CORE-Trocar

K211148 · Incore Co., Ltd. · GCJ · Jun 21, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211148
• Device Name: CORE-Trocar
• Applicant: Incore Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

Device Story

CORE-Trocar is a single-use, bladeless endoscopic trocar consisting of a cannula and an obturator. It provides a port for the insertion of endoscopic instruments during endoscopic procedures. The cannula assembly includes seals (main and secondary), a valve, and a stopcock to maintain CO2 pneumoperitoneum pressure during instrument insertion or withdrawal. The device is available in various diameters (2mm to 12mm) and lengths. It is used by clinicians in surgical settings. The device is inserted into the patient's abdominal cavity; the seals prevent gas leakage, allowing the surgeon to maintain the working space required for endoscopic surgery. The device is provided sterile via EO gas.

Clinical Evidence

Bench testing only. Testing included sterility validation (ISO 11135), biocompatibility (ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen), and performance bench testing (dimension, insertion force, air leakage, seal test, instrument compatibility, and extractable substances per USP 38 <661>). Comparative testing against the predicate confirmed equivalent performance in seal integrity, instrument compatibility, obturator mating, and cannula stability using pig skin models.

Technological Characteristics

Single-use bladeless trocar; cannula and obturator assembly. Materials: unspecified polymers/metals. Dimensions: 2-12mm diameter, 100-150mm length. Sterilization: EO gas (SAL 10^-6). Shelf life: 3 years (ASTM F1980 accelerated aging). Features: main/secondary seals, valve, stopcock for CO2 maintenance.

Indications for Use

Indicated for use as a port of entry for endoscopic instruments during endoscopic procedures. Intended for single-use.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Unimicro Trocar Kit (K141594)

Submission Summary (Full Text)

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Incore CO., LTD. Mr. Jae-Hun Lee Department Head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, Republic of Korea

Re: K211148

Trade/Device Name: CORE-Trocar (Nine Models) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 19, 2022 Received: May 19, 2022

Dear Jae-Hun 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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K21148

Device Name

CORE-Trocar, (Model : IC-TC02, IC-TC02S, IC-TC03, IC-TC05, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12)

Indications for Use (Describe)

The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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/0 description: The image shows the logo for INCORE, a company that specializes in innovative core technologies of medical devices. The logo features the company name in bold, sans-serif font, with a tagline underneath. To the left of the company name are three overlapping circles. The image also includes the text "K211148" in bold font.

### Section 5 - 510(K) Summary

In accordance with the Food and Drug Adminstration Rule to implement provisions of the Safe Medical Device Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CORE-Trocar.

#### I. Submitted by

Company Name : INCORE CO.,LTD. Company Address : 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, Republic of Korea

Contact Person : Mr. Jae-Hun, Lee Department head of Regulatory Affairs

Contact Phone : [phone] Contact Fax : [phone]

Date of Preparation : June 15, 2022

#### II. Device

Trade of Device : CORE-Trocar, (Model : IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) Common or Usual Name : Bladeless Endoscopic Trocar Classification Name : Laparoscope, General & Plastic Surgery Device Product Code : GCJ Regulatory Class : Class II Device Classification Panel : General & Plastic Surgery

#### III. Predicate Device

Device Name : Unimicro Trocar Kit (K141594) Manufacturer : Unimicro Medical Systems (ShenZhen) Company, Ltd. Classification Name : Laparoscope, General & Plastic Surgery Regulatory Class : Class II

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Image /page/4/Picture/1 description: The image contains the logo for INCORE, a company that specializes in innovative core technologies of medical devices. The logo features a circular design with overlapping elements on the left side, followed by the company name in bold, capitalized letters. Below the name, there is a tagline that describes the company's focus on innovative core technologies of medical devices. The text "K211149" is located at the bottom left of the image.

## K211148

Product Code : GCJ

The predicates have not been subject to a design-related recall. No reference devices were used in this submission.

## IV. Device Description

The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10° The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.

## V. Indications for Use

The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

## VI. Comparison of Technological Characteristics with predicate device

There is no technical difference between the CORE-Trocar and the Unimicro Trocar Kit. Even if some test's name is a little different, the intention of the test is same.

| Item | Proposed Device | Predicate Device |
|---------------|-----------------|---------------------|
| 510(K) number | CORE-Trocar | Unimicro Trocar Kit |
| Classfication | K211148 | K141594 |
| Classfication | 21 CFR 876.1500 | 21 CFR 876.1500 |

## Table 1 : Comparison to Predicate Device

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Image /page/5/Picture/0 description: The image shows the logo for INCORE, a company that specializes in innovative core technologies of medical devices. The logo features three overlapping circles on the left side, with the company name "INCORE" in bold, sans-serif font to the right. Below the company name is the tagline "innovative core technologies of medical devices" in a smaller font size.

# K211148

| regulation | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Classification<br>and Code | Class II, GCJ | Class II, GCJ | | | | | | | | | | | | | | | | | | | | | | |
| Device Classfication<br>Name | Laparoscope, General &<br>Plastic Surgery | Laparoscope, General &<br>Plastic Surgery | | | | | | | | | | | | | | | | | | | | | | |
| Indications for<br>Use | A single-use medical device to<br>have a port to insert endoscopic<br>instruments for endoscopic<br>procedures. | Applicate in a variety of<br>endoscopic procedures to<br>provide a port of entry for<br>endoscopic instruments. | | | | | | | | | | | | | | | | | | | | | | |
| Compared elements | Cannula<br>Tip of obturator | Cannula<br>Tip of obturator | | | | | | | | | | | | | | | | | | | | | | |
| Performance - Bench | Dimentsion<br>Insertion force<br>Air leakage<br>Seal Test<br>Instrument compatibility test<br>Seal Test | - | | | | | | | | | | | | | | | | | | | | | | |
| Performance test -<br>Comparative | Instrument compatibility test<br>Obturator compatibility<br>Insertion & Cannula stability<br>Air leakage | Obturator compatibility<br>Insertion & cannula stability<br>Air leakage | | | | | | | | | | | | | | | | | | | | | | |
| Disposable | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | |
| Dimension | Diameter : 2 ~ 12mm | Diameter : 5 ~ 12mm | | | | | | | | | | | | | | | | | | | | | | |
| | Type Diameter Type Diameter 2mm 2.45mm 8mm 8.1mm 3mm 3.75mm 10m<br>m 11.8mm 5mm 6mm 12m<br>m 12.9mm<br>Length : 100 ~ 150mm Type Length 2mm, 3mm, 5mm 100.5mm,<br>125.5mm 8mm 130mm 10mm, 12mm 149.5mm | | | | | | | | | | | | | | | | | | | | | | | |
| Sterilization | EO Sterilization (SAL 10-6) | EO Sterilization (SAL 10-6) | | | | | | | | | | | | | | | | | | | | | | |
| Combination list | Bladeless Trocar<br>/<br>/ | Bladeless Trocar<br>Auto-Locking Trocar<br>Hasson Trocar | | | | | | | | | | | | | | | | | | | | | | |

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Image /page/6/Picture/0 description: The image shows the logo for INCORE, which is written in bold, black letters. Underneath the name is the tagline "innovative core technologies of medical devices" in a smaller font. To the left of the name is a graphic of three overlapping circles. The text "K211148" is located at the bottom left of the image.

### VII. Test summary

(1) Safety Test

1) Sterility

A sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL.

The Sterility test is tested with a direct method. No evidence of microbial growth is found, the test article to be examined complies with sterility test.

#### 2) Biocompatibility Testing

Biocompatibility testing has been conducted in accordance with ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

The CORE-Trocar is considered tissue contacting for a duration of less than 24 hours.

This device passed all biocompatibility tests. In accordance to ISO10993-1:2018, the following biocompatibility tests were performed : Cytotoxicity, Maximization Sensitization, Irritation/Intractutaneous Reactivity, Acute Systemic Toxicity, Pyrogen.

| Test | Subject device | Criteria | Standard | Result |
|-----------------|----------------------------------|-------------------------------------------------------------------------|-------------------|--------|
| Dimension | CORE-Trocar<br>(All model) | The tolerance of the nominal<br>size should be ±10 % of the<br>stndard. | Internal standard | Pass |
| Insertion force | CORE-Trocar<br>(IC-TC12) | $1.5kgf \ge$ Insertion force | Internal standard | Pass |
| Air leakage | CORE-Trocar<br>(IC-TC12) | No air leakage | Internal standard | Pass |
| Seal Test | CORE-Trocar<br>(IC-TC05,IC-TC12) | No air leakage | Internal standard | Pass |
| Instrument | CORE-Trocar | no crash, no damage, no | USP 38, <661> | Pass |

## (2) Performance test - bench

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Image /page/7/Picture/0 description: The image shows the logo for INCORE. The logo features a graphic of three overlapping circles on the left, with a dark blue fill in the intersection of the circles. To the right of the graphic is the word "INCORE" in bold, black letters. Below the word "INCORE" is a thin black line, and below that is the text "innovative core technologies of medical devices" in a smaller font.

| compatibility test | | (IC-TC05, IC-TC12) | strong friction | | |
|--------------------|---------------------|--------------------------|-------------------------------------|----------------------|------|
| Extractable | Nonvolatile Residue | CORE-Trocar<br>(IC-TC03) | Residue gap, below 15mg | Physicochemical Test | Pass |
| | Residue on Ignition | | Residue gap, below 5 mg | | Pass |
| | Buffering Capacity | | Not be darker | | |
| Substance | H e a v y Metal | | Titrant gap (or sum),<br>below 10mL | | Pass |

## 1) Dimension

#### - Test methods

When measured by vernier calipers, the tolerance of the nominal size should be ±10 % of the stndard.

#### - Acceptance Criteria

The tolerance of the nominal size should be ±10 % of the stndard.

#### 2) Insertion force

#### - Test methods

When pushing the trocar into the cannula(150mm/min), apply a force below the test standard to verify that it passes through the main and secondary seals. Under the conditions of the above method, the insertion force shall be not more than 1.5 kgf.

The Insertion force of CORE-Trocar was tested, and a force averaged 0.964 kgf (min. 0.738 and max. 1.095) was found to comply with the requirements required.

The CORE-Trocar therefore meets the performance required by insertion force test.

- Acceptance Criteria 1.5kgf ≥ Insertion force
- 3) Air leakage
- Test methods

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Image /page/8/Picture/0 description: The image shows the logo for INCORE, which is a company that specializes in innovative core technologies of medical devices. The logo features the company name in bold, sans-serif font, with a tagline underneath. To the left of the company name is a graphic of overlapping circles. Below the logo is the text string "K211148".

When sealing the valve and applying air at a pressure of 15 mmHg at the bottom of the cannula body, check for air leaks at the top of the test article or at the valve. Under the conditions of the above method, the test article shall be no air leakage.

The air leakage of CORE-Trocar was tested and, there is no air leakage.

The CORE-Trocar therefore meets the performance required by air leakage test.

- Acceptance Criteria No air leakage

4) Seal Test

#### - Test methods

Connect a pressure tester at the botton of the each canulla. and set to test leakage at a pressure fo 17mmHg(0.329psi). Test initially with the trocar ports empty, and then with 2 different diameters(2mm and 12mm) metal probes traversing the seal to simulate small and large laparoscopic instrument insertion. repeat traversing 20 and check the leakage. The seal leakage of CORE-Trocar was tested and, there is no air leakage. The CORE-Trocar therefore meets the performance required by seal test.

- Acceptance Criteria No air leakage

5) Instrument Comparative test

#### - Test methods

Put in and draw out the proves below through the each canulla. and check Compatible by O.D size(Maximum and Minimum) with instruments.

In the Instrument compatibility test, all the instruments or bars used were compatible with CORE-Trocar and There's no crash, no damage, no strong friction. Therefore, CORE-Trocar is acceptable with Instrument compatibility test.

- Acceptance Criteria no crash, no damage, no strong friction

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Image /page/9/Picture/0 description: The image shows the logo for INCORE, which is a company that specializes in innovative core technologies of medical devices. The logo features a series of overlapping circles on the left side, with the word "INCORE" in bold letters to the right. Below the word "INCORE" is the tagline "innovative core technologies of medical devices" in a smaller font. The text "K211148" is located at the bottom left of the image.

## 6) Physical/Chemical

### - Test methods

Put in and draw out the proves below through the each canulla. and check Compatible by O.D size(Maximum and Minimum) with instruments. There

Extractable Substance Test is tested accordance with USP 38 <661>.

Nonvolatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity are acceptable level.

- Nonvolatile Residue
- Test methods

50.0 mL of the test article extract into a white gold plate were evaporated on water bath. After evaporation and transfer Dry Oven on 1 hour at 105 ℃. Measure the weight of a plate and calculate the difference between evaporation before and after. The test result is 0.11mg, which is acceptable.

- Acceptance Criteria Residue gap, below 15mg

- Residue on Ignition
- Test methods

Proceeded with the Nonvolatile Residue obtained from the test article extract and from the Blank, using, if necessary, additional sulfuric acid but adding the same amount of sulfuric acid to each crucible, Calculated the difference between the amount of residue on ignition obtained from the test article extract and the blank did not exceed 5 mg. The test result is not applicable.

- Acceptance Criteria Residue gap, below 5 mg

- Buffering Capacity
- Test methods

Titrated the previously collected 20mL portion of the test article extract potentiometrically to

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Image /page/10/Picture/0 description: The image shows the logo for INCORE, which is a medical device company. The logo features the company name in bold, sans-serif font, with the tagline "Innovative core technologies of medical devices" underneath. To the left of the company name are three overlapping circles. The image also includes the text "K211148" at the bottom left.

a PH of 7.0, using either 0.010N hydrochloric acid or 0.010N sodium hydroxide, as required. Treated a 20mL portion of the blank similarly: if the same titrant was required for both test article extract and blank, the difference between the two volumes is not greater than 10.0mL: and if acid was required for either the test article extract: or the blank and alkali for the other, the total of the two volumes required is not greater than 10.0mL. The test result is 0.02mL, which is acceptable.

- Acceptance Criteria Not be darker

- Heavy Metals
- Test methods

Each 20mL of the test article extract and blank into nessler tube, put 2mL of Pb standard solution in the blank. Adjusted with 1N acetic acid or 6N ammonium hydroxide to a PH between 3.0 and 4.0, using shory-range PH paper as an external indicator, diluted with water to about 35mL, and mixed. After add Thioacetamide-glycerin base TS 1.2mL and PH 3.5 Acetate Buffer 2mL, dilute with water to 50mL, and mix. Compare with the color of the blank and test article extract in white surface(1mg/L(ppm) in extract). As a result, it was not be darker.

- Acceptance Criteria Titrant gap (or sum), below 10mL

| Test | Subject device | Criteria | Standard | Result |
|----------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------|--------|
| Seal Test | CORE-Trocar<br>(IC-TC05,<br>IC-TC12) | The pressure should be maintained<br>at 12~15mmHg. | Internal<br>standard | Pass |
| Instrument<br>compatibility test | VS<br>Unimicro Trocar<br>System<br>(BTRDSB0510,<br>BTRDSB1210) | No crash, damage, strong friction | Internal<br>standard | Pass |
| Obturator<br>compatibility | | It should be mated properly without<br>friction, crash, damage.<br>$Mating force≤26.7N$ | Internal<br>standard | Pass |
| Insertion &<br>Cannula stability | | $Insertion≤67.8N$<br>$Removal≤26.7N$<br>$Fixing≥26.7N$ | Internal<br>standard | Pass |

(3) Performance test - Comparative

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Image /page/11/Picture/0 description: The image shows the logo for INCORE, which is a medical device company. The logo features a stylized graphic of overlapping circles in the upper left corner, followed by the company name in bold, sans-serif font. Below the name is the tagline "innovative core technologies of medical devices" in a smaller, lighter font. The text "K211148" is located at the bottom left of the image.

| Air leakage | CORE-Trocar<br>(IC-TC12)<br><br>VS<br><br>Unimicro Trocar<br>System<br>(BTRDSB1210) | The pressure should be maintained<br>at 12~15mmHg. | Internal<br>standard | Pass |
|-------------|-------------------------------------------------------------------------------------|----------------------------------------------------|----------------------|------|
|-------------|-------------------------------------------------------------------------------------|----------------------------------------------------|----------------------|------|

#### 1) Seal Test

#### - Test methods

Connect a tube at the check valve of the cannula. Connect a pressure tester and a pressure measuring instrument to the 2-way valve after connecting a 2-way valve to the end of the tube set the pressure tester at a pressure of 15mmHg. Test with the trocar ports empty, and then with 2 different diameters initially metal traversing the seal to simulate small and large laparoscopic instrument probes insertion. repeat traversing 20 times and check the leakage.

- Acceptance Criteria

The pressure should be maintained at 12~15mmHg.

2) Instrument compatibility test

## - Test methods

Put in and draw out the proves(Instrument) through the cannula. Repeat putting in and drawing out at least 5 times. check compatibility by O.D size(Maximum and Minimum) with instruments. The size of the probe(Instrument) is chosen as the largest and smallest model that can be inserted into each cannula.

- Acceptance Criteria No crash, damage, strong friction

3) Obturator compatibility

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Image /page/12/Picture/0 description: The image shows the logo for INCORE, which is a company that specializes in innovative core technologies of medical devices. The logo features a stylized graphic of overlapping circles on the left, followed by the company name in bold, sans-serif font. Below the company name is the tagline "innovative core technologies of medical devices" in a smaller font. The image also contains the text "K211148" in bold font.

### - Test methods

When mating the obturator with the cannula, the obturator and cannula should mated properly without friction, crash, damage. And the mating force must not exceed be 26.7N

#### - Acceptance Criteria

It should be mated properly without friction, crash, damage. Mating force_26.7N

4) Insertion & Cannula stability

- Test methods

We selected pig skin as a sample. And like the surgical conditions, a 0.5~1.5cm incision is the size of the trocar. When conducting made depending on the insertion of Trocar (Obturator + Cannula), removal of Obturator, and fixing of Cannula in conditions similar to the human abdominal cavity, the force must satisfy the acceptance criteria.

- Acceptance Criteria Insertion≤67.8N, Removal<26.7N, Fixing≥26.7N

- Typical Condition of abdominal tissue Under the room temperature of 20 ~ 24℃, pig abdominal skin stored in the oven at 38℃ is subjected to the test as soon as it is taken out of the oven.

5) Air leakage

- Test methods

In conditions similar to the human abdominal cavity, insert the cannula. And then Connect a check valve of the cannula. Connect a pressure tester and tube at the a 2-way valve after connecting a 2-way valve pressure measuring instrument to the of tester at a pressure the end the tube set the pressure of 15mmHq. to then with 2 Test initially with the trocar ports empty, and different diameters metal probes traversing the seal to simulate small and large laparoscopic instrument insertion. repeat traversing 20 times and check the leakage value.

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Image /page/13/Picture/0 description: The image shows the logo for INCORE, a company that specializes in innovative core technologies for medical devices. The logo features a stylized graphic of overlapping circles in the upper left corner, followed by the company name in bold, sans-serif font. Below the company name is the tagline "Innovative core technologies of medical devices" in a smaller font size. The text "K211148" is located at the bottom left of the image.

#### - Acceptance Criteria

The pressure should be maintained at 12~15mmHg.

- Typical Condition of abdominal tissue

Under the room temperature of 20 ~ 24℃, pig abdominal skin stored in the oven at 38℃ is subjected to the test as soon as it is taken out of the oven.

## (4) Shelf Life Test

## - Test methods

The CORE-Trocar has a maximum shelf life of 3 years from the date of sterilization.

In compliance with the standard of ASTM F1980 ; Standard Guide For Accelerated Aging of Sterile Barrier System for Medical Device, accelerated aging studies for start and three(3) years were performed to determine product integrity over its lifespan, with acceptable results. A real-time aging study is currently in process to verify the result found in the accelerated aging studies.

## VIII. Conclusion

test(Biocompatibility Test, Sterility Test) of the CORE-Trocar is passed. The satety substantially equivalent to the cited predicate device. Performance(Bench, Comparative) of the CORE-Trocar met all acceptance criteria to confirm effectiveness. Through analyzing of comparative test data, we confirmed the subject device CORE-Trocar is substantially equivalent to the predicated device with respect to safety and effectiveness.