The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

Device Description

The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.

Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.

The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.

AI/ML Overview

Based on the provided text, the device in question is CORE-SPORT, a surgical instrument for minimally invasive laparoscopic surgery. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, the performance data presented is primarily bench testing and comparative testing against self-defined criteria, rather than clinical studies involving human patients or complex AI algorithms requiring ground truth establishment by experts.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Test Name	Acceptance Criteria	Reported Device Performance and Conclusion
Safety Tests
Sterility	Sterility Validation	Demonstrate a 10⁻⁶ SAL (Sterility Assurance Level). No evidence of microbial growth.	Passed. No evidence of microbial growth found; complies with sterility test.
Biocompatibility	Cytotoxicity	N/A (Tests conducted in accordance with ISO 10993-1:2018 requirements.)	Passed.
	Animal Intracutaneous Reactivity	N/A	Passed.
	Guinea Pig Maximization	N/A	Passed.
	Acute Systemic Toxicity	N/A	Passed.
	Pyrogen	N/A	Passed.
Performance Tests - Bench
Bench Test	Tensile Strength Test	No defects found after loading 10N of force.	Met the criteria. No defects were found after loading 10N in both sheath and ring body/remover parts.
Bench Test	Air Leak Test	Pressure maintained over 15mmHg for 30 seconds after injecting air at 25mmHg.	Met the criteria. All test results met the criteria.
Physical/Chemical	Extraction Test (USP 38 <661>)	Nonvolatile Residue, Residue on Ignition, Heavy Metal, Buffering Capacity at acceptable level.	Met the criteria. All components were at acceptable levels.
Performance Tests - Comparative
Comparative Test	Cavity Access Test	Measured widest width does not exceed 30mm when flattening 1/3 of the retractor ring body.	Verified. Size is appropriate for cavity access; test result did not exceed setting criteria.
Comparative Test	Maintenance of Pneumoperitoneum	Maintain 12-15 mmgH pressure for 30 seconds under given pressure.	Satisfied. Test results satisfied the standard.
Comparative Test	Ability to Manipulate Instruments	No friction, crash, or damage when applying instruments. (Insufficient if even one occurs.)	Confirmed. Set criteria were satisfied even in the worst case of applying a maximum of 4 surgical instruments.
Shelf Life Test
Shelf Life Test	Accelerated Aging Studies	Demonstrate product integrity over a 3-year lifespan (ASTM F1980).	Acceptable results. Accelerated aging studies for start and three years were performed, showing acceptable results. Real-time aging study is ongoing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify specific sample sizes for each test. It generally states that tests were "conducted" or "performed." For device performance, the data provenance is from bench testing and comparative testing within a laboratory setting. The company is INCORE CO., LTD. from Republic of Korea. The studies described are pre-market testing for regulatory submission, and therefore are inherently prospective in their design (intended to evaluate the device against pre-defined criteria).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes a medical device (surgical port), not an AI-assisted diagnostic device. Therefore, the concept of "ground truth established by experts" (e.g., radiologists interpreting images) is not applicable in the context of these described performance tests. The "ground truth" for these tests is based on objective physical measurements, adherence to industry standards (e.g., ISO, USP, ASTM), and the predefined acceptance criteria for mechanical and material properties. There is no mention of human expert readers for "test sets" in the diagnostic sense.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

Since this is not an AI diagnostic study relying on human interpretation for "ground truth," there is no adjudication method described or necessary. The "adjudication" is essentially the device passing or failing against the established objective metrics and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The CORE-SPORT is a physical surgical instrument, not an AI or diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Again, this question is primarily relevant for AI algorithms. The "standalone performance" described here refers to the device's physical and material properties and its function (e.g., air leak, tensile strength). The tests are designed to show the device's inherent capabilities and safety without human intervention in its functionality, but the evaluation is performed by human testers against these criteria.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on COR-SPORT is based on:

Industry Standards: ISO 11135 (sterility), ISO 10993 (biocompatibility), USP 38 <661> (extraction), ASTM F1980 (accelerated aging).
Engineering Specifications and Bench Test Parameters: Pre-defined force limits (10N for tensile strength), pressure maintenance values (15mmHg for 30 seconds for air leak), and size parameters (30mm for cavity access).
Absence of Adverse Events: "No defects," "no evidence of microbial growth," "no friction, crash, damage."

8. The Sample Size for the Training Set

The concept of a "training set" applies to machine learning or AI models. Since CORE-SPORT is a physical medical device, there is no training set in this context. The manufacturing process and quality control would be based on established engineering principles and production runs, not data training.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for a physical medical device, this question is not applicable.

Summary

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

9/28/2022

Incore Co., Ltd. Lee Jae-Hun Department Head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, 41072 Korea, South

Re: K220081

Trade/Device Name: CORE-SPORT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 22, 2022 Received: August 24, 2022

Dear Lee Jae-Hun:

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

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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 (OS) 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 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,

for Colin Chen

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) K220081

Device Name CORE-SPORT

Indications for Use (Describe)

The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

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 word "INCORE" in a sans-serif font. To the left of the word is a graphic of three overlapping circles. The overlapping circles are arranged in a triangular pattern, with the top circle slightly offset to the left. The color of the text and the graphic is a dark blue.

K220081 - 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-SPORT.

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 : (82) 2-866-3514 Contact Fax : (82) 2-6919-1346

Date of Preparation : Dec 09, 2021

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Image /page/4/Picture/0 description: The image contains the word "INCORE" in a bold, sans-serif font. To the left of the word is a graphic consisting of three overlapping circles. The overlapping area of the circles is filled with a solid color, creating a focal point within the design.

II. Device

Trade of Device : CORE-SPORT (K220081) Model : IC-SP01, IC-SP02, IC-SP03, IC-SP04, IC-SP05 Common or Usual Name : Endoscopy Surgery Instrument Classification Name : Laparoscope, General & Plastic Surgery Device Product Code : GCJ Review Panel : General & Plastic Surgery Regulation Number : 21 CFR 876.1500 Endoscope and Accessories Regulatory Class : Class II

III. Predicate Device

Trade of Device : GLOVE PORT (K141715) Common or Usual Name : Endoscopy Surgery Instrument Classification Name : Laparoscope, General & Plastic Surgery Device Product Code : GCJ Review Panel : General & Plastic Surgery Requlation Number : 21 CFR 876.1500 Endoscope and Accessories Regulatory Class : Class II

IV. Device Description

Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.

The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.

V. Indications for Use

The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

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Image /page/5/Picture/0 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side of the word INCORE. The circles are different sizes and are arranged in a way that creates a sense of depth and movement. The word INCORE is written in a sans-serif font and is in a dark blue color.

VI. Comparison of Technological Characteristics with predicate device

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

Item	Proposed DeviceCORE-SPORTPort-Assay A + Retractor	Predicate DeviceGlove Port	SubstantialEquivalence
Common orUsual Name	Endoscopy Surgery Instrument	Endoscopy Surgery Instrument	Same
Classficationregulation	21 CFR 876.1500	21 CFR 876.1500	Same
Classificationand Code	Class II , GCJ	Class II , GCJ	Same
DeviceClassficationName	Laparoscope, General & PlasticSurgery	Laparoscope, General & PlasticSurgery	Similar
510(K) number	K220081	K141715	-
Indications forUse	The CORE-SPORT is intendedto provide access for multipleinstruments and/or endoscope tothe abdominal cavity through asingle incision during minimallyinvasive laparoscopic surgery.	The Glove Port is intended toprovide access for multipleinstruments and/or endoscope tothe abdominal cavity through asingle incision during minimallyinvasive laparoscopic surgery.	Same
Configuration	Image: CORE-SPORT Configuration	Image: Glove Port Configuration	Similar
Assembly	Combine Port Base with it,after putting the Retractor onthe Bottom part.	No need to assemble(In advance assembled)	Similar
Disposable	Yes	Yes	Same
Material	Polyurethane	Polyurethane	Same
NumberofPorts	3 or 4 ea	3~4 ea	Same
Port Size	5 and/or 12 mm	5, 12, and/or 15 mm	Similar
Ring Diameter	86mm	60 ~ 95mm	Similar
Sterilization	EO Gas Sterilization	EO Gas Sterilization	Same

Table 1 : Comparison to Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side of the word INCORE. The word INCORE is written in a sans-serif font and is a dark blue color.

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Image /page/7/Picture/0 description: The image shows the logo for Incore. The logo consists of three overlapping circles on the left and the word "INCORE" in blue on the right. The circles are arranged in a way that creates a sense of interconnectedness and collaboration.

VII. Performance Data

(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-SPORT 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 biocompatibility tests were performed : Cytotoxicity, Animal intracutaneous following reactivity, Guinea pig maximization, Acute systemic toxicity, Pyrogen.

(2) Performance Test - Bench

1) Tensile strength Test

This product is tested for tensile strength in two parts. One is the sheath part, and the other is the ring body and remover part.

First for the sheath part test, fix the retractor ring to one jig of the tensioner and the ring body to the other jig. The product is tensioned at a speed of 150mm/Sec. Second, the test on the ring body and the remover part is conducted under the same test conditions as the first test. Under the conditions of the above method, Test whether the sheath is ruptured by pulling it with a force of 10N.

The tensile strength test of CORE-SPORT was tested, and in both tests, no defects were found after loading 10N. Therefore the CORE-SPORT meets the performance required by tensile strength test.

2) Air leak test

To measure the air tightness of the product, an air leak test was performed. After

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connecting the retractor and port-assay with a connector, block the retractor and open one stopcock to inject air at a pressure of 25mmHg.

Under the conditions of the above method, the pressure is maintained over 15mmHg for 30 seconds.

The Air leak test of CORE-SPORT was conducted, and All test results met the criteria. Therefore the CORE-SPORT meets the performance required by Air leak test of CORE-SPORT test.

3) Physical/Chemical

Extraction Test is tested accordance with USP 38 <661>.

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

(3) Performance Test - Comparative

1) Cavity access test

The cavity access test is a test to prove accessibility for inserting a port during surgery. Check whether the port is of an appropriate size to be inserted into the incision site. When flattening 1/3 of the ring body of the retractor, measure the length of the widest width. As the test result does not exceed the setting criteria(30mm), it is verified that the size is appropriate for cavity access.

2) Maintenance of pneumoperitoneum

the test conducted to confirm that there is no air leakage and pneumoperitoneum is maintained during the operation. The test recognition criteria have to maintain 12-15 mmgH for 30 seconds under the given pressure, and the test results are determined to satisfy this standard.

3) Ability to manipulate instruments

Ability to manipulate instruments is planned to demonstrate that the laparoscopic surgical instruments is applied properly without friction, crash, damage during laparoscopic surgery. If even one friction, crash, damage occurs in the data, it is determined as insufficient.

As a result of the test, it was confirmed that the set criteria were satisfied in the worst case of applying a maximum of 4 surgical instruments.

(4) Shelf Life Test

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Image /page/9/Picture/0 description: The image contains the word "INCORE" in a sans-serif font. To the left of the word is a graphic of three overlapping circles. The overlapping circles are a lighter color than the word "INCORE". The word "INCORE" is in all capital letters.

CORE-SPORT Traditional 510(K)

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

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.