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Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.

Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.

Automatic Core Biopsy Instrument has seven models. Some models are automatic firing, and others have both automatic firing and delay firing options. The structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block, Protective sheath, Adjustable Knob (on some models), Charging handle (on some models), and Security Lock (on some models). Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Semi-Automatic Core Biopsy Instrument has two models. It consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded. The Cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Disposable Coaxial Biopsy Needle has two models. It consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula, Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional). An adjustable depth stopper is included and is color-coded. It is available in several needle gauge sizes and lengths. It is intended for use as a guiding needle with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible biopsy instrument/needle. The Cutting cannula has numerical scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

This document describes the premarket notification (510(k)) for three medical devices: Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, and Disposable Coaxial Biopsy Needle, manufactured by Zhejiang CuraWay Medical Technology Co., Ltd.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, indications for use, and non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance
• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The document explicitly states under section 5. Clinical data: "No clinical data was provided." This reinforces that the review was based on non-clinical (bench) testing and comparison to predicate devices, not on a study demonstrating clinical performance or AI/ML algorithm performance.

Summary of available information (Non-Clinical Testing):

The manufacturer performed the following bench testing to demonstrate the intended use of the products:

• Biological Testing (Biocompatibility):
  • In Vitro Cytotoxicity Test (ISO 10993-5: 2009)
  • Intracutaneous Reactivity Test (ISO 10993-23: 2021)
  • Skin Sensitization test (ISO 10993-10: 2021)
  • Irritation or Intracutaneous Reactivity (ISO 10993-10)
  • Acute Systemic Toxicity Test (ISO 10993-11: 2017)
  • Pyrogen Test (ISO 10993-11: 2017)
• Sterilization validation: Performed according to ISO 11135: 2014, with EO and ECH validated per ISO 10993-7: 2008. Sterility test per ISO 11737-2: 2019. SAL=10^-6.
• Packaging and shelf-life testing: Performed according to ASTM F1980: 2016.
• Performance comparison with predicate devices: Included appearance, dimensions, sampling performance, connection firmness, stiffness, toughness, resistance to corrosion, puncture force, and chemical properties.

Conclusion stated in the document:
"The indications for use, design and nonclinical performance testing indicate that the technological characteristics of subject device are equivalent to that of predicate devices. In conclusion, it can be determined that subject device is substantially equivalent to predicate devices."

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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:

1. 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.
2. 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).
3. 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.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical medical device (biopsy needle), not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the type of device and studies described.
8. The sample size for the training set: Not applicable (no AI/machine learning involved).
9. 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.

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The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 13 1 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows:

Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality.

Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

The Shengwei Biopsy needle include semi-automatic and automatic spring powered guns (disposable). Cannula accessory is provided in a variety of sizes, designed to work with the manufacturer's semi-automatic and automatic guns to obtain and deliver a soft tissue core sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shengwei Biopsy Needles (Model 121, Model 111/112, and Model 131 Disposable Coaxial Biopsy Needle).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: For performance testing (Depth Projection, Penetration Force, Activation Force, Mechanical Durability, Extraction), "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes." For Depth Projection, Activation Force, and Extraction, testing was performed "over 50 shots per use." For Penetration Force, "Each tested subject and predicate device was activated 50 times." For Shelf-life, "Three lots of aged and non-aged subject devices were tested in triplicate."
• Data Provenance: The document does not explicitly state the country of origin of the data for these performance tests. It also does not explicitly state whether the tests were retrospective or prospective, but given they are laboratory performance tests, they are inherently prospective for the purpose of this submission.
• Clinical Data: No clinical data was included in this 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)

• This information is not applicable as the studies described are laboratory performance tests focusing on mechanical and biological properties of the device, not clinical performance requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not applicable as the studies described are laboratory performance tests measuring quantifiable physical properties of the device, not clinical studies involving interpretation or adjudication.

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 study was done. This document is for a medical device (biopsy needle), not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No standalone (algorithm only) performance study was done. This document is for a physical medical device (biopsy needle), not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series and USP tests) which define acceptable biological responses.
• For performance testing, the ground truth is established by specific criteria outlined in the testing protocols (e.g., "Needle Advancement > 20 mm," "Breakage Force (SHENGWEI) > FPredicate") and comparison to legally marketed predicate devices. Quantitative measurements are taken against these predefined standards or predicates.

8. The sample size for the training set

• This information is not applicable as the document describes laboratory performance and biocompatibility testing for a physical medical device, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

• This information is not applicable for the same reason as point 8.

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