(57 days)
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.
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The provided 510(k) summary for the M-CORE disposable core biopsy needle does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on demonstrating substantial equivalence to predicate devices based on design and materials, and mentions "Performance testing summary" but does not elaborate on the specific tests or their results within this summary.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., biopsy sample quality scores, tensile strength, or cutting efficiency thresholds). Instead, it relies on demonstrating that the device is "substantially equivalent" to predicate devices, implying similar performance.
The summary states: "Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivalent to the predicate device(s)." This is a general statement of performance, not a quantified measurement against an acceptance criterion.
The table provided in the document compares device characteristics, not performance metrics:
| Characteristic | Reported Device (M-CORE Needle) Performance (Implicitly equivalent to predicate) | Acceptance Criteria (Not explicitly stated in this document) |
|---|---|---|
| Cannula and Stylet Material | 304SS | (Implicitly: Same as predicate) |
| Cannula and Stylet Hub Material | Polycarbonate | (Implicitly: Same as predicate) |
| Sheath | LDPE | (Implicitly: Same as predicate) |
| Stylet Sample Notch | 19mm | (Implicitly: Same as predicate) |
| Spacer | Thermoplastic | (Implicitly: Same as predicate) |
| Non-Pyrogenic | Yes, LAL Test | Yes (Implicitly: Demonstrated by LAL Test) |
| Sterile Packaging | Tyvek pouch | (Implicitly: Same as predicate) |
| Sterilization Method | Gamma, 11137, VDMax25, SAL 10-6 Dose: 25 - 40 kGy | (Implicitly: Equivalent or superior to predicate's EO SAL 10-6 or Gamma) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for performance testing (e.g., number of biopsies performed, number of needles tested). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
No information is provided about experts used to establish ground truth. The summary mentions "the quality of the samples obtained," suggesting an evaluation of biopsy specimens, but does not detail how this quality was assessed or by whom.
4. Adjudication Method for the Test Set
No information is provided regarding any adjudication method for performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. This device is a biopsy needle, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
While not explicitly called "ground truth," the performance testing likely involved assessing the "quality of samples obtained." This would typically be evaluated through:
* Histopathology/Pathology: Examination of the tissue samples by a pathologist to determine adequacy for diagnosis.
* Visual Inspection/Gross Examination: Assessment of the sample size, integrity, and appearance.
The document does not specify which of these, or any other method, was used.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
In summary, the provided 510(k) notification primarily focuses on demonstrating substantial equivalence through a comparison of design and materials with predicate devices, and a general statement about performance testing confirming sample quality. It lacks the specific details about acceptance criteria, study sizes, methodologies, and expert involvement that your detailed questions request. This level of detail is often found in the full test reports referenced (e.g., "See Section 18" for Performance Testing Summary), but not typically within the concise 510(k) summary itself.
§ 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.