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The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces

The provided text describes a 510(k) submission for a medical device, the "Sonopsy Aspiration Biopsy Needle." This type of submission establishes substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel AI or diagnostic device might.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of regulatory submission.

Here's why:

• 510(k) for Substantial Equivalence: A 510(k) premarket notification demonstrates that a new device is "substantially equivalent" to a predicate device already legally marketed. This process primarily focuses on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical trials to establish performance against pre-defined clinical acceptance criteria.
• Device Type: The Sonopsy Aspiration Biopsy Needle is a Class II gastroenterology-urology biopsy instrument. These are typically mechanical devices where performance is assessed through bench testing (e.g., needle sharpness, strength, material compatibility) and comparison of specifications to predicate devices. Clinical studies with human subjects to determine performance metrics like sensitivity, specificity, or accuracy (as would be relevant for an AI diagnostic tool) are generally not required for this type of device to obtain 510(k) clearance.

The key takeaway from the provided text is that the device was deemed substantially equivalent to the predicate devices listed (INRAD/MANAM Accucore Biopsy Needle, E-Z-EM, INC. Lufkin Aspiration Needle, DAUM Corp. DAUM Aspiration Needle) based on its technological characteristics and intended use, which is sufficient for 510(k) clearance.

If this were an AI-powered diagnostic device, a much more comprehensive study section detailing the points you've listed would be present.

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The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows:

Mode of Operation: B-Mode

Clinical Application:

Small Organ (breast, thyroid, testes) Abdominal

The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions.

The Sonopsy LA System is indicated for use for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead.

Prescription Use (Per 21 CFR 801.109)

The Sonopsy LA System provides a means for performing a volumetric scan of the breast to image and determine the position of a suspect target. For biopsy procedures, the Sonopsy LA System allows the alignment of an integral needle guidance device that insures that the needle will sample along a line that includes the determined target. The real-time ultrasound image is aligned such that the scan plane corresponds to the plane that the needle will penetrate, which enables the user to make a determination that the needle penetrated to the target area (by virtue of the real-time image).

The system operates in B-mode with an automatic scanning annular array • transducer for breast applications and a hand-held linear array scanhead for small organ and abdominal imaging.

This 510(k) summary (K980423) is for a diagnostic ultrasound system, which has different acceptance criteria and study requirements than AI/ML-based medical devices. The document highlights safety and equivalence to predicate devices, rather than performance metrics typically found in AI/ML studies.

1. Table of Acceptance Criteria and Reported Device Performance

• UL-2601 for Safety (Medical Electrical Equipment)
• CSA C22.2 No. 125-601.1 (Electromedical Devices)
• IEC 601-1-1 (Safety of Medical Equipment) | "The Sonopsy LA System has been designed to comply with the following voluntary performance standards:" (Implies performance meets these standards, but no explicit test results are presented.) |
  | Biocompatibility:
  Patient and user contact materials do not pose a biocompatibility risk (per ISO-10993) | "Testing of patient contact materials in accordance with the FDA memorandum Use of International Standard ISO-10993... indicates that none of the patient or user contact materials pose a biocompatibility risk." (Compliance is stated.) |
  | Software Hazards Analysis:
  Identify and control potential equipment design hazards related to diagnostic errors or injury. | "A hazards analysis has been conducted... and appropriate steps have been taken to control all identified risks for this type of ultrasound equipment." (Implies successful risk mitigation without explicit performance metrics.) |

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical performance study with a "test set" in the context of an AI/ML device. The "study" mentioned for this ultrasonic system primarily focuses on engineering verification and validation, technical performance, and biocompatibility, as outlined in the sections on Acoustic Output, Performance Standards, Safety and Effectiveness, and Software.

For acoustic output, it states: "Measurement results will be maintained in the Device Master Record for this device." This suggests internal testing, but no details on sample size or data provenance (country of origin, retrospective/prospective) are provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As this is not an AI/ML device, there is no "ground truth" in the sense of expert labeling for an algorithm's output. The performance validation relies on engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the context of an AI/ML device.

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 is not an AI/ML device, and no MRMC study is described. The device is a diagnostic ultrasound system for imaging and guiding biopsies, not an AI-assisted diagnostic tool.

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

Not applicable. This is not a standalone AI algorithm. It is a diagnostic ultrasound system that produces images for a human operator to interpret and use for guidance.

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

The concept of "ground truth" used here is related to engineering specifications, safety standards, and physical measurements. For example, acoustic output measurements are compared against regulatory limits, and material biocompatibility is assessed against recognized standards (ISO-10993). In the context of its diagnostic output, the device provides images, and the interpretation of those images for diagnosis or guidance would be done by a physician using their clinical expertise, potentially correlated with pathology or outcomes. However, the device's performance itself is not measured against such "ground truth" in this submission.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment in that context.

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