(73 days)
This instrument has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
The NA-201SX-4022 Single Use Aspiration Needle consists of a handle section, needle section, rne NN20 North section. The handle section is connected to the endoscopes instrument channel port via the single use adapter biopsy valve (MAJ-1414). The handle section facilitates the advancement of the needle section during puncture of the targeted site. The syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-201SX-4022. The syringe is used to aspirate the specimen that was punctured with the needle. The syringe has a lock function which can lock the piston (plunger) is pulled. When the stopcock is closed and the piston (plunger) keeps it evacuated. For aspiration, the syringe should be connected with the needle and the stopcock should be opened just before aspiration. The lock Connected with the need for the operator to keep pulling the piston during the procedure thus improving usability. The position to lock the piston (plunger) is selected from 4 levels. Accordingly, the operator can select the specimen size required.
The provided text is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-201SX-4022. It explicitly states in section F that no clinical data was required to establish substantial equivalence for this device. Therefore, a study proving device acceptance criteria was not performed or reported in this document. The decision was based on the device not incorporating any significant change that impacts safety and effectiveness compared to predicate devices, thus obviating the need for clinical data.
Reason for Not Requiring Clinical Data (as stated in the document):
"When compared to the predicate device, the Single Use Aspiration Needle NA-201SX-4022, WAJ-1414 and Syringe does not incorporate any significant change that impacts safety and Mro-1414 and Dynings acos not history drive. Therefore, clinical data is not necessary to establish the subject device."
Given this, the following sections cannot be answered based on the provided document:
- A table of acceptance criteria and the reported device performance: This would be generated from a clinical study, which was not performed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a clinical study was used.
- 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): No ground truth for a clinical study was established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set required adjudication.
- 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 medical device, not an AI-assisted diagnostic tool, and no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI-driven algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth established for a clinical study.
- The sample size for the training set: No training set for a clinical study was used.
- How the ground truth for the training set was established: No ground truth for a training set was established.
The document focuses on the substantial equivalence of the new device to existing predicate devices based on design and intended use, rather than presenting clinical performance data from a specific study.
§ 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.