(261 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a surgical access port, with no mention of AI or ML capabilities.
No.
The device is described as a surgical instrument intended to provide access to the abdominal cavity during laparoscopic surgery, not to treat or diagnose a disease or condition.
No
The device is a surgical instrument intended to provide access for other instruments and endoscopes during laparoscopic surgery. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a surgical instrument consisting of a Port-Assay and a Retractor, which are physical components used in surgery. The performance studies also focus on physical properties like tensile strength, air leak, and biocompatibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery." This describes a surgical access device used during a medical procedure.
- Device Description: The description details a surgical instrument consisting of a Port-Assay and a Retractor, designed for physical access during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing these specimens.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device during surgery (tensile strength, air leak, cavity access, instrument manipulation), not on the accuracy or reliability of diagnostic results.
The CORE-SPORT is a surgical instrument used for access during a medical procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.
Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.
The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-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
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
minimally invasive laparoscopic surgery
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)
1) Sterility
A sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL.
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-SPORT 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, Animal intracutaneous following reactivity, Guinea pig maximization, Acute systemic toxicity, Pyrogen.
1) Tensile strength Test
This product is tested for tensile strength in two parts. One is the sheath part, and the other is the ring body and remover part.
First for the sheath part test, fix the retractor ring to one jig of the tensioner and the ring body to the other jig. The product is tensioned at a speed of 150mm/Sec. Second, the test on the ring body and the remover part is conducted under the same test conditions as the first test. Under the conditions of the above method, Test whether the sheath is ruptured by pulling it with a force of 10N.
The tensile strength test of CORE-SPORT was tested, and in both tests, no defects were found after loading 10N. Therefore the CORE-SPORT meets the performance required by tensile strength test.
2) Air leak test
To measure the air tightness of the product, an air leak test was performed. After connecting the retractor and port-assay with a connector, block the retractor and open one stopcock to inject air at a pressure of 25mmHg.
Under the conditions of the above method, the pressure is maintained over 15mmHg for 30 seconds.
The Air leak test of CORE-SPORT was conducted, and All test results met the criteria. Therefore the CORE-SPORT meets the performance required by Air leak test of CORE-SPORT test.
3) Physical/Chemical
Extraction Test is tested accordance with USP 38 .
Nonvolatile Residue, Residue on Ignition, Heavy Metal, Buffering Capacity are acceptable level.
1) Cavity access test
The cavity access test is a test to prove accessibility for inserting a port during surgery. Check whether the port is of an appropriate size to be inserted into the incision site. When flattening 1/3 of the ring body of the retractor, measure the length of the widest width. As the test result does not exceed the setting criteria(30mm), it is verified that the size is appropriate for cavity access.
2) Maintenance of pneumoperitoneum
the test conducted to confirm that there is no air leakage and pneumoperitoneum is maintained during the operation. The test recognition criteria have to maintain 12-15 mmgH for 30 seconds under the given pressure, and the test results are determined to satisfy this standard.
3) Ability to manipulate instruments
Ability to manipulate instruments is planned to demonstrate that the laparoscopic surgical instruments is applied properly without friction, crash, damage during laparoscopic surgery. If even one friction, crash, damage occurs in the data, it is determined as insufficient.
As a result of the test, it was confirmed that the set criteria were satisfied in the worst case of applying a maximum of 4 surgical instruments.
Shelf Life Test
The CORE-SPORT 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): 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
9/28/2022
Incore Co., Ltd. Lee Jae-Hun Department Head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, 41072 Korea, South
Re: K220081
Trade/Device Name: CORE-SPORT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 22, 2022 Received: August 24, 2022
Dear Lee Jae-Hun:
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,
for Colin Chen
Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220081
Device Name CORE-SPORT
Indications for Use (Describe)
The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
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/0 description: The image shows the word "INCORE" in a sans-serif font. To the left of the word is a graphic of three overlapping circles. The overlapping circles are arranged in a triangular pattern, with the top circle slightly offset to the left. The color of the text and the graphic is a dark blue.
K220081 - 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-SPORT.
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 : Dec 09, 2021
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Image /page/4/Picture/0 description: The image contains the word "INCORE" in a bold, sans-serif font. To the left of the word is a graphic consisting of three overlapping circles. The overlapping area of the circles is filled with a solid color, creating a focal point within the design.
II. Device
Trade of Device : CORE-SPORT (K220081) Model : IC-SP01, IC-SP02, IC-SP03, IC-SP04, IC-SP05 Common or Usual Name : Endoscopy Surgery Instrument Classification Name : Laparoscope, General & Plastic Surgery Device Product Code : GCJ Review Panel : General & Plastic Surgery Regulation Number : 21 CFR 876.1500 Endoscope and Accessories Regulatory Class : Class II
III. Predicate Device
Trade of Device : GLOVE PORT (K141715) Common or Usual Name : Endoscopy Surgery Instrument Classification Name : Laparoscope, General & Plastic Surgery Device Product Code : GCJ Review Panel : General & Plastic Surgery Requlation Number : 21 CFR 876.1500 Endoscope and Accessories Regulatory Class : Class II
IV. Device Description
The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.
Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.
The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.
V. Indications for Use
The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
5
Image /page/5/Picture/0 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side of the word INCORE. The circles are different sizes and are arranged in a way that creates a sense of depth and movement. The word INCORE is written in a sans-serif font and is in a dark blue color.
VI. Comparison of Technological Characteristics with predicate device
There is no technical difference between the CORE-SPORT and the Glove Port. Even if some test's name is a little different, the intention of the test is same.
| Item | Proposed Device
CORE-SPORT
Port-Assay A + Retractor | Predicate Device
Glove Port | Substantial
Equivalence |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Common or
Usual Name | Endoscopy Surgery Instrument | Endoscopy Surgery Instrument | Same |
| Classfication
regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification
and Code | Class II , GCJ | Class II , GCJ | Same |
| Device
Classfication
Name | Laparoscope, General & Plastic
Surgery | Laparoscope, General & Plastic
Surgery | Similar |
| 510(K) number | K220081 | K141715 | - |
| Indications for
Use | The CORE-SPORT is intended
to provide access for multiple
instruments and/or endoscope to
the abdominal cavity through a
single incision during minimally
invasive laparoscopic surgery. | The Glove Port is intended to
provide access for multiple
instruments and/or endoscope to
the abdominal cavity through a
single incision during minimally
invasive laparoscopic surgery. | Same |
| Configuration | Image: CORE-SPORT Configuration | Image: Glove Port Configuration | Similar |
| Assembly | Combine Port Base with it,
after putting the Retractor on
the Bottom part. | No need to assemble
(In advance assembled) | Similar |
| Disposable | Yes | Yes | Same |
| Material | Polyurethane | Polyurethane | Same |
| Number
of
Ports | 3 or 4 ea | 3~4 ea | Same |
| Port Size | 5 and/or 12 mm | 5, 12, and/or 15 mm | Similar |
| Ring Diameter | 86mm | 60 ~ 95mm | Similar |
| Sterilization | EO Gas Sterilization | EO Gas Sterilization | Same |
Table 1 : Comparison to Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side of the word INCORE. The word INCORE is written in a sans-serif font and is a dark blue color.
7
Image /page/7/Picture/0 description: The image shows the logo for Incore. The logo consists of three overlapping circles on the left and the word "INCORE" in blue on the right. The circles are arranged in a way that creates a sense of interconnectedness and collaboration.
VII. Performance Data
(1) Safety Test
1) Sterility
A sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL.
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-SPORT 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, Animal intracutaneous following reactivity, Guinea pig maximization, Acute systemic toxicity, Pyrogen.
(2) Performance Test - Bench
1) Tensile strength Test
This product is tested for tensile strength in two parts. One is the sheath part, and the other is the ring body and remover part.
First for the sheath part test, fix the retractor ring to one jig of the tensioner and the ring body to the other jig. The product is tensioned at a speed of 150mm/Sec. Second, the test on the ring body and the remover part is conducted under the same test conditions as the first test. Under the conditions of the above method, Test whether the sheath is ruptured by pulling it with a force of 10N.
The tensile strength test of CORE-SPORT was tested, and in both tests, no defects were found after loading 10N. Therefore the CORE-SPORT meets the performance required by tensile strength test.
2) Air leak test
To measure the air tightness of the product, an air leak test was performed. After
8
connecting the retractor and port-assay with a connector, block the retractor and open one stopcock to inject air at a pressure of 25mmHg.
Under the conditions of the above method, the pressure is maintained over 15mmHg for 30 seconds.
The Air leak test of CORE-SPORT was conducted, and All test results met the criteria. Therefore the CORE-SPORT meets the performance required by Air leak test of CORE-SPORT test.
3) Physical/Chemical
Extraction Test is tested accordance with USP 38 .
Nonvolatile Residue, Residue on Ignition, Heavy Metal, Buffering Capacity are acceptable level.
(3) Performance Test - Comparative
1) Cavity access test
The cavity access test is a test to prove accessibility for inserting a port during surgery. Check whether the port is of an appropriate size to be inserted into the incision site. When flattening 1/3 of the ring body of the retractor, measure the length of the widest width. As the test result does not exceed the setting criteria(30mm), it is verified that the size is appropriate for cavity access.
2) Maintenance of pneumoperitoneum
the test conducted to confirm that there is no air leakage and pneumoperitoneum is maintained during the operation. The test recognition criteria have to maintain 12-15 mmgH for 30 seconds under the given pressure, and the test results are determined to satisfy this standard.
3) Ability to manipulate instruments
Ability to manipulate instruments is planned to demonstrate that the laparoscopic surgical instruments is applied properly without friction, crash, damage during laparoscopic surgery. If even one friction, crash, damage occurs in the data, it is determined as insufficient.
As a result of the test, it was confirmed that the set criteria were satisfied in the worst case of applying a maximum of 4 surgical instruments.
(4) Shelf Life Test
9
Image /page/9/Picture/0 description: The image contains the word "INCORE" in a sans-serif font. To the left of the word is a graphic of three overlapping circles. The overlapping circles are a lighter color than the word "INCORE". The word "INCORE" is in all capital letters.
CORE-SPORT Traditional 510(K)
The CORE-SPORT 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
test(Biocompatibility Test, Sterility Test) CORE-SPORT is The satety of the passed. substantially equivalent to the cited predicate device . Performance(Bench, of the CORE-SPORT Comparative) met aaall acceptance criteria to confirm Through analyzing of comparative test data, we confirmed effectiveness. the subject device CORE-SPORT is substantially equivalent to the predicated device Glove Port with respect to safety and effectiveness.