(266 days)
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.
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.
The provided text is a 510(k) summary for a medical device (Disposable Double Lumen Endobronchial Tube) and focuses on non-clinical performance testing and biocompatibility. It does not describe a study involving an AI algorithm or human readers.
Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, effect size of AI assistance) are not applicable to this document.
The document primarily describes non-clinical performance testing to demonstrate functional and material equivalence to a predicate device.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance (Non-Clinical)
The submission provides a table of non-clinical performance test items, their reference standards, acceptance criteria, and reported test results.
1. Table of Acceptance Criteria and Reported Device Performance:
| 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 components | / | 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 burst pressure of the cuff shall meet the RBP 30kPa. | Pass |
Biocompatibility Testing:
The biocompatibility evaluation was conducted based on the device's classification as a surface device in contact with mucosal membrane for limited exposure (<24 hours) and as a breathing gas pathway device.
| No. | Test Items (General Biocompatibility) | Standards |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 |
| 2 | Intracutaneous test | ISO 10993-10:2010 |
| 3 | Skin Sensitization | ISO 10993-10:2010 |
| No. | Test Items (Biocompatibility of Breathing Gas Pathways) | Standards |
|---|---|---|
| 1 | Particulate Matter Emissions | ISO 18562-2:2017 |
| 2 | Volatile Organic Compounds (VOCs) Emissions | ISO 18562-3:2017 |
| 3 | Leachable in Condensate | ISO 18562-4:2017 |
| 4 | Biological Risk Evaluation Report | ISO 18562-1:2017 |
All biocompatibility evaluation acceptance criteria were met.
Regarding the other requested information, which pertains to AI/algorithm-based medical devices, the provided document explicitly states that it is not applicable:
2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical medical device, not an AI/algorithm. Performance testing was non-clinical (laboratory tests) rather than on a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not a concept relevant to the testing performed for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of clinical data/AI is not relevant here. The "ground truth" for the non-clinical tests would be the established engineering/physical principles and standards (e.g., ISO standards defining dimensions, pressures, etc.).
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
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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.
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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
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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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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
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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.
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Table 1 – Comparison Between Proposed Disposable Double Lumen Endobronchial Tube & Predicate Ambu VivaSight 2 DLT (K203749)
| Comparison between proposed device and predicate device | ||||
|---|---|---|---|---|
| ComparisonItems | Proposed Device | Predicate Device | Discussion ofDifferences | |
| Device Name | Disposable Double LumenEndobronchial Tube | Ambu VivaSight 2 DLT,Ambu VivaSight 2 Adapter CableK203749 | --- | |
| 510k Number | --- | CBI | --- | |
| Product Code | CBI | CBI | Identical | |
| RegulationNumber | 21 CFR 868.5740 | 21 CFR 868.5740 | Identical | |
| Regulation Name | Tracheal/BronchialDifferential Ventilation Tube | Tracheal/Bronchial DifferentialVentilation Tube | Identical | |
| Device Class | Class II | Class II | Identical | |
| ClassificationName | Tube, Tracheal/Bronchial,Differential Ventilation(W/Wo Connector) | Tube, Tracheal/Bronchial, DifferentialVentilation (W/Wo Connector) | Identical | |
| Review Panel | Anesthesiology | Anesthesiology | Identical | |
| Indications forUse | The Disposable DoubleLumen Endobronchial Tubeis used to isolate the left orright lung of a patient forsurgery, one lung ventilationor one lung anesthesia.It is indicated for patients withpathological lung conditionsor other medical conditionsthat require endobronchialintubation, mechanicalventilation and isolation ofone lung from the other, e.g.for thoracic surgery.The Disposable DoubleLumen Endobronchial Tubeis indicated for adults useonly. | Intubation with VivaSight 2 DLT isindicated for patients with pathologicallung conditions or other medicalconditions that require endobronchialintubation, mechanical ventilation andisolation of one lung from the other,e.g. for thoracic surgery. | Identical.They both aredesigned toachieve single-lung ventilation. | |
| Direction for Use | Prescription Use | Prescription Use | Identical | |
| PatientPopulation | Patients undergoing surgicalprocedure requiring isolationof one lung | Patients undergoing surgicalprocedure requiring isolation of onelung | Identical | |
| Environment ofUse | Hospitals-OR and ICU | Hospitals-OR and ICU | Identical | |
| Intended User | Trained Physicians | Trained Physicians | Identical | |
| Design Features | • Double lumen shaft• Two cuffs: Bronchial Cuffand Tracheal Cuff• With visible channel, allowsto insert flexiblebronchoscope or laryngealscope (O.D. less than2.4mm) into the visible lumenfor verifying tube placementand repositioning. (For VisibleType B & Visible Type)• With flushing channel, flushline with flush exits next to thevisible lumen exits | • Double lumen shaft• Two cuffs: Bronchial Cuff andTracheal Cuff• With an embedded video camera andlight source at the distal end of thetracheal lumen and integrated videocable with video connector.• A flush line with flush exits next to thecamera lens ensures possibility forcleaning 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 TypeOrdinary Right TypeVisible Left Type BVisible Right Type BVisible Left TypeVisible Right TypeSize: 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 10993-1Cytotoxicity Test (ISO 10993-5)Irritation Test (ISO 10993-5)Sensitization Test (ISO 10993-10) | ISO 10993-1Cytotoxicity Test (ISO 10993-5)Irritation Test (ISO 10993-5)Sensitization Test (ISO 10993-10) | Identical |
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Table 2- Composition Material Informations
| Type | Ordinary LeftType | Ordinary LeftType | Visible Left TypeB | Visible Right TypeB | Visible Left Type | Visible RightType |
|---|---|---|---|---|---|---|
| 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+ColorAdditive:PIGMENT BLUE | Bronchial cuff:PVC+ColorAdditive:PIGMENT BLUE | Bronchial cuff:PVC+ColorAdditive:PIGMENT BLUE | Bronchial cuff:PVC+ColorAdditive:PIGMENT BLUE | Bronchial cuff:PVC+ColorAdditive:PIGMENT BLUE | Bronchial cuff:PVC+ColorAdditive:PIGMENT BLUE |
| 4 | Tube bodyconnector: PVC | Tube bodyconnector: PVC | Tube bodyconnector: PVC | Tube bodyconnector: PVC | Tube bodyconnector: PVC | Tube bodyconnector: PVC |
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| Sub tube: | Sub tube: | Sub tube: | Sub tube: | Sub tube: | Sub tube: | |
|---|---|---|---|---|---|---|
| 5 | PVC+ColorAdditive:PIGMENT BLUE | PVC+ColorAdditive:PIGMENT BLUE | PVC+ColorAdditive:PIGMENT BLUE | PVC+ColorAdditive:PIGMENT BLUE | PVC+ColorAdditive:PIGMENT BLUE | PVC+ColorAdditive: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+ColorAdditive:PIGMENT BLUE | Inflating tube:PVC+ColorAdditive:PIGMENT BLUE | Inflating tube:PVC+ColorAdditive:PIGMENT BLUE | Inflating tube:PVC+ColorAdditive:PIGMENT BLUE | Inflating tube:PVC+ColorAdditive:PIGMENT BLUE | Inflating tube:PVC+ColorAdditive:PIGMENT BLUE |
| 13 | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE | Pilot balloon:PVC+ColorAdditive:PIGMENT BLUE |
| 14 | One-way valve:ABS + Stainlesssteel | One-way valve:ABS + Stainlesssteel | One-way valve:ABS + Stainlesssteel | One-way valve:ABS + Stainlesssteel | One-way valve:ABS + Stainlesssteel | One-way valve:ABS + Stainlesssteel |
| 15 | Adhesive:Acrylic | Adhesive:Acrylic | Adhesive:Acrylic | Adhesive:Acrylic | Adhesive:Acrylic | Adhesive:Acrylic |
| 16 | / | / | Visible channelextension tube:PVC | Visible channelextension tube:PVC | Visible channelextension tube:PVC | Visible channelextension 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. | PerformanceTest Items | ReferenceStandards | Acceptance Criteria | Testresult |
| 1 | Dimensions | ISO 5361:2016/ISO 16628:2008 | When tested in accordance with the testmethod, the L1、L2、L3、OD、ID shallmeet the requirements on size andtolerances. | Pass |
| 2 | Inflating tubeO.D. & Angle | ISO 5361:2016 | Inflating tube O.D.≤3.0mm;The angle between the inflating tube andthe Endobronchial Tube at the point ofseparation shall not exceed 45°。 | Pass |
| 3 | Cuff seal(Sealing ofcuff inflatingsystem) | / | When tested in accordance with the testmethod, no bubble shall be noted overthe 10-s interval. | Pass |
| 4 | Cuffed tubecollapse | ISO 5361:2016 | When tested in accordance with the testmethod in ISO 5361 Annex C, the steelball shall pass freely through the lumen ofthe tube. | Pass |
| 5 | Cuffherniation | ISO 5361:2016 | When tested in accordance with the testmethod in ISO 5361 Annex D, no part ofthe inflated cuff shall reach beyond thenearest edge of the bevel. | Pass |
| 6 | Cuff RestingDiameter | ISO 5361:2016 | When tested in accordance with the testmethod in ISO 5361 Annex B, at apressure of 2 kPa, the cuff diameter shallmeet the requirements on size andtolerances. | Pass |
| 7 | Air leakage ofone way valve | / | When tested according to the testmethod, the pilot balloon should be ableto naturally fill up and flat deflate. | Pass |
| 8 | Liquid leakageof one wayvalve | ISO 80369-7:2021 | When tested in accordance with the testmethod, there shall be no leakagesufficient to form a falling drop of water. | Pass |
| 9 | Size of theMurphy Eye | ISO 5361:2016 | The area of the Murphy eye shall be notless than 80 % of the cross-sectional areaderived from the minimuminsidediameter for that size tube. | Pass |
| 10 | Security ofConstructionof connectioncomponants | / | When tested in accordance with the testmethod, the force required to detach anycomponent permanently attached to theshaft shall be not less than that specifiedin standard. | Pass |
| 11 | 15mmconnector | ISO5356-1:2004 | When tested in accordance with the testmethod, 15mm conical connectors shallcomply with the ISO5356-1. | Pass |
| 12 | Colour Coding | ISO16628:2008 | When tested in accordance with the testmethod, the color coding of bronchial cuffand its pilot balloon were entirelycoloured blue. | Pass |
| 13 | Segmentdifferentiationof the trachealsegment andthe bronchialsegments | ISO16628:2008 | When tested in accordance with the testmethod, the segment differentiation of thetracheal segment and the bronchialsegments were clearly distinguished. | Pass |
| 14 | Test forballoondiameter toinflationpressure | ISO10555-4:2013 | When tested in accordance with the testmethod, can reflect the relationshipbetween balloon diameter and inflationpressure. | Pass |
| 15 | Cuff thickness | / | When tested in accordance with the testmethod, the cuff thickness shall meet therequirements on size and tolerances. | Pass |
| 15 | Cuff burstpressure | / | When tested in accordance with the testmethod, the brust pressure of the cuffshall 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 (<24 hours).
Biological endpoints testing should be considered as following:
Cytotoxicity -
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- -Sensitization
- -Irritation (intracutaneous reactivity)
In addition, the Disposable Double Lumen Endobronchial Tube is classified as a breathing gaspathway device, biocompatibility evaluation of breathing gas pathways is performed in accordance with ISO 18562-1:2017 including ISO 10993-17:2002.
Based on the device categorization, the following biological effects were evaluated for the Disposable Double Lumen Endobronchial Tube.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 |
| 2 | Intracutaneous test | ISO 10993-10:2010 |
| 3 | Skin Sensitization | ISO 10993-10:2010 |
1), General Biocompatibility (ner ISO 10903-1)
2) Biocompatibility of Breathing Gas Pathways (per ISO 18562-1)
| No. | Test Items | Standards |
|---|---|---|
| 1 | Particulate Matter Emissions | ISO 18562-2:2017 |
| 2 | Volatile Organic Compounds (VOCs) Emissions | ISO 18562-3:2017 |
| 3 | Leachable in Condensate | ISO 18562-4:2017 |
| 4 | Biological Risk Evaluation Report | ISO 18562-1:2017 |
Biocompatibility was completed on the Disposable Double Lumen Endobronchial Tube according to the following standards:
- 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
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible. All evaluation acceptance criteria were met.
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Conclusions Drawn from the Non-Clinical Testing
The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicate and support a determination of substantial equivalence.
9. Clinical Testing and animal testing
Clinical and animal testing were not performed for Disposable Double Lumen Endobronchial Tube as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Disposable Double Lumen Endobronchial Tube, did not require clinical and animal studies to support substantial equivalence.
10. Conclusion
The Disposable Double Lumen Endobronchial Tube is substantially equivalent to predicate device Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable(K203749). Based on the indications for use, principle of operation, performance characteristics, and technological characteristics, the proposed Disposable Double Lumen Endobronchial Tube is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable(K203749).
§ 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).