Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, materials, and standard performance testing of an endotracheal tube, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes.
The device facilitates breathing and airway management, which are therapeutic interventions for patients.

Diagnostic

No
The endotracheal tube is described as a device used for airway management and breathing assistance during intubation, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of PVC and stainless steel, and the performance studies focus on material properties, sterilization, and physical performance according to ISO standards, indicating a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for oral or nasal intubation and airway management. This is a direct intervention on the patient's body to facilitate breathing, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The description details a tube inserted into the trachea to manage airflow. It does not describe any components or functions related to analyzing biological samples.
Performance Studies: The performance studies focus on physical properties, sterilization, biocompatibility, and shelf life of the device itself, not on the accuracy or reliability of a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic/supportive purpose (airway management).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 prone position so that a non-reinforced tracheal tube might become kinked.

Product codes (comma separated list FDA assigned to the subject device)

BTR

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Trachea

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data

Shelf life test: After accelerated aging, the package integrity and physical performance of the proposed devices were tested, and all of the results meet the acceptance criteria. Therefore, the product has a shelf life of 5 years was proved.
EO sterilization validation: The sterilization validation was conducted according to ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The sterilization validation, bioburden test, product sterility test, and Biological Indicators (BI) sterility test were conducted.
Biocompatibility test: The Endotracheal tubes have been subjected to biocompatibility studies to demonstrate the biocompatibility of the device. The biocompatibility studies were evaluated in accordance with #G95-1 and ISO 10993-1. There is no additional risk for the proposed products when compared with the predicate devices. The Biocompatibility testing show below: In Vitro Cytotoxicity, Skin Sensitization, Oral mucosa Irritation, Oral mucosa Prolonged Irritation, Genotoxicity Test, Implantation Test, Acute Systemic Toxicity Test, Subchronic Systemic Toxicity Test, Endotoxin Test, Pyrogen, EO and ECH Residual Test, DEHP Residual Test.
Performance test: The performance of the endotracheal tubes was evaluated in accordance with ISO 5361: 2012. The results showed that the endotracheal tubes meet the requirement of ISO 5361, which also demonstrated comparable results between the proposed devices and predicate devices.

Clinical Performance Data
As Endotracheal tubes have been on the global markets for many years already (including cuffed/uncuffed normal and reinforced endotracheal tubes), there is enough evidence to demonstrate substantial equivalence for the device. Therefore, there was no clinical testing needed for supporting the device as the indications for use is equivalent to the predicate device. In the substantial equivalence of the device, the detail information of non-clinical testing would be supported.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140228, K111406

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

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.
R. CHINA
Post Code	524094
Phone No.	86-759-2701619
Fax No.	86-759-2706838
Contact Person	Rongsheng Tang
Email	Tangrs@starcompany.com.cn
Date Prepared	01/19/2017

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, No.55 Shizhou Middle Road, Nanshan
District,
Shenzhen,
Guangdong,
P.R.China
Image	Image: Company Logo
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Jessie You; Field Fu
Email	Jessie@cefda.com; cefda13485@163.com

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
ISO 5361: 2012.
Biocompatibility tests were done in conformance
with relevant requirements of ISO10993.

4

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
ISO 5361: 2012.
Biocompatibility tests were done in conformance
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,
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

5

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-
Endotracheal tube | The predicate device-
Disposable Tracheal Tube
K140228 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II
21 CFR 868.5730
BTR | II
21 CFR 868.5730
BTR |
| Indications for use | The Endotracheal tube is
intended for oral or nasal
intubation and for airway
management. | Disposable endotracheal tube is
intended for oral or nasal
intubation and for airway
management. |
| Structure and
composition | The uncuffed tube:

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

6

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8

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

| Items | The proposed device-
Reinforced Endotracheal
tube | The predicate device-
BEVER™ Reinforced
Endotracheal Tube
K111406 | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Classification | II
21 CFR 868.5730
BTR | II
21 CFR 868.5730
BTR | |
| Indications for
use | 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. | The BEVER™ Reinforced
Endotracheal Tube is indicated
for airway management by oral
or nasal intubation of the trachea
during anesthesia. The product
may be used where the patient's
neck is likely to be moved or
flexed or the patient is in the
prone position so that a
non-reinforced tracheal tube
might become kinked. | |
| Structure and
composition | The cuffed tube:

Main tube
Cuff
Inflating system (contains
inflating tube, valve and
pilot balloon)
Reinforced stainless steel
The uncuffed tube:
Main tube
Reinforced stainless steel | The cuffed tube:
Main tube
Cuff
Inflating system (including
inflating tube, valve and pilot
balloon)
Steel reinforcement
Standard connector
The uncuffed tube:
Main tube
Steel reinforcement
Standard connector | |
| Specifications | Reinforced cuffed/uncuffed
Endotracheal tubes: 3.0mm- | 1. Cuffed BEVER™ Reinforced
Endotracheal tubes: | |
| | 9.0mm | 3.0mm-10.0mm; | |
| | | 2. Uncuffed
BEVERTM Reinforced | |
| | | Endotracheal tubes: | |
| | | 2.0mm-7.0mm | |
| Materials | The products are primarily
made from polyvinyl chloride
(PVC) materials, and the
reinforced stainless steel is
made by stainless steel. | Tube is made of PVC material
and stainless steel wire. | |
| Mechanism of
action | The Reinforced Endotracheal
tube intubation is the first aid
basic operation of severe
surgical and ICU departments.
The basic principle is inserting
the tube through the mouth,
throat into the patient's trachea
and to build artificial respiration
channel to ensure patient
breathes smoothly. The tube
has a smooth surface, and
there is little mucosal injury for
the trachea. The additional
metal wire spiral reinforcement
to provide kink-resistance. | The BEVERTM Reinforced
Endotracheal Tube is an
Endotracheal tube with
additional metal wire spiral
reinforcement to provide
kink-resistance. The product is
typically used during operations
where a high degree of flexibility
is required from the tube, for
instance prone position, head
and neck surgery, and oral
surgery, which is indicated for
airway management by oral or
nasal intubation of the trachea
during anesthesia. | |
| Biocompatibilit
y | The proposed device is
considered as external
communicating device in
contact with tissue less than 30
days, and evaluation was
conducted in accordance with
#G95-1 and ISO 10993-1,
which contains:
In Vitro Cytotoxicity
Skin Sensitization
Oral mucosa Irritation
Oral mucosa Prolonged
Irritation
Genotoxicity Test
Implantation Test
Acute Systemic Toxicity | Biocompatibility testing was
performed based on ISO 10993
standards. The subject device
passed the following
biocompatibility testing:
Cytotoxicity
Sensitization
Irritation
Genotoxicity
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 | | sharp edges); |
| | (including outside diameter, | | 6. Inflating tubes for cuffs |
| | angle between the inflating | | (including outside diameter, |
| | tube and at the tracheal tube at | | angle between the inflating tube |
| | the point of separation, pilot | | and at the tracheal tube at the |
| | balloon); | | point of separation, pilot |
| | 7. Curvature of the | | balloon); |
| | tube(including radius of | | 7. Curvature of the tube |
| | curvature, | | (including radius of curvature, |
| | maintain intended shape); | | maintain intended shape); |
| | 8. Kink resistance; | | 8. Kink resistance; |
| | 9. Additional requirement for | | 9. Additional requirement for |
| | Murphy eye (Size and | | Murphy eye (Size and location); |
| | location); | | 10. Sterility assurance; |
| | 10. Sterility assurance; | | 11. Marking. |
| | 11. Marking. | | The results showed that |

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10

Endotracheal tube/Reinforced Subject product: Endotracheal tube

Version: A/0

11

Version: A/0

| The results showed that the
endotracheal tubes meet the
requirement of ISO 5361. | BEVER™ Reinforced
Endotracheal tubes are
conformed to ISO 5361: 1999. |

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

8. Non-Clinical Performance Data

8.1 Shelf life test

After accelerated aging, the package integrity and physical performance of the proposed devices were tested, and all of the results meet the acceptance criteria. Therefore, the product has a shelf life of 5 years was proved.

8.2 EO sterilization validation

The sterilization validation was conducted according to ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The sterilization validation, bioburden test, product sterility test, and Biological Indicators (BI) sterility test were conducted.

8.3 Biocompatibility test

The Endotracheal tubes have been subjected to biocompatibility studies to demonstrate the biocompatibility of the device. The biocompatibility studies were evaluated in accordance with #G95-1 and ISO 10993-1. There is no additional risk for the proposed products when compared with the predicate devices. The Biocompatibility testing show below: In Vitro Cytotoxicity Skin Sensitization Oral mucosa Irritation Oral mucosa Prolonged Irritation

Genotoxicity Test Implantation Test Acute Systemic Toxicity Test Subchronic Systemic Toxicity Test Endotoxin Test Pyrogen
EO and ECH Residual Test

DEHP Residual Test

8.4 Performance test

The performance of the endotracheal tubes was evaluated in accordance with ISO 5361: 2012. The results showed that the endotracheal tubes meet the requirement of ISO 5361, which also demonstrated comparable results between the proposed devices and predicate devices.

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9. Clinical Performance Data

As Endotracheal tubes have been on the global markets for many years already (including cuffed/uncuffed normal and reinforced endotracheal tubes), there is enough evidence to demonstrate substantial equivalence for the device. Therefore, there was no clinical testing needed for supporting the device as the indications for use is equivalent to the predicate device. In the substantial equivalence of the device, the detail information of non-clinical testing would be supported.

10. Statement of Substantial Equivalence

The Indications for Use and technological characteristics for Endotracheal tubes and Reinforced Endotracheal tubes are same to the referenced predicate devices (K140228 and K111406). The non-clinical performance testing demonstrates that the proposed devices are as safe and as effective as the predicate devices. Therefore, the results show that it is Substantially Equivalent (SE) between products and predicate devices.