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510(k) Data Aggregation
(254 days)
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 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.
The provided document describes the non-clinical performance testing for the CORE-INJECTOR device to demonstrate its substantial equivalence to a predicate device. It does not contain information about a comparative effectiveness study (MRMC) or a standalone (algorithm-only) study for a medical imaging AI device. The device in question is an endoscope injection needle, not an AI or imaging device. Therefore, many of the requested fields are not applicable.
Here's the information that can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility | 10⁻⁶ SAL (Sterility Assurance Level) following ISO 11135; meets requirements of ISO 10993-7 (ethylene oxide sterilization residuals). No microbial growth. | Achieved 10⁻⁶ SAL; met ISO 10993-7 requirements. No evidence of microbial growth. |
| Biocompatibility | Passed tests for Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, Pyrogen test (in accordance with ISO 10993-1:2018 for tissue contact < 24 hours). | All specified biocompatibility tests passed. |
| Appearance and Dimension | According to Incore's own system (details not provided). | Met Incore's own system requirements. |
| Tensile Strength (Handle) | Inner hub attached to outer hub when applying a force of 15N. | No defect after loading 15N. Met performance requirement. |
| Needle Drawing Test (Pull-out) | Needle attached to inner sheath when pulling with a force of 10N. | Needle remained attached to the inner sheath when applying a force of 10N. Met performance requirement. |
| Air Leakage Test | No air leakage when applying 50 kPa air pressure for 15 seconds. | Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device."). |
| Liquidity Test | Measure amount of distilled water ejected from the needle after injection (specific criteria not provided). | Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device."). |
| Maneuverability Test | Needle goes in when handle slider is pulled, comes out when pushed; handle and needle operate smoothly. | Not explicitly stated, but implied to have met the criteria ("Performance testing... The test results show that the subject device is substantially equivalent to the predicate device."). |
| Elasticity Test (Needle) | Needle returns to original state after bending to 12° with weight for 1 minute and then removing weight. | Needle returned to its original state when the weight was removed. Met performance requirement. |
| Physical/Chemical (Extraction) | Acceptable levels for appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal (according to Korean Pharmacopoeia). | Acceptable levels reported for all parameters. |
| Shelf Life | Product integrity maintained for 3 years (accelerated aging). Real-time study in process. | Acceptable results for accelerated aging for 3 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing of a medical device (endoscope injection needle), not a study involving patient data or a test set in the context of an AI device. The tests are performed on the device itself.
- Sample Size for Test Set: Not specified in terms of number of devices for each test, but standard engineering testing applies.
- Data Provenance: Not applicable in the context of patient data. The tests are conducted in a laboratory setting by the manufacturer (Incore Co., Ltd., Republic of Korea).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for the performance tests is based on objective measurements and established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI or imaging device requiring adjudication of interpretations.
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
Not applicable. The CORE-INJECTOR is a physical medical device, not an AI or imaging diagnostic tool that would be used in an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The CORE-INJECTOR is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Established international and national standards (e.g., ISO 11135, ISO 10993, ASTM F1980, Korean Pharmacopoeia).
- Objective physical measurements (e.g., force in Newtons, pressure in kPa, observed functionality).
- Manufacturer's internal specifications and test protocols.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve machine learning or a "training set."
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