(16 days)
The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
The provided document is a 510(k) summary for Medical Device Technologies, Inc.'s Manan™ Soft Tissue Biopsy Needles. This document establishes the substantial equivalence of the new needles to previously marketed predicate devices.
This document describes a medical device (biopsy needles), not an AI/ML powered device. Therefore, the concepts of acceptance criteria for AI algorithm performance, sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable here.
The primary "acceptance criterion" for a traditional medical device in a 510(k) submission is demonstrating substantial equivalence to a previously legally marketed device (predicate device).
Here's how the document addresses the "acceptance criteria" and the "study" that proves the device meets them, interpreted for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for 510(k) submission) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Substantial Equivalence to a Predicate Device (in terms of indications for use, technological characteristics, and safety/effectiveness) | The Manan™ Soft Tissue Biopsy Needles are substantially equivalent to the predicate devices listed (Medical Device Technologies, Inc.'s Manual Biopsy Needles K944837 and various Manan Medical Products biopsy needles: Franseen Needle K851831, Greene Needle K851835, Westcott Needle K851837, Chiba Needle K851838, Trocar Needle K852426, Spinal Needle K852427, Turner Needle K873208). |
| Intended Use (Percutaneous soft tissue biopsies under guidance) | The device's intended use is identical to, or within the scope of, the predicate devices: for percutaneous soft tissue biopsies (pleura cavity, abdominal cavity, etc.), inserted by a qualified physician under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy) to retain a tissue specimen. |
| Technological Characteristics (as implies by substantial equivalence) | Implied to be sufficiently similar in design, materials, and operating principle to the predicate devices such that no new questions of safety or effectiveness are raised. The description states "These devices are intended to be used... and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle," which describes the fundamental operation of the predicate devices. |
| Safety and Effectiveness (as implies by substantial equivalence) | Implied to be as safe and effective as the predicate devices, as no new safety or effectiveness concerns were identified during the review. The FDA's decision to allow marketing (K980122) confirms this. |
2. Sample size used for the test set and the data provenance
- Not Applicable. For a 510(k) substantial equivalence submission for a traditional medical device like a biopsy needle, there isn't a "test set" in the sense of a dataset to evaluate an algorithm's performance. The "testing" often refers to bench testing (e.g., material strength, needle sharpness, tissue capture effectiveness) and potentially pre-clinical in-vivo models. These details are typically in supporting documentation not included in this summary. There is no mention of human subject data, retrospective or prospective studies in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a medical device's performance would be established through established engineering standards, material science, and clinical practice, rather than expert annotation of a dataset.
4. Adjudication method for the test set
- Not Applicable. As there is no "test set" for algorithm evaluation, no adjudication method is relevant.
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 is specific to AI/ML devices and human-in-the-loop studies. This document concerns a basic surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is specific to AI/ML algorithms.
7. The type of ground truth used
- Not Applicable (in the AI/ML sense). For a traditional medical device, the "ground truth" for its function and safety is based on scientific principles, engineering design, manufacturing quality, and comparison to existing, legally marketed devices with a known safety and efficacy profile.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of medical device's submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
In summary: The provided document is purely a 510(k) summary for a traditional medical device (biopsy needles) seeking regulatory clearance based on substantial equivalence. It does not involve any artificial intelligence or machine learning components, and therefore, the detailed questions about AI acceptance criteria, data sets, expert ground truth, and studies are not applicable to this submission. The "study" here is the comparative analysis demonstrating substantial equivalence to predicate devices, which the FDA affirmed.
§ 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.