(75 days)
The Full Core Biopsy System is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
The Full Core Biopsy System (the "System") includes an automatic spring powered Biopsy Device (the "Device") and a Coaxial Introducer (K954265, Promex Technologies, LLC) ("the Introducer"). As described more fully in the scientific concepts section below, the Device obtains and delivers a core tissue sample. The end-cut design of the Device allows the entire inner diameter of the cutting cannula to be open to capture tissue. The System (2 components) is comprised of; 1. The Device 2. The Introducer and are provided sterile in a pouch and intended for single patient use only. The System will be provided in 16, 18, and 20 gage and the working lengths range from 10cm to 25cm. The Device includes a Franseen-style cutting geometry on the end of the cannula and the Introducer includes a standard trocar tip.
Here's an analysis of the acceptance criteria and study information for the Full Core Biopsy System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Penetration Force | The penetration force of the System falls between the penetration forces of the SABD™ Predicate and the BioPince® Predicate. (This implies that the device's penetration is within an acceptable range, not too hard as to cause excessive trauma, and not too soft as to be ineffective). |
| Stroke Length | The stroke length of the Device is the stroke length of the SABD™ Predicate and has a stroke length that is equivalent to one of the settings of the BioPince® Predicate. (This ensures consistency in the amount of tissue captured per biopsy). |
| Tissue Sample Retrieval | Test results confirmed that the Full Core Biopsy System would retrieve a tissue sample that was substantially equivalent to the tissue sample retrieved by the predicate devices. (This is a key performance metric, demonstrating the device's ability to obtain adequate diagnostic samples). |
| Mechanical Durability | The Device utilizes the same components, springs, manufacturing processes, and tests as used in the assembly of the SABD™ Predicate. Mechanical Durability testing of the Device will be a part of the normal inspection process, which is the same as the inspection process for the 510k Owner's SABD™ Predicate. (Implies durable performance aligned with previously cleared devices). |
| Sterilization Efficacy | The sterilization process will be identical for the System as the SABD™ Predicate. The SABD™ Predicate and the Introducer have been validated for gamma sterilization at a minimum level of 25kGy and a maximum of 50kGy. The process is validated and monitored to a 10⁻⁶ SAL per ISO11137-2:2006, method VDmax25. (Ensures sterility is achieved and maintained). |
| Shelf-Life Stability | The SABD™ Predicate has been evaluated for shelf-life stability using accelerated aging as well as real-time shelf exposure under normal storage conditions. All materials, manufacturing methods, and packaging are the same for the subject Device and the SABD™ Predicate; therefore no further testing of the System is necessary. (Ensures product remains safe and effective over its shelf life). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the "test set" in the bench testing. It describes a "side-by-side comparison" against two predicate devices. It suggests that various tests (penetration, stroke length, tissue retrieval) were performed.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that this is a 510(k) submission, the testing would have been conducted to support regulatory clearance, likely in a controlled, prospective manner by the device manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the context of the performance testing described (penetration, stroke length, tissue retrieval). These appear to be objective, quantifiable measurements. For tissue sample retrieval, it states "Test results confirmed that the Full Core Biopsy System would retrieve a tissue sample that was substantially equivalent to the tissue sample retrieved by the predicate devices," which implies comparison against established samples, but not expert-based ground truthing in the typical sense of a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. The performance tests described (penetration force, stroke length, tissue sample equivalence) are objective measurements rather than subjective assessments requiring adjudication by multiple readers or experts.
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 mechanical biopsy system, not an AI-powered diagnostic tool. The document describes performance testing of the mechanical components and tissue retrieval, not a comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical biopsy system.
7. The Type of Ground Truth Used
The ground truth for the bench testing was primarily objective physical measurements for penetration force and stroke length. For tissue sample retrieval, the "ground truth" was likely established by visual and/or volumetric comparison of the retrieved samples against those obtained by the legally marketed predicate devices, with the goal of demonstrating substantial equivalence (i.e., that the samples were comparable in size, integrity, and diagnostic utility as those from the predicate devices). There is no mention of pathology, outcomes data, or expert consensus in establishing ground truth for these specific performance parameters.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a mechanical device, there is no ground truth established for it.
§ 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.