(266 days)
The Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate. It is not intended for use in bone.
The disposable biopsy needle is a sterile, spring loaded, disposable percutaneous soft tissue biopsy instrument. The disposable biopsy needle consists of a cannula, an inner stylet, a mechanical power device and a protective cover. It is used to obtain tissue samples for tissue biopsy, suitable for tissue biopsy of various organs such as the kidney, liver, prostate etc. The needle need to be inserted by a qualified physician under ultrasound guidance. The button of the mechanical power unit comply with the color coding requirements of ISO 6009, i.e. 18 gauge = Pink. The disposable biopsy needle includes three models: CMBNA/1810, CMBNA/1815, CMBNA/1820.
The provided text is a 510(k) clearance letter for a "Disposable Biopsy Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.
Therefore, many of the requested elements cannot be extracted from this document. However, I can provide what is available, noting where information is absent.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
The document does not explicitly present a table of "acceptance criteria" against which a clinical device performance study was measured. Instead, it details that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. The performance data provided is primarily related to the physical and material characteristics of the device, rather than diagnostic accuracy or clinical outcomes.
Summary of Reported Performance (Non-Clinical):
| Performance Aspect (Acceptance Criteria Implicitly Met by Testing) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity), -10 (sensitization), -23 (irritation), -11 (systemic toxicity), -4 (blood interactions), ASTM F756-17 (hemolytic properties), USP-NF (pyrogen test). |
| Packaging Verification | Complies with ASTM F1886/F1886M-16 (seal integrity), ASTM F1929-23 (dye penetration), ASTM F88/F88M-2021 (seal strength), DIN 58953-6:2023 (microbial barrier), USP-NF (sterility). |
| Sterilization & Shelf Life | Ethylene oxide sterilization complies with ISO 11135 (process), ISO 10993-7 (ETO residuals), USP-NF (bacterial endotoxins), ANSI AAMI ST72:2019 (bacterial endotoxins), ISO 11737-2 (sterility tests). Shelf life demonstrated for 2 years (compared to 3 years for predicate) through ASTM F1980-21 (accelerated aging), ASTM D4169-23 (shipping stability). |
| Mechanical Performance (Needle Tubing) | Complies with ISO 9626 (stainless steel needle tubing), ISO 7864 (hypodermic needles for single use), ISO 6009 (color coding). |
| Sampling Ability | Samples collected from in vitro porcine liver, porcine kidney, and canine prostate were comparable in mass and quality to those collected using the predicate device. |
| Functional Reliability | Completed 24 repeated sampling steps on in vitro tissues and pork; device fired correctly, and safety lock functioned normally, meeting acceptance criteria (implicitly, for smooth operation). |
| Visibility (Ultrasound) | B-ultrasound image display test report provided to prove visibility. |
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any "test set" in the context of clinical performance. For non-clinical functional testing, "24 repeated sampling steps" were conducted for functional reliability.
- Data Provenance: Not specified for any clinical data. Non-clinical bench testing was conducted.
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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):
- Not applicable/Not provided. No clinical test set requiring expert ground truth was described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set requiring adjudication was described.
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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:
- No MRMC study was mentioned. This device is a biopsy needle, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (biopsy needle), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical ground truth. For non-clinical sampling verification, the "mass and quality" of collected tissue samples were compared.
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The sample size for the training set:
- Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a 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.