(254 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a disposable injection needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an injection needle used for delivering medicine and medical supplies into a mucous membrane or blood vessel, primarily for stopping bleeding or hardening vessels during endoscopic procedures. It does not actively treat a disease or condition itself, but rather facilitates the delivery of a substance that does.
No
The device description indicates that the CORE-INJECTOR is used for injecting medicine and medical supplies to stop bleeding or harden vessels, and for submucosal dye marking. These are therapeutic and procedural uses, not diagnostic.
No
The device description explicitly details physical components like a stainless steel needle, sheath, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, the CORE-INJECTOR is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to perform endoscopic injections for therapeutic purposes (treating varices, submucosal marking). This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a needle designed for injecting substances into tissue or blood vessels. This is a surgical/interventional tool, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (e.g., reagents, analyzers, test strips, etc.).
IVD devices are used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The CORE-INJECTOR is a therapeutic/interventional device used directly on the patient.
N/A
Intended Use / Indications for Use
The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
Product codes
FBK
Device Description
The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure.
The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm.
The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). 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 (mucosa of the human digestive 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)
Performance testing such as Tensile Strength, Needle drawing out, Leakage test, Liquidity test, Maneuverability test. The test results show that the subject device is substantially equivalent to the predicate device.
-
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". 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.
-
Biocompatibility Testing: Biocompatibility testing has been conducted in accordance with ISO 10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The CORE-INJECTOR is considered tissue contacting for a duration of less than 24 hours. This device passed all biocompatibility tests. In accordance to ISO10993-1:2018, the biocompatibility tests were performed: Cytotoxicity, Sensitization, Intracutaneous following reactivity, Acute Systemic Toxicity, Pyrogen test.
-
Performance Testing:
(1) Appearance and dimension: Performance tests such as the appearance and dimensions of the proposed device were according to the Incore's own system.
(2) Tensile strength (handle): The proposed device was tested, and there was no defect after loading 15N. The CORE-INJECTOR therefore meets the performance required by tensile strength of handle.
(3) Needle drawing test (Pull-out) (needle): The proposed device was tested, and the needle attached to the inner sheath when applying a force of 10N. Therefore, the CORE-INJECTOR meets the performance required by pull-out of needle test.
(4) Air leakage test: When observing air leakage while blocking one end of the product and applying air pressure of 50 kPa to the inside of the product for 15 seconds, there should be no air leakage.
(5) Liquidity test: Attach a syringe containing 10g of distilled water into the injection port of the injector. Then, the distilled water is injected by pushing the piston with a constant force. After receiving the distilled water ejected from the injector needle into the cylinder, measure the amount of distilled water.
(6) Maneuverability test: Check that the needle goes in when the handle slider is pulled, and the needle comes out when pushed, and check that the handle and needle operate smoothly.
(7) Elasticity test (needle): The proposed device was tested, and the needle returned to its original state when the weight was removed. Therefore, the CORE-INJECTOR meets the performance required by elasticity test of needle. -
Physical/Chemical: Extraction Test is tested in accordance with KP(Korean Pharmacopia) appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level.
-
Shelf Life Test: The CORE-INJECTOR 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of 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 Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 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: K221054 Trade/Device Name: Core-Injector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: March 22, 2022 Received: April 11, 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
1
Federal 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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) K221054
Device Name CORE-INJECTOR
Indications for Use (Describe)
The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in 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 a logo with the word "INCORE" in bold, black letters. Below the word is a thin black line, and under that line is the text "innovative core technologies of medical devices" in a smaller font. Below the logo is the text "510(K) Summary" in a large, bold font.
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 CORE-INJECTOR.
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 18, 2022
II. Device
Trade of Device : CORE-INJECTOR Model : IC-IJ2312, IC-IJ2316, IC-IJ2318, IC-IJ2323, IC-IJ2512, IC-IJ2516, IC-IJ2518, IC-IJ2523 Common or Usual Name : Disposable endoscope injection needle Classification Name : Endoscope and Accessories Device Product Code : FBK Review Panel : Gastroenterology/Urology Regulatory Class : Class II Regulation Number: 21 CFR 876.1500 Endoscope and Accessories
III. Predicate Device
Device Name : INJECTION NEEDLE Manufacturer : Micro-Tech (Nanjing)CO., Ltd.
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K221054 Page 2 of 7
Image /page/4/Picture/1 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left, with the word "INCORE" in bold, sans-serif font to the right. Underneath the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read.
CORE-INJECTOR Traditional 510(K)
510(K) Number : K150434 Classification Name : Endoscope and Accessories Product Code : FBK Regulatory Class : Class II Regulation number : 21 CFR 876.1500
The predicates have not been subject to a design-related recall. No reference devices were used in this submission.
IV. Device Description
The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure.
The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm.
The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
V. Indications for Use
The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.
VI. Comparison of Technological Characteristics with predicate device
The CORE-INJECTOR has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Micro-Tech (Nanjing)CO., Ltd.'s INJECTION NEEDLE, K150434. the differences between the proposed device and the predicated devices do not raise any
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Image /page/5/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular graphic to the left of the word "INCORE" in bold, sans-serif font. Below the word "INCORE" is a tagline in a smaller font that reads "innovative core technologies of medical devices."
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 Tensile Strength, Needle drawing out, Leakage test, Liquidity test, Maneuverability test. The test results show that the subject device is substantially equivalent to the predicate device.
| Item | Proposed Device
CORE-INJECTOR | Predicate Device
INJECTION NEEDLE | Substantial
Equivalence |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Classfication
regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification
and Code | Class II , FBK | Class II , FBK | Same |
| Device
Classfication
Name | Endoscopy and Accessories | Endoscopy and Accessories | Same |
| 510(K) number | K221054 | K150434 | - |
| Indications for
Use | The CORE-INJECTOR is to
be used in conjunction with
an endoscope to perform
endoscopic injections, such
as the treatment of
esophageal and gastric
varices and for submucosal
dye marking in the GI tract. | The INJECTION NEEDLE is
to be used in conjunction
with an endoscope to
perform endoscopic
injections, such as for the
treatment of esophageal and
gastric varies and for
submucosal dye marking in
the GI tract. | Same |
| Configuration | Needle, Inner tube, Outer
tube, Handle, Slider | Needle, Inner
sheath(Tube), Outer
Outer shell(tube), Handle,
Luer lock | Similar
Both subject and
predicate device
are substantially
equivalent in the
indications for use. |
| Material
(Needle) | Stainless-Steel | Stainless-Steel | Same |
| Outer Sheath
Material | Outer : Polyethylene | Outer : Thermoplastic-PTFE
Polymer | Different |
| | | | This difference |
| | | | does not alter the |
| | | | suitability of the |
| | | | proposed device |
| | | | for its intended |
| | | | use. We conducted |
| | | | a biocompatibility |
| | | | evaluation of the |
| | | | device. The results |
| | | | show the device is |
| | | | safe in the aspect |
| | | | of |
| | | | biocompatibility |
| | | | evaluation |
| Disposable | Yes | Yes | Same |
| | | | Similar |
| Gauge size | 23G, 25G | 19G, 22G, 25G | Both subject and |
| | | | predicate device
are substantially
equivalent in the
indications for use. |
| Needle length | 4mm | 4mm, 5mm, 6mm | Same |
| Outer Sheath
Diameter | 2.3mm | 2.3mm | Same |
| | | | Similar |
| Working Length | 1200mm, 1600mm, 1800m,
2300mm | 1800mm, 2000m, 2300mm | Both subject and |
| | | | predicate device
are substantially
equivalent in the
indications for use. |
| Sterilization | EO Sterilization (SAL 10-6) | EO Sterilization (SAL 10-6) | Same |
| Packaging | Single-use EO sterilized pouch
with one device per pouch | Single-use EO sterilized pouch
with one device per pouch | Same |
Table 1 : Comparison to Predicate Device
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Image /page/6/Picture/1 description: The image shows the logo for "INCORE", which appears to be a medical device company. The logo features a graphic of three overlapping circles, with the overlapping area colored in a dark blue. Below the company name is the text "innovative core technologies of medical devices" in a smaller font.
CORE-INJECTOR Traditional 510(K)
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"
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Image /page/7/Picture/1 description: The image shows the logo for INCORE. The logo consists of a graphic of three overlapping circles on the left, with the word "INCORE" in bold, sans-serif font to the right of the graphic. Below the word "INCORE" is a thin line, and below that line is some smaller text that is difficult to read.
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 conducted in accordance with ISO 10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" The CORE-INJECTOR is considered tissue contacting for a duration of less than 24 hours. This device passed all biocompatibility tests. In accordance to ISO10993-1:2018, the biocompatibility tests were performed : Cytotoxicity, Sensitization, Intracutaneous following reactivity, Acute Systemic Toxicity, Pyrogen test.
-
- Performance Testing
- (1) Appearance and dimension
Performance tests such as the appearance and dimensions of the proposed device were according to the Incore's own system.
-
(2) Tensile strength (handle)
The product that cut to about 4 inches from the outer hub is held in a tensile taster set to 3 inches in gage length. Then, the inner hub is pulled from the outer hub at a speed of 10 in/min. Under the conditions of the above method, the inner hub should be attached to the outer hub when applying a force of 15N. The proposed device was tested, and there was no defect after loading 15N. The CORE-INJECTOR therefore meets the performance required by tensile strength of handle. -
(3) Needle drawing test(Pull-out) (needle)
The prodcut, the inner hub is pulled from the outer hub and the inner sheath is pulled from the outer sheath by pulling on the sheath. After cutting this to about 3 inches from the crimp band, mount it with the needle facing upward in a tensile tester set to 2 inches in gauge length. Check that the needle is attached to the inner sheath with a force of 10N when pulling at a speed of 10 in/min.
8
Under the conditions of the above method, the needle should be attached to the inner sheath.
The proposed device was tested, and the needle attached to the inner sheath when applying a force of 10N.
Therefore, the CORE-INJECTOR meets the performance required by pull-out of needle test.
-
(4) Air leakage test
When observing air leakage while blocking one end of the product and applying air pressure of 50 kPa to the inside of the product for 15 seconds, there should be no air leakage. -
(5) Liquidity test
Attach a syringe containing 10g of distilled water into the injection port of the injector. Then, the distilled water is injected by pushing the piston with a constant force. After receiving the distilled water ejected from the injector needle into the cylinder, measure the amount of distilled water. -
(6) Maneuverability test
Check that the needle goes in when the handle slider is pulled, and the needle comes out when pushed, and check that the handle and needle operate smoothly. -
(7) Elasticity test (needle)
Fix A point of the needle randomly and bend to 12° with weight and 1 minutes at B point. Under the conditions of the above method, the needle shall return after remove weight.
TThe proposed device was tested, and the needle returned to its original state when the weight was removed.
Therefore, the CORE-INJECTOR meets the performance required by elasticity test of needle.
-
- Physical/Chemical
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Image /page/9/Picture/1 description: The image shows the logo for INCORE. The logo consists of a graphic of three overlapping circles on the left, 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.
Extraction Test is tested in accordance with KP(Korean Pharmacopia) appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level.
5) Shelf Life Test
The CORE-INJECTOR 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-INJECTOR has been found to have a safety and efficacy profile that is substantially equivalent to the predicate device INJECTION NEEDLE which is marketed for the same intended use.