The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

Device Description

The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

AI/ML Overview

The provided document describes the non-clinical performance testing for the CORE-INJECTOR device to demonstrate its substantial equivalence to a predicate device. It does not contain information about a comparative effectiveness study (MRMC) or a standalone (algorithm-only) study for a medical imaging AI device. The device in question is an endoscope injection needle, not an AI or imaging device. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Sterility	10⁻⁶ SAL (Sterility Assurance Level) following ISO 11135; meets requirements of ISO 10993-7 (ethylene oxide sterilization residuals). No microbial growth.	Achieved 10⁻⁶ SAL; met ISO 10993-7 requirements. No evidence of microbial growth.
Biocompatibility	Passed tests for Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, Pyrogen test (in accordance with ISO 10993-1:2018 for tissue contact < 24 hours).	All specified biocompatibility tests passed.
Appearance and Dimension	According to Incore's own system (details not provided).	Met Incore's own system requirements.
Tensile Strength (Handle)	Inner hub attached to outer hub when applying a force of 15N.	No defect after loading 15N. Met performance requirement.
Needle Drawing Test (Pull-out)	Needle attached to inner sheath when pulling with a force of 10N.	Needle remained attached to the inner sheath when applying a force of 10N. Met performance requirement.
Air Leakage Test	No air leakage when applying 50 kPa air pressure for 15 seconds.	Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device.").
Liquidity Test	Measure amount of distilled water ejected from the needle after injection (specific criteria not provided).	Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device.").
Maneuverability Test	Needle goes in when handle slider is pulled, comes out when pushed; handle and needle operate smoothly.	Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device.").
Elasticity Test (Needle)	Needle returns to original state after bending to 12° with weight for 1 minute and then removing weight.	Needle returned to its original state when the weight was removed. Met performance requirement.
Physical/Chemical (Extraction)	Acceptable levels for appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal (according to Korean Pharmacopoeia).	Acceptable levels reported for all parameters.
Shelf Life	Product integrity maintained for 3 years (accelerated aging). Real-time study in process.	Acceptable results for accelerated aging for 3 years.

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

The document describes non-clinical performance testing of a medical device (endoscope injection needle), not a study involving patient data or a test set in the context of an AI device. The tests are performed on the device itself.

Sample Size for Test Set: Not specified in terms of number of devices for each test, but standard engineering testing applies.
Data Provenance: Not applicable in the context of patient data. The tests are conducted in a laboratory setting by the manufacturer (Incore Co., Ltd., Republic of Korea).

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

Not applicable. This is not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for the performance tests is based on objective measurements and established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI or imaging device requiring adjudication of interpretations.

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

Not applicable. The CORE-INJECTOR is a physical medical device, not an AI or imaging diagnostic tool that would be used in an MRMC study.

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

Not applicable. The CORE-INJECTOR is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on:

Established international and national standards (e.g., ISO 11135, ISO 10993, ASTM F1980, Korean Pharmacopoeia).
Objective physical measurements (e.g., force in Newtons, pressure in kPa, observed functionality).
Manufacturer's internal specifications and test protocols.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. This device does not involve machine learning or a "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

December 21, 2022

Incore Co., Ltd. Jae-Hun Lee Department head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, 41072 KOREA, SOUTH

Re: K221054 Trade/Device Name: Core-Injector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: March 22, 2022 Received: April 11, 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

Sivakami Venkatachalam -S

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K221054

Device Name CORE-INJECTOR

Indications for Use (Describe)

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/1 description: The image contains a logo with the word "INCORE" in bold, black letters. Below the word is a thin black line, and under that line is the text "innovative core technologies of medical devices" in a smaller font. Below the logo is the text "510(K) Summary" in a large, bold font.

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 CORE-INJECTOR.

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 : March 18, 2022

II. Device

Trade of Device : CORE-INJECTOR Model : IC-IJ2312, IC-IJ2316, IC-IJ2318, IC-IJ2323, IC-IJ2512, IC-IJ2516, IC-IJ2518, IC-IJ2523 Common or Usual Name : Disposable endoscope injection needle Classification Name : Endoscope and Accessories Device Product Code : FBK Review Panel : Gastroenterology/Urology Regulatory Class : Class II Regulation Number: 21 CFR 876.1500 Endoscope and Accessories

III. Predicate Device

Device Name : INJECTION NEEDLE Manufacturer : Micro-Tech (Nanjing)CO., Ltd.

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K221054 Page 2 of 7

Image /page/4/Picture/1 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left, with the word "INCORE" in bold, sans-serif font to the right. Underneath the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read.

CORE-INJECTOR Traditional 510(K)

510(K) Number : K150434 Classification Name : Endoscope and Accessories Product Code : FBK Regulatory Class : Class II Regulation number : 21 CFR 876.1500

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

IV. Device Description

The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm.

The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

V. Indications for Use

VI. Comparison of Technological Characteristics with predicate device

The CORE-INJECTOR has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Micro-Tech (Nanjing)CO., Ltd.'s INJECTION NEEDLE, K150434. the differences between the proposed device and the predicated devices do not raise any

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Image /page/5/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular graphic to the left of the word "INCORE" in bold, sans-serif font. Below the word "INCORE" is a tagline in a smaller font that reads "innovative core technologies of medical devices."

questions regarding its safety and effectiveness. the differences are listed in the table below. The following tests evaluate the substantial equivalence of the subject device through the performance test applying the same standard as the predicate device.

Performance testing such as Tensile Strength, Needle drawing out, Leakage test, Liquidity test, Maneuverability test. The test results show that the subject device is substantially equivalent to the predicate device.

Item	Proposed DeviceCORE-INJECTOR	Predicate DeviceINJECTION NEEDLE	SubstantialEquivalence
Classficationregulation	21 CFR 876.1500	21 CFR 876.1500	Same
Classificationand Code	Class II , FBK	Class II , FBK	Same
DeviceClassficationName	Endoscopy and Accessories	Endoscopy and Accessories	Same
510(K) number	K221054	K150434	-
Indications forUse	The CORE-INJECTOR is tobe used in conjunction withan endoscope to performendoscopic injections, suchas the treatment ofesophageal and gastricvarices and for submucosaldye marking in the GI tract.	The INJECTION NEEDLE isto be used in conjunctionwith an endoscope toperform endoscopicinjections, such as for thetreatment of esophageal andgastric varies and forsubmucosal dye marking inthe GI tract.	Same
Configuration	Needle, Inner tube, Outertube, Handle, Slider	Needle, Innersheath(Tube), OuterOuter shell(tube), Handle,Luer lock	SimilarBoth subject andpredicate deviceare substantiallyequivalent in theindications for use.
Material(Needle)	Stainless-Steel	Stainless-Steel	Same
Outer SheathMaterial	Outer : Polyethylene	Outer : Thermoplastic-PTFEPolymer	Different
			This difference
			does not alter the
			suitability of the
			proposed device
			for its intended
			use. We conducted
			a biocompatibility
			evaluation of the
			device. The results
			show the device is
			safe in the aspect
			of
			biocompatibility
			evaluation
Disposable	Yes	Yes	Same
			Similar
Gauge size	23G, 25G	19G, 22G, 25G	Both subject and
			predicate deviceare substantiallyequivalent in theindications for use.
Needle length	4mm	4mm, 5mm, 6mm	Same
Outer SheathDiameter	2.3mm	2.3mm	Same
			Similar
Working Length	1200mm, 1600mm, 1800m,2300mm	1800mm, 2000m, 2300mm	Both subject and
			predicate deviceare substantiallyequivalent in theindications for use.
Sterilization	EO Sterilization (SAL 10-6)	EO Sterilization (SAL 10-6)	Same
Packaging	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilized pouchwith one device per pouch	Same

Table 1 : Comparison to Predicate Device

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Image /page/6/Picture/1 description: The image shows the logo for "INCORE", which appears to be a medical device company. The logo features a graphic of three overlapping circles, with the overlapping area colored in a dark blue. Below the company name is the text "innovative core technologies of medical devices" in a smaller font.

CORE-INJECTOR Traditional 510(K)

VII. Non-clinical testing data

1) Sterility

A Sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL. And the proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"

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Image /page/7/Picture/1 description: The image shows the logo for INCORE. The logo consists of a graphic of three overlapping circles on the left, with the word "INCORE" in bold, sans-serif font to the right of the graphic. Below the word "INCORE" is a thin line, and below that line is some smaller text that is difficult to read.

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-INJECTOR 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, Sensitization, Intracutaneous following reactivity, Acute Systemic Toxicity, Pyrogen test.

1. Performance Testing
- (1) Appearance and dimension

Performance tests such as the appearance and dimensions of the proposed device were according to the Incore's own system.

(2) Tensile strength (handle)
The product that cut to about 4 inches from the outer hub is held in a tensile taster set to 3 inches in gage length. Then, the inner hub is pulled from the outer hub at a speed of 10 in/min. Under the conditions of the above method, the inner hub should be attached to the outer hub when applying a force of 15N. The proposed device was tested, and there was no defect after loading 15N. The CORE-INJECTOR therefore meets the performance required by tensile strength of handle.
(3) Needle drawing test(Pull-out) (needle)
The prodcut, the inner hub is pulled from the outer hub and the inner sheath is pulled from the outer sheath by pulling on the sheath. After cutting this to about 3 inches from the crimp band, mount it with the needle facing upward in a tensile tester set to 2 inches in gauge length. Check that the needle is attached to the inner sheath with a force of 10N when pulling at a speed of 10 in/min.

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Under the conditions of the above method, the needle should be attached to the inner sheath.

The proposed device was tested, and the needle attached to the inner sheath when applying a force of 10N.

Therefore, the CORE-INJECTOR meets the performance required by pull-out of needle test.

(4) Air leakage test
When observing air leakage while blocking one end of the product and applying air pressure of 50 kPa to the inside of the product for 15 seconds, there should be no air leakage.
(5) Liquidity test
Attach a syringe containing 10g of distilled water into the injection port of the injector. Then, the distilled water is injected by pushing the piston with a constant force. After receiving the distilled water ejected from the injector needle into the cylinder, measure the amount of distilled water.
(6) Maneuverability test
Check that the needle goes in when the handle slider is pulled, and the needle comes out when pushed, and check that the handle and needle operate smoothly.
(7) Elasticity test (needle)
Fix A point of the needle randomly and bend to 12° with weight and 1 minutes at B point. Under the conditions of the above method, the needle shall return after remove weight.

TThe proposed device was tested, and the needle returned to its original state when the weight was removed.

Therefore, the CORE-INJECTOR meets the performance required by elasticity test of needle.

1. Physical/Chemical

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Image /page/9/Picture/1 description: The image shows the logo for INCORE. The logo consists of a graphic of three overlapping circles on the left, with the word "INCORE" in bold, sans-serif font to the right. Below the word "INCORE" is a thin line, and below that is the text "Innovative core technologies of medical devices" in a smaller font.

Extraction Test is tested in accordance with KP(Korean Pharmacopia) appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level.

5) Shelf Life Test

The CORE-INJECTOR 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

The conclusion drawn from the technological characteristics is that the CORE-INJECTOR has been found to have a safety and efficacy profile that is substantially equivalent to the predicate device INJECTION NEEDLE which is marketed for the same intended use.

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.