The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Device Description

Clear-Jet Injection Catheter consists of a stainless-steel needle attached to inner tube, an Injector Head attached to Catheter tube, and Slider where a standard syringe can be attached for injection of solutions through the lumen of the needle into tissue. It is available in various sizes and working lengths. The needle sizes are 21 gauge (outer diameter 0.8mm) and 23 gauge (outer diameter 0.6mm), and the needle lengths are 4.0mm and 6.0mm. The needle wall thicknesses are 0.1mm, 0.05mm, and the Catheter Tube length (=Working length) includes 1,800mm, 2,300mm.

There are two types of Clear-Jet Injection Catheter such as Head type and Non-head type has the Injector Head made of stainless steel alloys attached to the Catheter Tube, Non -head type does not have the Injector Head made of stainless steel alloys.

This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Clear-Jet Injection Catheter), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a specific device performance against pre-defined acceptance criteria using clinical studies.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a diagnostic AI product is not directly applicable to this document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract information related to the non-clinical testing that was performed to support the substantial equivalence claim.

Regarding your specific questions:

A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and performance metrics in the way you might see for a diagnostic AI product (e.g., sensitivity, specificity thresholds). Instead, it states that the device was tested to evaluate its substantial equivalence according to various standards for medical devices. The "performance" reported is that the device met these standards and demonstrated substantial equivalence.

Acceptance Criterion/Standard	Reported Device Performance
Biocompatibility ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006	Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity tests were completed and met.
Performance testing (appearance and dimension)	Performed as per Finemedix's design control system, results met.
Physical and Chemical Safety Testing (color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test)	Performed as per Finemedix's design control system, results met.
EO Sterilization Testing ISO 11737-1:2006 and ISO 11737-2:2009	Met the standards.
Shelf Life Testing ASTM F1980	Met the standard.

Sample sized used for the test set and the data provenance:
The document does not detail specific sample sizes for each non-clinical test. These tests typically involve material samples and/or device units rather than patient data. There is no information on data provenance in terms of country of origin or retrospective/prospective data as this is non-clinical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance process, not a diagnostic study requiring expert ground truth for classification.
Adjudication method for the test set:
Not applicable (see #3).
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. This is not an AI/diagnostic product that would involve human readers or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Clear-Jet Injection Catheter is a medical device (catheter), not an algorithm or AI product.
The type of ground truth used:
For the non-clinical tests, the "ground truth" or reference is the established performance specifications and regulatory standards (e.g., ISO standards for biocompatibility, sterility, etc.). Tests are designed to confirm the device meets these pre-defined objectives.
The sample size for the training set:
Not applicable. This is not a machine learning model; therefore, there is no "training set."
How the ground truth for the training set was established:
Not applicable (see #8).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

December 21, 2018

Finemedix Co. Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, CA 92620

Re: K181690

Trade/Device Name: Clear-Jet Injection Catheter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: November 13, 2018 Received: November 20, 2018

Dear April 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 mav, 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 avare 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel G. Walter Jr -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181690

Device Name Clear-Jet Injection Catheter

Indications for Use (Describe)

The Clear-Jet Injection Catheter is to be used in conjunction with an endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in blue and has an orange circle above the letter 'E'. The text is in all caps and is a sans-serif font.

FINEMEDIX CO., LTD. 60, Maeyeo-ro, Dong-gu, Daegu, Republic of Korea (41065)

510(k) Summary

Submitter

FINEMEDIX CO., LTD. Hee Kyung Kwon 60, Maeyeo-ro, Dong-gu, Daegu 41065 South Korea Email: hkyung1230@finemedix.com Tel. +82-53-741-8388 Fax. +82-53-741-8168

Official Correspondent

Withus Group Inc April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Clear-Jet Injection Catheter ●
Common Name: Endoscopic Injection Needle ●
Classification Name: Endoscopic injection needle, gastroenterology-urology ●
. Product Code: FBK
Panel: Gastroenterology/Urology
Regulation Number: 21 CFR 876.1500 Endoscope and Accessories
Device Class: Class II
. Date Prepared: 06/20/2018

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K 150434, Injection Needle manufactured by Micro-Tech (Nanjing) Co., Ltd.

Indication for Use:

The Clear-Jet Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Device Description:

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Summary of Technological Characteristics:

		Subject Device	Primary Predicate	SubstantialEquivalence
Company		Finemedix Co., Ltd.	Micro-Tech Co., Ltd.	-
Device Name		Clear-Jet Injection Catheter	Injection Needle	-
510(k) Number		NA	K150434	-
DeviceClassification Name		Endoscopic injection needle,gastroenterology-urology	Endoscopic injection needle,gastroenterology-urology	me
Product Code		FBK	FBK	Same
Regulation Number		876.1500	876.1500	Same
Indications for Use		The Clear-Jet InjectionCatheter is to be used inconjunction with anendoscope to performendoscopic injections, such asthe treatment of esophagealsubmucosal dye marking inthe GI tract	The Injection Needle is to beused in conjunction with anendoscope to performendoscopic injections, such asthe treatment of esophagealSaand gastric varies, and forand gastric varies and forsubmucosal dye marking inthe GI tract.	me
Material	NeedleTube	Stainless-SteelThermoplastic-PTFE Polymer	Stainless-SteelThermoplastic-PTFE Polymer	SameSame
Components		Needle, Inner Tube, CatheterTube, Handle, Slider	Needle, Innersheath, outershell, outer sheath and luerSimi	lar
Gauge size		21,23 Gauge	19,22,25 Gauge	Within the range
Supplied Sterile		Yes	Yes	Same
Outer SheathDiameter	2.35mm	2.3mm	Similar
Working Length	1800, 2300 mm	1800, 2000, 2300 mm	Within the range
Needle Length	4, 6 mm	4,5,6 mm	Within the range
Packaging	Single-use EO SterilizedPouch with one device perpouch	Single-use EO SterilizedPouch with one device perpouch	Same
Single Use	Yes	Yes	Same
Similarities	Both subject and predicate device are substantially equivalent in the indications for use,Material, Components, Design, sterility, outer sheath diameter, working length, needle length,and packaging as charted.
Differences	The differences between the subject and predicate devices are gauge size and outer sheathdiameter. The subject device has 21 and 23 gauge and the predicate device has 19,22,25 gauge.But the subject device gauges are contained within the range of the predicate's gauges, so itdoes not affect the safety and effectiveness.The other difference is outer sheath diameter. The outer sheath diameter of the subject device is2.35mm and the outer sheath diameter of the predicate device is 2.3mm. But this size differencedoesn't affect the safety and effectiveness during surgery.Any differences in technology characteristics are accompanied by information thatdemonstrated the device is substantially equivalent as the predicate and do not raise differentquestions of safety and effectiveness than the predicate.

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Image /page/5/Picture/1 description: The image shows the word "FINEMEDIX" in a bold, sans-serif font. The letters are a dark blue color. Above the "E" in "FINEMEDIX" is a small orange circle.

FINEMEDIX CO., LTD.

60, Maeyeo-ro, Dong-gu, Daegu, Republic of Korea (41065)

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Image /page/6/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in purple and has an orange circle above the letters 'ME'. The text is bold and sans-serif.

Non-clinical testing data:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 . and ISO 10993-11:2006
. Performance testing such as appearance and dimension
Physical and Chemical Safety Testing such as color and transparent, pH, KMnO4 Consumption, . Non-Volatile residue, ultraviolet absorption, heavy metal as lead, EO Sterilization residuals test, and sterility test
EO Sterilization Testing according to ISO 11737-1:2006 and ISO 11737-2:2009
Shelf Life Testing according to ASTM F1980 ●

The biocompatibility evaluation for Clear-Jet Injection Catheter was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (May 1, 1995). The following tests were completed: Cytotoxicity, Sensitization, Intracutaneous reactivity and Acute Systemic Toxicity.

Performance testing such as appearance and dimension and extractable testing such as color and transparent, pH, KMnO4 Consumption, Non-Volatile residue, ultraviolet absorption, and heavy metal as lead were performed as per Finemedix's design control system.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion:

Clear-Jet Injection Catheter constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Clear-Jet Injection Catheter and its predicate are substantially equivalent.

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.