(259 days)
Not Found
No
The device description and performance studies focus on the mechanical function and physical properties of the endoscopic clip and delivery system, with no mention of AI or ML.
Yes
The device is used for hemostasis and closure of perforations, which are therapeutic interventions.
No
The device is described as a metallic mechanical device (endoscopic clip) used to close mucosal surfaces, prevent bleeding, and close perforations. Its functions (marking, hemostasis, closure) are all therapeutic or interventional, rather than diagnostic.
No
The device description clearly describes a metallic mechanical device (endoscope clip) and its associated delivery system (handle slider, coil, clip body, disconnection connector part). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the gastrointestinal tract for mechanical actions like marking, hemostasis, and closure of perforations. These are all direct interventions on the patient's body.
- Device Description: The device is described as a metallic mechanical device used in endoscopy to physically close mucosal surfaces. It functions like a suture.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, tissue, or other bodily fluids) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic and procedural device used directly on the patient during an endoscopic procedure.
N/A
Intended Use / Indications for Use
It 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 U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 23, 2022
Incore Co., Ltd. % Seon-Mi Kim Consultant KMC. Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul. 08390 KOREA, SOUTH
Re: K213338
Trade/Device Name: Core-clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: May 20, 2022 Received: May 23, 2022
Dear Seon-Mi Kim:
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
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statutes and regulations administered by other Federal agencies. 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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
Enclosure
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Indications for Use
510(k) Number (if known) K213338
Device Name CORE-CLIP
Indications for Use (Describe)
It 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 (K213338)
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: May 19, 2021
1. INFORMATION
1.1 Submitter Information
- Submitter Name: INCORE Co., Ltd.
- . Address
- : 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, Republic of Korea
- Telephone Number: +82-2-866-3514 . 트 Fax: +82-2-6919-1346
1.2 Contact Person
- Name: Seon-mi Kim (Consultant / KMC, Inc.)
- 트 Address: Rm. No. 1709, 123, Digital-ro 26-gil, Guro-gu, 08390, Republic of Korea
- Telephone Number: +82-70-8965-5554 Fax: +82-2-2672-0579 트
- 트 E-mail: ctr1903@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: CORE-CLIP
- 2.2 Common Name: Disposable endoscope clip
- 2.3 Product Code: PKL
- 2.4 Classification Regulation: 21CFR 876.4400
- 2.5 Device Class: Class II
- 2.6 Classification Panel: Gastroenterology/Urology
3. PREDICATE DEVICE
| Manufacturer | Finemedix Co., Ltd. |
|---|---|
| Device Name (Trade Name) | ClearEndoclip |
| 510(k) Number | K183021 |
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4. OVERVIEW OF THE PEODUCT
The endoscope clip is a metallic mechanical device used in endoscopy in order to close two mucosal surfaces without the need for surgery and suturing. Its function is similar to a suture in gross surgical applications, as it is used to join together two disjointed surfaces, but, can be applied through the channel of an endoscope under direct visualization. The endoscope clip has found use in treating gastrointestinal bleeding (both in the upper and lower GI tract), in preventing bleeding after therapeutic procedures such as polypectomy, and in closing gastrointestinal perforations.
The Handle Slider and the coil are connected, and the clip are connected. When the Handle Slider is moved backward, the coil connected to the Handle Slider is pulled back, and the clip is also pulled back and the clip is closed as the clip enters the Clip Body. After the clip is completely closed, the clip will no longer be pulled back and when the threshold is reached, the Disconnection connector part will eventually break. As a result, the delivery device and the clip are completely separated, and the clip remains alone to maintain hemostasis.
5. INDICATIONS FOR USE
It 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 , ASTM F88, ASTM F1929
-
Biocompatibility Test
The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with ISO 10993-1, ISO 10993-5, -10, -3, -11, -6, and FDA Guidance -Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". -
Performance
The following tests were performed to assess effectiveness of the bench product performance. The tests were performed in accordance with in house hold standard caused by predicate device to demonstrate substantial equivalence between subject device and predicate device.
| Test Item | Test Item |
|---|---|
| Rotation test | Tensile strength |
| (Between Clip and Coil wire) | |
| Repeat open/close test | Tensile strength |
| (Between Coil and Handle) | |
| Clamping retention time |
The mechanical properties tests were performed by being based on each product different properties and dimensions.
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
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8. Clinical and Animal Test
In vivo animal testing was performed for the adhesion safety and hemostatic performance to support indication for use
9. Conclusion
The comparison between the subject device and the predicate device shows that the general information, some technical and material information are the same. Although there are some differences, the bench performance test reports are supported to the substantial equivalence of the subject device, the bench performance test reports are provided to demonstrate substantial equivalence of the subject device. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject devices are substantially equivalent to the predicate device