(53 days)
The Ultrasound Transducer Standoff is placed over a diagnostic ultrasound transducer / probe / scanhead to control the distance (offset) between transducer and body surfaces for optimal focusing by shifting the transducer, effectively offsetting the focal zone, for improved visualization of near-field and superficial structures. The transducer standoff device can be used to perform scanning and needle guided procedures for body surface and endocavity diagnostic uttrasound. Standoff devices are furnished as a non-sterile; single use patient / procedure, with limited reuse capability (as designated in instructions for use) if properly cleaned / disinfected between patient uses.
The Ultrasound Transducer Standoff device provides a firm, conformal fit to the ultrasound transducer that elevates the transducer from the body surface for near-field imaging. The standoff device provides a fixed height to which the sound transmits through allowing the focal zone of the transducer to be repositioned on near field tissue. Standoff materials are silicone or urethane elastomers. The standoff device material's purpose is to provide a media to offset the transducer from the body surface to be scanned, thereby, shifting the focal zone of the transducer, while still providing a media through which the user can obtain an acceptable image visualization of near-field and superficial structures. Transmission of the sound through the standoff material should not introduce a large amount, if any, of distortion and artifacts, nor absorb a great deal of sound.
Standoff devices are custom designed to each, specific ultrasound transducer geometry and scanning depth needs. Product categories / models include:
General Purpose Transducer Standoff [integral self-bracketing type] Biopsy Transducer Standoff [standoff inserts into needle guide bracket] Bi-Plane Endocavity Transducer Standoff
The standoff device is offered in three configurations:
- one-piece, flexible conformal-fit to transducer design
- two-piece design a flexible standoff "insert" captured by a rigid plastic transducer bracket with or without needle guidance capability
- one-piece, flexible conformal-fit endocavity design.
Standoffs are installed against the face of the transducer with a small amount of gel at the interface to provide adequate ultrasonic coupling. Instructions for use include the recommendation for always using a transducer cover in endocavity and/or needle puncture procedures.
Standoff devices have limited reuse capability (# of reuses per instructions for use) if properly cleaned / disinfected. The level of disinfection or sterilization should be appropriate for the intended clinical use. Reprocessing of the standoff device is required between single patient uses and can be accomplished using the following validated methods - cleaning with enzymatic detergent & water; disinfection / sterilization by 2% glutaraldehyde based solution; sterilization of solid one-piece (silicone only) standoffs can be accomplished by steam autoclaving.
Standoff devices are packaged in a non-sterile "procedure kit" form. Standoff devices are furnished separately and in procedure kits supplied with transducer covers, and with or without coupling gel packet. Standoff devices are also combined with needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.
The provided text is a 510(k) summary for a medical device called "Ultrasound Transducer Standoff" by CIVCO Medical Instruments Company, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, the information required for a detailed description of acceptance criteria and a study proving those criteria are met, particularly regarding human-in-the-loop performance, statistical significance, and ground truth establishment, is largely not present in the provided text.
However, I can extract the relevant information that is available and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way that would be typical for a clinical study. Instead, it relies on demonstrating that the CIVCO Ultrasound Transducer Standoff is substantially equivalent to legally marketed predicate devices, implying that if the predicate devices are effective and safe, then the new device, being substantially equivalent, also is.
The "performance" is primarily assessed through:
- Biocompatibility testing: To ensure safety for patient contact.
- Material properties and functionality: To ensure it can physically perform its intended function of offsetting the transducer and allowing sound transmission with acceptable image visualization.
- Comparison to predicate devices: Assuming their established safety and effectiveness.
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (CIVCO Ultrasound Transducer Standoff) |
|---|---|---|
| Intended Use | Must be similar to predicate devices: Control distance (offset) between transducer and body surfaces for optimal focusing, shifting focal zone for improved visualization of near-field and superficial structures. Used for scanning and needle-guided procedures (body surface & endocavity). Limited reuse if reprocessed. | Same. Placed over diagnostic ultrasound transducer/probe/scanhead to control distance (offset) for optimal focusing by shifting the transducer, offsetting the focal zone, for improved visualization of near-field and superficial structures. Used for scanning and needle-guided procedures for body surface and endocavity diagnostic ultrasound. Non-sterile; single-use patient/procedure, with limited reuse capability if properly cleaned/disinfected. |
| Design | Must be functionally comparable to existing pads or self-bracketing configurations. | Same. (self-bracketing, conformal type). Additional to CIVCO design is a two-piece standoff insert/bracket design for use with needle guide bracket devices. (This is presented as an enhancement, not a deviation in function). |
| Material | Must use materials known to be safe and compatible with ultrasound transmission. Predicate devices use aqueous polymer gel, PVC, or silicone rubber. | Synthetic Elastomeric Polymers: Silicone rubber (same as B&K Ultrasound material), Silicone gel, Urethane. (Matches or is similar to predicate materials). |
| Sterility/Reprocessing | Must be furnished non-sterile and/or have validated reprocessing methods if intended for limited reuse, demonstrating chemical compatibility and effectiveness of cleaning/disinfection/sterilization methods (enzymatic detergent, 2% glutaraldehyde, steam autoclave for solid silicone). | Same. Devices are furnished non-sterile and intended for limited reuses. Reprocessing by user required: clean with enzymatic detergent / disinfect or sterilize by cold chemical solution / sterilize solid silicone configurations with steam autoclave. Reusables validated for chemical compatibility and reprocessing methods per AAMI TIR No. 12-1994 and FDA Reviewer Guidance. |
| Device Body Contact Category | Must fall into "surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration ( |
§ 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.