(151 days)
It is to be used for taking cytological and histological biopsies of soft tissue.
The device is a hand-operated, non-electronic, with Chiba tip for tissue pathological examination/testing.
- -Trasparent Luer Lock connector.
- Sharpened cannula for a safe and painless insertion and penetration. -
- External echogenic treatment for a correct positioning under ultrasound guidance.
- -Centimeter markings and sliding stopper.
- -Sterilized by ETO, shelf life 5 years.
lt's a relatively invasive procedure and is performed by radiologist under guidance of imaging techniques such as ultrasound, X-ray.
This is a single-use device.
Not intended for use in bone.
The provided text describes a 510(k) submission for the Promisemed Fine Biopsy Needle. It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes that would typically be associated with medical device performance studies.
The section titled "Performance Testing Summary" mentions various bench tests conducted to verify the device's performance against the predicate device. These tests primarily focus on physical and mechanical characteristics relevant to the manufacturing quality and basic functionality of a biopsy needle, rather than clinical performance or diagnostic efficacy.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 1) between the subject device (Promisemed Fine Biopsy Needle) and the predicate device (Pan® Aspirating Needle (Chiba), K970872). However, this table lists parameters of the device itself and manufacturing/material specifications, not acceptance criteria for clinical performance or diagnostic accuracy. The "Performance" section within the table lists "Echogenic" and "Connector transparency" and states "Same" in comparison to the predicate. The "Performance Testing Summary" lists a series of bench tests, but no specific numerical acceptance criteria or performance metrics (like accuracy, sensitivity, or specificity) are provided for these tests. The conclusion states: "The performance test results are indicated that performance of Fine Biopsy Needles meet the specific requirements." This is a general statement without specific data.
Table of Device Characteristics & Performance (from document)
| Items | Subject Device Performance/Characteristic | Predicate Device Performance/Characteristic | Comments / Acceptance |
|---|---|---|---|
| Performance (general) | |||
| Echogenic | Yes | Yes | Same (Implied acceptance: Yes) |
| Connector transparency | Transparent/lock | Transparent/lock | Same (Implied acceptance: Transparent/lock) |
| Reuse durability | Single Use | Single Use | Same (Implied acceptance: Single Use) |
| Material/Physical Properties | |||
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, 22G, 23G | 18G, 20G, 21G, 22G, 23G, 25G | Subject device includes 16G, 19G; "do not introduce any new concerns for safety or efficacy." |
| Needle Length | 90mm, 100mm, 150mm, 200mm | 50mm, 80mm, 90mm, 150mm, 200mm | Different (Subject device has less needle length options); no impact on safety/efficacy implied. |
| Inner needle hub color | Per ISO 6009 | Per ISO 6009 | Each color in accordance with ISO 6009 (Implied acceptance: ISO 6009 compliance) |
| Needle tube tip type | Chiba | Chiba | Same (Implied acceptance: Chiba tip) |
| Bond between outer needle tube and hub | Meets axial static force (e.g., 23G 34 N) | (Not explicitly stated for predicate but "Same") | Implied acceptance: Meets specified axial static force for 10s |
| Bond between inner needle tube and hub | Meets axial static force (e.g., 23G 10 N) | (Not explicitly stated for predicate but "Same") | Implied acceptance: Meets specified axial static force for 10s |
| Needle tube performance | Per ISO 9626: Resistance to breakage; Resistance to corrosion | Per ISO 9626: Resistance to breakage; Resistance to corrosion | Same (Implied acceptance: ISO 9626 compliance) |
| Scale identification | Clearly discernible, 10mm±1.5mm from tip to first mark and between marks | Clearly discernible, 10mm±1.5mm from tip to first mark and between marks | Same (Implied acceptance: Meets specified scale identification) |
| Luer lock Connector performance | Per ISO 80369-7 (Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding) | Per ISO 80369-7 (same list) | Same (Implied acceptance: ISO 80369-7 compliance) |
| Sterilization method | EO Sterilization | EO Sterilization | Same (Implied acceptance: EO Sterilization) |
| Shelf life | 5 years | 5 years | Same (Implied acceptance: 5 years) |
| Biocompatibility | Complied with ISO10993 series (Cytotoxicity, Skin Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogen) | Complied with ISO10993 series (same list) | Same (Implied acceptance: ISO10993 series compliance) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing" but does not specify sample sizes for these tests, nor does it refer to human or animal test sets. The provenance of the data is implied to be from the manufacturer (Promisemed Hangzhou Meditech Co., Ltd. in China) as they conducted the tests. Whether the tests were prospective (designed for this submission) or retrospective (using existing data) is not specified, but bench testing for a 510(k) is typically conducted prospectively for the submission.
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)
Not applicable/Not provided. The testing described is bench testing of physical and mechanical properties, not a study requiring expert-established ground truth for a diagnostic or clinical outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical outcomes, which is not described here.
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
No MRMC comparative effectiveness study was mentioned or conducted. This device is a manual biopsy needle, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the bench tests performed, the "ground truth" would be the engineering specifications and ISO standards referenced (e.g., ISO 9626 for needle tube performance, ISO 6009 for color codes, ISO 80369-7 for connector performance).
8. The 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 the ground truth for the training set was established
Not applicable. (See point 8).
In summary: The provided document is a 510(k) premarket notification for a physical medical device (biopsy needle). The "performance" assessment focuses on showing that the device's physical and mechanical properties are substantially equivalent to a predicate device through bench testing and compliance with recognized standards. It does not present clinical performance data (like diagnostic accuracy, sensitivity, or specificity) or studies involving human subjects, therefore, many of the requested elements pertaining to such studies are not present in the document.
§ 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.