(259 days)
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 < 3cm
(b) Bleeding ulcers
(c) Arteries < 2 mm
(d) Polyps < 1.5 cm in diameter
(e) Diverticula in the colon
(3) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
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.
The provided text is a 510(k) summary for a medical device called "CORE-CLIP," a disposable endoscope clip. It aims to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria, performance metrics, and the full scope of a comparative effectiveness study as one might expect for an AI/CADe device. This device is a mechanical one, and the non-clinical and animal testing focus on its mechanical and biological safety and performance rather than AI algorithm performance.
Therefore, for the questions related to AI/CADe systems (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance), the information is not present as it is not an AI-powered device.
Here's an analysis of the provided text based on your questions, with N/R (Not Reported) or N/A (Not Applicable) where the information is not relevant or present for this type of mechanical device submission:
Acceptance Criteria and Device Performance (Based on available information for a mechanical device)
Given that this is a mechanical device, the "acceptance criteria" discussed are for its mechanical and biological safety and performance, not for an AI algorithm's diagnostic accuracy. The document states that the "results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device "meets the acceptance criteria" by performing comparably to the predicate and adhering to relevant standards.
1. Table of acceptance criteria and the reported device performance:
The document mentions several non-clinical tests performed, and the acceptance criteria are implicitly the successful completion and meeting of standards within these tests. The reported device performance is that it met these standards.
| Test Item Category | Specific Test Item | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Sterilization Validation | EO Gas Sterilization Validation | In accordance with ISO 11135:2014, ISO 11138-1:2017, etc. | Met the criteria of the standards |
| Packaging Validation | Shelf-life and integrity test | In accordance with ISO 11607-1:2019, ASTM F1980, etc. | Met the criteria of the standards |
| Biocompatibility Test | Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Genotoxicity | In accordance with ISO 10993-1, -5, -10, -3, -11, -6 and FDA Guidance | Met the criteria of the standards |
| Mechanical Performance (Bench Testing) | Rotation test | In accordance with in-house standard based on predicate device | Met the criteria of the standards, demonstrated substantial equivalence |
| Repeat open/close test | In accordance with in-house standard based on predicate device | Met the criteria of the standards, demonstrated substantial equivalence | |
| Clamping retention time | In accordance with in-house standard based on predicate device | Met the criteria of the standards, demonstrated substantial equivalence | |
| Tensile strength (Between Clip and Coil wire) | In accordance with in-house standard based on predicate device | Met the criteria of the standards, demonstrated substantial equivalence | |
| Tensile strength (Between Coil and Handle) | In accordance with in-house standard based on predicate device | Met the criteria of the standards, demonstrated substantial equivalence | |
| Animal Testing (In Vivo) | Adhesion safety and hemostatic performance | Supported indication for use | Supported indication for use |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: For the non-clinical bench tests (e.g., rotation, open/close, tensile strength, clamping retention time), specific numerical sample sizes are N/R. These tests would typically involve a specific number of units, but the report only states "The mechanical properties tests were performed by being based on each product different properties and dimensions."
- Data Provenance:
- Country of Origin: The submitter is INCORE Co., Ltd., Republic of Korea. The testing was conducted by them or their contracted labs.
- Retrospective or Prospective: These are non-clinical, benchtop, and animal tests, not human retrospective/prospective clinical studies. They are specifically performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is for AI/CADe systems where human experts establish ground truth for image interpretation. For a mechanical device, performance is typically assessed against engineering specifications, material standards, and functional requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This applies to human expert adjudication for image interpretation in AI studies.
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:
- N/A. This is a mechanical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a mechanical device, not an AI algorithm.
7. The type of ground truth used:
- For the non-clinical tests: The "ground truth" is defined by established engineering and biological standards (e.g., ISO, ASTM, AAMI, USP, in-house predicate-based standards).
- For the animal test: The "ground truth" for adhesion safety and hemostatic performance would be direct observation and measurement in the animal model.
8. The sample size for the training set:
- N/A. This is for AI algorithms. This device does not have a "training set."
9. How the ground truth for the training set was established:
- N/A. This is for AI algorithms.
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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 < 3cm
- (b) Bleeding ulcers
- (c) Arteries < 2 mm
- (d) Polyps < 1.5 cm in diameter
- (e) Diverticula in the colon
(3) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
| 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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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 < 3cm
- (b) Bleeding ulcers
- (c) Arteries < 2 mm
- (d) Polyps < 1.5 cm in diameter
- (e) Diverticula in the colon
- (3) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
6. SUBSTANTIAL EQUIVALENCE
6.1 Comparison Table
Comparison of the technical characteristics of the subject device and predicate devices is shown in the Table of Substantial Equivalence Below
6.1.1 Indications for use
The Indications for Use Statements are compared in the tables below. It can be seen that the Indications for Use Statements of the Subject and Primary Predicate device are similar as support
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as an endoscopic clip placement within the gastrointestinal tract.
Although some indications are different between the subject device and primary predicate device, the test results of bench test of the rest of the products demonstrated that this difference does not raise new safety or effectiveness concerns for the provided intended use.
| Descriptive | Subject Device | Primary Predicate Device |
|---|---|---|
| Information | (K213338) | (K183021) |
| Manufacturer | Incore, Co., Ltd. | Finemedix Co., Ltd. |
| Product Name | Core-Clip | ClearEndoclip |
| Regulation | 21CFR 876.4400 | 21CFR 876.4400 |
| Product Code | PKL | PKL, FHN, MND |
| Indications for Use | It is intended to be used withFDA-cleared endoscope forendoscopic clip placement withinthe gastrointestinal tract. It isindicated to be used for(1) Endoscopic marking(2) Hemostasis for(a) Mucosal/sub-mucosal defects< 3cm(b) Bleeding ulcers(c) Arteries < 2 mm(d) Polyps < 1.5 cm in diameter(e) Diverticula in the colon(3) As a supplementary method,closure of GI tract luminalperforations <20 mm that canbe treated conservatively | ClearEndoclip is intended to beused with FDA-cleared endoscopefor endoscopic clip placementwithin the gastrointestinal tract. Itis indicated to be used for(1) Endoscopic marking(2) Hemostasis for(a) Mucosal/sub-mucosal defects< 3cm(b) Bleeding ulcers(c) Arteries < 2 mm(d) Polyps < 1.5 cm in diameter(e) Diverticula in the colon(3) Anchoring to affix jejunalfeeding tubes to the wall of thesmall bowel(4) As a supplementary method,closure of GI tract luminalperforations <20 mm that can betreated conservatively |
6.1.2 Technical
| Descriptive | Subject Device(K213338) | Primary Predicate Device(K183021) |
|---|---|---|
| Information | ||
| Picture | Image: Subject Device (K213338) | Image: Primary Predicate Device (K183021)ClipTube JointSliderStopperHandle |
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| Clip Picture | ||
|---|---|---|
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 3 years | 3 years |
| Target | Gastrointestinal mucosal/submucosal | Gastrointestinal mucosal/submucosal |
| Single use / Re-use | Single-use | Single-use |
| Clipopeningwidth(Unit: mm) | 11mm | 9mm / 11mm / 13mm / 16mm |
| HandleControlled ClipRotation | 360° | 360° |
| Coil length(Unit: cm) | 160cm, 230cm | 165cm, 230cm |
| Outer Diameter(Unit: mm) | 2.4mm | 2.6 |
| Material | Clip: Stainless-steelSheath Coating Coil: Polypropylene,Stainless-steelHandle: ABS | Clip: Stainless-steelSheath Outer: HDPEStopper: Polypropylene |
| MR Environment | MR Unsafe | MR Unsafe |
6.2 Comparison Conclusion to predicate device
The subject device is substantially equivalent to the predicate device with respect to indications for use, technology and construction. The differences between the predicate devices and the subject devices are minor and any risks have been mitigated through testing.
7. NON-CLINICAL DATA
As part of demonstrating substantial equivalence of the CORE-CLIP to the predicate device, INCORE Co., Ltd. conducted performance testing on the subject device. Although there are slightly different points such as dimension or material, it does not impact the ability to determine substantial equivalence of the subject device because the substantial equivalence of performance for CORE-CLIP is demonstrated by the following verification and validation data to demonstrate the safety and performance effectiveness.
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Sterilization CORE-CLIP is sterilized by EO GAS on the sterilization process.
-
A. EO Gas Sterilization Validation Report in accordance with ISO 11135:2014, ISO 11138-1:2017, ISO 11138-2:2017, ISO 11737-1:2018, ISO 11737-2:2019, EN ISO 10993-7:2008/AMD:2019 and AAMI TIR28: 2009/(R)2013
Packing Validation with shelf-life and integrity test Stability and the effectiveness of packaging as sterilized product by evaluation in process of time and performance of packaging material according to the ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980, USP39 <71>, 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
§ 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.