(58 days)
The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.
The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections. The major components of the devices are the catheter, needle, and hub.
The provided text is a 510(k) summary for the Boston Scientific Interject™ Injection Therapy Needle. Based on the document, this device is a medical instrument and not an AI or software as a medical device (SaMD). Therefore, the standard acceptance criteria, study types (e.g., MRMC, standalone), and data provenance considerations typically associated with evaluating AI/SaMD are not directly applicable here.
This 510(k) submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria for AI-driven diagnostic accuracy.
Here's an analysis based on the information provided, highlighting why certain questions are not relevant in this context:
Acceptance Criteria and Device Performance
Since this is a submission for a physical medical device (an injection needle) and not an AI/SaMD product, there isn't a table of quantitative performance metrics (like sensitivity, specificity, AUC) that would be applicable to AI.
The "acceptance criteria" in this context are tied to demonstrating substantial equivalence. The document states:
Acceptance Criteria (Implied by Substantial Equivalence):
- Biocompatibility: Patient- and fluid-contact materials of the device must be biocompatible.
- Design/Technological Characteristics: The proposed device's design and technological characteristics must be equivalent to predicate devices.
- Indications for Use: The device must safely and effectively fulfill its stated indications for use, building on the safety and effectiveness established for predicate devices.
Reported Device Performance (from the document):
- "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interject Injection Therapy Needle with satisfactory results."
- "The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication."
- "A thorough comparison of the descriptive characteristics between the proposed Interject device and the predicate device show equivalence."
Table of (Applicable) Acceptance Criteria and Performance:
| Acceptance Criteria Category (Implied for Substantial Equivalence of physical device) | Reported Device Performance / Evidence |
|---|---|
| Material Biocompatibility | Satisfactory biocompatibility assessment performed on predicate device. Proposed and predicate devices are identical in patient/fluid contact materials. |
| Technological/Design Equivalence | "Thorough comparison... between the proposed Interject device and the predicate device show equivalence." |
| Safety & Effectiveness for Indication | Leveraged established safety & effectiveness of predicate devices for the new indications. |
Study Details (Not applicable for this type of device and submission)
The questions regarding sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not applicable to this 510(k) submission for a physical injection needle.
Here's why:
- AI/SaMD Specific: These questions are designed to evaluate the performance and validation of Artificial Intelligence or Software as a Medical Device (AI/SaMD) products, which rely on data and algorithms. The Interject™ Injection Therapy Needle is a conventional, physical medical instrument.
- Substantial Equivalence: The primary "study" for this 510(k) was a comparison to predicate devices to demonstrate substantial equivalence. This typically involves engineering assessments, material testing (like biocompatibility), and a review of intended use and technological characteristics, not clinical studies in the manner described for AI.
- No Algorithm/Data-Driven Performance: There's no AI algorithm to train or test, no diagnostic accuracy metrics (like sensitivity, specificity) to calculate, and no human-in-the-loop scenario to evaluate for this device.
Therefore, the following information cannot be extracted from the provided 510(k) summary:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary: The K012864 510(k) for the Interject™ Injection Therapy Needle demonstrates substantial equivalence based on material biocompatibility and design/technological characteristics comparison to existing predicate devices. It is not an AI/SaMD product, and thus, the detailed performance study criteria relevant to AI-driven devices are not present or applicable.
§ 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.