(127 days)
The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Merit's Corvocet Biopsy System is a core needle biopsy device intended to obtain core biopsy samples from soft tissues. It is an automatic device that uses a spring coupled to a cutting needle to obtain full core soft tissue specimens. It has an echo-enhanced tip to aid with visibility under ultrasound, fully adjustable throw length (10-25mm) and depth markings on the needle. The device also features a light weight design, ergonomic grip, dual firing triggers, a ready indicator, and an optional safety interlock.
The Corvocet Biopsy System is available in several needle gauge sizes and lengths to accommodate soft tissue biopsy needs. The top and rear firing triggers are color coded according to the various gauge sizes (e.g. yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The biopsy system will be offered as stand-alone as well as paired with the Corvocet™ Coaxial Introducer.
The Merit Corvocet Biopsy System is supplied sterile and is intended for single use only.
The provided text is a 510(k) summary for the Corvocet Biopsy System. It contains information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not include specific details about a clinical study with a test set, ground truth establishment by experts, sample sizes for training or testing sets, MRMC studies, or standalone algorithm performance.
The submission focuses on bench performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the information that is available in the provided text, and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Performance Testing | |
| Dimensional verification | Met the acceptance criteria |
| Tensile of joints | Met the acceptance criteria |
| Adjustable throw accuracy | Met the acceptance criteria |
| Multiple Samples | Met the acceptance criteria |
| Cycle/Fatigue | Met the acceptance criteria |
| Device Visibility | Met the acceptance criteria |
| Ink adherence | Met the acceptance criteria |
| Simulated Use | Met the acceptance criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Met the acceptance criteria |
| Sensitization | Met the acceptance criteria |
| Irritation | Met the acceptance criteria |
| Acute Systemic Toxicity | Met the acceptance criteria |
| Pyrogenicity | Met the acceptance criteria |
| Chemical Characterization | Met the acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing refers to "Performance Testing - Bench" which implies laboratory testing, not a clinical study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there's no mention of a clinical test set with patient data, there's no discussion of experts establishing ground truth for such a set. The performance data relates to mechanical and biological characteristics of the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No clinical test set means no adjudication method described.
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
An MRMC comparative effectiveness study was not conducted. This device is a biopsy instrument, not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical biopsy instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench performance and biocompatibility testing, the "ground truth" used would be established through engineering specifications, recognized standards (e.g., ISO, ASTM), and laboratory protocols. For example, dimensional verification would be compared against design specifications, and biocompatibility tests against established criteria for toxicity. There is no mention of clinical ground truth like pathology or outcomes data for a patient test set.
8. The sample size for the training set
This information is not provided and is not applicable. There is no "training set" as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no training set mentioned or implied.
In summary, the provided document details the regulatory submission for a physical medical device (a biopsy system) and focuses on demonstrating its safety and effectiveness through bench testing against established engineering and biological standards, rather than through clinical studies involving patient data, expert review, or AI algorithms.
§ 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.