Clear-Tip EUS-FNA

K180363 · Finemedix Co., Ltd. · FCG · Nov 1, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180363
• Device Name: Clear-Tip EUS-FNA
• Applicant: Finemedix Co., Ltd.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Nov 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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 Story

Clear-Tip EUS-FNA is a manual biopsy instrument used with an ultrasound endoscope to obtain tissue samples. The device consists of a handle, catheter tube, needle, and stylet. The needle features a spiral-shaped dimpled pattern for enhanced ultrasonic visualization. During the procedure, the physician advances the needle into the target site; a syringe and stopcock attached to the handle provide vacuum suction to aspirate tissue. The device allows for manual adjustment of needle length and sheath extension. It is a single-use, sterile device intended for use in clinical settings by trained medical professionals. By enabling ultrasound-guided sampling of masses within or near the GI tract, the device assists in diagnostic procedures, potentially benefiting patients by facilitating accurate tissue acquisition for pathological analysis.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993), physical/chemical safety, performance testing (appearance, dimension, elasticity, bending/tensile strength), EO sterilization validation (ISO 11737), and shelf-life testing (ASTM F1980).

Technological Characteristics

Needle: Stainless steel alloy. Stylet: Nitinol. Components: Catheter tube, needle, stylet, syringe, stopcock. Principle: Manual cutting/aspiration. Visualization: Spiral-shaped dimpled needle. Dimensions: 19, 22, 25 gauge. Sterilization: EO gas. Single-use. Shelf life: 3 years.

Indications for Use

Indicated for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract using an ultrasound endoscope.

Regulatory Classification

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.

Predicate Devices

• Cook Ireland EchoTip Procore® HD Ultrasound Biopsy Needle (K142688)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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)

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.

| 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: [e-mail] Tel. [phone] Fax. [phone]

#### Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

## 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:

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

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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®<br>HD Ultrasound Biopsy Needle |
| 510(k) Number | | N/A | K142688 |
| Device Classification Name | | Gastroenterology-urology biopsy<br>instrument | Gastroenterology-urology biopsy<br>instrument |
| Product Code | | FCG | FCG |
| Regulation Number | | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Intended Use | | The Clear-Tip EUS-FNA is used<br>with an ultrasound endoscope for<br>fine needle biopsy of submucosal<br>lesions, mediastinal masses,<br>lymph nodes and intraperitoneal<br>masses within or adjacent to the<br>gastrointestinal tract. | The device is used with an<br>ultrasound endoscope for fine<br>needle biopsy of submucosal<br>lesions, mediastinal masses,<br>lymph nodes and intraperitoneal<br>masses within or adjacent to the<br>gastrointestinal tract. |
| Material | Needle | Stainless Steel Alloys | Stainless Steel Alloys |
| | Stylet | Nickel-Titanium Alloys (Nitinol) | Nickel-Titanium Alloys (Nitinol) |
| Components | | Catheter Tube, Needle, Stylet,<br>Syringe, Stopcock | Catheter Tube, Needle, Stylet,<br>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,<br>Bevel type | Bevel type | |
| Stylet tip options | Ball tip | Ball tip or Bevel tip | |
| Compatibility with an<br>ultrasound endoscope | Yes | Yes | |
| Minimum accessory channel<br>(Ultrasound endoscope) | 2.0 | 2.0 | |
| Use with a syringe and<br>stopcock | Yes | Yes | |
| Principle of Operation | Manual, sampling using cutting and<br>aspiration | Manual, sampling using cutting and<br>aspiration | |
| Method of needle and sheath<br>adjustment | Handle part | Handle part | |
| Needle length adjustment range | 0 ~ 8cm | 0 ~ 8cm | |
| Sheath extension adjustment<br>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<br>intended use, Material, Components, Gauge size, Design, Stylet tip option,<br>Compatibility with an ultrasound endoscope, Minimum accessory channel<br>(Ultrasound endoscope), Use with a syringe and stopcock, Principle of<br>Operation, Method of needle and sheath adjustment, Needle length<br>adjustment range, Sheath extension adjustment range, for single use,<br>Sterility, and Shelf Life as charted. | | |
| Differences | The difference between the subject and predicate devices is “Dimple pattern<br>of Echo part". The pattern of the subject device is spiral shape, while the one<br>of the predicate device is dot shape. The spiral shape is to allow<br>visualization of the needle more clearly and easy positioning than dot shape<br>under endoscopic ultrasound. Any differences in technology characteristics<br>are accompanied by information that demonstrated the device is<br>substantially equivalent as the predicate and do not raise different questions<br>of 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.