(297 days)
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
The EchoTip® Ultra Fiducial Needle is composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures.
Here's an analysis of the provided text regarding the EchoTip® Ultra Fiducial Needle's acceptance criteria and studies:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative clinical study. Therefore, many of the requested data points (like sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance with precise metrics) are not present in this type of submission. The "acceptance criteria" here are implicitly related to the device meeting its intended use and safety profile, as demonstrated through non-clinical testing and comparison to predicates.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for a Class II device, the "acceptance criteria" are not reported as specific quantitative thresholds (e.g., sensitivity > X%, accuracy > Y%) that would be found in a clinical performance study for an AI/diagnostic device. Instead, acceptance is based on the device demonstrating:
- Ability to meet intended use: Successfully implanting fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
- Substantial equivalence: Demonstrating similar safety and effectiveness to legally marketed predicate devices.
- Biocompatibility: Absence of toxicological concerns.
- Functional performance: No detachment or breakage, fiducial visibility under imaging, and MR Conditional status.
Therefore, the table below reflects the implied acceptance criteria based on the information provided, which largely revolves around successful functional and safety performance, and the reported outcomes from the studies conducted.
| Acceptance Criteria (Implied from 510(k) submission) | Reported Device Performance (Conclusions from Tests) |
|---|---|
| Intended Use: Successfully implant fiducials to radiographically mark soft tissue. | Demonstrated ability to mark soft tissues for future therapeutic procedures via endoscopic ultrasound placement. |
| Functional Performance (Delivery System): Effective and safe deployment of fiducials. | Simulated use demonstrated that the device could be used effectively without detachment or breakage. |
| Imaging Visibility: Fiducials are visible under relevant imaging modalities. | Fiducials were visible under ultrasound and common radiographic imaging techniques. |
| MR Compatibility/Safety: Device must be MR Conditional. | Fiducials are MR Conditional, as defined by ASTM F2503-08 and FDA guidance on Passive Implants in the MR Environment. |
| Biocompatibility: No toxicological concerns from implanted pure gold fiducials. | No toxicological concerns for pure gold implanted fiducials were identified by a Risk Assessment (inclusive of exhaustive extraction with chemical characterizations) and biocompatibility tests (cytotoxicity, irritation, sensitization, implantation). |
| Substantial Equivalence: To predicate devices in intended use, biological safety, and technological characteristics. | Established substantial equivalence to the predicate devices (BiomarC® Preloaded Tissue Marker Device and EchoTip® Ultra Ultrasound Needle) in terms of intended use, biological safety, and technological characteristics. The delivery system is a modified version of the EchoTip® Ultra Ultrasound Needle, with specific additions (laser cut track for fiducials, thumb ring) noted, but overall equivalence maintained. |
Study Details (Based on available 510(k) information)
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Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "simulated use" and "biocompatibility tests," but does not provide the number of devices or subjects/samples used for these tests.
- Data provenance: Not explicitly stated, but it would have been generated internally by Cook based on design verification and validation testing. There is no indication of external clinical data or specific geographic origin beyond internal company testing. The nature of the studies (biocompatibility, simulated use) suggests laboratory or animal testing rather than human clinical data.
- Retrospective or prospective: These were likely prospective engineering/pre-clinical studies conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the non-clinical nature of the tests (biocompatibility, simulated use, imaging visibility), "ground truth" as typically defined for a diagnostic AI study (e.g., expert consensus on medical images) is not applicable here. Performance was likely assessed by engineers and technicians against design specifications and international standards (e.g., ASTM for MR compatibility).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None stated/applicable. Adjudication methods are typically relevant for clinical studies involving human observers and their interpretations, especially for diagnostic devices. These were engineering and biocompatibility tests.
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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, an MRMC comparative effectiveness study was not done. This device is a medical instrument (fiducial marker and delivery system), not an AI-powered diagnostic tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant or present in this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to established international standards (e.g., ISO 10993 series, implied by "cytotoxicity, irritation sensitization and implantation") and chemical characterizations.
- For functional performance: Design specifications and confirmed functional outcomes (e.g., "no detachment or breakage").
- For imaging visibility: Direct observation under ultrasound and radiographic imaging techniques.
- For MR compatibility: Adherence to ASTM F2503-08 and FDA guidance, meaning it met defined criteria for MR safety classifications.
- This is primarily a "truth by measurement/standard" or "truth by design specification" rather than a clinical "ground truth" derived from patient data.
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The sample size for the training set:
- Not applicable. This device is hardware; there is no AI algorithm with a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no AI algorithm, there is no training set or ground truth for such a set.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.