Endobronchial Tube

K152251 · Henan Tuoren Medical Device Co., Ltd. · CBI · Jun 10, 2016 · Anesthesiology

Device Facts

• Record ID: K152251
• Device Name: Endobronchial Tube
• Applicant: Henan Tuoren Medical Device Co., Ltd.
• Product Code: CBI · Anesthesiology
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5740
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Device Story

Endobronchial tube; double-lumen PVC tube with two cuffs; used to isolate left or right lung for surgery, one-lung ventilation, or anesthesia. Input: manual placement by clinician in hospital OR or ICU. Operation: tube inserted into trachea/bronchus; cuffs inflated to isolate lung; 15mm connectors attach to ventilation source. Output: isolated lung ventilation. Benefits: enables selective lung ventilation during thoracic surgery. Includes radiopaque line for X-ray detection; stylet and Carlens adapter included. Single-use, disposable.

Clinical Evidence

No clinical or animal data provided. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993) and mechanical performance testing (cuff diameter, collapse, herniation, seal, kink resistance, valve gauging, bond strength, and radiopacity).

Technological Characteristics

Materials: PVC. Design: Double-lumen tube with 2 cuffs, 15mm connectors, radiopaque line. Standards: ISO 5361 (cuffed tubes), ISO 5356-1 (connectors), ISO 8836 (suction catheters), ISO 10993 (biocompatibility). Sterilization: Ethylene Oxide (ISO 11135). Dimensions: 26Fr to 41Fr. Connectivity: None (mechanical).

Indications for Use

Indicated for patients undergoing surgical procedures requiring isolation of one lung for one lung ventilation or one lung anesthesia.

Regulatory Classification

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.

Predicate Devices

• Well LEAD Endobronchial Tubes (K092886)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol composed of three overlapping profiles facing right. The profiles are rendered in black and create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2016

Henan Tuoren Medical Device Co., Ltd C/O Long Yang COO Shenzhen Hlongmed Biotech Company R15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District, Shenzhen, Guangdong, 518054 China

Re: K152251 Trade/Device Name: Endobronchial Tube Models: Left: Fr26, Fr28, Fr31, Fr32, Fr33, Fr35, Fr37, Fr39, Fr41; Right: Fr26, Fr28, Fr31, Fr32, Fr33, Fr35, Fr37, Fr39, Fr41 Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: May 6, 2016 Received: May 12, 2016

Dear Long Yang:

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K152251

#### Device Name

Endobronchial Tube

Models: Left: Fr26, Fr31, Fr32, Fr33, Fr35, Fr37, Fr39, Fr41; Right: Fr26, Fr28, Fr33, Fr33, Fr33, Fr37, Fr39, Fr41

Indications for Use (Describe)

The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

TUOREN Henan Tuoren Medical Device Co., Ltd

## 510(k) Summary

(as required by 807.92(c))

The assigned 510(K) number is: K152251

Date of Summary: June 9, 2016

#### 1. Submitter information

Manufacturer Name: Henan Tuoren Medical Device Co., Ltd

Address: Weiyuan Industrial Zone, Menggang ,Changyuan Country, Henan, China

Establishment Registration Number: 3006984712

Contact Person and Title: Meizi Zhang/Manager of Registration Department

Tel: [phone]

Fax: [phone]

Email: [e-mail]

#### 2. Contact person

#### 2.1 Primary Contact Person

Long Yang (COO) Shenzhen Hlongmed Biotech Company R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### 2.2 Secondary Contact Person

Meizi Zhang(Manager of Registration Department) Henan Tuoren Medical Device Co., Ltd Tel: [phone]

#### 3. Device Classification

| Device Sponsor | Henan Tuoren Medical Device Co., Ltd |
|----------------|--------------------------------------|
|----------------|--------------------------------------|

{4}------------------------------------------------

| Trade/Device Name | Endobronchial Tube |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Model | Left: Fr26, Fr28, Fr31, Fr32, Fr33, Fr35, Fr37, Fr39, Fr41<br>Right: Fr26, Fr28, Fr31, Fr32, Fr33, Fr35, Fr37, Fr39, Fr41 |
| Common Name | Endobronchial Double Lumen Tube |
| Classification Name | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Regulatory Class | Class II |
| Classification regulation | 21CFR 868.5740 |
| Review Panel | Anesthesiology |
| Regulation Medical Specialty | Anesthesiology |
| Regulation Name | Tracheal/bronchial differential ventilation tube |
| Product Code | CBI |

## OREN Henan Tuoren Medical Device Co., Ltd

#### 4. Intended Use/ Indications for Use

The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

#### 5. Predicate Device

Well LEAD Endobronchial Tubes(K092886)

#### 6. Device Description

The Endobronchial Tube is made of Polyvinylchloride and is available in sizes 26fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray. Environments of use: Hospital-OR and ICU

#### 7. Substantial Equivalence

Henan Tuoren Medical Device Co., Ltd claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K092886. Henan Tuoren Medical

{5}------------------------------------------------

# TUOREN Henan Tuoren Medical Device Co., Ltd

Device Co.. Ltd claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix, the comparison matrix can be referred to the below table. The differences between subject device and the predicate device is just the size and packaging, these differences do not effect substantial equivalence, the analysis and justification is: For the size differences, all models of proposed devices comply to the same standard ISO 5361 compared to predicate devices. For the packaging differences, the multi-functional joint of proposed device comply to the same standard ISO 5356-1 compared to predicate devices, and the suction catheters of proposed devices comply to the same standard ISO 8836 compared to predicate devices..

{6}------------------------------------------------

| Item | Element Of Comparison | Proposed Device | Predicate Device | S/D* |
|------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| 1 | Classification Name | Tube, Tracheal/Bronchial, Differential Ventilation<br>(W/Wo Connector) | Tube, Tracheal/Bronchial, Differential Ventilation<br>(W/Wo Connector) | S |
| 2 | Regulatory Class | Class II | Class II | S |
| 3 | Classification regulation | 21CFR 868.5740 | 21CFR 868.5740 | S |
| 4 | Classification Panel | Anesthesiology | Anesthesiology | S |
| 5 | Product Code | CBI | CBI | S |
| 6 | Regulation Name | Tracheal/bronchial differential ventilation tube | Tracheal/bronchial differential ventilation tube | S |
| 7 | Indications<br>for<br>Use/Intended Use | Endobronchial Tubes is used to isolate the left or the<br>right lung of a patient for surgery,one lung ventilation<br>or one lung anesthesia. | The Well Lead Endobronchial Tubes is used to<br>isolate the left or the right lung of a patient for<br>surgery,one lung ventilation or one lung anesthesia. | S |
| 8 | Directions for Use | Prescription Use | Prescription Use | S |
| 9 | Patient Population | Patients undergoing surgical procedure requiring<br>isolation of one lung | Patients undergoing surgical procedure requiring<br>isolation of one lung | S |
| 10 | Patient contact Material | Tube-PVC and Cuff-PVC | Tube-PVC and Cuff-PVC | S |
| 11 | Size(Fr) | 26 to 41 French | 28 to 41 French | D, does not affect the<br>product performance |
| 12 | Design Features | Double lumen shaft, 2 cuffs, Stylet, Carlens adapter | Double lumen shaft, 2 cuffs, Stylet, Carlens adapter | S |
| 13 | Composition<br>of<br>Endobronchial Tubes | main tube, cuff, connector, inflating tube, valve, pilot<br>balloon | main tube, cuff, connector, inflating tube, valve,<br>pilot balloon | S |
| 14 | Angle of bevel | 70° | 70° | S |
| 15 | Radius of curvature | 140mm | 140mm | S |
| Item | Element Of Comparison | Proposed Device | Predicate Device | S/D* |
| 16 | Radiopaque line | Yes | Yes | S |
| 17 | Connection to ventilation<br>source | 15mm connector | 15mm connector | S |
| 18 | Shelf-life | 5 years | 5 years | S |
| 19 | Single Use<br>Single patient, disposable | Yes | Yes | S |
| 20 | Method of sterilization | Ethylene Oxide Sterilized per ISO 11135 | Ethylene Oxide Sterilized per ISO 11135 | S |
| 21 | The Sterility Assurance<br>Level | SAL 10-6 | SAL 10-6 | S |
| 22 | EO and ECH residual | The ethylene oxide residual is conform to ISO<br>10993:7 for Limited Exposure Devices of 4mg/day<br>for EO and 9/mg/day for ECH. | The ethylene oxide residual is conform to ISO<br>10993:7 for Limited Exposure Devices of 4mg/day<br>for EO and 9/mg/day for ECH. | S |
| 23 | Biocompatibility | 1.Cytotoxicity testing per 10993-5<br>2. Sensitization testing per ISO 10993-10<br>3.Irritation Test per ISO 10993-10<br>All the test passed. | 1. Cytotoxicity testing per 10993-5<br>2. Sensitization testing per ISO 10993-10<br>3. Irritation Test per ISO 10993-10<br>All the test passed. | S |
| 24 | Applied Standards | ISO 5361<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 11135<br>ISO 10993-7 | ISO 5361<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 11135<br>ISO 10993-7 | S |
| 25 | Packaging | Sterile, packed with a multi-functional joint and three<br>Suction Catheters | Sterile, packed with switch connector and two<br>suction catheters | D, does not affect the product performance |
| 26 | Environments of use | Hospital-OR and ICU | Hospital-OR and ICU | S |

{7}------------------------------------------------

{8}------------------------------------------------

# TUORen Henan Tuoren Medical Device Co., Ltd

#### 8. Product Performance Testing

All testing that is required by the required standards has been performed. Non-clinical testing was performed and included standards such as ISO 5361 and ISO 10993-1. The Endobronchial Tube have been found to fall within the required limits of the testing. The test results can be found in both the Biocompatibility (Section16) and the Performance Testing_Bench (Section19) of this submission. Therefore we have concluded that the Endobronchial Tube are substantially equivalent.

A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

| Type of Test | Referenced Standard | Test result |
|---------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| in vitro cytotoxicity | ISO10993-5:2009 | Under the conditions of using ISO10993-5: 2009<br>test method MTT method MEM extract, the test<br>article Endobronchial Tube extract showed no<br>potential toxicity to L-929 cells. |
| | | Under the conditions of using ISO10993-5: 2009<br>test method MTT method MEM with 10% FBS<br>extract, the test article Endobronchial Tube extract<br>showed no potential toxicity to L-929 cells. |
| Skin sensitization<br>Test using Guinea<br>Pig Maximization<br>test | ISO10993-10:2010 | Under the conditions of using ISO10993-10: 2010<br>test methods guinea pig maximization test 0.9%<br>sodium chloride injection extract, the test article<br>Endobronchial Tube extract showed no significant<br>evidence of causing skin sensitization in the guinea<br>pig; |
| | | Under the conditions of using ISO10993-10:2010<br>test methods guinea pig maximization test sesame<br>oil extract, the test article Endobronchial Tube<br>extract showed no significant evidence of causing<br>skin sensitization in the guinea pig; |

#### 1) Biocompatibility testing

{9}------------------------------------------------

| Type of Test | Referenced Standard | Test result |
|--------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Oral Mucosa<br>Irritation test | ISO10993-10:2010 | Under the conditions of using ISO10993-10:2010<br>test methods 0.9% sodium chloride extract, the test<br>result showed that the test article Endobronchial<br>Tube extract show no significant evidence of<br>causing oral irritation in the hamster.<br><br>Under the conditions of using ISO10993-10:2010<br>test methods sesame oil extract, the test result<br>showed that the test article Endobronchial Tube<br>extract show no significant evidence of causing<br>oral irritation in the hamster. |

# TUOREN Henan Tuoren Medical Device Co., Ltd

#### 2) Performance Testing

| Type of Bench Test | Reference standards | Acceptable Criteria | Pass/fail |
|----------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| cuff diameter | ISO 5361: 2012 | The maximum cuff diameter shall be within ± 0.5mm of the nominal value when tested according to ISO 5361 Annex B | Pass |
| cuffed tube collapse test | ISO 5361: 2012 | the steel ball shall pass freely through the tube when tested according to ISO 5361 Annex C | Pass |
| Cuff herniation test | ISO 5361: 2012 | no part of the inflated cuff shall reach beyond the nearest edge of the bevel when tested according to ISO 5361 Annex D | Pass |
| Seal testing | ISO 5361: 2012 | The leakage limit is ≤2.0ml/h at cuff pressures not to exceed 2,7 kPa (27 cmH2O) when tested according to ISO 5361 Annex G | Pass |
| / | | Sealing of cuff inflating system:<br>No air leakage happens under the condition of continuous 3kPa positive pressure imposition for 10 seconds | Pass |
| / | | Sealing of connector assembly:<br>No air leakage happens on any joints under the condition of continuous 6kPa gas pressure imposition to lumen of main tube(shaft) for 60 seconds. | Pass |
| inflating tube | ISO 5361: 2012 | The inflating tube shall have an outside diameter of not more than 3.0mm | Pass |
| | ISO 5361: 2012 | The angle between the inflating tube and the Endobronchial tube at the point of separation shall not exceed 45°. | Pass |
| Kink resistance test | ISO 5361: 2012 | the steel ball shall pass freely through the lumen of the tube when tested according to ISO 5361 Annex H | Pass |
| Gauging of One Way Valve | ISO 594/1 1986 | The plane of the maximum diameter at the opening of the female conical fitting of One Way Valve lie between the two limit planes of the gauge. | Pass |
| Liquid leakage of One Way Valve | ISO 594/1 1986 | no leakage sufficient to form a falling drop of water | Pass |
| Air leakage of One Way Valve | ISO 594/1 1986 | Continued formation of air bubbles not be evident | Pass |
| Separation force of One Way Valve | ISO 594/1 1986 | The conical fitting under test remain attached to the test fixture | Pass |
| Stress cracking | ISO 594/1 1986 | There shall be no evidence of stress cracking of the conical fitting | |
| Security of construction of suction catheter | ISO 8836-2007 | the force required to detach any component permanently attached to the shaft shall be not less than that specified in standard | Pass |
| Shaft resistant to negative pressure of suction catheter | ISO 8836-2007 | a vacuum source at 40kPa below ambient pressure for 15s at a temperature of 23°C ±2°C with the patient end occluded, the shaft shall not collapse | Pass |
| 15mm connector | ISO5356-1: 2004 | Comply with the ISO5356-1: 2004 | Pass |
| Burst Testing | / | Cuff burst: The volume of injected gas when cuff bursting happens is larger than 40ml during inflation of endobronchial tube<br>bursting between cuff and main tube:<br>There should be no fracture on junctions while inflated 30kpa gas. | Pass |
| Bond Strength | / | The joints of endobronchial tube should be firm bonding.When an axial force of 50±5N is applied at 50±5mm/min, the testing portion(between connector and | Pass |
| Henan Tuoren Medical Device Co., Ltd | | | |
| Air flow resistance | / | Pressure increment should no more than 0.2Kpa/h when testing the endobronchial tube under the specified flow rate(3, 6, 9L/min) | Pass |
| Radiopaque test | / | When exposing the Endobronchial tube with the low dose rays, the X-ray machine should have film development. | Pass |
| Endotoxin test | USP36_NF31<85> | 0.25EU/ml, 20EU/Device | Pass |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "TUORen" in blue font. The "O" in the word is a circle filled with a pattern of small dots. The font is sans-serif and the letters are connected.

TUORen Henan Tuoren Medical Device Co., Ltd

{11}------------------------------------------------

## TU●Ren Henan Tuoren Medical Device Co., Ltd

#### 9. Clinical Testing and animal testing

Clinical and animal testing were not performed for Endobronchial Tube as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Endobronchial Tube, did not require clinical and animal studies to support substantial equivalence.

### 10. Substantial Equivalence Conclusion

The information provided in the 510(k) submission is sufficient to demonstrate the substantial equivalence of subject device to the predicate device.