(30 days)
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device for obtaining biopsies from soft tissues. The performance of this device was assessed by comparing it to a predicate device, the Revolution® Full Core Biopsy Device (K090611). The tests conducted aimed to confirm that the quality of samples obtained with the EliteCore™ device is equivalent to that of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (How Equivalent) | Reported Device Performance |
|---|---|---|
| Package Inspection | Identical testing performed on predicate device with equivalent results. | Visually inspected packaging for damage, loose components, secure tip protector, and variable throw set at 22mm. Results were equivalent to predicate device. |
| Burst Test | Identical testing performed on predicate device with equivalent results. | Measured pressure at which sealed tray fails. Results were equivalent to predicate device. |
| Device Inspection | Identical testing performed on predicate device with equivalent results. | Visually inspected device for damage. Results were equivalent to predicate device. |
| Dimensional (Variable Throw) | Identical testing performed on predicate device with equivalent results. | Measured variable throw desired vs. actual. Results were equivalent to predicate device. |
| Dimensional (Variable Throw after Dry Fires) | Identical testing performed on predicate device with equivalent results. | Measured variable throw after dry fires, desired vs. actual. Results were equivalent to predicate device. |
| Force to Fire Front Triggers (RH / LH) | Identical testing performed on predicate device with equivalent results. | Measured force to fire front triggers. Results were equivalent to predicate device. |
| Force to Fire Rear Trigger | Identical testing performed on predicate device with equivalent results. | Measured force to fire rear trigger. Results were equivalent to predicate device. |
| Tissue Test (Chicken and Liver) | Identical testing performed on predicate device with equivalent results. | Able to take tissue samples in chicken and liver. Results were equivalent to predicate device. |
| Tissue Test (Various Throw Distances) | Additional testing that was not performed on predicate. | Able to take tissue samples at various throw distances. (No direct comparison to predicate stated for this specific aspect, but overall tissue test performance confirmed equivalence). The document states identical testing performed on predicate device with equivalent results. |
| Tissue Test (1st vs. Last Sample Weight) | Identical testing performed on predicate device with equivalent results. | Measured 1st sample as compared to last sample for sample weight and verified no loss of effectiveness. Results were equivalent to predicate device. |
| Mates with Adjustable Coaxial and Able to Take Sample | Identical testing performed on predicate device with equivalent results. | The device successfully mated with an adjustable coaxial and was able to take a sample. The results were equivalent to the predicate device. |
| Verify Weld Integrity (Visual Inspection after Functional Testing) | Identical testing performed on predicate device with equivalent results. | Visually inspected device for damage along weld joints after functional testing. Results were equivalent to predicate device. |
| Dimensional (Cannula, Spoon, and Stylet Migration) | Identical testing performed on predicate device with equivalent results. | Measured cannula, spoon, and stylet for migration. Results were equivalent to predicate device. |
| Dimensional (Joint Strength for Cannula, Spoon, and Stylet) | Identical testing performed on predicate device with equivalent results. | Measured the joint strength for the cannula, spoon, and stylet. Results were equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific number of devices or biopsy attempts used for each test. Instead, it broadly states that "Identical testing performed on predicate device w/ equivalent results" for most tests. The tissue tests mention "chicken and liver" and "various throw distances," indicating a lab-based, prospective evaluation with animal tissue. No country of origin for the data is specified, but given the submission to the FDA, it is presumed to be conducted by the manufacturer, Inrad, Inc., located in Kentwood, MI, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The performance testing appears to be based on objective physical measurements and visual inspections rather than expert interpretation of biopsy samples.
4. Adjudication Method for the Test Set:
Not applicable. The tests are focused on device performance metrics (e.g., dimensions, forces, ability to take tissue samples) rather than diagnostic accuracy that would require an adjudication process.
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. This device is a biopsy instrument, not an AI-powered diagnostic tool. The performance evaluation is based on engineering and basic tissue procurement capabilities.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for most tests was based on objective physical measurements (e.g., pressure, force, dimensions, weight) and visual inspections for damage or proper function. For tissue tests, the ground truth was the ability to successfully obtain a tissue sample and verify its properties (e.g., weight, no loss of effectiveness). The comparison was made against the performance of a legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML device requiring a training set. The performance testing is for a physical medical instrument.
9. How the Ground Truth for the Training Set was Established:
Not applicable. (See #8)
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.