(78 days)
The Corvocet Coaxial Introducer is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors.
The Merit Corvocet Coaxial Introducer is used as a guiding needle for a biopsy device obtaining core biopsy samples from soft tissues. It is a three-part disposable device consisting of the following: a stainless steel outer cannula with a female Luer lock hub and an echo-enhanced tip to aid with visibility under ultrasound; a stainless steel inner trocar attached to a unique trocar hub design that allows it to be released by squeezing both sides of the hub; and a flexible silicone slip ring-style depth stop that is color-coded for gauge identification and can be manually adjusted to maintain the depth of the coaxial introducer in a procedure. An optional stainless steel blunt stylet with hub can be included with 17G and 19G coaxial introducers. The blunt stylet may be used to manipulate through soft tissue and around vasculature or other organs to minimize the risk of unintentional damage to these areas. The Merit Corvocet Coaxial Introducer is supplied sterile and is single use only.
This document describes the performance testing and safety evaluations for the Merit Corvocet Coaxial Introducer (K151373) to demonstrate its substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document lists various performance and biocompatibility tests conducted. For each test category, the report states that the device "met the standards' established acceptance criteria applicable to the safety and efficacy of the device." Specific numerical acceptance criteria and reported device performance values are not provided in this document. Instead, it indicates conformity to recognized standards and guidance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing - Bench | |
| Dimensions | Met established acceptance criteria per ISO standards |
| Tensile of Joints Needle-to-Hub | Met established acceptance criteria per ISO standards |
| Tensile of Joints Trocar-to-Hub | Met established acceptance criteria per ISO standards |
| Tensile of Joints Blunt Stylet-to-Hub | Met established acceptance criteria per ISO standards |
| Luer - Gauging | Met established acceptance criteria per ISO standards |
| Luer Liquid Leakage | Met established acceptance criteria per ISO standards |
| Luer Air Leakage | Met established acceptance criteria per ISO standards |
| Luer Separation Force | Met established acceptance criteria per ISO standards |
| Luer Unscrewing Torque | Met established acceptance criteria per ISO standards |
| Luer Ease of Assembly | Met established acceptance criteria per ISO standards |
| Luer Resistance to Overriding | Met established acceptance criteria per ISO standards |
| Luer Stress Cracking | Met established acceptance criteria per ISO standards |
| Depth Stop | Met established acceptance criteria per ISO standards |
| Introducer Visibility | Met established acceptance criteria |
| Simulated Use | Met established acceptance criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Met established acceptance criteria per ISO 10993 |
| Sensitization | Met established acceptance criteria per ISO 10993 |
| Irritation | Met established acceptance criteria per ISO 10993 |
| Acute Systemic Toxicity | Met established acceptance criteria per ISO 10993 |
| Pyrogenicity | Met established acceptance criteria per USP 37, NF 32 |
| Chemical Characterization | Met established acceptance criteria per ISO 10993 |
Details of the Study:
The provided document describes a series of performance and biocompatibility tests rather than a single "study" in the context of clinical trials involving human subjects or AI algorithms.
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Sample size for the test set and data provenance:
- The document does not specify the sample sizes (e.g., number of needles/introducers tested) for each individual bench test or biocompatibility test.
- The data provenance is from bench testing and laboratory biocompatibility testing of the device components and final product. There is no indication of human subject data or data from specific countries of origin for these tests beyond the device manufacturer's location (South Jordan, Utah, USA).
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Number of experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the tests described are primarily engineering performance tests and laboratory-based biocompatibility evaluations against predefined standards. There is no "ground truth" established by experts in the context of diagnosing conditions or interpreting images.
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Adjudication method for the test set:
- Not applicable for the types of tests described. Results are evaluated against objective criteria outlined in the referenced standards.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No MRMC study was done. This device is an introducer needle for biopsy, not an imaging or diagnostic AI device that would involve human readers.
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Standalone (i.e., algorithm only without human-in-the-loop performance) study:
- No standalone algorithm performance study was done. This device is a physical medical instrument, not an AI algorithm.
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Type of ground truth used:
- The "ground truth" for the performance tests is derived from recognized international and national standards and guidance documents (e.g., ISO standards, ASTM standards, FDA guidance, USP). These standards define the acceptable physical properties, functionality, and biological safety limits for such medical devices.
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Sample size for the training set:
- Not applicable. This is not a machine learning device; therefore, there is no training set in the AI sense. The design and manufacturing processes are likely informed by prior experience and engineering principles.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of AI. The device's design and manufacturing are based on established engineering principles and compliance with the referenced standards.
§ 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.