K Number

Device Name

Clear-Tip EUS-FNA

Manufacturer

Finemedix Co. Ltd.

Date Cleared

2018-11-01

(265 days)

Product Code

FCG

Regulation Number

876.1075

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142688

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a biopsy needle, with no mention of AI/ML or image processing for analysis or guidance.

Therapeutic

No
Explanation: The device is used for fine needle biopsy, which is a diagnostic procedure for tissue sample collection, not a therapeutic intervention to treat a disease.

Diagnostic

Yes

Explanation: The device is used for fine needle biopsy, which involves collecting tissue samples to diagnose medical conditions such as submucosal lesions, mediastinal masses, and lymph nodes. Biopsy is a diagnostic procedure.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as a handle section, insertion (catheter tube, needle, stylet), and accessories like a syringe and stopcock. The performance studies also detail testing on physical properties like elasticity, bending strength, and tensile strength, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for "fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract." This describes a procedure to obtain tissue samples from the body.
Device Description: The description details a physical device used to puncture tissue and aspirate samples. It does not describe a test or assay performed on a sample outside of the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue) in vitro to diagnose a condition, monitor treatment, or screen for diseases. The device is used to collect the sample, not to perform a diagnostic test on it.

In summary, the Clear-Tip EUS-FNA is a device used for tissue collection (biopsy), which is a procedure performed in vivo (within the living body). IVDs are used to perform tests in vitro (outside the living body) on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

FCG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142688

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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.

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

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)
-------------------------------------------------	--

|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.

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.

		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 biopsy
instrument	Gastroenterology-urology biopsy
instrument
Product Code		FCG	FCG
Regulation Number		21 CFR 876.1075	21 CFR 876.1075
Intended Use		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.	The device 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.
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 an
ultrasound endoscope	Yes	Yes
Minimum accessory channel
(Ultrasound endoscope)	2.0	2.0
Use with a syringe and
stopcock	Yes	Yes
Principle of Operation	Manual, sampling using cutting and
aspiration	Manual, sampling using cutting and
aspiration
Method of needle and sheath
adjustment	Handle part	Handle part
Needle length adjustment range	0 ~ 8cm	0 ~ 8cm
Sheath extension adjustment
range	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 the
intended 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 of
Operation, Method of needle and sheath adjustment, Needle length
adjustment 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 pattern
of Echo part". The pattern of the subject device is spiral shape, while the one
of the predicate device is dot shape. The spiral shape is to allow
visualization of the needle more clearly and easy positioning than dot shape
under endoscopic ultrasound. Any differences in technology characteristics
are accompanied by information that demonstrated the device is
substantially equivalent as the predicate and do not raise different questions
of safety and effectiveness than the predicate.

Summary of Technological Characteristics:

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)

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 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.