FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called the "SwannShidi Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might find for novel AI-powered diagnostic devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this 510(k) submission.

Here's why and what information is provided:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The 510(k) process for this type of device does not typically involve pre-defined acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy. Instead, substantial equivalence is demonstrated by comparing the new device's design, materials, intended use, and operational principles to legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. No clinical test set data or studies are presented. The submission relies on a comparison table to predicate devices.

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. There is no test set or ground truth established in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set involved.

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. This device is a manual aspiration needle, not an AI-powered diagnostic tool. MRMC studies would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable. No ground truth needed as no diagnostic performance claim is being made.

8. The sample size for the training set:

Not Applicable. This is not an AI-powered device and therefore does not have a training set.

9. How the ground truth for the training set was established:

Not Applicable. No training set.

What the document does provide in lieu of performance criteria and studies:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices. This is achieved by comparing various attributes of the SwannShidi Bone Marrow Aspiration Needle to its predicates:

Intended Use: The SwannShidi is for "aspiration of bone marrow or autologous blood by use of a standard syringe." This is shown to be substantially equivalent to the predicates, which also involve bone marrow aspiration.
Design Features: The device consists of a 15ga needle, angled tip stylet, depth gauge, locking mechanism, and a luer lock connection. These features are compared visually and descriptively to the predicates.
Materials: Stainless steel for the needle/stylet and medical-grade plastic for plastic components are consistent with predicate devices.
Sterilization Method: Ethylene Oxide is the chosen method, which is also consistent with predicates.
Minor Technological Differences: The submission explicitly states, "The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness."

Predicate Comparison Summary Table:

The table explicitly compares the SwannShidi to three predicate devices (Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle, H.S. Hospital Service BMN "I" Type Marrow Biopsy Needle, and Ranfac Goldenberg SNARECOIL Needle) across several criteria:

Product Code: KNW (consistent for all except Ranfac which also lists FCG)
Regulation Name: Gastroenterology-urology biopsy instrument (consistent across all)
Intended Use: Similar for all, focusing on bone marrow aspiration/biopsy.
Needle Size: 15 gauge (consistent with Busse and H.S.; Ranfac has a range including 15g)
Stylet, Angled Tip, Male luer connection: All "Yes" and consistent with predicates.
Material (Needle/Stylet, Plastic Components): Stainless Steel and Medical Grade Plastic, consistent with predicates.
Sterilization Method: Ethylene Oxide, consistent with predicates.

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are effectively that the device is substantially equivalent in safety and effectiveness to existing legally marketed predicate devices, and the "study" demonstrating this is a direct comparison of features and intended use rather than a clinical performance study.

Summary

Regulation Number and Section

§ 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.