Endotracheal tube; Reinforced Endotracheal tube

K170234 · Zhanjiang Star Enterprise Co., Ltd. · BTR · Jan 17, 2018 · Anesthesiology

Device Facts

• Record ID: K170234
• Device Name: Endotracheal tube; Reinforced Endotracheal tube
• Applicant: Zhanjiang Star Enterprise Co., Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Jan 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endotracheal tube is intended for oral or nasal intubation and for airway management. The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved of flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

Device Story

Disposable endotracheal tubes (ETTs) and reinforced ETTs facilitate airway management and artificial ventilation. Standard ETTs consist of a PVC tube, connector, and optional cuff/inflation system; reinforced ETTs include a 304 stainless steel wire spiral for kink resistance. Used in ORs and ICUs by clinicians for oral or nasal intubation. Devices are inserted into the trachea to establish a patent airway. Cuffed variants provide a tracheal seal to route gases. Reinforced variants are used when patient positioning (e.g., prone, head/neck surgery) risks tube kinking. Devices are supplied sterile, single-use, and intended for short-term use (up to 30 days).

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), sterilization validation (ISO 11135-1), and performance testing (ISO 5361:2012) covering dimensions, cuff integrity, kink resistance, and mechanical properties.

Technological Characteristics

Materials: Polyvinyl chloride (PVC), 304 stainless steel (reinforced models). Sensing/Actuation: Passive airway management. Dimensions: 2.0mm-10.0mm ID (standard), 3.0mm-9.0mm ID (reinforced). Connectivity: None. Sterilization: Ethylene Oxide. Standards: ISO 5361:2012, ISO 10993-1, ISO 11135-1.

Indications for Use

Indicated for patients requiring airway management via oral or nasal intubation during anesthesia, artificial ventilation, or assisted breathing. Reinforced version indicated for patients where neck flexion or prone positioning risks tube kinking.

Regulatory Classification

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.

Predicate Devices

• Disposable Tracheal Tube (K140228)
• BEVERTM Reinforced Endotracheal Tube (K111406)

Submission Summary (Full Text)

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January 17, 2018

Zhanjiang Star Enterprise Co., Ltd % Jessie You Official Correspondent Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road Nanshan District Shenzhen, GD755 TW

Re: K170234

Trade/Device Name: Endotracheal Tube; Reinforced Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: November 15, 2017 Received: November 30, 2017

Dear Jessie You:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Tara A. Ryan -S 2018.01.17 06:29:26 -05'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170234

Device Name

Endotracheal tube / Reinforced Endotracheal tube

Indications for Use (Describe)

The Endotracheal tube is intended for oral or nasal intubation and for airway management.

The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved of flexed or the prone position so that a non-reinforced tracheal tube might become kinked.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Version: A/0

# VOL_006:001_510(k) Summary

## 1. Submission Sponsor

| Applicant Name | Zhanjiang Star Enterprise Co., Ltd |
|----------------|------------------------------------------------------------|
| Address | NO.1, West Jinhua Rd. Zhanjiang, Guangdong, P.<br>R. CHINA |
| Post Code | 524094 |
| Phone No. | 86-759-2701619 |
| Fax No. | 86-759-2706838 |
| Contact Person | Rongsheng Tang |
| Email | [e-mail] |
| Date Prepared | 01/19/2017 |

## 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|----------------------------------------------------------------------------------------------------|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District,<br>Shenzhen,<br>Guangdong,<br>P.R.China |
| Image | Image: Company Logo |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Jessie You; Field Fu |
| Email | [e-mail]; [e-mail] |

## 3. Devices Identification

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Trade name | Endotracheal tube |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Tracheal tube |
| Classification | II |
| Classification name | Tracheal tube |
| Regulation number | 21 CFR 868.5730 |
| Product code | BTR |
| 510(k) review panel | Anesthesiology |
| Performance standards | The performance was evaluated in accordance with<br>ISO 5361: 2012.<br>Biocompatibility tests were done in conformance<br>with relevant requirements of ISO10993. |

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Version: A/0

| Trade name | Reinforced Endotracheal tube |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Tracheal tube |
| Classification | II |
| Classification name | Tracheal tube |
| Regulation number | 21 CFR 868.5730 |
| Product code | BTR |
| 510(k) review panel | Anesthesiology |
| Performance standards | The performance was evaluated in accordance with<br>ISO 5361: 2012.<br>Biocompatibility tests were done in conformance<br>with relevant requirements of ISO10993. |

#### 4. Legally Marketed Predicate Devices

| Trade name | Disposable Tracheal Tube |
|-------------------|----------------------------------------------------|
| Regulation number | 21 CFR 868.5730 |
| Regulation name | Tracheal tube |
| Regulatory class | II |
| 510 (k) number | K140228 |
| Product code | BTR |
| Manufacturer | Suzhou Weikang Medical Apparatus Co., Ltd |
| Trade name | BEVERTM Reinforced Endotracheal Tube |
| Regulation number | 21 CFR 868.5730 |
| Regulation name | Tracheal tube |
| Regulatory class | II |
| 510 (k) number | K111406 |
| Product code | BTR |
| Manufacturer | Hangzhou Bever Medical Devices Company,<br>Limited |

### 5. Device Description

The Endotracheal tubes are used for oral or nasal intubation and for airway management, which are mainly for patients that require repeated anesthesia, artificial ventilation and assisted breathing. The Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway. The structure of Cuffed Endotracheal tube contains a main tube (patient end, machine end and murphy eye), cuff, and inflating system (including inflating tube, valve and pilot balloon). The uncuffed Endotracheal tube contains main tube (patient end, shaft and machine end). All variants have a Murphy eye. The products are primarily made from polyvinyl chloride (PVC) materials. The Endotracheal tubes are available in a number of sizes: the nominal inside

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diameter of uncuffed Endotracheal tubes are from 2.0mm to 10.0mm; the nominal inside diameter of cuffed Endotracheal tubes are from 2.5mm to 10.0mm. The Endotracheal tubes are disposable and are supplied sterile. The contact time should be no more than 30 days.

The reinforced Endotracheal tubes are a tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. The products are always used during operations where a high degree of flexibility is required from the tube. The reinforced Endotracheal tubes are also available in cuffed and uncuffed variants, and nominal inside diameter of both the uncuffed and cuffed reinforced Endotracheal tubes are from 3.0mm to 9.0mm. The only difference between reinforced Endotracheal tubes and Endotracheal tubes is the metal wire spiral inside the tube, which is made by 304 stainless steel and used for reinforcement that maintains the patency of the lumen.

## 6. Indications for Use Statement

The Endotracheal tube is intended for oral or nasal intubation and for airway management.

The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved of flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

## 7. Substantial Equivalence Discussion

| Table 1: Substantial equivalence comparison between Endotracheal tube and |
|---------------------------------------------------------------------------|
| Disposable Tracheal Tube. |

| Items | The proposed device-<br>Endotracheal tube | The predicate device-<br>Disposable Tracheal Tube<br>K140228 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II<br>21 CFR 868.5730<br>BTR | II<br>21 CFR 868.5730<br>BTR |
| Indications for use | The Endotracheal tube is<br>intended for oral or nasal<br>intubation and for airway<br>management. | Disposable endotracheal tube is<br>intended for oral or nasal<br>intubation and for airway<br>management. |
| Structure and<br>composition | The uncuffed tube:<br>1. Main tube<br>2. Connector<br>The cuffed tube:<br>1. Main tube<br>2. Cuff | The tracheal tube without a cuff:<br>1. Tubular body<br>2. Standard connector<br>The cuffed tracheal tube:<br>1. Tubular body<br>2. Cuff |
| | 3. Inflating system (contains<br>inflating tube, valve and<br>pilot balloon) | 3. One-way valve<br>4. Pilot balloon<br>5. Inflating tube<br>6. Standard connector |
| Specifications | 1. Cuffed Endotracheal tubes: 2.5mm-10.0mm;<br>2. Uncuffed Endotracheal<br>tubes: 2.0mm-10.0mm | 1. Cuffed Endotracheal tubes: 2.0mm-10.0mm;<br>2. Uncuffed Endotracheal<br>tubes: 2.0mm-10.0mm |
| Materials | The products are primarily<br>made from polyvinyl chloride<br>(PVC) materials. | The disposable tracheal tubes<br>are made from polyvinyl chloride<br>material (PVC). |
| Mechanism of<br>action | The Endotracheal tube<br>intubation is the first aid basic<br>operation of severe surgical<br>and ICU departments. The<br>basic principle is inserting the<br>Endotracheal tube through the<br>mouth, throat into the patient's<br>trachea and to build artificial<br>respiration channel to ensure<br>patient breathes smoothly. The<br>single use endotracheal tube<br>has a smooth surface, and<br>there is little mucosal injury for<br>the trachea. | As the device functions in airway<br>management/gas transport for<br>anesthesia or resuscitation, it is<br>required to be flexible and<br>resistant to kinking. The airway<br>management of patients is<br>achieved by inserting the<br>endotracheal tube into trachea<br>through oral or nasal intubation. |
| Biocompatibility | The proposed device is<br>considered as external<br>communicating device in<br>contact with tissue less than 30<br>days, and evaluation was<br>conducted in accordance with<br>#G95-1 and ISO 10993-1,<br>which contains:<br>1. In Vitro Cytotoxicity<br>2. Skin Sensitization<br>3. Oral mucosa Irritation<br>4. Oral mucosa Prolonged<br>Irritation<br>5. Genotoxicity Test<br>6. Implantation Test<br>7. Acute Systemic Toxicity<br>Test | The device is considered as<br>external communicating device<br>in contact with tissue with<br>cumulative contact up to 24<br>hours, and evaluation was<br>conducted in accordance with<br>#G95-1 and ISO 10993-1. The<br>battery of testing included the<br>following tests:<br>1. Cytotoxicity<br>2. Sensitization<br>3. Irritation |
| | 8. Subchronic Systemic<br>Toxicity Test | |
| | 9. Endotoxin Test | |
| | 10. Pyrogen | |
| | 11. EO and ECH Residual Test | |
| | 12. DEHP Residual Test | |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Performance | The performance of<br>the endotracheal tubes was<br>evaluated in accordance with<br>ISO 5361: 2012. The testing<br>items contain: | Essential performance of<br>the shaft of the tube are<br>evaluated according to the<br>following standard respectively:<br>-ISO 5361: 2012<br>The testing items contain: |
| | 1. Size designation; | 1. Size designation; |
| | 2. Dimensions (including basic<br>dimensions, inside diameter,<br>outside diameter, tracheal<br>tubes connectors, machine<br>end, inside diameter of the<br>machine end, patient end,<br>opening at the patient end); | 2. Dimensions (including basic<br>dimensions, inside diameter,<br>outside diameter, tracheal tubes<br>connectors, machine end, inside<br>diameter of the machine end,<br>patient end, opening at the<br>patient end); |
| | 3. Tracheal tube bevel<br>(including angle of bevel, free<br>from sharp edges); | 3. Tracheal tube bevel (including<br>angle of bevel, free from sharp<br>edges); |
| | 4. Tracheal tubes cuffs<br>(including tube collapse, free of<br>sharp edges); | 4. Tracheal tubes cuffs<br>(including tube collapse, free of<br>sharp edges); |
| | 6. Inflating system for cuffs<br>(including outside diameter,<br>angle between the inflating<br>tube and at the tracheal tube at<br>the point of separation, pilot<br>balloon); | 6. Inflating system for cuffs<br>(including outside diameter,<br>angle between the inflating tube<br>and at the tracheal tube at the<br>point of separation, pilot<br>balloon); |
| | 7. Curvature of the tube<br>(including radius of curvature,<br>maintain intended shape); | 7. Curvature of the tube<br>(including radius of curvature,<br>maintain intended shape); |
| | 8. Kink resistance; | 8. Kink resistance; |
| | 9. Additional requirement for<br>Murphy eye; | 9. Additional requirement for<br>Murphy eye; |
| | 10. Sterility assurance; | 10. Sterility assurance; |
| | 11. Marking.<br>The results showed that the<br>endotracheal tubes meet the | 11. Marking.<br>-ISO 11990-1: 2011 |
| requirement of ISO 5361. | The testing results demonstrate that the proposed devices meet the requirements of the standards listed above. | |

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Version: A/0

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| Table 2: Substantial equivalence comparison between Reinforced Endotracheal |
|-----------------------------------------------------------------------------|
| tube and BEVERTM Reinforced Endotracheal Tube. |

| Items | The proposed device-<br>Reinforced Endotracheal<br>tube | The predicate device-<br>BEVER™ Reinforced<br>Endotracheal Tube<br>K111406 | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Classification | II<br>21 CFR 868.5730<br>BTR | II<br>21 CFR 868.5730<br>BTR | |
| Indications for<br>use | The Reinforced Endotracheal<br>tube is intended for airway<br>management by oral or nasal<br>intubation of the trachea during<br>anesthesia. It is a device<br>inserted into the trachea<br>through the mouth or nose to<br>facilitate breathing and it may<br>be used where the patient's<br>neck is likely to be moved of<br>flexed or the patient is in the<br>prone position so that a<br>non-reinforced tracheal tube<br>might become kinked. | The BEVER™ Reinforced<br>Endotracheal Tube is indicated<br>for airway management by oral<br>or nasal intubation of the trachea<br>during anesthesia. The product<br>may be used where the patient's<br>neck is likely to be moved or<br>flexed or the patient is in the<br>prone position so that a<br>non-reinforced tracheal tube<br>might become kinked. | |
| Structure and<br>composition | The cuffed tube:<br>1. Main tube<br>2. Cuff<br>3. Inflating system (contains<br>inflating tube, valve and<br>pilot balloon)<br>4. Reinforced stainless steel<br>The uncuffed tube:<br>1. Main tube<br>2. Reinforced stainless steel | The cuffed tube:<br>1. Main tube<br>2. Cuff<br>3. Inflating system (including<br>inflating tube, valve and pilot<br>balloon)<br>4. Steel reinforcement<br>5. Standard connector<br>The uncuffed tube:<br>1. Main tube<br>2. Steel reinforcement<br>3. Standard connector | |
| Specifications | Reinforced cuffed/uncuffed<br>Endotracheal tubes: 3.0mm- | 1. Cuffed BEVER™ Reinforced<br>Endotracheal tubes: | |
| | 9.0mm | 3.0mm-10.0mm; | |
| | | 2. Uncuffed<br>BEVERTM Reinforced | |
| | | Endotracheal tubes: | |
| | | 2.0mm-7.0mm | |
| Materials | The products are primarily<br>made from polyvinyl chloride<br>(PVC) materials, and the<br>reinforced stainless steel is<br>made by stainless steel. | Tube is made of PVC material<br>and stainless steel wire. | |
| Mechanism of<br>action | The Reinforced Endotracheal<br>tube intubation is the first aid<br>basic operation of severe<br>surgical and ICU departments.<br>The basic principle is inserting<br>the tube through the mouth,<br>throat into the patient's trachea<br>and to build artificial respiration<br>channel to ensure patient<br>breathes smoothly. The tube<br>has a smooth surface, and<br>there is little mucosal injury for<br>the trachea. The additional<br>metal wire spiral reinforcement<br>to provide kink-resistance. | The BEVERTM Reinforced<br>Endotracheal Tube is an<br>Endotracheal tube with<br>additional metal wire spiral<br>reinforcement to provide<br>kink-resistance. The product is<br>typically used during operations<br>where a high degree of flexibility<br>is required from the tube, for<br>instance prone position, head<br>and neck surgery, and oral<br>surgery, which is indicated for<br>airway management by oral or<br>nasal intubation of the trachea<br>during anesthesia. | |
| Biocompatibilit<br>y | The proposed device is<br>considered as external<br>communicating device in<br>contact with tissue less than 30<br>days, and evaluation was<br>conducted in accordance with<br>#G95-1 and ISO 10993-1,<br>which contains:<br>1. In Vitro Cytotoxicity<br>2. Skin Sensitization<br>3. Oral mucosa Irritation<br>4. Oral mucosa Prolonged<br>Irritation<br>5. Genotoxicity Test<br>6. Implantation Test<br>7. Acute Systemic Toxicity | Biocompatibility testing was<br>performed based on ISO 10993<br>standards. The subject device<br>passed the following<br>biocompatibility testing:<br>1. Cytotoxicity<br>2. Sensitization<br>3. Irritation<br>4. Genotoxicity<br>5. Implantation | |
| | 8. Subchronic Systemic | | |
| | Toxicity Test | | |
| | 9. Endotoxin Test | | |
| | 10. Pyrogen | | |
| | 11. EO and ECH Residual Test | | |
| | 12. DEHP Residual Test | | |
| Sterilization | Ethylene Oxide | | Ethylene Oxide |
| Performance | The performance of | | The dimension, design, material, |
| | the endotracheal tubes was | | sterility, packaging and labeling |
| | evaluated in accordance with | | of BEVERTM Reinforced |
| | ISO 5361: 2012. The testing | | Endotracheal tubes are |
| | items contain: | | conformed with ISO 5361: 1999. |
| | 1. Size designation; | | The testing items contain: |
| | 2. Dimensions (including basic | | 1. Size designation; |
| | dimensions, inside diameter, | | 2. Dimensions (including basic |
| | outside diameter, tracheal | | dimensions, inside diameter, |
| | tubes connectors, machine | | outside diameter, tracheal tubes |
| | end, inside diameter of the | | connectors, machine end, inside |
| | machine end, patient end, | | diameter of the machine end, |
| | opening at the patient end); | | patient end, opening at the |
| | 3. Tracheal tube bevel | | patient end); |
| | (including angle of bevel, free | | 3. Tracheal tube bevel (including |
| | from sharp edges); | | angle of bevel, free from sharp |
| | 4. Tracheal tubes cuffs | | edges); |
| | (including tube collapse, free of | | 4. Tracheal tubes cuffs |
| | sharp edges); | | (including tube collapse, free of |
| | 6. Inflating system for cuffs |…