(306 days)
Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.
The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths. The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula. The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided text describes a 510(k) premarket notification for a Disposable Coaxial Biopsy Needle. It includes a summary of non-clinical testing, but does not contain any information about acceptance criteria or a study proving the device meets those criteria (e.g., clinical studies, human-in-the-loop studies, or detailed performance metrics from a test set).
The document explicitly states: "No clinical study is included in this submission." and focuses on bench testing, biocompatibility, and sterilization validations to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text.
Specifically, the following points from your request cannot be addressed based on the provided document:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria with numerical performance targets are provided, beyond general statements that "Conformity has been demonstrated" for bench tests.
- Sample sized used for the test set and the data provenance: No sample sizes for performance tests are given, nor data provenance (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical or human-in-the-loop studies are mentioned.
- Adjudication method for the test set: Not applicable.
- 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, as this is a physical medical device (biopsy needle), not an AI/software device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the type of device and studies described.
- The sample size for the training set: Not applicable (no AI/machine learning involved).
- How the ground truth for the training set was established: Not applicable (no AI/machine learning involved).
The document details the following about the device and its testing:
- Type of Study: Primarily non-clinical bench testing, sterilization validation, and biocompatibility testing.
- Bench Tests Performed (Summary, no detailed results or acceptance criteria given):
- Depth projection (to confirm no over-throw)
- Penetration force (comparative to predicate device)
- Mechanical durability
- Ultrasound Visibility (of the invasive part)
- Qualification of metal tubing/needle component (conforms to ISO 9626)
- Biocompatibility Testing: Successfully tested for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity according to ISO 10993 standards.
- Sterilization and Shelf Life: EO sterilized, 3 years shelf life, validated per ISO 11607-1.
The overall conclusion is based on the "substantial equivalence" to a predicate device (MDL INTRO Coaxial Introducer Needles, K160316), primarily through comparing technological characteristics and non-clinical performance, rather than clinical or user-performance studies.
§ 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.