(439 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.
No.
The device is used for airway management and subglottic drainage, which are supportive functions, not a direct treatment for a disease or condition.
No.
This device is an endotracheal tube primarily used for airway management and subglottic drainage, with no described function in diagnosing conditions.
No
The device description clearly outlines a physical medical device (endotracheal tube) with various hardware components (tube, cuff, lumens, connectors, etc.) and does not mention any software functionality.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endotracheal Tube with Evacuation Lumen is a medical device used for airway management and drainage of the subglottic space. It is inserted directly into the patient's body to maintain an open airway and remove secretions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "oral intubation and drainage of the subglottic space for airway management." This is a therapeutic and supportive function, not a diagnostic one based on in vitro analysis.
- Device Description: The description details the physical components and how they function within the patient's airway. There is no mention of analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic or supportive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
Product codes
BTR
Device Description
The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.
The only modification that was made is the materials: The Endotracheal Tube with Evacuation Lumen differs from the predicate device in that the cuff is made of PVC which are not made with DEHP and PU. The predicate device cuff is made of PVC which contains DEHP. In addition, the materials of the tube (including main tube, inflation tube and suction line) and pilot balloon are modified to PVC which is not made of DEHP.
The PVC materials used for the modified device are not made with DEHP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The tube is inserted into a patient's tracheal via the oral to maintain an open airway.
Indicated Patient Age Range
Not Found
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
The following performance testing and biocompatibility testing comparing the modified device to the predicate device was conducted.
- Performance Bench testing has been conducted to verify that the performance of the proposed Endotracheal Tube with Evacuation Lumen is substantially equivalent to the predicate device, and that the Endotracheal Tube with Evacuation Lumen will perform as intended. Bench-top testing was conducted to assure conformance to the following standards: ISO 5361:2016-Anaesthetic And Respiratory Equipment-Tracheal Tubes and Connectors
- The following Biocompatibility testing was performed in accordance with ISO 10993-1 ♦ Cytotoxicity ♦ Sensitization ♦ Irritation/Intracutaneous reactivity ♦ Acute systemic toxicity ♦ Subchronic systemic toxicity ♦ Genotoxicity ♦ Material-mediate pyrogenicity ♦ Implantation
- Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen
- A risk analysis according to ISO standard "14971 Medical Devices Application of risk management to medical devices" was carried out for the Endotracheal Tube with Evacuation Lumen. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.
- The following bench testing was conducted to support the performance of the Suction Line component of Endotracheal Tube with Evacuation Lumen. The test results demonstrated that the device meets the performance requirements for its intended use: ♦ Suction Line O.D. & Length ♦ Tensile Force Test (Inflating tube and tracheal tube) ♦ Tensile Force Test (Suction tube and the connector of suction tube) ♦ Negative Pressure Resistance of Suction Line
Conclusions Drawn from the Non-Clinical Testing: The performance and biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K110269-Well Lead Endotracheal Tube with Evacuation Lumen
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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
December 23, 2019
Well Lead Medical Co., Ltd. Jenny Zhu Regulatory Affairs Specialist No.47, Guomao Avenue South, Hualong, Panyu Guangzhou, CN 511434 Guangdong
Re: K182739
Trade/Device Name: Endotracheal Tube with Evacuation Lumen Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: September 25, 2018 Received: September 28, 2018
Dear Jenny Zhu:
This letter corrects our substantially equivalent letter of December 11, 2019.
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.
1
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 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.
Ka N. To -S5 2019.12.23 14:30:38 -05'00' For 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Endotracheal Tube with Evacuation Lumen
Indications for Use (Describe)
The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
Type of Use (Select one or both, as applicable)
× 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
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 12/23/2019 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address: C-4 # Jinhu Industrial Estate, Hualong, Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Jenny Zhu |
| Regulatory Affairs Specialist | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: jenny_zhu@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | Endotracheal Tube with Evacuation Lumen |
| Common Name: | Tracheal Tube |
| Regulation Number: | 21 CFR 868.5730 |
| Regulation Name: | Tracheal Tube |
| Product Code: | BTR |
| Regulatory Class: | Class II |
| Predicate Device(s): | K110269-Well Lead Endotracheal Tube with Evacuation |
| Lumen |
1. Intended Use
The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
2. Device Description
The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists
4
of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.
The only modification that was made is the materials:
The Endotracheal Tube with Evacuation Lumen differs from the predicate device in that the cuff is made of PVC which are not made with DEHP and PU. The predicate device cuff is made of PVC which contains DEHP. In addition, the materials of the tube (including main tube, inflation tube and suction line) and pilot balloon are modified to PVC which is not made of DEHP.
The PVC materials used for the modified device are not made with DEHP.
The intended use of the modified device, as described in its labeling, has not changed as a results of the modification.
3. Substantial Equivalence-Comparison to Predicate Devices
The predicate device to which we claim equivalence is the Well Lead Endotracheal Tube with Evacuation Lumen (K110269).
The Endotracheal Tube with Evacuation Lumen maintains the same intended use as the predicate device. It is intended for oral intubation and drainage of the subglottic space for airway management. The proposed device and the predicate device consist of the same fundamental technology.
The Endotracheal Tube with Evacuation Lumen differs from the predicate device in that the cuff is made of PVC which are not made of DEHP and PU. The predicate device cuff is made of PVC which contains DEHP. In addition, the materials of the tube (including main tube, inflation tube and suction line) and pilot balloon are modified to PVC which is not made of DEHP.
The PVC materials used for the modified device are not made with DEHP.
The modification has not altered the fundamental scientific technology of the predicate Well Lead Endotracheal Tube with Evacuation Lumen.
Therefore the modified Endotracheal Tube with Evacuation Lumen is substantially equivalent to the current legally marketed Well Lead Endotracheal Tube with Evacuation Lumen (K110269) device. The proposed device is substantially equivalent in intended use, design, performance and principles of operation to the predicate device.
The differences between the Endotracheal Tube with Evacuation Lumen and the predicate device raise no different issues of safety and effectiveness.
A Risk Analysis was conducted and is detailed in the Design Control Summary Section. No new issues of safety and effectiveness were identified during this process.
The Endotracheal Tube with Evacuation Lumen and the predicate device consist of the same fundamental technology and are sterilized with acceptable methods. Below is a comparison table that summarizes the technological characteristics of the proposed and predicate endotracheal tubes.
5
| Comparison between proposed device and predicate device | ||
|---|---|---|
| Comparison | Proposed Device | Predicate Device |
| Device Name | Endotracheal Tube with Evacuation Lumen | Well Lead Endotracheal Tube with |
| 510k Number | --- | K110269 |
| Product Code | BTR | BTR |
| Regulation Number | 21 CFR 868.5730 | 21 CFR 868.5730 |
| Regulatory Class | Class II | Class II |
| Classification Pannel | Anesthesiology | Anesthesiology |
| Indications for Use/ | ||
| Intended Use | The Endotracheal Tube with Evacuation | |
| Lumen is intended for oral intubation and | ||
| drainage of the subglottic space for | ||
| airway management. | Same. | |
| The Well Lead Endotracheal Tube with | ||
| Evacuation Lumen is intended for oral | ||
| intubation and drainage of the | ||
| subglottic space for airway | ||
| management. | ||
| Anatomical site | The tube is inserted into a patient's | |
| tracheal via the oral to maintain an open | ||
| airway. | Same | |
| Materials | ||
| Main Tube | PVC not made with DEHP | PVC which contains DEHP |
| Pilot Balloon | PVC not made with DEHP | PVC which contains DEHP |
| Cuff | PU | PVC which contains DEHP |
| Inflation Tube | PVC not made with DEHP | PVC which contains DEHP |
| Suction Line | PVC not made with DEHP | PVC which contains DEHP |
| 15mm | PP | Same |
| Design | ||
| Size(ID) | ID6.0mm-ID90.mm | Same |
| 15mm | ||
| Connector | Yes | Same |
| Radiopaque | ||
| Line | Yes | Same |
| Structure | ||
| Composition | Main tube, Cuff, Inflation Tube, 15mm | |
| Connector, Pilot Balloon, non-return | ||
| Valve, Suction Line, Suction Line | ||
| Connector | Same | |
| Supplied Sterile | Yes | Same |
| Sterilization | ||
| Method | EO sterilized | Same |
| Single Use | Yes | Same |
6
4. Summary of Non-Clinical Testing
The following performance testing and biocompatibility testing comparing the modified device to the predicate device was conducted.
-
- Performance Bench testing has been conducted to verify that the performance of the proposed Endotracheal Tube with Evacuation Lumen is substantially equivalent to the predicate device, and that the Endotracheal Tube with Evacuation Lumen will perform as intended. Bench-top testing was conducted to assure conformance to the following standards:
- ↑ ISO 5361:2016-Anaesthetic And Respiratory Equipment-Tracheal Tubes and Connectors
- Performance Bench testing has been conducted to verify that the performance of the proposed Endotracheal Tube with Evacuation Lumen is substantially equivalent to the predicate device, and that the Endotracheal Tube with Evacuation Lumen will perform as intended. Bench-top testing was conducted to assure conformance to the following standards:
-
- The following Biocompatibility testing was performed in accordance with ISO 10993-1
- ♦ Cytotoxicity
- ♦ Sensitization
- ♦ Irritation/Intracutaneous reactivity
- ♦ Acute systemic toxicity
- ♦ Subchronic systemic toxicity
- ♦ Genotoxicity
- ♦ Material-mediate pyrogenicity
- ♦ Implantation
- The following Biocompatibility testing was performed in accordance with ISO 10993-1
-
- Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen
-
- A risk analysis according to ISO standard "14971 Medical Devices Application of risk management to medical devices" was carried out for the Endotracheal Tube with Evacuation Lumen. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.
-
- The following bench testing was conducted to support the performance of the Suction Line component of Endotracheal Tube with Evacuation Lumen. The test results demonstrated that the device meets the performance requirements for its intended use:
- ♦ Suction Line O.D. & Length
- ♦ Tensile Force Test (Inflating tube and tracheal tube)
- ↑ Tensile Force Test (Suction tube and the connector of suction tube)
- ♦ Negative Pressure Resistance of Suction Line
- The following bench testing was conducted to support the performance of the Suction Line component of Endotracheal Tube with Evacuation Lumen. The test results demonstrated that the device meets the performance requirements for its intended use:
Conclusions Drawn from the Non-Clinical Testing
The performance and biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.
5. Conclusion
The Endotracheal Tube with Evacuation Lumen is substantially equivalent to predicate device. Based on the intended use, principle of operation, performance characteristics, and technological characteristics, the proposed Endotracheal Tube with Evacuation Lumen is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device.