(266 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material safety of a standard double-lumen endobronchial tube, with no mention of AI/ML capabilities or data processing.
Yes
The device is used to isolate a lung for surgery, one-lung ventilation, or anesthesia, and is indicated for patients with pathological lung conditions, which are all therapeutic interventions. It provides mechanical ventilation and isolation during medical procedures for specific conditions.
No
The Disposable Double Lumen Endobronchial Tube is used for isolating and ventilating a lung, which is a therapeutic and interventional function, not a diagnostic one.
No
The device description clearly outlines a physical, disposable medical device made of PVC with lumens, cuffs, and a stylet. It is intended for physical insertion into the body.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Double Lumen Endobronchial Tube is a physical device inserted into the body to manage ventilation during surgery or for specific medical conditions. It does not analyze biological samples.
- Intended Use: The intended use clearly describes a procedure involving the physical manipulation of the airway and lungs for ventilation and isolation, not the analysis of biological specimens.
- Device Description: The description focuses on the physical components and function of the tube for airway management.
- Performance Studies: The performance studies mentioned relate to the physical and material properties of the device and its compliance with standards for medical devices used in the airway, not the accuracy of diagnostic results from biological samples.
Therefore, the Disposable Double Lumen Endobronchial Tube is a medical device used for airway management and ventilation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
Product codes
CBI
Device Description
The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.
The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).
The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.
The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.
The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, trachea, bronchus
Indicated Patient Age Range
Adults use only.
Intended User / Care Setting
Trained Physicians / Hospitals-OR and ICU
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. The test results demonstrated that the proposed device complies with the following standards:
- ISO 16628:2008 Tracheobronchial tubes - Sizing and marking
- ISO 5356-1:2004 Anesthetic and respiratory equipment – Conical connectors - Part 1: Cones and sockets
- ISO 5361:2016 Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Non clinical tests were conducted to verify that the proposed device met all design specifications. The tests included:
- Dimensions (Pass)
- Inflating tube O.D. & Angle (Pass)
- Cuff seal (Sealing of cuff inflating system) (Pass)
- Cuffed tube collapse (Pass)
- Cuff herniation (Pass)
- Cuff Resting Diameter (Pass)
- Air leakage of one way valve (Pass)
- Liquid leakage of one way valve (Pass)
- Size of the Murphy Eye (Pass)
- Security of Construction of connection componants (Pass)
- 15mm connector (Pass)
- Colour Coding (Pass)
- Segment differentiation of the tracheal segment and the bronchial segments (Pass)
- Test for balloon diameter to inflation pressure (Pass)
- Cuff thickness (Pass)
- Cuff burst pressure (Pass)
Biocompatibility testing was performed according to:
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation And Testing . Within A Risk Management Process
- ISO 10993-5:2009 - Biological evaluation of medical devices -- Part 5: Tests for in vitro cvtotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation . and skin sensitization
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of . allowable limits for leachable substances
- 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 18562-4:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
All evaluation acceptance criteria were met.
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
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
May 13, 2024
Shenzhen Insighters Medical Technology Co., Ltd. Kevin Huang Official Correspondent The 13th floor of Hengtemei Building Ganli Road No.3 Shenzhen, Guangdong 518000 China
Re: K232529
Trade/Device Name: Disposable Double Lumen Endobronchial Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: April 10, 2024 Received: April 18, 2024
Dear Kevin Huang:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Bradley Q. Quinn -S
Bradley Quinn 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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232529
Device Name
Disposable Double Lumen Endobronchial Tube
Indications for Use (Describe)
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
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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4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date of Preparation: April 10, 2024
1. Applicant:
510(k) Owner's Name: Shenzhen Insighters Medical Technology Co., Ltd. Address: The 13th floor of Hengtemei Building Ganli Road No.3 518000 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Contact Person: Bonnie Fang Title: Regulatory Affairs Email: fangbaohong@insighters.cn Tel: +86 755-89313133 Fax: +86 755-84509803
2. Submission Correspondent:
Contact Person: Kevin Huang Email: Kevin huang1021@Sina.com Tel: +86-13602471659 Fax: +86-20- 84558599
3. Device Information
Device Name: Disposable Double Lumen Endobronchial Tube Trade Name: Disposable Double Lumen Endobronchial Tube (Ordinary Left Type, 28Fr, 32Fr, 37Fr, 39Fr, 41Fr)
Disposable Double Lumen Endobronchial Tube (Ordinary Right Type, 28Fr, 32Fr, 37Fr, 39Fr. 41Fr)
Disposable Double Lumen Endobronchial Tube (Visible Left Type B, 28Fr, 32Fr, 37Fr, 39Fr, 41Fr)
Disposable Double Lumen Endobronchial Tube (Visible Right Type B, 28Fr, 32Fr, 37Fr, 39Fr, 41Fr)
Disposable Double Lumen Endobronchial Tube (Visible Left Type, 28Fr, 32Fr, 37Fr, 39Fr, 41Fr)
Disposable Double Lumen Endobronchial Tube (Visible Right Type, 28Fr, 32Fr, 37Fr, 39Fr, 41Fr)
Submission Number: K232529
Submission Type: Traditional 510(k)
Common Name: Endobronchial Tube, Bronchial Tube
Regulation Number: 21 CFR 868.5740
Regulation Name: Tracheal/bronchial differential ventilation tube
Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class: II
Product Code: CBI
Review Panel: Anesthesiology
5
4. Predicate Device Identification
The Disposable Double Lumen Endobronchial Tube is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name | Primary Predicate |
|---|---|---|
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | √ |
5. Indications for Use
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
6. Device Description
The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.
The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).
The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which
is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.
The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.
The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.
7. Substantial Equivalence-Comparison to Predicate Device
A side by side comparison of the proposed device and the predicate device are provided below.
6
Table 1 – Comparison Between Proposed Disposable Double Lumen Endobronchial Tube & Predicate Ambu VivaSight 2 DLT (K203749)
| Comparison between proposed device and predicate device | ||||
|---|---|---|---|---|
| Comparison | ||||
| Items | Proposed Device | Predicate Device | Discussion of | |
| Differences | ||||
| Device Name | Disposable Double Lumen | |||
| Endobronchial Tube | Ambu VivaSight 2 DLT, | |||
| Ambu VivaSight 2 Adapter Cable | ||||
| K203749 | --- | |||
| 510k Number | --- | CBI | --- | |
| Product Code | CBI | CBI | Identical | |
| Regulation | ||||
| Number | 21 CFR 868.5740 | 21 CFR 868.5740 | Identical | |
| Regulation Name | Tracheal/Bronchial | |||
| Differential Ventilation Tube | Tracheal/Bronchial Differential | |||
| Ventilation Tube | Identical | |||
| Device Class | Class II | Class II | Identical | |
| Classification | ||||
| Name | Tube, Tracheal/Bronchial, | |||
| Differential Ventilation | ||||
| (W/Wo Connector) | Tube, Tracheal/Bronchial, Differential | |||
| Ventilation (W/Wo Connector) | Identical | |||
| Review Panel | Anesthesiology | Anesthesiology | Identical | |
| Indications for | ||||
| Use | The Disposable Double | |||
| Lumen Endobronchial Tube | ||||
| is used to isolate the left or | ||||
| right lung of a patient for | ||||
| surgery, one lung ventilation | ||||
| or one lung anesthesia. | ||||
| It is indicated for patients with | ||||
| pathological lung conditions | ||||
| or other medical conditions | ||||
| that require endobronchial | ||||
| intubation, mechanical | ||||
| ventilation and isolation of | ||||
| one lung from the other, e.g. | ||||
| for thoracic surgery. | ||||
| The Disposable Double | ||||
| Lumen Endobronchial Tube | ||||
| is indicated for adults use | ||||
| only. | Intubation with VivaSight 2 DLT is | |||
| indicated for patients with pathological | ||||
| lung conditions or other medical | ||||
| conditions that require endobronchial | ||||
| intubation, mechanical ventilation and | ||||
| isolation of one lung from the other, | ||||
| e.g. for thoracic surgery. | Identical. | |||
| They both are | ||||
| designed to | ||||
| achieve single- | ||||
| lung ventilation. | ||||
| Direction for Use | Prescription Use | Prescription Use | Identical | |
| Patient | ||||
| Population | Patients undergoing surgical | |||
| procedure requiring isolation | ||||
| of one lung | Patients undergoing surgical | |||
| procedure requiring isolation of one | ||||
| lung | Identical | |||
| Environment of | ||||
| Use | Hospitals-OR and ICU | Hospitals-OR and ICU | Identical | |
| Intended User | Trained Physicians | Trained Physicians | Identical | |
| Design Features | • Double lumen shaft | |||
| • Two cuffs: Bronchial Cuff | ||||
| and Tracheal Cuff |
• With visible channel, allows
to insert flexible
bronchoscope or laryngeal
scope (O.D. less than
2.4mm) into the visible lumen
for verifying tube placement
and repositioning. (For Visible
Type B & Visible Type)
• With flushing channel, flush
line with flush exits next to the
visible lumen exits | • Double lumen shaft
• Two cuffs: Bronchial Cuff and
Tracheal Cuff
• With an embedded video camera and
light source at the distal end of the
tracheal lumen and integrated video
cable with video connector.
• A flush line with flush exits next to the
camera lens ensures possibility for
cleaning of the camera lens. | Different① | |
| possibility for cleaning of the camera lens. (For Visible Type)
※ The Ordinary Type does not contain visible channel and flushing channel. | | | | |
| Component/ Accessory | | • Endobronchial Tube
• Y-connector
• Suction Catheter | • Endobronchial Tube
• Y-connector
• Suction Catheter
• Video camera and light source
• Cable | |
| Type & Sizes (Fr; French) | | Type:
Ordinary Left Type
Ordinary Right Type
Visible Left Type B
Visible Right Type B
Visible Left Type
Visible Right Type
Size: 28 to 41 French | 35 to 41 French | Different② |
| | Cuffed | Yes | Yes | Identical |
| Connection to ventilation source | | 15mm Connector | 15mm Connector | Identical |
| Patient Contact Materials | Tube body | PVC | PVC | Different③ |
| | Tracheal tube cuff | PVC | PVC | |
| | Bronchial tube cuff | PVC | PVC | |
| | Others※ | See Table 2 | Unknow | |
| Sterilization Method | | EtO Sterilized per ISO 11135 | EtO Sterilized per ISO 11135 | Identical |
| The Sterility Assurance Level | | SAL 10-6 | SAL 10-6 | Identical |
| Packaging | | Supplied individually packaged | Supplied individually packaged | Identical |
| | Use | Single Use, Disposable | Single Use, Disposable | Identical |
| | Biocompatibility | ISO 10993-1
Cytotoxicity Test (ISO 10993-5)
Irritation Test (ISO 10993-5)
Sensitization Test (ISO 10993-10) | ISO 10993-1
Cytotoxicity Test (ISO 10993-5)
Irritation Test (ISO 10993-5)
Sensitization Test (ISO 10993-10) | Identical |
7
Table 2- Composition Material Informations
| Type | Ordinary Left
Type | Ordinary Left
Type | Visible Left Type
B | Visible Right Type
B | Visible Left Type | Visible Right
Type |
|------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| No. | Component &
Meterial | Component &
Meterial | Component &
Meterial | Component &
Meterial | Component &
Meterial | Component &
Meterial |
| 1 | Tube body:PVC | Tube body:PVC | Tube body:PVC | Tube body:PVC | Tube body:PVC | Tube body:PVC |
| 2 | Tracheal cuff:PVC | Tracheal cuff:PVC | Tracheal cuff:PVC | Tracheal cuff:PVC | Tracheal cuff:PVC | Tracheal cuff:PVC |
| 3 | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE | Bronchial cuff:
PVC+Color
Additive:
PIGMENT BLUE |
| 4 | Tube body
connector: PVC | Tube body
connector: PVC | Tube body
connector: PVC | Tube body
connector: PVC | Tube body
connector: PVC | Tube body
connector: PVC |
8
| Sub tube: | Sub tube: | Sub tube: | Sub tube: | Sub tube: | Sub tube: | |
|---|---|---|---|---|---|---|
| 5 | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | PVC+Color | |||||
| Additive: | ||||||
| PIGMENT BLUE | ||||||
| 6 | Sub tube connector: | |||||
| PP | Sub tube connector: | |||||
| PP | Sub tube connector: | |||||
| PP | Sub tube connector: | |||||
| PP | Sub tube connector: | |||||
| PP | Sub tube connector: | |||||
| PP | ||||||
| 7 | Sub adaptor: | |||||
| PP | Sub adaptor: | |||||
| PP | Sub adaptor: | |||||
| PP | Sub adaptor: | |||||
| PP | Sub adaptor: | |||||
| PP | Sub adaptor: | |||||
| PP | ||||||
| 8 | Endoscope adaptor: | |||||
| PP | Endoscope adaptor: | |||||
| PP | Endoscope adaptor: | |||||
| PP | Endoscope adaptor: | |||||
| PP | Endoscope adaptor: | |||||
| PP | Endoscope adaptor: | |||||
| PP | ||||||
| 9 | Cap: PVC | Cap: PVC | Cap: PVC | Cap: PVC | Cap: PVC | Cap: PVC |
| 10 | Connection tube: | |||||
| PVC | Connection tube: | |||||
| PVC | Connection tube: | |||||
| PVC | Connection tube: | |||||
| PVC | Connection tube: | |||||
| PVC | Connection tube: | |||||
| PVC | ||||||
| 11 | Three-port adaptor: | |||||
| PP | Three-port adaptor: | |||||
| PP | Three-port adaptor: | |||||
| PP | Three-port adaptor: | |||||
| PP | Three-port adaptor: | |||||
| PP | Three-port adaptor: | |||||
| PP | ||||||
| 12 | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Inflating tube: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | ||||||
| 13 | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | Pilot balloon: | |||||
| PVC+Color | ||||||
| Additive: | ||||||
| PIGMENT BLUE | ||||||
| 14 | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | One-way valve: | |||||
| ABS + Stainless | ||||||
| steel | ||||||
| 15 | Adhesive: | |||||
| Acrylic | Adhesive: | |||||
| Acrylic | Adhesive: | |||||
| Acrylic | Adhesive: | |||||
| Acrylic | Adhesive: | |||||
| Acrylic | Adhesive: | |||||
| Acrylic | ||||||
| 16 | / | / | Visible channel | |||
| extension tube: | ||||||
| PVC | Visible channel | |||||
| extension tube: | ||||||
| PVC | Visible channel | |||||
| extension tube: | ||||||
| PVC | Visible channel | |||||
| extension tube: | ||||||
| PVC | ||||||
| 17 | / | / | Airtight valve: | |||
| PC | Airtight valve: | |||||
| PC | Airtight valve: | |||||
| PC | Airtight valve: | |||||
| PC | ||||||
| 18 | / | / | / | / | Flushing channel: | |
| PVC | Flushing channel: | |||||
| PVC | ||||||
| 19 | / | / | / | / | Flushing adaptor: | |
| PVC | Flushing adaptor: | |||||
| PVC |
Similarities Between Proposed and Predicate Devices
The proposed Disposable Double Lumen Endobronchial Tube, comes in three models: Ordinary Type, Visible Type B and Visible Type, have the same technological characteristics as the predicate device (K203749-Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable). The proposed and predicate device are based on the following same technological elements:
- · Same intended use
- · Same Indications for Use
- · Same operating principals
- Same patient population
- Same Environment of Use
- · Composed of biocompatible materials
- Provided sterile for single-use
- · Ethylene Oxide Sterilized
Differences Between Proposed and Predicate Device
The differences between proposed and predicate device, as shown in the following:
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(1) Components/Accessories
The proposed device does not include accessories such as video camera, LED light source and cable.
Although the proposed and predicate device have different accessories but the overall structure of the Endobronchial Tube is similar. Both of two Endobronchial Tube are consisted with double lumen shaft with stylet, 2 cuffs (Bronchial Cuff and Tracheal Cuff). Both of them are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
This difference does not raise any new concerns of safety and effectiveness.
2 Model/Type/Size
The proposed device comes in three model: Ordinary Type, Visible Type B and Visible Type while its predicate device come in one type. The three models have the same indications for use and principle of operation, they can be submitted in one submission. Although size of the proposed device is different with size of predicate device, the proposed device is verified by test such as appearance test, dimension test. Both of the proposed and predicate device are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. This difference does not raise any new concerns of safety and effectiveness.
3 Materials
Although the materials for patient contact components are not identical, the proposed device is verified by test such as a biocompatibility test according to ISO 10993-1, ISO 18562 and FDA Guidance ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process").
As a result, there are not any problems, which influence safety of the proposed device as well as influence substantial equivalence between the proposed device and predicate device. Both of them are manufactured from materials that meet all the requirements of biocompatibility. This difference does not raise any new concerns of safety and effectiveness.
Conclusions
The proposed Disposable Double Lumen Endobronchial Tube described in this 510(k) has similar technological and performance characteristics to the predicate device. The proposed device is substantially equivalent in performance, indication for use, design and materials as to predicate device. The similarities and differences between the proposed and predicate device have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. The minor differences in the device do not introduce new issues of safety and efficacy. Changes or modifications to the device outside its intended use should not be done as this could affect the safety and effectiveness of the device.
Therefore, the proposed Disposable Double Lumen Endobronchial Tube are substantially equivalent to predicate device Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable(K203749). The proposed device has the same classification information, same indications for use and technological characteristics as compared to the predicate device.
8. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications
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as was same to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
1) Performance Testing
Performance testing was carried out to verify the safety and the effectiveness of the subject device.
Nonclinical functional performance testing was performed in accordance with:
ISO 16628:2008 Tracheobronchial tubes - Sizing and marking
ISO 5356-1:2004 Anesthetic and respiratory equipment – Conical connectors - Part 1: Cones and sockets
ISO 5361:2016 Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -
Part 7: Connectors for intravascular or hypodermic applications
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test provided in this submission include:
| Non-Clinical Testing | ||||
|---|---|---|---|---|
| No. | Performance | |||
| Test Items | Reference | |||
| Standards | Acceptance Criteria | Test | ||
| result | ||||
| 1 | Dimensions | ISO 5361:2016/ | ||
| ISO 16628:2008 | When tested in accordance with the test | |||
| method, the L1、L2、L3、OD、ID shall | ||||
| meet the requirements on size and | ||||
| tolerances. | Pass | |||
| 2 | Inflating tube | |||
| O.D. & Angle | ISO 5361:2016 | Inflating tube O.D.≤3.0mm; | ||
| The angle between the inflating tube and | ||||
| the Endobronchial Tube at the point of | ||||
| separation shall not exceed 45°。 | Pass | |||
| 3 | Cuff seal | |||
| (Sealing of | ||||
| cuff inflating | ||||
| system) | / | When tested in accordance with the test | ||
| method, no bubble shall be noted over | ||||
| the 10-s interval. | Pass | |||
| 4 | Cuffed tube | |||
| collapse | ISO 5361:2016 | When tested in accordance with the test | ||
| method in ISO 5361 Annex C, the steel | ||||
| ball shall pass freely through the lumen of | ||||
| the tube. | Pass | |||
| 5 | Cuff | |||
| herniation | ISO 5361:2016 | When tested in accordance with the test | ||
| method in ISO 5361 Annex D, no part of | ||||
| the inflated cuff shall reach beyond the | ||||
| nearest edge of the bevel. | Pass | |||
| 6 | Cuff Resting | |||
| Diameter | ISO 5361:2016 | When tested in accordance with the test | ||
| method in ISO 5361 Annex B, at a | ||||
| pressure of 2 kPa, the cuff diameter shall | ||||
| meet the requirements on size and | ||||
| tolerances. | Pass | |||
| 7 | Air leakage of | |||
| one way valve | / | When tested according to the test | ||
| method, the pilot balloon should be able | ||||
| to naturally fill up and flat deflate. | Pass | |||
| 8 | Liquid leakage | |||
| of one way | ||||
| valve | ISO 80369- | |||
| 7:2021 | When tested in accordance with the test | |||
| method, there shall be no leakage | ||||
| sufficient to form a falling drop of water. | Pass | |||
| 9 | Size of the | |||
| Murphy Eye | ISO 5361:2016 | The area of the Murphy eye shall be not | ||
| less than 80 % of the cross-sectional area | ||||
| derived from the minimum | ||||
| inside | ||||
| diameter for that size tube. | Pass | |||
| 10 | Security of | |||
| Construction | ||||
| of connection | ||||
| componants | / | When tested in accordance with the test | ||
| method, the force required to detach any | ||||
| component permanently attached to the | ||||
| shaft shall be not less than that specified | ||||
| in standard. | Pass | |||
| 11 | 15mm | |||
| connector | ISO5356-1:2004 | When tested in accordance with the test | ||
| method, 15mm conical connectors shall | ||||
| comply with the ISO5356-1. | Pass | |||
| 12 | Colour Coding | ISO16628:2008 | When tested in accordance with the test | |
| method, the color coding of bronchial cuff | ||||
| and its pilot balloon were entirely | ||||
| coloured blue. | Pass | |||
| 13 | Segment | |||
| differentiation | ||||
| of the tracheal | ||||
| segment and | ||||
| the bronchial | ||||
| segments | ISO16628:2008 | When tested in accordance with the test | ||
| method, the segment differentiation of the | ||||
| tracheal segment and the bronchial | ||||
| segments were clearly distinguished. | Pass | |||
| 14 | Test for | |||
| balloon | ||||
| diameter to | ||||
| inflation | ||||
| pressure | ISO10555-4: | |||
| 2013 | When tested in accordance with the test | |||
| method, can reflect the relationship | ||||
| between balloon diameter and inflation | ||||
| pressure. | Pass | |||
| 15 | Cuff thickness | / | When tested in accordance with the test | |
| method, the cuff thickness shall meet the | ||||
| requirements on size and tolerances. | Pass | |||
| 15 | Cuff burst | |||
| pressure | / | When tested in accordance with the test | ||
| method, the brust pressure of the cuff | ||||
| shall meet the RBP 30kPa | Pass |
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Testing datas and results are included in this submission, and demonstrated that the Disposable Double Lumen Endobronchial Tube meets all the pre-determined testing and acceptance criteria.
2) Biocompatibility
The contact duration of the proposed device Disposable Double Lumen Endobronchial Tube is less than 24 hours. According to ISO 10993-1:2018 Annex A Table A.1 and FDA Biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", the Disposable Double Lumen Endobronchial Tube is considered a Surface Device that comes in contact with the Mucosal Membrane for limited exposure (