The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Device Description

Clear-Tip EUS-FNA is used in conjunction with an ultrasound endoscope. It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port. The insertion is composed of the Catheter Tube, Needle, and Stylet. A Syringe is attached to the aspiration port on the handle section to aspirate that was punctured with the Needle. Syringe and Stopcock are accessories to provide and control the vacuum suction to aspirate the tissue specimen. They also can be used to expel the samples after the procedure. Clear-Tip EUS-FNA is offered in various needle gauges for insertion. The available needle gauge sizes of 19, 22 and 25 gauges. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the Catheter Tube and Needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a Stylet to aid in inserting the Needle which is removed for injection and aspiration. 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. This device is for Rx used only.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Clear-Tip EUS-FNA" device, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on comparing the new device's characteristics and performance to an already legally marketed device, rather than extensive clinical studies or acceptance criteria defined for a specific performance metric.

Therefore, the document does not contain information on acceptance criteria for a specific device performance metric (e.g., sensitivity, specificity for an AI algorithm) or a study proving the device meets such criteria.

The "acceptance criteria" mentioned in the document relate to non-clinical testing standards to demonstrate substantial equivalence, not to performance metrics like those for an AI algorithm. The study described is a non-clinical testing program to show that the device is as safe and effective as the predicate.

Here's a breakdown of the available information from the document with respect to your requested points:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a physical medical device (biopsy needle) and not an AI/ML diagnostic tool, the "acceptance criteria" are not in the format of performance metrics like accuracy, sensitivity, or specificity. Instead, they are related to established international and FDA standards for medical device safety and functionality.

Acceptance Criteria (Non-Clinical Standards)	Reported Device Performance (Compliance)
Biocompatibility (ISO 10993-1, -5, -10, -11)	Compliant (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity tests completed)
Performance testing (appearance, dimension, elasticity, bending strength, tensile strength)	Performed as per Finemedix's design control system (implies compliance)
Physical and Chemical Safety Testing (color, transparency, pH, KMnO4 consumption, non-volatile residue, UV absorption, heavy metal, EO sterilization residuals, sterility)	Performed (implies compliance)
EO Sterilization Testing (ISO 11737-1, 11737-2)	Performed (implies compliance)
Shelf Life Testing (ASTM F1980)	Performed (implies compliance; shelf life reported as 3 years)

Study Details (Non-Clinical Testing for Substantial Equivalence)

The document describes a series of non-clinical tests to demonstrate substantial equivalence to the predicate device, not a study focused on a specific performance metric.

Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." The "test set" here refers to physical samples of the Clear-Tip EUS-FNA device that underwent various laboratory tests (biocompatibility, mechanical properties, sterilization, etc.). The document does not specify the number of samples used for each test. The provenance is the manufacturer, FINEMEDIX CO., LTD., located in Republic of Korea. The testing is assumed to be prospective, laboratory-based testing of the manufactured device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and the results obtained from standardized laboratory procedures, not by expert consensus on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 are typically used for clinical study endpoints, particularly when human readers are involved in disagreement resolution. These are laboratory tests against predefined standards.
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 device is a physical biopsy needle, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is adherence to the specified parameters and ranges defined by the international standards (e.g., ISO 10993 for biocompatibility, ASTM F1980 for shelf life, specific values for tensile strength, etc.).
The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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

November 1, 2018

FINEMEDIX CO., LTD. % April Lee Consultant Withus Group, Inc. 106 Superior Irvine, CA 92620

Re: K180363

Trade/Device Name: Clear-Tip EUS-FNA Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: September 18, 2018 Received: September 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,

Mark R. Kreitz -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) K180363

Device Name Clear-Tip EUS-FNA

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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|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 shows the logo for FINEMEDIX. The logo is in purple and has an orange circle above the letters 'ME'. The text is in all capital letters 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. Heon-Sik Lee 60, Maeyeo-ro, Dong-gu, Daegu 41065 South Korea Email: hslee@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-Tip EUS-FNA ●
Common Name: Biopsy needle ●
. Classification Name: Gastroenterology-urology biopsy instrument
Product Code: FCG
Panel: Gastroenterology/Urology
Regulation Number: 21 CFR 876.1075
Device Class: Class II
Date Prepared: 02/05/2018 ●

Predicate Devices:

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

K142688, Cook Ireland EchoTip Procore® HD Ultrasound Biopsy Needle by Cook Ireland Ltd. ●

Indication for Use:

Device Description:

Clear-Tip EUS-FNA is used in conjunction with an ultrasound endoscope.

It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port. The insertion is composed of the Catheter Tube, Needle, and Stylet. A Syringe is attached to the aspiration port on the handle section to aspirate that was punctured with the Needle. Syringe and Stopcock are accessories to provide and control the vacuum suction to aspirate the tissue specimen. They also can be used to expel the samples after the procedure.

Clear-Tip EUS-FNA is offered in various needle gauges for insertion. The available needle gauge sizes of 19, 22 and 25 gauges. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the Catheter Tube and Needle to enable the user to adjust for the working length of the endoscope and to control

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Image /page/4/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in a bold, sans-serif font and is colored in a dark blue or purple hue. Above the "E" in "FINEMEDIX" is a small orange circle, which serves as a visual accent to the logo.

needle insertion depth. It is preloaded with a Stylet to aid in inserting the Needle which is removed for injection and aspiration.

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. This device is for Rx used only.

		Subject Device	Primary Predicate
Company		Finemedix Co., Ltd	Cook Ireland Ltd.
Device Name		Clear-Tip EUS-FNA	Cook Ireland EchoTip Procore®HD Ultrasound Biopsy Needle
510(k) Number		N/A	K142688
Device Classification Name		Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument
Product Code		FCG	FCG
Regulation Number		21 CFR 876.1075	21 CFR 876.1075
Intended Use		The Clear-Tip EUS-FNA is usedwith an ultrasound endoscope forfine needle biopsy of submucosallesions, mediastinal masses,lymph nodes and intraperitonealmasses within or adjacent to thegastrointestinal tract.	The device is used with anultrasound endoscope for fineneedle biopsy of submucosallesions, mediastinal masses,lymph nodes and intraperitonealmasses within or adjacent to thegastrointestinal tract.
Material	Needle	Stainless Steel Alloys	Stainless Steel Alloys
	Stylet	Nickel-Titanium Alloys (Nitinol)	Nickel-Titanium Alloys (Nitinol)
Components		Catheter Tube, Needle, Stylet,Syringe, Stopcock	Catheter Tube, Needle, Stylet,Syringe, Stopcock
Gauge size		19,22,25 ga	19,20,22,25 ga
Dimple pattern of Echo part		Spiral shape	High Definition dot shape
Needle Design	Non-bevel type,Bevel type	Bevel type
Stylet tip options	Ball tip	Ball tip or Bevel tip
Compatibility with anultrasound endoscope	Yes	Yes
Minimum accessory channel(Ultrasound endoscope)	2.0	2.0
Use with a syringe andstopcock	Yes	Yes
Principle of Operation	Manual, sampling using cutting andaspiration	Manual, sampling using cutting andaspiration
Method of needle and sheathadjustment	Handle part	Handle part
Needle length adjustment range	0 ~ 8cm	0 ~ 8cm
Sheath extension adjustmentrange	3 ~ 5cm	3 ~ 5cm
For single use	Yes	Yes
Sterility	EO Gas sterilization	EO Gas sterilization
Shelf Life	3 years	3 years
Similarities	Both subject and predicate devices are substantially equivalent in theintended use, Material, Components, Gauge size, Design, Stylet tip option,Compatibility with an ultrasound endoscope, Minimum accessory channel(Ultrasound endoscope), Use with a syringe and stopcock, Principle ofOperation, Method of needle and sheath adjustment, Needle lengthadjustment range, Sheath extension adjustment range, for single use,Sterility, and Shelf Life as charted.
Differences	The difference between the subject and predicate devices is “Dimple patternof Echo part". The pattern of the subject device is spiral shape, while the oneof the predicate device is dot shape. The spiral shape is to allowvisualization of the needle more clearly and easy positioning than dot shapeunder endoscopic ultrasound. Any differences in technology characteristicsare accompanied by information that demonstrated the device issubstantially equivalent as the predicate and do not raise different questionsof safety and effectiveness than the predicate.

Summary of Technological Characteristics:

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Image /page/5/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in purple and has an orange circle above the "E" in FINEMEDIX. The logo is simple and modern.

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 text "FINEMEDIX" is written in a bold, sans-serif font and is colored in a dark blue or purple hue. Above the "N" in "FINEMEDIX" is a small, orange circle, which serves as a visual element in the logo. The logo appears to be for a company or organization named FINEMEDIX.

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, dimension, elasticity, bending strength test, and Tensile strength test
. 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-Tip EUS-FNA 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.

The device specific guidance document was consulted in preparing this premarket submission, Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology. Performance testing such as appearance, dimension, elasticity, bending strength test, and Tensile strength test 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-Tip EUS-FNA 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-Tip EUS-FNA and its predicate are substantially equivalent.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.