(129 days)
This device provides a mechanical means for performing needle / instrument guided procedures with the use of the diagnostic ultrasound endocavity transducer. Needle guide is attached over endocavity transducer I probe / scanhead instruments. This device provides a fixed path for the needle or instrument that when coupled by the ultrasound system software corresponds to on-screen imaging quidelines for visualizing guided instrument placement procedures. CIVCO Endocavity Ultrasound Needle / Biopsy Guides are furnished sterile; single use patient / procedure, The single use, disposable feature helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.
The subject device provides a fixed path by which to allow needle / instrument guidance in relationship to a specific ultrasound transducer geometry. Various sizes and shapes of endocavity needle guides are engineered and manufactured by CIVCO - each is designed to fit to a specific OEM ultrasound transducer or family of transducers. The endocavity guide design integrates the mounting bracket and cannula into a single, disposable component that attaches externally, over the transducer with a clip-on action. The removal process is accomplished by pulling the needle guide off the transducer in a reverse method from the application. Design variables address the mounting features / dimensional characteristics / presentation angle necessary to accommodate differences in transducer geometries, and the cannula size (gauge) as required by the needle / instrument to be guided. Open and encased cannula guide configurations are essentially the same in appearance and function. All guides are designed for conformal fit with locator features for secure alignment to the transducer. Exterior shapes of the needle guide are contoured for patient comfort. The device is furnished sterile; and the entire guide is single use patient / procedure, disposable.
This document is a 510(k) premarket notification for a medical device and therefore does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner that a performance study would for an AI/ML device.
Instead, this submission focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "effectiveness" section describes how the design and manufacturing processes ensure proper function and improved safety compared to the predicate, rather than reporting quantitative performance metrics against pre-defined acceptance criteria.
However, based on the provided text, we can infer the aspects considered for its effectiveness and safety, which serve as the implicit "acceptance criteria" for regulatory clearance based on substantial equivalence.
Here's an attempt to structure the information, acknowledging the limitations for a traditional acceptance criteria table and performance study details:
1. Table of Implied "Acceptance Criteria" and Reported Device Performance
| Implied Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance/Characteristics |
|---|---|
| Functional Equivalence: Provides a mechanical means for performing needle/instrument guided procedures with diagnostic ultrasound endocavity transducers. Provides a fixed path corresponding to on-screen imaging guidelines. | The subject device provides a fixed path for needle/instrument guidance in relation to a specific ultrasound transducer geometry. Ensures accurate needle/instrument path and placement in relation to the transducer. |
| Transducer Compatibility: Secure and aligned fit to the transducer without altering its design or function. | Guides are designed for conformal fit with locator features for secure alignment to the transducer. |
| Patient Comfort: Contoured exterior shapes with no sharp edges. | Exterior shapes of the needle guide are contoured for patient comfort. No sharp edges are explicitly stated but implied by "contoured for patient comfort." |
| Sterility & Single Use: Furnished sterile and designed for single-use to prevent transfer of microorganisms and fluids. | The device is furnished sterile, and the entire guide is single use patient/procedure, disposable. Helps prevent transfer of microorganisms, body fluids, and particulate material. |
| Biocompatibility: Materials are safe for human contact (limited duration, surface/external communicating tissue). | Biocompatibility tests (cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen) conducted per ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP. Demonstrated non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. |
| Material Safety (Manufacturing): Materials and manufacturing processes (including EtO sterilization) are safe for healthcare worker/patient. | Materials (ABS, polycarbonate, T304 Hypodermic Grade tubing) have been effectively used in CIVCO ultrasound endocavity needle guide applications for 7 years. Manufacturing (injection molded, bonded/insert-molded) and sterilization (EtO) are consistent with predicate disposables. |
| Attachment/Removal: Simplified attachment and removal compared to predicate. | Attaches with a clip-on action; removal is accomplished by pulling the needle guide off in reverse method. Described as "simplified vs. the predicate device." |
| Manufacturing Accuracy: Consistent part-to-part accuracy for repeatable performance. | Injection molding manufacturing process assures part-to-part accuracy for repeatable product performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical performance "test set" for an AI/ML device. This document describes a medical device, not an AI/ML algorithm. The evaluation for substantial equivalence primarily relies on design, material, manufacturing process, and intended use comparison to predicate devices.
- Data Provenance: Not applicable. The "proof" is through design documentation, material specifications, manufacturing processes, and testing standards (e.g., biocompatibility) rather than a clinical dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts/Qualifications: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image interpretation) is not part of this 510(k) submission for a physical medical device. The "ground truth" for this submission are the established regulatory standards and the performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of this 510(k) submission.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical needle guide, not an artificial intelligence or machine learning product designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical, disposable needle guide, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: For this 510(k) submission, the "ground truth" implicitly refers to:
- Regulatory Standards: Compliance with relevant FDA regulations and recognized standards (e.g., ISO 10993 for biocompatibility).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (CIVCO's Transrectal Needle/Biopsy Guide K875128/A and Transvaginal Needle/Biopsy Guide K875240/A). The subject device demonstrates that it performs as safely and effectively as these predicates.
- Scientific and Clinical Principles: Adherence to principles of mechanical design, sterile practice, and biocompatible materials for medical devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device employing a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.