(169 days)
As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use.
Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.
The provided text describes a medical device submission (K181756) for the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle. This submission is for a traditional medical device (biopsy needle) and does not involve an Artificial Intelligence/Machine Learning (AI/ML) powered device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.
However, I can extract information regarding the acceptance criteria and the studies performed for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a non-AI/ML medical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for clinical outcomes. Instead, they are related to compliance with recognized standards and design requirements for a biopsy needle. The "reported device performance" refers to the successful verification against these standards and requirements.
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | Passed: |
| - Cytotoxicity (ISO 10993) | Verified criteria are fulfilled. |
| - Sensitization (ISO 10993) | Verified criteria are fulfilled. |
| - Intracutaneous irritation (ISO 10993) | Verified criteria are fulfilled. |
| - Acute Systemic Toxicity (ISO 10993) | Verified criteria are fulfilled. |
| - Pyrogenicity (ISO 10993) | Verified criteria are fulfilled. |
| Qualification of Metal Tubing: | Conformity Demonstrated: |
| - Compliance with ISO 9626:2016 | Metal tubing is qualified and conforms. |
| Qualification of Needle Component: | Conformity Demonstrated: |
| - Compliance with ISO 7864:2016 | Needle component is qualified and conforms. |
| Conical Fittings: | Conformity Demonstrated: |
| - Compliance with ISO 594 | Luer lock fittings are qualified and conform. |
| Mechanical Performance: | Passed: |
| - All design requirements | Mechanical performance testing passed. |
| Verification of Penetration Force and Spring: | Passed: |
| - All design requirements | Penetration force and spring evaluation passed. |
| Sufficiency for Substantial Equivalence: | Substantial Equivalence Demonstrated, Safety Supported: |
| - Conformance to applicable technical requirements | Demonstrated. |
| - Conformance to user needs | Demonstrated. |
| - No new issues of safety and effectiveness (vs. predicate) | Not raised. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A) for an AI/ML device. For this traditional medical device, testing involved bench testing of components and the final device against engineering and biocompatibility standards. The document does not specify exact sample sizes for each test unless it's inherent in the standard (e.g., number of units tested for mechanical performance or biocompatibility). Data provenance is not described as country of origin, but rather as "bench testing." These were likely performed in a controlled laboratory setting by the manufacturer (AprioMed AB, Sweden). The nature of these tests is prospective for the device evaluation.
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):
- Not Applicable (N/A): This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. Ground truth for the tests performed (biocompatibility, mechanical strength, dimensional conformity) is established by adherence to recognized international standards and engineering specifications, verified by testing laboratories or internal qualified personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable (N/A): This concept primarily applies to AI/ML or diagnostic studies where human experts disagree on findings. For bench testing, results are typically objective measurements against set specifications.
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 (N/A): This is a traditional medical device (biopsy needle), not an AI/ML system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable (N/A): This is a traditional medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this traditional medical device, the "ground truth" for its performance is:
- Adherence to recognized international standards: e.g., ISO 10993 (biocompatibility), ISO 9626 (metal tubing), ISO 7864 (hypodermic needles), ISO 594 (conical fittings).
- Compliance with internal design requirements: for mechanical performance, penetration force, and spring force. These are objective engineering specifications.
8. The sample size for the training set:
- Not Applicable (N/A): This is a traditional medical device, not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable (N/A): As there is no training set for an AI/ML model, this question is irrelevant to the provided document.
§ 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.