(243 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and electrical properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is used to remove polyps and tissue from the GI tract, and when connected to an electrosurgical generator, delivers electrical current for therapeutic purposes.
No
The CORE-SNARE is described as a device used to cut out and remove tissues like polyps from the GI tract, especially when connected to an electrosurgical generator. This is a therapeutic, interventional function, not a diagnostic one.
No
The device description clearly outlines physical components (snare-loop, catheter tube, handle) and mentions connection to an electrosurgical generator, indicating it is a hardware device with potential electrical components, not software only.
Based on the provided information, the CORE-SNARE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the removal of polyps and tissue from within the GI tract using an endoscopic procedure. This is a surgical/interventional procedure performed in vivo (within the living body).
- Device Description: The device is a physical tool (snare) used to cut and remove tissue. It can also deliver electrical current for electrosurgery. This is a therapeutic/surgical device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CORE-SNARE does not perform any analysis or testing of samples outside the body.
Therefore, the CORE-SNARE is a surgical/interventional device, not an IVD.
N/A
Intended Use / Indications for Use
The CORE-SNARE is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Product codes
FDI
Device Description
The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures.
The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths.
Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion.
When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site.
The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterility: A sterility validation was completed following ISO 11135 requirements to demonstrate a 10^-6 SAL. The proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals." No evidence of microbial growth is found, the test article to be examined complies with sterility test.
Biocompatibility Testing: Performed in accordance with ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The CORE-Snare is considered tissue contacting for a duration of less than 24 hours. The proposed device passed all biocompatibility tests: Cytotoxicity, Maximization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen test.
Performance Testing:
(1) Dimension test: Measured by vernier calipers, dimensions of the core-snare non-rotation type product were measured. All dimensional values do not exceed the tolerance of ±10%.
(2) Tensile strength test:
(1) Electrode Cable: Performed in accordance with ANSI/AAMI HF 18 (2001) 4.2.5.5. No damage from 40 N pulling and 0.64 J impact.
(2) Inner rope-cutting wire: Strength between inner rope and cutting wire was confirmed to be more than 15 lbs.
(3) Catheter sheath-handle: Strength between catheter sheath and handle was confirmed to be more than 2 lbs.
(3) Cable Withstand voltage: Passed according to IEC 60601-2-2:2011. The rate accessory voltage specified by the manufacturer must withstand a peak voltage of 1000V, large DC or Mains frequency for 5 minutes. High-frequency withstand voltage must withstand for 30 seconds at high frequency voltage of 120% of the rated accessory voltage (Maximum voltage of accessory is 920 Vp).
(4) High Frequency leakage current test: Passed according to ANSI/AAMI HF 18(2001) 4.2.5.2. Monopolar high-frequency leakage current of the electrode cable shall be not more than 3.6 dfL mA.
(5) Conductive Inspection (Continuity test): Passed using electrical conduction circuit system, tips for connection with electrode tip must be electrically connected to each other.
Physical/Chemical: Extraction Test performed with in-house hold. Test items (Appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal) were at acceptable levels.
Shelf Life Test: Maximum shelf life of 3 years from the date of sterilization. Accelerated aging studies for start and three (3) years were performed according to ASTM F1980; Standard Guide For Accelerated Aging of Sterile Barrier System for Medical Device, with acceptable results. A real-time aging study is currently in process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2022
Incore Co., Ltd. Jae-Hun Lee Department head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, 41072 KOREA, SOUTH
Re: K220846
Trade/Device Name: Core-Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: March 15, 2022 Received: March 23, 2022
Dear Jae-Hun 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 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
1
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,
Sivakami Venkatachalam -S
for
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
2
Indications for Use
510(k) Number (if known) K220846
Device Name CORE-SNARE
Indications for Use (Describe)
The CORE-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 contains the words CORE-SNARE in large, bold, black font. Below that, the words Traditional 510(K) are written in a smaller, bold, black font. The image is simple and contains only text.
Image /page/3/Picture/2 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side, with the word "INCORE" in bold, sans-serif font to the right. Below the word "INCORE" is a thin line, and below that is the text "innovative core technologies of medical devices" in a smaller font size.
Section 5 - 510(K) Summary
In accordance with the Food and Drug Adminstration Rule to implement provisions of the Safe Medical Device Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CORE-SNARE.
I. Submitted by
Company Name : INCORE CO.,LTD. Company Address : 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, Republic of Korea
Contact Person : Mr. Jae-Hun, Lee Department head of Regulatory Affairs
Contact Phone : (82) 2-866-3514 Contact Fax : (82) 2-6919-1346
Date of Preparation : March 15, 2022
II. Device
Trade of Device : CORE-SNARE
- Model : IC-SN0210, IC-SN0215, IC-SN0310, IC-SN0315, IC-SN0324, IC-SN0330, IC-SN0410, IC-SN0413, IC-SN0415, IC-SN0424, IC-SN0430, IC-SN3310, IC-SN3313, IC-SN3315, IC-SN3324, IC-SN3330, IC-SN0410CR, IC-SN0415CR, IC-SN0424CR, IC-SNR0210, IC-SNR0215, IC-SNR0310, IC-SNR0313, IC-SNR0315, IC-SNR0324, IC-SNR0410, IC-SNR0413, IC-SNR0415, IC-SNR0424, IC-SNR0330, IC-SNR0430, IC-SNR3310, IC-SNR3313, IC-SNR3315, IC-SNR3324, IC-SNR3330, IC-SNR0410CR, IC-SNR0415CR, IC-SNR0424CR
Common or Usual Name : Disposable electrically-operated medical snare Classification Name : Endoscopic Electrosurgical Unit and Accessories Device Product Code : FDI Review Panel : Gastroenterology/Urology Regulation Number: 21 CFR 876.4300 Endoscopic Electrosurgical Unit and Accessories. Regulatory Class : Class II
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Image /page/4/Picture/1 description: The image shows the logo for "INCORE", with the tagline "innovative core technologies of medical devices" underneath. To the left of the text is a graphic of three overlapping circles, with the intersection of the circles filled in with a darker color. The text is in a sans-serif font and is black in color. The tagline is in a smaller font size than the main logo.
Ⅲ, Predicate Device
Device Name : ClearGrasp Snare Manufacturer : Finemedix Co. Ltd 510(K) Number : K183289 Classification Name : Endoscopic Electrosurgical Unit and Accessories Product Code : FDI Regulatory Class : Class II Regulation Number: 21 CFR 876.4300 Endoscopic Electrosurgical Unit and Accessories.
The predicates have not been subject to a design-related recall. No reference devices were used in this submission.
IV. Device Description
The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures.
The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths.
Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion.
When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site.
The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
V. Indications for Use
The CORE-SNARE is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
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Image /page/5/Picture/1 description: The image shows the logo for INCORE, a company that specializes in innovative core technologies for medical devices. The logo features a stylized graphic of overlapping circles in the upper left corner, followed by the company name in bold, sans-serif font. Below the name is a tagline that describes the company's focus on innovative core technologies for medical devices. The overall design is clean and modern, conveying a sense of innovation and expertise.
VI. Comparison of Technological Characteristics with predicate device
The CORE-SNARE has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Finemedix CO.,Ltd's ClearGrasp Snare, K183289. the differences between the proposed device and the predicated devices do not raise any questions regarding its safety and effectiveness. the differences are listed in the table below.
The following tests evaluate the substantial equivalence of the subject device through the performance test applying the same standard as the predicate device.
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. The test results show that the subject device is substantially equivalent to the predicate device.
| Item | Proposed Device | Predicate Device | Substantial
Equivalence |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Classfication
regulation | CORE-SNARE | ClearGrasp Snare | |
| | 21 CFR 876.4300 | 21 CFR 876.4300 | Same |
| Classification
and Code | Class II , FDI | Class II , FDI | Same |
| Device
Classfication
Name | Endoscopic Electrosurgical
Unit and Accessories | Endoscopic Electrosurgical
Unit and Accessories | Same |
| 510(K) number | K220846 | K183289 | - |
| Indications for
Use | The CORE-SNARE is
used endoscopically in the
removal of diminutive
polyps, sessile polyps,
pedunculated polyps and
tissue from within the GI
tract. | The ClearGrasp Snare is
used endoscopically in the
removal of diminutive
polyps, sessile polyps,
pedunculated polyps and
tissue from within the GI
tract. | Same |
| Configuration | Loop, Catheter Tube,
Handle(Slider, Body) | Loop, Catheter Tube,
Handle, Slider, Plug | Similar |
| Table 1 : Comparison to Predicate Device | |
|---|---|
| ------------------------------------------ | -- |
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Image /page/6/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular graphic to the left of the word "INCORE". The graphic is made up of three overlapping circles, with the intersection of the circles colored in blue. Below the word "INCORE" is a thin black line, and below that is some smaller text that is difficult to read.
| Loop | SUS 304 | SUS 304 | ||
|---|---|---|---|---|
| Material | Catheter | |||
| Tube | PTFE | PTFE | Same | |
| Handle | ABS | ABS | ||
| Shape of Loop | Oval and Crescent and | |||
| Diamond | Oval and Crescent | |||
| Working Length | 2200, 2400mm | 1600, 1800, 2200, 2400mm | Similar | |
| Loop Size | 10, 15, 24, 30mm | 6,10,13,15,24,30 mm | Similar | |
| Rotational/Non- | ||||
| Rotational | Both | Both | Same | |
| Sterilization | EO Sterilization | EO Sterilization | Same | |
| Single Use | Yes | Yes | Same | |
| Used with | ||||
| Electrosurgical | ||||
| Unit | Yes | Yes | Same |
VII. Non-clinical testing data
1) Sterility
A sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL. And the proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The Sterility test is tested with a direct method.
No evidence of microbial growth is found, the test article to be examined complies with sterility test.
2) Biocompatibility Testing
Biocompatibility testing has been performed in accordance with ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
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Image /page/7/Picture/1 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side, with the word "INCORE" in bold, sans-serif font to the right. Below the word "INCORE" is a tagline in a smaller font that reads "Innovative core technologies of medical devices."
The CORE-Snare is considered tissue contacting for a duration of less than 24 hours.
The proposed device passed all biocompatibility tests.
In accordance to ISO10993-1, the following biocompatibility tests were performed : Cytotoxicity, Maximization, Intractutaneous Reactivity, Acute Systemic Toxicity, Pvrogen test.
3) Performance Testing
(1) Demension test
When measured by vernier calipers, the tolerance of the nominal size should be ±10 % of the stndard. For the dimensional test, all dimensions of the core-snare non-rotation type product were measured. As a result of the measurement, it was confirmed that all dimensional values do not exceed the tolerance of ±10%. Therefore, the CORE-SNARE meets the performance required by demension test.
(2) Tensile strength test
(1) Electrode Cable
The tensile strength test method for Electrode Cable was performed in accordance with ANSI/AAMI HF 18 (2001) 4.2.5.5, and according to method, Electrode cables and connecting parts shall not be damaged from 40 N pulling and 0.64 J impact. The proposed device was tested, and there was no damaged from 40 N pulling and 0.64 J impact.
Therefore, the CORE-SNARE meets the performance required by tensile strength of electrode cable.
(2) Inner rope-cutting wire
The tensile strength (inner rope-cutting wire) was tested as follows.
The cutting knife is cut out from the sheath by manipulating the handle. The inner rope and the cutting wire are cut at a position of about 15cm from the end to make a specimen, and the specimen is pulled at a rate of 1.0 in/min.
Under the conditions of the above method, the strength between the inner rope and the cutting wire should be not less than 15 lbs.
The proposed device was tested, and It was confirmed the strength is more than 15 lbs.
Therefore, the CORE-SNARE meets the performance required by tensile strength of
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Image /page/8/Picture/2 description: The image shows the logo for INCORE. The logo features a graphic of three overlapping circles on the left side. To the right of the graphic is the word "INCORE" in large, bold, sans-serif font. Underneath the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read.
inner rope-cutting wire.
3 Catheter sheath-handle
The tensile strength (catheter sheath-handle) was tested as follows. After manipulating the handle, pull out the cutting knife out of the sheath, cut the sheath and cable at 2 inches of the distal end of the strain relief to make a specimen, and pulled at a rate of 1.0 in/min. Under the conditions of the above method, the strength between the catheter sheath and the handle should be not less than 2 lbs. The proposed device was tested, and there was more than 2 bs. Therefore, the CORE-SNARE meets the performance required by tensile strength of catheter sheath-handle.
- (3) Cable Withstand voltage
The main frequency withstand voltage meets the test criteria that the rate accessory voltage specified by the manufacturer of the high frequency surgical accessory must withstand a peak voltage of 1000V, large DC or Mains frequency for 5 minutes.
And the high-frequency withstand voltage must withstand for 30 seconds at high frequency voltage of 120% of the rated accessory voltage presented by the manufacturer. Maximum voltage of accessory is 920 Vp.
For the test, refer to the test method with the following IEC 60601-2-2:2011. The proposed device was tested according to the above criteria and passed. Therefore, the CORE-SNARE meets the performance required by Cable Withstand voltage.
- (4) High Frequency leakage current test
High frequency leakage current testing has been performed in accordance with ANSI / AAMI HF 18(2001) 4.2.5.2.
The monopolar high-frequency leakage current of the electrode cable shall be not more than 3.6 dfL mA and, the connection cord shall not have worked loose nor shall it show any damage.
For multiconductor cables there shall be no short circuits betwwen individual conductors.
The proposed device was tested according to the above criteria and passed.
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Image /page/9/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular design on the left and the word "INCORE" in bold, sans-serif font on the right. Below the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read. The circular design on the left appears to be three overlapping circles with a dark blue fill in the intersection.
Therefore, the CORE-SNARE meets the performance required by High frequency leakage current test
(5) Conductive Inspection (Continuity test)
This test is performed using electrical conduction circuit system, and tips for connection with electrode tip must be electrically connected to each other. The proposed device was tested according to the above criteria and passed. Therefore, the CORE-SNARE meets the performance required by Conductive inspection.
4) Physical/Chemical
Extraction Test is tested accordance with In-house hold.
Test items are Appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level.
5) Shelf Life Test
The CORE-SNARE has a maximum shelf life of 3 years from the date of sterilization. In compliance with the standard of ASTM F1980 ; Standard Guide For Accelerated Aging of Sterile Barrier System for Medical Device, accelerated aging studies for start and three(3) years were performed to determine product integrity over its lifespan, with acceptable results. A real-time aging study is currently in process to verify the result found in the accelerated aging studies.
VIII. Conclusion
The conclusion drawn from the technological characteristics is that the CORE-SNARE has been found to have a safety and efficacy profile that is substantially equivalent to the predicate device ClearGrasp Snare which is marketed for the same intended use.