K Number

Device Name

Disposable Endobronchial Blocker Tube

Manufacturer

Shenzhen Insighters Medical Technology Co., Ltd.

Date Cleared

2023-12-14

(111 days)

Product Code

CBI

Regulation Number

868.5740

Intended Use

The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only. Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

Device Description

The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor. The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced. The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits. The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093888

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical components and function of a disposable medical device for lung isolation, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as isolating the left or right lung for procedures requiring one-lung ventilation, such as surgery and anesthesia, which directly treats or manages a medical condition.

Diagnostic

Explanation: The device is intended to isolate a lung for procedures requiring one-lung ventilation, surgery, or anesthesia. It is a therapeutic/interventional device used to manage airflow in the respiratory system, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as a blocker catheter, cuff, connectors, and valve, indicating it is a hardware device. There is no mention of software as a primary or standalone component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Disposable Endobronchial Blocker Tube is a medical device used directly within the patient's body to physically isolate a lung for surgical or ventilation purposes. It does not analyze biological samples.
Intended Use: The intended use clearly describes a procedure performed on the patient's respiratory system, not the analysis of a sample.

Therefore, this device falls under the category of a surgical or respiratory medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocker Tube is indicated for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.

Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.

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

CBI

Device Description

The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced.

The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.

The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bronchus, Left or right lung

Indicated Patient Age Range

infants populations; children populations; adults use only.

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 tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Performance Testing:
- Nonclinical functional performance testing was performed in accordance with: ISO 5361:2016 Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors
- Non clinical tests were conducted to verify that the proposed device met all design specifications. The test provided in this submission include:
  - Dimensions
  - Cuff Resting Diameter
  - Cuff herniation
  - Cuff seal
  - Bond strength
  - Liquid leakage of one way valve
  - Air leakage of one way valve
  - Seal test
- Testing datas and results are included in this submission, and demonstrated that the Disposable Endobronchial Blocker Tube meets all the pre-determined testing and acceptance criteria.
Biocompatibility:
- The contact duration of the proposed device Disposable Endobronchial Blocker Tube is less than 24 hours. According to ISO 10993-1:2018 Annex A Table A.1 and FDA Biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" published on June 16, 2016, the Disposable Endobronchial Blocker Tube is considered a Surface Device that comes in contact with the Skin for limited exposure (

Regulation Number and Section

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).

Summary

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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2023

Shenzhen Insighters Medical Technology Co., Ltd. Kevin Huang Official Correspondent The 13th floor of Hengtemei Building Ganli Road No.3 Shenzhen, Guangdong 518000 China

Re: K232580

Trade/Device Name: Disposable Endobronchial Blocker Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: November 3, 2023 Received: November 6, 2023

Dear Kevin Huang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Disposable Endobronchial Blocker Tube

Indications for Use (Describe)

Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

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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Section 5: 510(k) Summary

Disposable Endobronchial Blocker Tube

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date of Preparation: November 3, 2023

1. Applicant:

510(k) Owner's Name: Shenzhen Insighters Medical Technology Co., Ltd. Address: The 13th floor of Hengtemei Building Ganli Road No.3 518000 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA Contact Person: Bonnie Fang Title: Regulatory Affairs Email: fangbaohong@insighters.cn Tel: +86 755-89313133 Fax: +86 755-84509803

2. Submission Correspondent:

Contact Person: Kevin Huang Email: Kevin huang1021@Sina.com Tel: +86-13602471659 Fax: +86-20- 84558599

3. Device Information

Device Name: Disposable Endobronchial Blocker Tube Common Name: Endobronchial Blocker Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Classification: II Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Product Code: CBI

4. Predicate Device

K093888— COOPDECH ENDOBRONCHIAL BLOCKER TUBE

5. Indications for Use

The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocker Tube is indicated for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.

Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

6. Device Description

The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.

Comparison between proposed device and predicate device
Comparison
Items	Proposed Device	Predicate Device	Discussion of
Differences
Devece Name	Disposable Endobronchial
Blocker Tube	COOPDECH ENDOBRONCHIAL
BLOCKER TUBE	Similar
510k Number	---	K093888	---
Product Code	CBI	CBI	Identical
Regulation
Number	21 CFR 868.5740	21 CFR 868.5740	Identical
Regulation
Name	Tracheal/Bronchial
Differential Ventilation Tube	Tracheal/Bronchial Differential
Ventilation Tube	Identical
Regulatory
Class	Class II	Class II	Identical
Classification
Name	Tube, Tracheal/Bronchial,
Differential Ventilation
(W/Wo Connector)	Tube, Tracheal/Bronchial, Differential
Ventilation (W/Wo Connector)	Identical
Indications for
Use	The
Disposable
Endobronchial
Blocker
Tube is
intended to
differentially
intubate a
patient's bronchus in order
to isolate the left or right
lung for procedures that
require
one-lung
ventilation.	The "COOPDECH ENDOBRONCHIAL
BLOCKER TUBE" is used to isolate the
left or right lung of a patient for surgery, one lung ventilation or one lung
anesthesia.	Identical
Patient
Population	Patients requiring one lung
isolation	Patients requiring one lung isolation.	Identical
Environment of
Use	Hospitals-OR and ICU	Hospitals-OR and ICU	Identical
Design Features	It is composed of blocker
catheter, cuff, three-way
connector, tube connector,	It consists of a bronchial blocker tube;
advanced through an endotracheal
catheter, and a joint connector,	Similar
		one-way valve (with a pilot balloon) and multi-functional adaptor.	connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
Lenth(mm)		600mm,695mm	300mm,400mm,500mm,600mm,700mm,800mm	Different. The length of predicated device includes size of the proposed device. This difference does not raise any new concerns of safety and effectiveness.
Tip Shape		Angled tip	Angled tip	Identical
Used in Conjunction with Endotracheal Tube		Yes	Yes	Identical
	Cuff	Polyurethane	Polyurethane
Patient Contact Materials	Blocker Catheter (Tube)	PA	Nylon	Similar
	Sterilization Method	EtO Sterilized	EtO Sterilized	Identical
Packaging		Peel pack comprises paper and film; Corrugated board outer case.	Peel pack comprises paper and film; Corrugated board outer case.	Identical
Use		Single Use, Disposable	Single Use, Disposable	Identical
Contact Duration		Less than 24h	Less than 24h	Identical
Biocompatibility		ISO 10993-1
Cytotoxicity
Skin Irritation
Sensitization	ISO 10993-1
Cytotoxicity
Irritation
Sensitization	Similar

7. Substantial Equivalence-Comparison to Predicate Devices

A side by side comparison of the proposed device and the predicate device are provided below.

Similarities Between Proposed and Predicate Devices

The proposed Disposable Endobronchial Blocker Tubes have the same technological characteristics as the predicate device(K093888— COOPDECH ENDOBRONCHIAL BLOCKER TUBE). The proposed and predicate device are based on the following same technological elements:

Same intended use
Same Indications for Use
· Same operating principals
Same patient population
Same Environment of Use
Composed of biocompatible materials
· Provided sterile for single-use

· Ethylene Oxide Sterilized

The proposed Disposable Endobronchial Blocker Tube described in this 510(k) has similar technological and performance characteristics to the predicate device. The proposed device is substantially equivalent in performance, indication for use, design and materials as to predicate device. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. The minor differences in the device do not introduce new issues of safety and efficacy. Changes or modifications to the device outside its intended use should not be done as this could affect the safety and effectiveness of the device.

Therefore, the proposed Disposable Endobronchial Blocker Tube are substantially equivalent to the COOPDECH ENDOBRONCHIAL BLOCKER TUBE(K093888). The proposed device has the same classification information, same indications for use and technological characteristics as compared to the predicate device.

8. Summary of Non-Clinical Performance Testing

1) Performance Testing

Performance testing was carried out to verify the safety and the effectiveness of the subject device.

Nonclinical functional performance testing was performed in accordance with:

ISO 5361:2016 Anaesthetic and Respiratory Equipment-Tracheal Tubes and Connectors

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test provided in this submission include:

· Dimensions
· Cuff Resting Diameter
· Cuff herniation
· Cuff seal
Bond strength
Liquid leakage of one way valve
Air leakage of one way valve
· Seal test

Testing datas and results are included in this submission, and demonstrated that the Disposable Endobronchial Blocker Tube meets all the pre-determined testing and acceptance criteria.

2) Biocompatibility

The contact duration of the proposed device Disposable Endobronchial Blocker Tube is less than 24 hours. According to ISO 10993-1:2018 Annex A Table A.1 and FDA Biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" published on

June 16, 2016, the Disposable Endobronchial Blocker Tube is considered a Surface Device that comes in contact with the Skin for limited exposure (