(100 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of a standard electrosurgical snare, with no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is described as a monopolar electrosurgical instrument used for grasping and resecting tissue, specifically for Endoscopic Mucosal Resection (EMR) by applying high-frequency current, rather than treating a disease or medical condition.
No
The device description indicates it is a monopolar electrosurgical instrument used for grasping and resecting tissue (therapy), not for diagnosis.
No
The device description clearly outlines physical components like a flexible Rope Wire, Catheter Tube, Handle, and Slider, and mentions connection to an electrosurgical generator, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. This testing is performed outside of the living body (in vitro).
- ClearGrasp Snare Function: The ClearGrasp Snare is a surgical instrument used within the human body (in vivo) during an endoscopic procedure. Its purpose is to physically grasp and resect tissue from the GI tract. It does not analyze or test specimens.
The description clearly indicates it's a surgical tool for tissue removal, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
Product codes
FDI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract / digestive 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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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:
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.
4
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 | Primary
Predicate Device | Reference Device | Reference Device | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Company | Finemedix Co.,
Ltd. | Hangzhou AGS
MedTech Co., Ltd. | United States
Endoscopy Group,
Inc. | Zhejiang Chuangxiang
Medical Technology
Co., LTD. | |
| Device Name | ClearGrasp Snare | Polypectomy Snare | Lariat Snare | Rotatable Snares,
Non-Rotatable Snares | |
| 510(k) Number | NA | K172729 | K151197 | K172758 | |
| Device
Classification
Name | Endoscopic
electrosurgical unit
and accessories | Endoscopic
electrosurgical unit
and accessories | Endoscopic
electrosurgical unit
and accessories | Endoscopic
electrosurgical unit
and accessories | |
| Product Code | FDI | FDI | FDI | FDI | |
| Regulation
Number | 876.4300 | 876.4300 | 876.4300 | 876.4300 | |
| Indications 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. | The Polypectomy
Snare is used
endoscopically in
the removal of
diminutive polyps,
sessile polyps,
pedunculated
polyps and tissue
from within the GI
tract. | The Lariat snare is
an electrosurgical
device designed to
be used to
endoscopically
grasp, dissect and
transect tissue
during GI
endoscopic
procedures. | The Polypectomy
Snare is used
endoscopically in the
removal and/or and
cauterization of
diminutive polyps,
sessile polyps,
pedunculated polys
and tissue from within
the gastrointestinal
tract. | |
| Principle of
Operation | Monopolar
electrosurgical
instrument
intended for EMR | Monopolar
electrosurgical
instrument
intended for EMR | Monopolar
electrosurgical
instrument intended
for EMR | Monopolar
electrosurgical
instrument intended
for EMR | |
| | Loop
Catheter
Tube
Handle | SUS 304 | SUS 304 | Unknown | Unknown |
| Material | | PTFE | PTFE | | |
| | | ABS | ABS | | |
| | Components | Loop, Catheter
Tube, Handle,
Slider, Plug | Loop, Catheter
Tube, Handle,
Slider, Plug | Loop, Catheter
Tube, Handle,
Slider, Plug | Loop, Catheter Tube,
Handle, Slider, Plug |
| | Shape of Loop | Oval and Crescent | Oval, Polygon,
Duck Bill,
Hexagonal and
Round | Oval, Hexagonal
and 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 |
| | Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| | Single Use | Yes | Yes | Yes | Yes |
| | Used with
Electrosurgical
Unit | 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 of
operation. | | | |
| | Differences | The difference between the subject and primary predicate are shape of loop, working
length, and loop size. To support the difference of the shape of loop such as the crescent
shape and working length such as 1600 and 2400mm, we added the K172758 as the
reference device. To support the difference of the loop size such as 6mm, we added the
K151197 as the reference device. These differences do not raise any questions of
substantial equivalence to the declared predicates. | | | |
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 a dark blue font, with a small orange circle above the letters 'NE'. The font is sans-serif and appears to be bolded.
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.