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.

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.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Endotracheal Tube and Reinforced Endotracheal Tube manufactured by Zhanjiang Star Enterprise Co., Ltd. This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving novel effectiveness.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices are based on compliance with international standards, primarily ISO 5361: 2012 for performance and ISO 10993-1 (and #G95-1) for biocompatibility. The reported device performance is that the "endotracheal tubes meet the requirement of ISO 5361" and that "all of the results meet the acceptance criteria" for shelf-life testing. The devices also passed various biocompatibility tests.

Table of Acceptance Criteria and Reported Device Performance:

Category	Acceptance Criteria (Standard / Test)	Reported Device Performance
General Performance	ISO 5361: 2012 (Tracheal tubes) - covering items such as: 1. Size designation 2. Dimensions (ID, OD, connectors, machine and patient ends, opening) 3. Tracheal tube bevel (angle, free from sharp edges) 4. Tracheal tubes cuffs (tube collapse, free of sharp edges) 6. Inflating system for cuffs (OD, angle, pilot balloon) 7. Curvature of the tube (radius, maintain intended shape) 8. Kink resistance 9. Additional requirement for Murphy eye 10. Sterility assurance 11. Marking	"The results showed that the endotracheal tubes meet the requirement of ISO 5361." "The testing results demonstrate that the proposed devices meet the requirements of the standards listed above." (Referencing ISO 5361:2012 for the proposed device and ISO 5361:1999 for the predicate for reinforced ETT)
Biocompatibility	#G95-1 and ISO 10993-1 - covering tests such as: 1. In Vitro Cytotoxicity 2. Skin Sensitization 3. Oral mucosa Irritation 4. Oral mucosa Prolonged Irritation 5. Genotoxicity Test 6. Implantation Test 7. Acute Systemic Toxicity Test 8. Subchronic Systemic Toxicity Test 9. Endotoxin Test 10. Pyrogen 11. EO and ECH Residual Test 12. DEHP Residual Test	"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,...There is no additional risk for the proposed products when compared with the predicate devices. The Biocompatibility testing show below: [list of all tests mentioned as passed]"
Shelf Life	Package integrity and physical performance after accelerated aging	"all of the results meet the acceptance criteria. Therefore, the product has a shelf life of 5 years was proved."
Sterilization	ISO 11135-1:2007 (Ethylene oxide sterilization) - covering: Sterilization validation, bioburden test, product sterility test, Biological Indicators (BI) sterility test	"The sterilization validation was conducted according to ISO 11135-1:2007... The sterilization validation, bioburden test, product sterility test, and Biological Indicators (BI) sterility test were conducted." (Implies successful completion and meeting of criteria)

Breakdown of Study Information:

2. Sample size used for the test set and the data provenance:

The document primarily describes non-clinical performance testing, which involves testing device samples against specified technical standards and biocompatibility requirements. It does not refer to a "test set" in the context of a clinical study or expert review of data from patients.
Data Provenance: The tests (physical performance, biocompatibility, shelf-life, sterilization) were performed on samples of the manufactured devices. The origin of the data is from these laboratory evaluations and not from patient data from a specific country or retrospective/prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of studies described. The "ground truth" for these tests is defined by the requirements of the international standards (e.g., ISO 5361, ISO 10993). Experts are typically involved in setting these standards and conducting the laboratory tests, but there's no mention of a specific ground truth established by a panel of experts for a clinical test set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations to resolve discrepancies among multiple expert readers. This document describes laboratory and bench testing against pre-defined technical standards.

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:

No, an MRMC comparative effectiveness study was not done. This document is for an endotracheal tube, a physical medical device, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, a standalone algorithm performance study was not done. This product is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For performance testing (ISO 5361), the ground truth is defined by the specifications and measurement tolerances provided within the ISO standard. This involves objective physical measurements and functional evaluations.
For biocompatibility testing (ISO 10993), the ground truth is established by biological test methods and criteria outlined in the standard, which assess the device's interaction with biological systems through various assays (cytotoxicity, irritation, sensitization, etc.).
For shelf-life and sterilization testing, the ground truth is based on pre-established quality parameters and microbial inactivation levels as defined by the relevant standards (e.g., ISO 11135-1).

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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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

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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 (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

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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.

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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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, NanshanDistrict,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 withISO 5361: 2012.Biocompatibility tests were done in conformancewith relevant requirements of ISO10993.

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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 withISO 5361: 2012.Biocompatibility tests were done in conformancewith 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

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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.

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 TubeK140228
Classification	II21 CFR 868.5730BTR	II21 CFR 868.5730BTR
Indications for use	The Endotracheal tube isintended for oral or nasalintubation and for airwaymanagement.	Disposable endotracheal tube isintended for oral or nasalintubation and for airwaymanagement.
Structure andcomposition	The uncuffed tube:1. Main tube2. ConnectorThe cuffed tube:1. Main tube2. Cuff	The tracheal tube without a cuff:1. Tubular body2. Standard connectorThe cuffed tracheal tube:1. Tubular body2. Cuff
	3. Inflating system (containsinflating tube, valve andpilot balloon)	3. One-way valve4. Pilot balloon5. Inflating tube6. Standard connector
Specifications	1. Cuffed Endotracheal tubes: 2.5mm-10.0mm;2. Uncuffed Endotrachealtubes: 2.0mm-10.0mm	1. Cuffed Endotracheal tubes: 2.0mm-10.0mm;2. Uncuffed Endotrachealtubes: 2.0mm-10.0mm
Materials	The products are primarilymade from polyvinyl chloride(PVC) materials.	The disposable tracheal tubesare made from polyvinyl chloridematerial (PVC).
Mechanism ofaction	The Endotracheal tubeintubation is the first aid basicoperation of severe surgicaland ICU departments. Thebasic principle is inserting theEndotracheal tube through themouth, throat into the patient'strachea and to build artificialrespiration channel to ensurepatient breathes smoothly. Thesingle use endotracheal tubehas a smooth surface, andthere is little mucosal injury forthe trachea.	As the device functions in airwaymanagement/gas transport foranesthesia or resuscitation, it isrequired to be flexible andresistant to kinking. The airwaymanagement of patients isachieved by inserting theendotracheal tube into tracheathrough oral or nasal intubation.
Biocompatibility	The proposed device isconsidered as externalcommunicating device incontact with tissue less than 30days, and evaluation wasconducted in accordance with#G95-1 and ISO 10993-1,which contains:1. In Vitro Cytotoxicity2. Skin Sensitization3. Oral mucosa Irritation4. Oral mucosa ProlongedIrritation5. Genotoxicity Test6. Implantation Test7. Acute Systemic ToxicityTest	The device is considered asexternal communicating devicein contact with tissue withcumulative contact up to 24hours, and evaluation wasconducted in accordance with#G95-1 and ISO 10993-1. Thebattery of testing included thefollowing tests:1. Cytotoxicity2. Sensitization3. Irritation
	8. Subchronic SystemicToxicity Test
	9. Endotoxin Test
	10. Pyrogen
	11. EO and ECH Residual Test
	12. DEHP Residual Test
Sterilization	Ethylene Oxide	Ethylene Oxide
Performance	The performance ofthe endotracheal tubes wasevaluated in accordance withISO 5361: 2012. The testingitems contain:	Essential performance ofthe shaft of the tube areevaluated according to thefollowing standard respectively:-ISO 5361: 2012The testing items contain:
	1. Size designation;	1. Size designation;
	2. Dimensions (including basicdimensions, inside diameter,outside diameter, trachealtubes connectors, machineend, inside diameter of themachine end, patient end,opening at the patient end);	2. Dimensions (including basicdimensions, inside diameter,outside diameter, tracheal tubesconnectors, machine end, insidediameter of the machine end,patient end, opening at thepatient end);
	3. Tracheal tube bevel(including angle of bevel, freefrom sharp edges);	3. Tracheal tube bevel (includingangle of bevel, free from sharpedges);
	4. Tracheal tubes cuffs(including tube collapse, free ofsharp edges);	4. Tracheal tubes cuffs(including tube collapse, free ofsharp edges);
	6. Inflating system for cuffs(including outside diameter,angle between the inflatingtube and at the tracheal tube atthe point of separation, pilotballoon);	6. Inflating system for cuffs(including outside diameter,angle between the inflating tubeand at the tracheal tube at thepoint of separation, pilotballoon);
	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 forMurphy eye;	9. Additional requirement forMurphy eye;
	10. Sterility assurance;	10. Sterility assurance;
	11. Marking.The results showed that theendotracheal 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.

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

Items	The proposed device-Reinforced Endotrachealtube	The predicate device-BEVER™ ReinforcedEndotracheal TubeK111406
Classification	II21 CFR 868.5730BTR	II21 CFR 868.5730BTR
Indications foruse	The Reinforced Endotrachealtube is intended for airwaymanagement by oral or nasalintubation of the trachea duringanesthesia. It is a deviceinserted into the tracheathrough the mouth or nose tofacilitate breathing and it maybe used where the patient'sneck is likely to be moved offlexed or the patient is in theprone position so that anon-reinforced tracheal tubemight become kinked.	The BEVER™ ReinforcedEndotracheal Tube is indicatedfor airway management by oralor nasal intubation of the tracheaduring anesthesia. The productmay be used where the patient'sneck is likely to be moved orflexed or the patient is in theprone position so that anon-reinforced tracheal tubemight become kinked.
Structure andcomposition	The cuffed tube:1. Main tube2. Cuff3. Inflating system (containsinflating tube, valve andpilot balloon)4. Reinforced stainless steelThe uncuffed tube:1. Main tube2. Reinforced stainless steel	The cuffed tube:1. Main tube2. Cuff3. Inflating system (includinginflating tube, valve and pilotballoon)4. Steel reinforcement5. Standard connectorThe uncuffed tube:1. Main tube2. Steel reinforcement3. Standard connector
Specifications	Reinforced cuffed/uncuffedEndotracheal tubes: 3.0mm-	1. Cuffed BEVER™ ReinforcedEndotracheal tubes:
	9.0mm	3.0mm-10.0mm;
		2. UncuffedBEVERTM Reinforced
		Endotracheal tubes:
		2.0mm-7.0mm
Materials	The products are primarilymade from polyvinyl chloride(PVC) materials, and thereinforced stainless steel ismade by stainless steel.	Tube is made of PVC materialand stainless steel wire.
Mechanism ofaction	The Reinforced Endotrachealtube intubation is the first aidbasic operation of severesurgical and ICU departments.The basic principle is insertingthe tube through the mouth,throat into the patient's tracheaand to build artificial respirationchannel to ensure patientbreathes smoothly. The tubehas a smooth surface, andthere is little mucosal injury forthe trachea. The additionalmetal wire spiral reinforcementto provide kink-resistance.	The BEVERTM ReinforcedEndotracheal Tube is anEndotracheal tube withadditional metal wire spiralreinforcement to providekink-resistance. The product istypically used during operationswhere a high degree of flexibilityis required from the tube, forinstance prone position, headand neck surgery, and oralsurgery, which is indicated forairway management by oral ornasal intubation of the tracheaduring anesthesia.
Biocompatibility	The proposed device isconsidered as externalcommunicating device incontact with tissue less than 30days, and evaluation wasconducted in accordance with#G95-1 and ISO 10993-1,which contains:1. In Vitro Cytotoxicity2. Skin Sensitization3. Oral mucosa Irritation4. Oral mucosa ProlongedIrritation5. Genotoxicity Test6. Implantation Test7. Acute Systemic Toxicity	Biocompatibility testing wasperformed based on ISO 10993standards. The subject devicepassed the followingbiocompatibility testing:1. Cytotoxicity2. Sensitization3. Irritation4. Genotoxicity5. 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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Endotracheal tube/Reinforced Subject product: Endotracheal tube

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The results showed that theendotracheal tubes meet therequirement of ISO 5361.	BEVER™ ReinforcedEndotracheal tubes areconformed to ISO 5361: 1999.
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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.

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).