(239 days)
No
The device description and performance studies focus on the mechanical aspects and physical properties of the clip and delivery system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for hemostasis, repair of defects, anchoring, and closure, all of which involve treating a medical condition or restoring function, thus classifying it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that the ClearEndoclip is used for therapeutic or interventional procedures such as hemostasis, endoscopic marking, anchoring, and closure of perforations, rather than for diagnosing conditions or diseases.
No
The device description clearly states it is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the delivery system and the clip. These are physical components made of materials like stainless steel, HDPE, and polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, the ClearEndoclip is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ClearEndoclip's Function: The ClearEndoclip is a device that is physically deployed and placed within the patient's gastrointestinal tract for therapeutic purposes (hemostasis, marking, anchoring, closure). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed (endoscopic marking, hemostasis, anchoring, closure of perforations) are all direct interventions within the body, not diagnostic tests performed on samples outside the body.
- Device Description: The description details a mechanical device for delivering a clip, not a system for analyzing biological specimens.
- Performance Studies: The performance studies focus on the physical properties, biocompatibility, and mechanical function of the device, not on the accuracy of diagnostic results from analyzing samples.
In summary, the ClearEndoclip is a therapeutic medical device used for interventions within the body, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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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 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 letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 28, 2019
Finemedix Co., Ltd. % Kyungyoon Kang Consultant K-Biotech, Inc. 589 Oakwood Drive Santa Clara, CA 95054
Re: K183021
Trade/Device Name: ClearEndoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL, FHN, MND Dated: May 17, 2019 Received: May 28, 2019
Dear Kyungyoon Kang:
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 may, 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 aware 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183021
Device Name ClearEndoclip
Indications for Use (Describe)
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in blue and has an orange circle above the letter 'E'. The word 'FINEMEDIX' is written in a bold, sans-serif font. There is a registered trademark symbol to the right of the 'X'.
510(k) SUMMARY
Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, Finemedix Co., Ltd. submits the following information as premarket notification for the proposed device, ClearEndoclip.
I. SUBMITTER
Company: Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu, Daegu Postal code: 41065, Republic of Korea Tel: 82-053-741-8388 Fax: 82-053-741-8168
510(k) Correspondent: Kyungyoon Kang (Kyungyoon.kang@kbiotechsolutions.com) Date Prepared: October 24, 2018
II. DEVICE
Trade Name: ClearEndoclip Common Name: Endoscopic Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Product Code: PKL (hemostatic metal clip for the GI tract), FHN (ligator, hemorrhoidal), MND (ligator, esophageal) Regulatory Class: II
III. PREDICATE DEVICE
Single Use Repositionable Clip (K123601), Manufacturer: Olympus Medical Systems Corp. This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is pre-loaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of
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Image /page/4/Picture/1 description: The image shows the logo for FINEMEDIX. The logo is in blue and features the company name in a bold, sans-serif font. There is an orange circle above the "M" in FINEMEDIX. A small "R" in a circle is to the right of the "X".
the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.
ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.
Component Name | Function |
---|---|
Clip | It is detached from the Inner Sheath and holds the tissue by physical |
force and fixes it to perform hemispheres, indication of lesion and | |
treatment of perforation substantially for the user's intended purpose. | |
Clip Ring | The clip ring moves according to the slider forward / backward. The |
Clip is opened / closed by the Clip Ring, and when the Slider is pushed | |
all the way, the Clip is clamped. | |
Delivery System/Clip Fixing Device | |
Inner Sheath (Coil) | The Clip is attached to the end of the Inner Sheath and is connected to |
the handle to transmit the force and movement from the handle to the | |
Clip. | |
Outer Sheath | |
(Polyethylene | |
Catheter Tube) | A plastic wrapping around the Inner Sheath and Clip helps protect the |
endoscope channel. | |
Tube Joint | When using the product, the outer sheath moves forward and backward |
to expose the clip from the outer sheath, and to recover the inner sheath | |
into the outer sheath when the product is recovered. | |
Stopper | It prevents the outer sheath from moving in the direction of Handle |
when the product is moved and stored, thereby preventing the clip from | |
opening. | |
Slider | It is used for open/close and detachment of clip. |
Handle | It serves to fix this device with user's hand |
Functional Descriptions for Critical Components of ClearEndoclip
As far as the raw material compositions are concerned, Clip of ClearEndoclip is constructed with stainless steel material and deployed from the delivery system during the clinical use. ClearEndoclip is engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. FINEMEDIX Page 2of 6
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V. INDICATIONS FOR USE
ClearEndoclip is intended to be used with FDA-cleared endoscope for endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
(a) Mucosal/sub-mucosal defects