(79 days)
The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.
The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm. The predicate devices listed contain identical or substantially equivalent materials and characteristics as described above.
The provided text details the submission of a 510(k) premarket notification for the "RP Cutting Needle" and states its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, or MRMC/standalone study results.
Here's an analysis of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness." and "Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
- This indicates that the acceptance criteria are based on substantial equivalence to predicate devices regarding general shape, size, method of function, and material properties. However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum bend angle, biopsy core length) and the reported performance against those numerical criteria are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on sample sizes for any testing (e.g., dimensional, quality verifications) is provided.
- Missing. No information on data provenance is provided.
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)
- Missing. No information about experts or ground truth establishment for a test set is provided, as no clinical or comparative performance study is detailed. The device is deemed substantially equivalent based on engineering/material comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. Not applicable, as no test set requiring ground truth adjudication is described.
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
- Missing. Not applicable. This document is for a biopsy needle, not an AI-powered diagnostic device, so an MRMC study with human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. Not applicable. This is a physical medical device (biopsy needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. Not applicable. The "ground truth" here seems to be engineering specifications and material properties of existing predicate devices for establishing substantial equivalence, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
- Missing. Not applicable. This is not an AI/machine learning device that would have a training set.
9. How the ground truth for the training set was established
- Missing. Not applicable.
Summary of available relevant information from the document related to substantial equivalence:
- Device Description: "The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm."
- Equivalence Claim: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness."
- Evidence for Equivalence: "All materials used were selected based on known biocompatibility and established histories of use in the medical device industry for non-implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed. The RP Cutting Needle has been designed to have the same general shape, size and method of function as the predicate devices. Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
- Predicate Devices:
- C.R. Bard®: Biopty-Cut® Needle; Magnum® Needle
- Remington Medical: MLL Needle; M-Needle
- Cook® Medical: Cook Biopsy Needle
Based on the provided text, the device's acceptance criteria are implicit in its claim of "substantial equivalence" to existing predicate devices regarding materials, general shape, size, and method of function. The "study" proving this substantial equivalence consists of "dimensional and quality verifications, along with material certification." Specific quantitative results or detailed study protocols are not included in this 510(k) summary.
§ 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.