(306 days)
Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone.
The extent of histological 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 histological 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 using standard surgical procedures.
The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle.
The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath.
It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath.
The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen.
The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided text describes the regulatory clearance (510(k)) of a medical device, the "Disposable Biopsy Refill Needle," and focuses on demonstrating its substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical (bench) testing and comparison to an already cleared device, rather than extensive clinical studies for standalone or comparative effectiveness of an AI/human-in-the-loop system.
Therefore, many of the requested elements for an AI-based device (like MRMC studies, ground truth establishment for large datasets, sample sizes for training/test sets for machine learning models, and expert qualifications for data labeling) are not applicable to this specific traditional medical device clearance.
Here's an analysis based solely on the provided text:
Device: Disposable Biopsy Refill Needle
Regulatory Submission Type: 510(k) Premarket Notification (for substantial equivalence to a predicate device, not an AI/ML device)
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are generally established by meeting recognized consensus standards and demonstrating performance equivalent to the predicate device. The performance is reported as "Conformity has been demonstrated" for various tests.
| Test Item | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Tests | ||
| Depth projection | Subject device will not extend over the stylet tip during use. | Conformity has been demonstrated. |
| Penetration force | Equivalent to predicate device. | Conformity has been demonstrated. |
| Stiffness | Meet requirements per ISO 9626. | Conformity has been demonstrated. |
| Resistance to Breakage | Meet requirements per ISO 9626. | Conformity has been demonstrated. |
| Bonding Strength | Meet requirements per ISO 7864 for connection firmness. | Conformity has been demonstrated. |
| Biopsy Tissue Sample Testing | Successfully retrieve biopsy specimen multiple times. | Conformity has been demonstrated. |
| Ultrasound Visibility | Invasive part visible in guided area/ultrasound range. | Conformity has been demonstrated. |
| Biocompatibility | ||
| Cytotoxicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Sensitization | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Intracutaneous irritation | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Acute systemic toxicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Material mediated pyrogenicity | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Hemolysis | Meet ISO 10993 criteria. | Successfully tested; criteria fulfilled. |
| Sterilization & Shelf Life | ||
| Sterility (EO) | SAL: 10-6, packaging maintains sterility per ISO 11607-1. | Successfully tested. |
| Shelf Life | Maintain safety and effectiveness for 3 years. | Label shelf life is 3 years. |
2. Sample sizes used for the test set and the data provenance
The document primarily discusses bench testing of a physical device. It does not refer to a "test set" in the context of a machine learning model, nor does it detail specific sample sizes for each bench test performed (e.g., how many needles were tested for penetration force). The data provenance is from non-clinical bench testing conducted by Suzhou Leapmed Healthcare Corporation. No country of origin for data is specified, as it's not a data-driven AI study. All tests are inherently retrospective as they are performed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device clearance. There is no "ground truth" in the sense of expert annotation of medical images or data for an AI algorithm. Ground truth for a physical device is established through engineering and quality control measurements against pre-defined specifications and international standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling disagreements among human readers/experts in AI model ground truth establishment or MRMC studies. For bench testing, results are quantitative or qualitative assessments against defined criteria, not subject to individual interpretation requiring adjudication.
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
There was no MRMC comparative effectiveness study done. The device is a physical biopsy needle, not an AI-assisted diagnostic or interventional system. The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" (or basis for acceptance) is derived from:
- Engineering specifications and design requirements: For physical properties like dimensions, material strength, and performance characteristics (e.g., penetration force, stiffness).
- International consensus standards: Such as ISO 9626 (needles), ISO 10993 (biocompatibility), ISO 11607-1 (packaging/sterilization), and ISO 7864 (bonding strength).
- Comparative testing against a legally marketed predicate device: Demonstrating that the new device performs equivalently to a device already deemed safe and effective.
8. The sample size for the training set
This is not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
§ 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.