ClearGrasp Snare is a monopolar electrosurgical instrument intended for EMR which is Endoscopic Mucosal Resection by applying high-frequency current during endoscopic electrosurgical procedures. It is used for grasping and resecting the targeted lesion within the digestive tract by opening and closing the loop. Users can choose an oval or a crescent type based on their preference and the characteristic of the lesion. The loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. There is a stiff type distinguished by the strength of loop. The device consists of a flexible Rope Wire and various size of loop, which can be extended and rotated from the flexible Catheter Tube using two handle control knobs such as Handle and Slider. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. This device passes through the working channel of endoscope, and the average contact time of the product and the 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

The provided text describes the 510(k) premarket notification for the "ClearGrasp Snare" device. It outlines the device's indications for use, its technical characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance, a study proving the device meets specific performance criteria with reported device performance metrics, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in studies for AI/software devices.

The document focuses on demonstrating substantial equivalence primarily through technical specifications, biocompatibility, and electrical safety testing, as is common for electrosurgical accessories. It does not present a study with specific performance metrics against defined acceptance criteria that would be relevant for an AI/software device.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, with clear indications where information is not present.

Acceptance Criteria and Study for ClearGrasp Snare

The provided 510(k) submission for the ClearGrasp Snare does not present a study with specific performance acceptance criteria and reported device performance metrics in the way a study for a diagnostic or AI device would. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical safety testing rather than a performance study against predefined numerical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Type of Test)	Reported Device Performance
Biocompatibility:
Cytotoxicity	Passed (compliant with ISO 10993-5:2009)
Sensitization	Passed (compliant with ISO 10993-10:2010)
Intracutaneous reactivity	Passed (compliant with ISO 10993-10:2010)
Acute Systemic Toxicity	Passed (compliant with ISO 10993-11:2006)
Pyrogen Test	Passed (compliant with ISO 10993-11:2006)
Performance Testing:
Appearance	Performed as per Finemedix's design control system (implies passed)
Dimension	Performed as per Finemedix's design control system (implies passed)
Continuity	Performed as per Finemedix's design control system (implies passed)
Tensile strength test of electrode cable	Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed)
Withstand voltage	Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed)
High frequency leakage current test of electrode cable	Compliant with IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001 (implies passed)
Sterilization & Shelf Life:
EO Sterilization residuals testing	Compliant with ISO 10993-7:2008 (implies passed)
EO Sterilization Validation Testing	Compliant with ISO 11737-1:2006 and ISO 11737-2:2009 (implies passed)
Shelf Life Testing	Compliant with ASTM F1980 (implies passed)

Note: The document only states that these tests were performed and implies successful completion ("demonstrate that the subject device is substantially equivalent"). It does not provide specific numerical results or quantitative acceptance criteria (e.g., "tensile strength > X N") for most of these tests in the publicly accessible summary.

Regarding AI/Software specific details (Items 2-9):

The ClearGrasp Snare is described as a monopolar electrosurgical instrument intended for Endoscopic Mucosal Resection (EMR). It is a physical medical device (snare) and not an AI or software device. Therefore, the following requested information is not applicable to this submission, as it relates to the evaluation of AI/software performance, which is not the subject of this 510(k).

2. Sample size used for the test set and the data provenance: Not applicable; this is a physical device, not an AI/software being tested on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable; this is a physical device, not an AI/software with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary

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March 6, 2019

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

Re: K183289

Trade/Device Name: ClearGrasp Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI Dated: January 29, 2019 Received: February 5, 2019

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 J. Antonino -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) K183289

Device Name ClearGrasp Snare

Indications for Use (Describe)

The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within 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)

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Image /page/3/Picture/1 description: The image shows the logo for FINEMEDIX. The logo consists of the word "FINEMEDIX" in a bold, sans-serif font, with an orange circle above the "E" in "FINEMEDIX". The word "FINEMEDIX" is in a dark blue color. The logo is simple and modern.

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: ClearGrasp Snare
Common Name: Snare, Flexible
Classification Name: Endoscopic electrosurgical unit and accessories
Product Code: FDI
Panel: Gastroenterology/Urology
Regulation Number: 21 CFR 876.4300
Device Class: Class II ●
. Date Prepared: 11/23/2018

Predicate Devices:

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

. K 172729, Polypectomy Snare manufactured by Hangzhou AGS MedTech Co., Ltd.
K151197, Lariat Snare by United States Endoscopy Group, Inc. ●
K172758, Rotatable Snares, Non-Rotatable Snares by Zhejiang Chuangxiang Medical Technology ● Co., LTD.

Indication for Use:

The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Device Description:

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Image /page/4/Picture/1 description: The image shows the word "FINEMEDIX" in large, bold, purple letters. Above the "E" in "FINEMEDIX" is a small orange circle. The background of the image is white.

The device consists of a flexible Rope Wire and various size of loop, which can be extended and rotated from the flexible Catheter Tube using two handle control knobs such as Handle and Slider. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. This device passes through the working channel of endoscope, and the average contact time of the product and the 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.

	Subject Device	PrimaryPredicate Device	Reference Device	Reference Device
Company	Finemedix Co.,Ltd.	Hangzhou AGSMedTech Co., Ltd.	United StatesEndoscopy Group,Inc.	Zhejiang ChuangxiangMedical TechnologyCo., LTD.
Device Name	ClearGrasp Snare	Polypectomy Snare	Lariat Snare	Rotatable Snares,Non-Rotatable Snares
510(k) Number	NA	K172729	K151197	K172758
DeviceClassificationName	Endoscopicelectrosurgical unitand accessories	Endoscopicelectrosurgical unitand accessories	Endoscopicelectrosurgical unitand accessories	Endoscopicelectrosurgical unitand accessories
Product Code	FDI	FDI	FDI	FDI
RegulationNumber	876.4300	876.4300	876.4300	876.4300
Indications for Use	The ClearGraspSnare is usedendoscopically inthe removal ofdiminutive polyps,sessile polyps,pedunculatedpolyps and tissuefrom within the GItract.	The PolypectomySnare is usedendoscopically inthe removal ofdiminutive polyps,sessile polyps,pedunculatedpolyps and tissuefrom within the GItract.	The Lariat snare isan electrosurgicaldevice designed tobe used toendoscopicallygrasp, dissect andtransect tissueduring GIendoscopicprocedures.	The PolypectomySnare is usedendoscopically in theremoval and/or andcauterization ofdiminutive polyps,sessile polyps,pedunculated polysand tissue from withinthe gastrointestinaltract.
Principle ofOperation	Monopolarelectrosurgicalinstrumentintended for EMR	Monopolarelectrosurgicalinstrumentintended for EMR	Monopolarelectrosurgicalinstrument intendedfor EMR	Monopolarelectrosurgicalinstrument intendedfor EMR
	LoopCatheterTubeHandle	SUS 304	SUS 304	Unknown	Unknown
Material		PTFE	PTFE
		ABS	ABS
	Components	Loop, CatheterTube, Handle,Slider, Plug	Loop, CatheterTube, Handle,Slider, Plug	Loop, CatheterTube, Handle,Slider, Plug	Loop, Catheter Tube,Handle, Slider, Plug
	Shape of Loop	Oval and Crescent	Oval, Polygon,Duck Bill,Hexagonal andRound	Oval, Hexagonaland Diamond	Oval, Hexagonal,Crescent, Round
	Working Length	1600,1800,2200,2400 mm	1800, 2300 mm	2300mm	1600, 1800, 2400mm
	Loop Size	6,10,13,15,24,30 mm	10,15,25,32 mm	6,10,30mm	10,15,22,25,32mm
	Rotational/Non-Rotational	Both	Both	Non-Rotational	Both
	Sterile/Non-Sterile	Sterile	Sterile	Sterile	Sterile
	SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
	Single Use	Yes	Yes	Yes	Yes
	Used withElectrosurgicalUnit	Yes	Yes	Yes	Yes
	Similarities	The subject device is substantially equivalent to the predicate device in Indications for Use,materials, components, shape of loop, rotationality, sterilization methods and principle ofoperation.
	Differences	The difference between the subject and primary predicate are shape of loop, workinglength, and loop size. To support the difference of the shape of loop such as the crescentshape and working length such as 1600 and 2400mm, we added the K172758 as thereference device. To support the difference of the loop size such as 6mm, we added theK151197 as the reference device. These differences do not raise any questions ofsubstantial equivalence to the declared predicates.

Summary of Technological Characteristics:

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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 a dark blue color, with an orange circle above the letters 'ME'. The text is in all capital letters and is a sans-serif font. The logo is simple and modern.

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, continuity, tensile strength test of electrode cable, withstand voltage, high frequency leakage current test of electrode cable according to IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001
EO Sterilization residuals testing according to ISO 10993-7:2008

Below tests were performed on our own device and they can be leveraged for the subject device:

EO Sterilization Validation Testing according to ISO 11737-1:2006 and ISO 11737-2:2009 ●
. Shelf Life Testing according to ASTM F1980

The biocompatibility evaluation for ClearGrasp Snare 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, Acute Systemic Toxicity and Pyrogen Test.

Performance testing such as appearance, dimension, and continuity 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:

ClearGrasp Snare 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, ClearGrasp Snare and its predicate are substantially equivalent.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).