(217 days)
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."
§ 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.