(251 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI/ML terms or functionalities like image processing, data analysis, or automated decision-making.
Yes
The device is indicated for therapeutic purposes such as hemostasis for various conditions (e.g., bleeding ulcers, polyps), anchoring feeding tubes, and closure of GI tract perforations.
No
Explanation: The device is used for therapeutic or interventional procedures such as hemostasis, anchoring, and closure of perforations, as well as endoscopic marking, not for diagnosing conditions.
No
The device description clearly outlines physical components like a delivery system, clip, handle, catheter, and materials like stainless steel and polypropylene. It is a hardware device used for physical intervention.
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 about a person's health. This testing is done outside of the body (in vitro).
- ClearEndoclip's Function: The ClearEndoclip is a device used within the body (in vivo) during an endoscopic procedure. Its purpose is to physically place clips within the gastrointestinal tract for various therapeutic and procedural reasons (marking, hemostasis, anchoring, closure). It does not analyze or test any bodily specimens.
The description clearly outlines a mechanical device used for physical intervention within the body, which is characteristic of a surgical or therapeutic device, not an IVD.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 5, 2020
Finemedix Co., Ltd. % Kyungyoon Kang CEO K-Bio Solutions 589 Oakwood Drive Santa Clara, CA 95054
Re: K200217
Trade/Device Name: ClearEndoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL, FHN, MND Dated: August 26, 2020 Received: September 1, 2020
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. You must comply with all the Act's
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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Shanil P. Haugen, Ph.D. Assistant 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
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Indications for Use
510(k) Number (if known) K200217
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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510(k) SUMMARY
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, CEO: K-Bio Solutions (Tel: 812-345-7485, Kyungyoon.kang@kbiotechsolutions.com)
Manufacturer Contact: Heon-Sik Lee, RA Manager, Finemedix (hslee@finemedix.com) Date Prepared: September 30th , 2020
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
Predicate Device: ClearEndoclip (K183021), Manufacturer: Finemedix Co., Ltd. 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 preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of 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
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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 | |
| 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.
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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