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 a mechanical endobronchial tube. There is no mention of AI, ML, image processing, or data-driven algorithms.

Therapeutic

Yes
The device is described as an Endobronchial tube intended for medical procedures like thoracic surgery and to provide selective inflation or deflation of lungs, which are therapeutic interventions.

Diagnostic

No

This device is designed for intubation and ventilation, specifically for isolating and ventilating one lung during surgical procedures. While it facilitates procedures that might follow a diagnosis, the device itself does not perform any diagnostic function. The ANKOR Cuff is mentioned for checking correct insertion, which is a functional verification, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical medical device (Endobronchial tube) made of silicone with multiple cuffs and a stylet, intended for surgical procedures. It is not software-only.

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 clearly describes a device used for surgical procedures (thoracic surgery, bronchospirometry, anesthesia administration) and ventilation (isolating and ventilating one lung). These are all procedures performed directly on or within the patient's body.
Device Description: The description details a physical tube with cuffs and connectors designed for insertion into the bronchus. This is a medical device used for a therapeutic or procedural purpose, not for analyzing samples from the body.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. The provided information does not mention any analysis of samples or diagnostic testing.

Therefore, this device falls under the category of a medical device used for surgical and ventilation purposes, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation of either lung.

Product codes

CBI

Device Description

ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

main stem bronchus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained Physicians / Hospital - OR and ICU

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 testing was performed and included standards such as ISO 16628, ISO 5356-1, ISO 5361, ISO 80369-7, ISO 8836. ISO 18562 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 and the Performance Testing of this submission. Therefore we have concluded that the subject device is substantially equivalent.

Biocompatibility (According to ISO 10993-1):

Cytotoxicity: Pass (Negative Control: reactivity of none; Positive Control: greater than mild)
Intracutaneous Reactivity: Pass (No observe skin responses such as the erythema, edema and etc.)
Sensitization: Pass (No induced any skin reaction in the Hartley guinea pig)

Biocompatibility of Breathing Gas Pathways (ISO 18562-1):

Emission Test of Particulate Matter (Including CO2, CO and Ozone): Pass (No increase the source gas concentration of particulates ≤2.5 µm aerodynamic diameter (PM2.5) more than 12 µg/m3; No increase the source gas of PM ≤ 10 µm diameter size (PM10) more than 150 µg/m3)
Volatile Organic Compounds (VOCs) Extraction Test: Pass (Unlikely to result in toxicological effects)

Risk Management: All risks were identified, evaluated, and controlled in accordance with ISO 14971:2007.

Sterilization Test: Performed according to ISO 11737-1:2018, ISO 11737-2:2009, and ISO 10993-7:2008.

Cleanroom Validation: Assured through verification of clean room validation in accordance with ISO 14644-1:2015.

Cleaning Validation: Contaminants and residues during the cleaning process were maintained continuously and consistently with acceptable numerical values through appearance test per manufacturer SOP and microbial test according to ISO 11737-1:2018.

Shelf-life Test:

Accelerated Aging Test: Pass (3 years)
Seal Strength: Pass (≥1.2 N/15mm after 3 years Accelerated aging device)
Sterile Barrier System Integrity (Dye Penetration): Pass (No leakage)
Sterility Test: Pass (No evidence of microbial growth)

Endotoxin Test: Pass (.

Performance Test:

Dimension Test (ISO 16628:2008): Pass
Colour Coding (ISO 16628:2008): Pass
Segment Differentiation (ISO 16628:2008): Pass
Tensile Strength: Pass (No damage to the connection when pulling for 15 seconds with a force of not less than 15 N)
Cuff Leakage Test: Pass (No leakage when put into the water)
Connector Bonding Strength (ISO 5356-1:2014): Pass (Hold the connector and tube vertically and do not separate from a force of 15 N or less when pulled.)
Cuff Resting Diameter (ISO 5361:2016): Pass
Tube Collapse (ISO 5361:2016): Pass
Cuff Herniation (ISO 5361:2016): Pass
Cuff burst pressure (Cuff Burst Evaluation): Pass (Do not damage at 90cmH2O pressure)
Cuff Bond Pressure (Cuff Bond Strength): Pass (ANKOR cuff: Must not be damaged at forces of 2.0 kgf or less; Bronchial cuff: Must not be damaged at forces of 1.0 kgf or less; Tracheal cuff: Must not be damaged at forces of 2.0 kgf or less.)
Bond strength testing of the joints of endobronchial tube: Pass (Do not damage at 90cmH2O pressure)
Liquid and Air leakage (ISO 80369-7:2016): Pass
Separation force of one way valve (ISO 80369-7:2016): Pass
Stress cracking (ISO 80369-7:2016): Pass
Radiopaque Test: Pass (The outline shall be clearly visible)
Dimension (ISO 8836:2014) (Suction catheter): Pass
Security of construction of suction catheter (Tensile Strength) (ISO 8836:2014): Pass
Shaft resistant to negative pressure of suction catheter (ISO 8836:2014): Pass

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

Not Found

Predicate Device(s)

K180253

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

December 28, 2020

Insung Medical Co., Ltd. % Dongha Lee Regulatory Affairs Consultant KMC.Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul. 08375 Korea, Republic Of

Re: K200968

Trade/Device Name: ANKOR Endobronchial Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: November 23, 2020 Received: November 27, 2020

Dear Dongha Lee:

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. 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 located 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.

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

1

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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Todd Courtney Assistant Director DHT1C: Division of ENT, 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

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Indications for Use

510(k) Number (if known) K200968

Device Name ANKOR endobronchial tube

Indications for Use (Describe)

This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation.

The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation of either lung.

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)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features green leaves above the word "INSUNG" in a bold, green font. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller, less bold font.

510(k) SUMMARY

This summary of 510(k) –safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Nov. 23, 2020

1. INFORMATION

1.1 Submitter Information

Submitter Name: INSUNG MEDICAL CO., LTD.
. Address

: 168, GIEOPDOSI-RO, JIJEONG-MYEON, WONJU-SI, GANGWON-DO, 26354, KOREA

. Telephone Number: +82-70-5077-0118

1.2 Contact Person

. Name: Milly (Consultant / KMC, Inc.)
. Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, Korea
Telephone Number: +82-70-8965-5554 . Fax: +82-2-2672-0579
. E-mail: milly@kmcerti.com

2. DEVICE INFORMATION

■ Trade Name / Proprietary Name	: ANKOR endobronchial tube
■ Model	: ABC33L, ABC35L, ABC37L, ABC39L,
ABC33R, ABC35R, ABC37R, ABC39R
HBC33L, HBC35L, HBC37L, HBC39L,
HBC33R, HBC35R, HBC37R, HBC39R
■ Common Name	: Endobronchial Double lumen tube
■ Classification Name	: Tube, Tracheal/Bronchial,
Differential Ventilation (W/Wo Connector)
■ Product Code	: CBI
■ Classification Regulation	: 21CFR 868.5740
■ Device Class	: Class II
■ Classification Panel	: Anesthesiology

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Image /page/4/Picture/2 description: The image contains a logo for INSUNG MEDICAL CO., LTD. The logo features the word "INSUNG" in large, bold, green letters. Above the word "INSUNG" are three green leaves. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller letters.

3. PREDICATE DEVICE

Predicate Device
Manufacturer	Teleflex Medical
Device Name (Trade Name)	Sheridan Endobronchial Tubes
510(k) Number	K180253

4. SUBJECT DEVICE DESCRIPTION

ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted.

ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter.

When user is lack of the experience or is not confidence with operation, ABC Model is intended to use.

When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226).

The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.

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Image /page/5/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features three green leaves at the top left, followed by the word "INSUNG" in large, bold, green letters. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller, thinner letters.

5. INTENDED USE

This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

6. SUBSTANTIAL EQUIVALENCE

ANKOR endobronchial tube is substantially equivalent to the predicate device (Endobronchial Tube; K180253). The following table is presented to demonstrate substantial equivalence.

| | Subject Device | Predicate Device
(K180253) | S/D |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Classification
Name | Tube, Tracheal/Bronchial,
Differential Ventilation
(W/Wo Connector) | Tube, Tracheal/Bronchial,
Differential Ventilation
(W/Wo Connector) | S |
| Product Code | CBI | CBI | S |
| Regulation
Number | 21CFR 868.5740 | 21CFR 868.5740 | S |
| Indications for Use | This device is intended for use in
thoracic surgery,
bronchospirometry,
administration of Endobronchial
anesthesia and other uses
commonly requiring
Endobronchial intubation.
The Endobronchial tube is
indicated for main stem bronchus
intubation and allows for selective
inflation or deflation of either
lung. | This device is intended for use in
thoracic surgery,
bronchospirometry,
administration of Endobronchial
anesthesia and other uses
commonly requiring
Endobronchial intubation.
The Endobronchial tube is
indicated for main stem bronchus
intubation and allows for selective
inflation or deflation of either
lung. | S |
| Environments of
Use | Hospital - OR and ICU | Hospital - OR and ICU | S |
| Direction for Use | Prescription Use | Prescription Use | S |
| Intended User | Trained Physicians | Trained Physicians | S |
| Patient Population | Patients requiring one-lung
isolation | Patients requiring one-lung
isolation | S |

S: Same, D: Different

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Image /page/6/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features the word "INSUNG" in large, bold, green letters. Above the word "INSUNG" are three green leaves. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller letters.

Design Features	Lumen Shaft, Cuffs, Stylet	Lumen Shaft, Cuffs, Stylet	S
Sizes (Fr; French)	33 to 39 French	28 to 41 French	D
Cuffed	Yes	Yes	S
Radiopaque	Yes	Yes	S
Connection to ventilation source	15mm Connector	15mm Connector	S
Single use	Single use	Single use	S
Sterilization (Method)	Yes
(EO Gas)	Yes
(EO Gas)	S
EO and ECH Residual	The ethylene oxide residual is conform to ISO 10993-7	The ethylene oxide residual is conform to ISO 10993-7	S
Package	Sterile, packed with Elbow connector and suction catheter	Sterile, packed with connector	D
Biocompatibility	Cytotoxicity Test
(ISO 10993-5)
Sensitization Test
(ISO 10993-10)
Irritation Test
(ISO 10993-10)
Particulate Matter Test
(ISO 18562-2:2017)
Volatile Organic Compound Extraction Test
(ISO 18562-3:2017)	Cytotoxicity Test
(ISO 10993-5)
Sensitization Test
(ISO 10993-10)
Irritation Test
(ISO 10993-10)
Particulate Matter Test
(ISO 18562-2:2017)
Volatile Organic Compound Extraction Test
(ISO 18562-3:2017)	S
DLT Materials	Silicon	PVC	D

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Image /page/7/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features a stylized green leaf design above the word "INSUNG" in large, bold, green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller font.

1 ) Same points between the subject device and the predicate device

. Classification Name
: The proposed classification name of the subject device is "Tracheal/bronchial differential ventilation tube". It is the same classification name both subject device (ANKOR Endobronchial Tube) and the predicate device (K180253).
Product Code ●
: The proposed product code of the subject device is "CBI". It is the same product code both subject device (ANKOR Endobronchial Tube) and the predicate device (K180253).
. Regulation Number
: The regulation number, which is applied to the subject device, is "21CFR868.5740". It is the same regulation number both subject device (ANKOR Endobronchial Tube) and the predicate device (K180253).
Indications for Use .
: The indications for use is "This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung." under both devices (Subject device and predicate device). It is same point.
. Environment of Use
: For environment of use, both devices (subject device and predicate device) is used at hospital in order to safely use the both. It is same point.
. Direction for use
: Both devices are prescription used device. It is same point.
. Intended User
: For intended user, trained physicians shall use the both device in order to safely use the both. It is same fact.

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Image /page/8/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features a stylized green leaf design above the word "INSUNG" in bold, green letters. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller font size.

. Patient Population
: Bothe device is used for patients requiring one-lung isolation as the patient population in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. It is same point.
. Design Features
: Under the main body of both devices, the design features are consisted with lumen Shaft, Cuff and Stylet. It is same point.
Single use
: Both devices (subject device and predicate device) is single used device which is E.O. Gas Sterilize. It is same point.
. Cuffed
: Both devices have cuffs such as bronchial cuff and tracheal cuff to block the bronchial or tracheal for isolating and ventilating one lung during surgical procedures. It is same point.
. Radiopaque line
: Under the tube (catheter) of both devices, the tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray. It is same point.
. Connection to ventilation source
: 15mm Connector is used under both devices (subject device and predicate device). The connector could be possible to assemble with ventilation source. It is same point.
Single use
: Both devices (subject device and predicate device) is single used device which is E.O. Gas Sterilize. It is same point.

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Image /page/9/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features a green and teal leaf design above the word "INSUNG" in large, bold, green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller, less bold font.

. Sterilization (Method)
: Both devices (subject device and predicate device) are single used devices which are E.O. Gas Sterilize. It is same point.
. EO and ECH Residual
: EO Gas Residual of Both devices (subject device and predicate device) are confirmed in accordance with ISO 10993-7. It is same point.
. Biocompatibility
: General Biocompatibility Tests of both devices (subject device and predicate device) are selected in accordance with ISO 10993-1. The same tests, such as following, are conducted.

Test Item	Standard
Cytotoxicity Test	ISO 10993-5:2009
Sensitization Test	ISO 10993-10:2010
Irritation Test	ISO 10993-10:2010

In addition, both device could be possible to be connected with breathing gas supplier. In accordance with "Biocompatibility of breathing gas pathway (ISO 18562-1:2017)" which considers risk related to breathing gas pathway, Particulate Matter Test (Per ISO 18562-2:2017) including CO, CO2 and O3 (Ozone) and Volatile Organic Compound Extraction Test (Per ISO 18562-3:2017) are conducted additionally to assure biocompatibility of subject device.

It leads the subject device is more safety than predicated device that is not assured on the "Biocompatibility of breathing gas pathway".

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Image /page/10/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features a stylized green leaf design above the word "INSUNG" in large, bold, green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller font, also in green.

Different points between the subject device and the predicate device

. Size
: Although size of the subject device is different with size of predicate device, the subject device is verified by test such as appearance test, dimension test.

And, the subject device is placed on the CE market and Korean Market since 2013 years. As a result, any problems, which influence safety and performance of the subject device, are not founded and received through the customer feedback.

In addition, the size of predicated device includes size of the subject device.

We cannot also found any risks related to the subject device, which has same size with subject device. It leads to safety device and effectiveness size to achieve same indication for use.

Refer to Performance Test Report (IS-20-1026-2) on the Attachment 6

Package .
: Packaging composition is different. It is depending on the manufacturer.

In addition, elbow connector of subject device complies with the ISO 5356-1:2014 and suction catheter is complies with the ISO 8836:2014 to ensure the safety and performance. The result of the test is passed and it leads to ensure the safety and performance.

As a result, there are not any problems, which influence safety of the subject device as well as influence substantial equivalence between the subject device and predicate device.

Refer to Performance Test Report (IS-20-0710) on the Attachment 6

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Image /page/11/Picture/2 description: The image contains the logo for INSUNG MEDICAL CO., LTD. The logo features a stylized green leaf design above the word "INSUNG" in bold, dark green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller, lighter font.

Materials .
: As a different point on the material between the subject device and predicate device, there is DLT Materials such as Silicon (Subject device) and PVC (Predicate Device)

Although the subject device is different with predicate device, the subject device is verified by test such as a biocompatibility test according to ISO 10993-1, ISO 18562 and FDA Guidance ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"). And, the endotoxin test is conducted in accordance with USP 39 to ensure safety of the materials.

As a result, there are not any problems, which influence safety of the subject device as well as influence substantial equivalence between the subject device and predicate device.

| Test | Report No. | Attachment
No. |
|--------------------------------------------------------------|-----------------------|-------------------|
| Bacterial Endotoxin Test | 20-048384-01-1 | 1 |
| Biocompatibility Test
(Per ISO 10993-1) | MTK-012652 | 1 |
| | MGK-201900654 | |
| | MGK-2019-000089 | |
| | MGK-2019-000088 | |
| Biocompatibility Evaluation Report
(Per ISO 18562-1:2017) | 1001018172-3248567BA | 2 |
| | ISO 18562-2:2017 Test | |
| ISO 18562-3:2017 Test | 1001018172-3248567 | 2 |

Refer to Biocompatibility Test with on the Attachment 1 and Attachment 2

3) Comparison to predicate device

The subject device is substantially equivalent to the predicate device with respect to indications for use, technology and construction. The differences between the predicate and the subject device is minor and any risks have been mitigated through testing.

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Image /page/12/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features three green leaves above the word "INSUNG" in large, bold, green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller, less bold letters.

7. PERFORMANCE DATA

All testing that is required by the required standards has been performed. Non-clinical testing was performed and included standards such as ISO 16628, ISO 5356-1, ISO 5361, ISO 80369-7, ISO 8836. ISO 18562 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 and the Performance Testing of this submission. Therefore we have concluded that the subject device is substantially equivalent. A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the below:

7.1 Biocompatibility

General Biocompatibility (According to ISO 10993-1)

The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with the following standards and FDA Guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

No.	Test Items	Standards	Criteria
1	Cytotoxicity	ISO 10993-5:2009	Negative Control: reactivity of none
Positive Control: greater than mild	Pass
2	Intracutaneous
Reactivity	ISO 10993-10:2010	No observe skin responses such as
the erythema, edema and etc.	Pass
3	Sensitization	ISO 10993-10:2010	No induced any skin reaction in the
Hartley guinea pig	Pass

	Refer to Biocompatibility Test with on the Attachment 1
--	---------------------------------------------------------

| Test | Report No. | Attachment
No. |
|--------------------------------------------|-----------------|-------------------|
| Biocompatibility Test
(Per ISO 10993-1) | MTK-012652 | |
| | MGK-201900654 | 1 |
| | MGK-2019-000089 | |
| | MGK-2019-000088 | |

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Biocompatibility of Breathing Gas Pathways (ISO 18562-1)

Biocompatibility evaluation of breathing gas pathways is performed in accordance with ISO 18562-1:2017 including ISO 10993-17:2002 to identify which compounds emitted into the airstream of the Endobronchial Double Lumen Tube (ANKOR Endobronchial Tube) are considered chemicals of concern (COCs) and require additional risk review.

No.	Test Items	Criteria
1	Emission Test of
Particulate Matter
(Including CO2, CO
and Ozone)	ISO 18562-
2:2017	No increase the source gas
concentration of particulates ≤2.5 $\mu$ m
aerodynamic diameter (PM2.5) more
than 12 µg/m3	Pass
		No increase the source gas of PM ≤ 10
$\mu$ m diameter size (PM10) more than
150 µg/m3	Pass
2	Volatile Organic
Compounds
(VOCs) Extraction
Test	ISO 18562-
3:2017	Unlikely to result in toxicological
effects	Pass

Refer to Biocompatibility Test with on the Attachment 2

| Test | Report No. | Attachment
No. |
|-----------------------------------------------------------------|----------------------|-------------------|
| Biocompatibility
Evaluation Report
(Per ISO 18562-1:2017) | 1001018172-3248567BA | 2 |
| ISO 18562-2:2017 Test | 1001018172-3248568P | 2 |
| ISO 18562-3:2017 Test | 1001018172-3248567 | 2 |

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Image /page/14/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features the word "INSUNG" in large, bold, green letters. Above the word "INSUNG" are three green leaves. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller, thinner letters.

7.2 Risk Management

All risks, related to biocompatibility hazard, function hazard and etc., including device problem founded by TPLC (Total Product Life Cycle),, were identified, evaluated, and controlled in accordance with ISO 14971:2007.

| No. | Items | Standards | Attachment No.
(Report No.) |
|-----|-----------------|----------------|---------------------------------------------|
| 1 | Risk Management | ISO 14971:2007 | Attachment 4
(IM-RMR-09)
(IS-RMR-202) |

7.3 Sterilization Test

The sterilization test was performed to assess inactivation of the microbiological contaminants, and thereby the device the device is verified as a non-sterile medical device into sterile ones. The tests were performed in accordance with following standards.

| No. | Test Items | Standards | Attachment No.
(Report No.) |
|-----|----------------------------------|------------------|-----------------------------------------------|
| 1 | Microbiological quality | ISO 11737-1:2018 | Attachment 10
(IS-SVP-1901)
(IS-SVR-02) |
| 2 | Sterility Test | ISO 11737-2:2009 | Attachment 10
(IS-SVP-1901)
(IS-SVR-02) |
| 3 | E.O. Gas Sterilization Residuals | ISO 10993-7:2008 | Attachment 10
(IS-SVP-1901)
(IS-SVR-02) |

7.4 Cleanroom Validation

Clean rooms are managed by being based on our work environment management regulations. Clean rooms validation is assured through the verification of clean room validation in accordance with verification method for subject device's safety an hygienically.

| No. | Test Items | Standards | Attachment No.
(Report No.) |
|-----|---------------|------------------|----------------------------------------------|
| 1 | Particle Test | ISO 14644-1:2015 | Attachment 11
(IS-CVP-01)
(IS-CVR1-01) |

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Image /page/15/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features the word "INSUNG" in large, bold, green letters. Above the word "INSUNG" are three green leaves. Below the word "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in smaller, thinner letters.

7.5 Cleaning Validation

Contaminants and residues during the cleaning process were maintained continuously and consistently with acceptable numerical values through the appearance test according to manufacturer SOP and microbial test according to ISO 11737-1:2018

| No. | Test Items | Standards | Attachment No.
(Report No.) |
|-----|-----------------|------------------|--------------------------------|
| 1 | Appearance Test | Manufacturer SOP | Attachment 11
(IS-WVR-02) |
| 2 | Microbial Test | ISO 11737-1:2018 | Attachment 11
(IS-WVR-02) |

7.6 Shelf-life Test

The shelf-life test was performed to decide expiration date and to assess a stability of physical properties of their packaging materials within the duration of the proposed shelf-life. The tests were performed in accordance with following standards.

| No. | Test Items | Standards | Criteria | Pass/Fail | Attachment No.
(Report No.) |
|-----|------------------------|-------------|----------|-----------|--------------------------------|
| 1 | Accelerated Aging Test | ASTM F 1980 | 3 years | Pass | Attachment 12
(MSK-000970) |

According to ISO 11607-1, sterile barrier system and packaging system are established and maintained. The maintenance of this system has been validating for patient safety according to ISO 11607-2

| No. | Test Items | Standards | Criteria | Pass/Fail | Attachment No.
(Report No.) |
|-----|----------------------------------------------------------|---------------|------------------------------------------------------------------------|-----------|--------------------------------|
| 1 | Seal Strength | ASTM F88:2000 | ≥1.2(Unit:
N/15mm)
(After 3years
Accelerated
aging device) | Pass | Attachment 12
(MSK-000970) |
| 2 | Sterile Barrier
System Integrity
(Dye Penetration) | ASTM F1929 | No leakage | Pass | Attachment 12
(MSK-000970) |
| 3 | Sterility Test | KP | No evidence of
microbial
growth | Pass | Attachment 12
(MSK-000970) |

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Image /page/16/Picture/2 description: The image shows the logo for INSUNG MEDICAL CO., LTD. The logo features a stylized green leaf design above the word "INSUNG" in bold, green letters. Below "INSUNG" is the text "INSUNG MEDICAL CO., LTD." in a smaller font size.

7.7 Endotoxin Test

Bacterial Endotoxin Test (Kinetic), using the lysate reagent for Endobronchial Double Lumen Tube, was conducted in accordance with USP 39 including USP and "Guidance for industry pyrogen and endotoxin testing: Questions and Answers".

Therefore, the endotoxin concentration of the test article extract used in the test was decided to be less than 0.5 EU/mL.

| No. | Test Items | Standards | Criteria | Pass/Fail | Attachment No.
(Report No.) |
|-----|-----------------------------|-------------|------------|-----------|----------------------------------|
| 1 | Bacterial
Endotoxin Test | USP 39 |