritation | ||
| Skin | |||
| Sensitization | No Sensitization | ||
| Acute | |||
| Toxicity | No Systemic Toxicity | ||
| Subacute | |||
| Toxicity | No Subacute Toxicity | ||
| Bacterial | |||
| Reverse | |||
| Mutation | Not induce backward mutation | ||
| Gene | Non-mutagenic |
7
| Mutation Test | |||
|---|---|---|---|
| Implantation | Non-irritant to the subcutaneous tissue | ||
| Pyrogen Test | No pyrogen | ||
| Sterilization | |||
| Method | Ethylene Oxide | Ethylene Oxide | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
Similar Analysis 1- Indication for Use
The description of indication for use for proposed device is different from predicate device. However, both of them are indicated for airway management, jet ventilation and the administration of oxygen. Therefore, this difference does not affect substantially equivalence.
Similar Analysis 2- Configuration
The components were named by manufacturer and may be different from each other. From above table, the components for the proposed device are different from predicate device. The proposed device does not have the configuration of Insufflation Access Pilot Balloon Valve for Cuff Inflation and cuff. This difference was caused by that the proposed device is uncuffed. However, this difference does not affect intended use. Therefore, the difference in components does not affect substantially equivalence.
Different Analysis 3-Size
From above table, the size specifications for the proposed device is less than the predicate device. This difference was caused by different intended population. However, the sizes of proposed device are covered by the predicate device. Therefore, the difference in the sizes does not affect substantially equivalence.
Different Analysis 4- Intended Population
The intended population of proposed device is not same as the predicate device. However, the intended population for the proposed device can be covered by the predicate device. Therefore, the difference in the intended population does not affect substantially equivalence.
Different Analysis 5- Anatomical Site
The anatomical site of proposed device is oral, and this anatomical site can be covered by the predicate device. Therefore, the difference in the anatomical site does not affect substantially equivalence.
Different Analysis 6- Patient-contact Material
The patient-contact material for predicate device is unknown. However, the biocompatibility tests have been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standards. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device.
8
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISTA 2A, Transport test of single package product
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- A ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
-
ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- A ISO 10993-6: 2016 Biological Evaluation of Medical Devices-Part 6: Test for Local effects after implantation
-
ISO 10993-3:2014 Biological Evaluation of Medical Devices-Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
-
USP Pyrogen Test
-
ISO 80369-7:2016 Small-bore connectors for liguids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
-
ISO 5356-1: 2015 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
-
ASTM F1573-95 (2000) Standard Specification for Anesthetic Equipment-Oropharyngeal and Nasopharyngeal Airways
-
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
-
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
-
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
-
ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
Connecter testing listed in following table were performed on the proposed device. The test results show that the device conform to the requirements of related standards.
9
| Test | Standard |
|---|---|
| Conical connectors | ISO 5356-1:2015: Anaesthetic and respirator equipment-Conical |
| connectors-Part 1: Cones and sockets | |
| Luer connector | ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare |
| applications — Part 7: Connectors for intravascular or hypodermic | |
| applications | |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare | |
| applications — Part 20: Common test methods |
Table 2 Performance Testing
The comparative test for length, diameter, bevel angle, curvature, kink resistance and connectors were performed on the proposed device and predicate device. A summary of the tests performed is provided in the table below:
| Test | Test Method Summary | Result and Conclusion |
|---|---|---|
| Length Test | Verify length using specified | |
| measurement tools. Record | ||
| measurements. | Length verification met acceptance criteria. | |
| The difference between the proposed device | ||
| and the predicate device does not affect the | ||
| safety and effectiveness of the product. | ||
| Outer Diameter Test | Verify dimensions using | |
| specified measurement tools. | The test results comply with the requirements | |
| of acceptance criteria of the proposed device | ||
| the test result of the proposed device and the | ||
| predicate device are very similar. | ||
| Radius of Curvature | ||
| Test | The curvature radius of the | |
| product is measured using a | ||
| curvature test plate. | Curvature radius met acceptance criteria. The | |
| difference between the proposed device and | ||
| the predicate device does not affect the safety | ||
| and effectiveness of the product. | ||
| Angle of Bevel Test | The curvature radius of the | |
| product is measured using angle | ||
| ruler. | The test results comply with the requirements | |
| of acceptance criteria of the proposed device | ||
| and the test result of the proposed device and | ||
| the predicate device are similar. | ||
| Inner Diameter Test | Verify dimensions using plug | |
| gauge. | Both test result of the proposed device and the | |
| predicate device comply with the requirements | ||
| of acceptance criteria of the proposed device | ||
| Kink Resistance Test | The proposed device was | |
| evaluated per ASTM F1573 to | ||
| demonstrate that the device | ||
| kink resistance | Both test result of the proposed device and the | |
| predicate device comply with the requirements | ||
| of acceptance criteria of the proposed device |
Table 3 Summary of Performance Testing
10
| Connector Strength | Use a tensile test machine to apply a tensile load to the sample and determine whether the maximum tensile force meets the acceptance criteria. Use a tensile test machine to apply a tensile load to the sample and determine whether the maximum tensile force meets the acceptance criteria. |
|---|---|
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Biocompatibility testing
The contact level of the proposed device is tissue, and the contact duration is prolonged contact (>24 hours to 30 days). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that the proposed device is biocompatible.
-
Cytotoxicity,
- A Sensitization,
- A Irritation,
-
Systemic toxicity,
-
Pyrogen,
-
Subcutaneous Implant
- A Subacute Toxic Implantation
- A Bacterial Reverse Mutation
-
Gene Mutation
-
Particulate Matter
-
Volatile Organic Compounds
-
Toxicological Risk Assessment
Sterility, Shipping, and Shelf -life
The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 106). EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life.
- Package integrity test after environmental conditioning, simulated transportation testing in . accordance to ISTA 2A on final, packaged, and sterile device.
- . Sterile Barrier Packaging performed on the proposed device:
- o Visual inspection ASTM F1886/F1886M-16
- 0 Seal strength ASTM F88/F88-15
- o Dye penetration ASTM F1929-15
- . Shelf-life of 5-years is validated using FDA recognized standard ASTM F1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
11
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Conclusion
The subject device has the same intended use as the predicate device. The technological differences do not raise new questions of safety and effectiveness. The biocompatibility, sterility and bench performance testing demonstrate that the Wei Nasal Jet Tube is substantially equivalent to the predicate device.