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.

Device Description

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.

AI/ML Overview

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 (< 24 hours)."	Same. Surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (< 24 hours). Note: Urethane material restricted to surface, skin contact only.
Safety	Materials must be non-toxic, non-irritating, non-sensitizing for intended body contact. Demonstrated primarily through biocompatibility testing in accordance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP. Implied AC: Biocompatibility tests must show materials are non-toxic, non-irritating, non-sensitizing.	Biocompatibility tests for cytotoxicity, acute systemic toxicity, irritation, and sensitization have demonstrated the silicone rubber, silicone gel, and urethane materials / standoff devices are: non-toxic, non-irritating, non-sensitizing; and, thereby, safe for use as a surface device contacting intact skin / mucosal membranes / breached surfaces. Testing is in accordance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP).
Effectiveness	Must provide an adequate standoff and allow for improved visualization of near-field and superficial structures. Implied AC: Material properties (mechanical, elastomeric) suitable for function, and demonstrated capability of shifting transducer to improve visualization using a quality assurance phantom.	Evaluation testing has shown that the silicone and urethane materials are adequate for the intended use: Mechanical properties of the material allows for rigid conformal fit to the transducer, while elastomeric characteristics provide flexibility for conformance to surfaces being scanned. Material has been demonstrated capable, using a quality assurance phantom, of shifting the transducer to improve the visualization of near-field and superficial structures. (Direct comparison suggests this is on par with predicate devices' "historical marketing / sales and successful user experiences").

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of a clinical test set with patient data. The effectiveness evaluation mentions "using a quality assurance phantom," implying a laboratory-based test. No sample size for cases (e.g., number of phantom scans) is provided.
Data Provenance: Not applicable as no clinical test set data from patients is described. The "quality assurance phantom" testing would be laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set involving expert review for ground truth is described.

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

Not applicable. No clinical test set requiring adjudication is described.

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:

No. This document describes a physical medical device (ultrasound transducer standoff), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

No. This is not an AI algorithm; it is a physical accessory for an ultrasound transducer. Standalone performance as described for AI is not applicable. The effectiveness was evaluated in a lab setting using a phantom.

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

For safety, the "ground truth" was established by biocompatibility testing against recognized standards (ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP), which directly determined if the materials were non-toxic, non-irritating, and non-sensitizing.
For effectiveness, the "ground truth" was established through evaluation testing using a quality assurance phantom. This phantom allowed for an objective assessment of the device's ability to shift the transducer's focal zone and improve visualization of near-field structures, compared to implied expectations for ultrasound imaging.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable. This is not an AI algorithm that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Instruments, along with the date AUG 17 1990. The logo features a stylized globe-like design on the left. The text "CIVCO" is prominently displayed, with "MEDICAL INSTRUMENTS" written in smaller letters below it.

K992152

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(As required by 21 CFR 807.92)

Ultrasound Transducer Standoff

A. General Information

Submitter's Name:	CIVCO Medical Instruments Company, Inc.
Address:	102 First Street South, Kalona, IA 52247
Telephone No.:	phone (319) 656-4447 fax: (319) 656-4451
Contact Person:	J. William Jones, Manager - Regulatory Affairs

Establishment Registration Number: 1937223 CIVCO Medical Instruments is registered as a medical device manufacturer.

Device Trade:	Ultrasound Transducer Standoff
Device Common:	Ultrasound Transducer Standoff
Device Classification Name:	Ultrasonic Diagnostic Transducer Accessories

Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 Radiology 90 ITX

Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.

B. Device Description

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

Page II - 1

IVCO Europe

Avenue Louise 65, box 11 1050 Brussels Belgium Phone: +32(02)535.7881 Fax: +32(02)535.7700 ww.civcomedical.com

CIVCO North America

72 First Street South .alona, 1A 52247-9589 USA Phone: 319.656.4447 Fax: 319.656.4451 www.civcomedical.com

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The standoff device is offered in three configurations:

one-piece, flexible conformal-fit to transducer design [Figures A & B] 1.
two-piece design a flexible standoff "insert" captured by a rigid plastic 2. transducer bracket with or without needle guidance capability [Figure C]
one-piece, flexible conformal-fit endocavity design [Figure D]. 3.

Configurations of Ultrasound Transducer Standoffs

Image /page/1/Picture/5 description: The image contains two 3D renderings of geometric shapes. Both shapes appear to be trapezoidal prisms, with one positioned on the left and the other on the right side of the image. The shapes are rendered in grayscale, with variations in shading that suggest a light source illuminating them from above.

Figure A

Self-bracketing wedge configuration is solid silicone or urethane material, or may be solid material encapsulating an inner silicone gel material depending on design requirements and specifications.

Image /page/1/Picture/8 description: The image is a black and white photograph of an object. The object is dark and has a rounded shape. There are two small white dots on the object. The background is white.

Image /page/1/Picture/9 description: The image is a black and white photograph of a dark, irregularly shaped object. The object appears to be solid and opaque, with a smooth surface. There is a curved, lighter-colored streak running across the surface of the object, possibly a reflection or a scratch. The background is plain white, which helps to isolate the object and emphasize its shape and texture.

Figure B

Self-bracketing flat configuration is solid silicone or urethane material, or may be solid material encapsulating an inner silicone gel material depending on design requirements and specifications.

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Image /page/2/Picture/0 description: The image shows two separate diagrams of a small, dark-colored object. The object on the left is a wedge shape, with a small slit on the side. The object on the right is a larger, more complex shape, with a similar wedge shape next to it. The larger object has a series of ridges on top.

Figure C

Wedge configuration for inserting into biopsy bracket is solid silicone or urethane material, or may be solid material encapsulating an inner silicone gel material depending on design requirements and specifications. Standoff is captured inside the bracket. An advantage to this design is the reduced risk of puncturing the standoff during a needle biopsy procedure.

Image /page/2/Picture/3 description: The image shows two capsules on a white background. The capsule on the left has two rings around the bottom. The capsule on the right is smooth.

Image /page/2/Figure/4 description: The image shows the text "Figure D". The text is in a sans-serif font and is black. The background is white.

Endocavity standoff is solid silicone material, or may be solid silicone material encapsulating an inner silicone gel material depending on design requirements and specifications.

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C. Intended Use / Indications for Use

The intended use and indications for use place Ultrasound Transducer Standoffs in device body contact categories as follows:

a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (< 24 hours)
Note: The urethane material will be restricted to surface, skin contact only.

D. Predicate Device(s)

The Ultrasound Transducer Standoff device is identified as substantially equivalent to the following legally marketed device(s):

Predicate Device(s)	510(k) Reference	Manufacturer
Aquaflex® Ultrasound Gel Pad	K851895	Parker Laboratories
Proxon Sector-Scan Standoff*	K873159	Cone Instruments
*included in Cone Instruments Combison 310A ultrasound scanner 510(k).
Standoff Kit EA 4015	addition to 510(k) file**	B&K Ultrasound Systems

** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056.

E. Substantial Equivalence Summary

The Ultrasound Transducer Standoff is substantially equivalent in safety and effectiveness to the predicate device(s). The comparison table on the following page demonstrates this substantial equivalence.

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Parameter	Ultrasound Transducer Standoff	Predicate DevicesUltrasound Standoffs / Gel Pad
Intended Use /Indications forUse	Same.	The Ultrasound Transducer Standoffis placed over a diagnostic ultrasoundtransducer / probe / scanhead to controlthe distance (offset) betweentransducer and body surfaces foroptimal focusing by shifting thetransducer, effectively offsetting thefocal zone, for improved visualization ofnear-field and superficial structures.The standoff device is used to performscanning of body surface andendocavity anatomy.
Design	Same. [self-bracketing, conformal type]- Additional to CIVCO design is a two-piece standoff insert / bracket designfor use with needle guide bracketdevices.	- One-piece pad type.- Self-bracketing conformal totransducer geometry configurations.
Material	- Synthetic Elastomeric Polymers:◦ Silicone rubber [same as B&KUltrasound material]◦ Silicone gel◦ Urethane	- Aqueous polymer gel [Parker Labs]- Polyvinylchloride (PVC), Sonogel®Proxon [Cone Instruments]- Silicone rubber [B&K Ultrasound]
Manufacturing	Same.	- Gel pad [Parker Labs] solidified gelby casting.- Sector Scan Standoff [Cone Inst.]by injection molding (mfg. bySonogel ® for Kretztechnik / Cone)- EA4015 Standoff [B&K Ultrasound]by injection molding (mfg. byCIVCO Medical for B&K)
Quality Systems	Same.	- FDA/QSR cGMP 21CFR Part 820.- ISO 9001 / EN46001 / ISO 13485.
Parameter	Ultrasound Transducer Standoff	Predicate DevicesUltrasound Standoffs / Gel Pad
Sterility	Same.Devices are furnished non-sterile and intended for limited reuses. Reprocess by user: clean with enzymatic detergent / disinfect or sterilize by cold chemical solution / sterilize solid silicone configurations with steam autoclave. Reusables are validated for chemical compatibility and reprocessing method(s) per Design, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, AAMI TIR No. 12-1994 and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, ODE.	Reusables and single-use disposables [Parker Labs] are furnished non-sterile. Reusables can be reprocessed by the user: clean by detergent & water / disinfect by alcohol based spray.
Device BodyContact Category	Same.	surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (< 24 hours).
Safety	Biocompatibility tests for cytotoxicity, acute systemic toxicity, irritation, and sensitization have demonstrated the silicone rubber, silicone gel, and urethane materials / standoff devices are: non-toxic. non-irritating. non-sensitizing; and, thereby, safe for use as a surface device contacting intact skin / mucosal membranes / breached surfaces.Testing is in accordance with -ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP).	The historical sale and use of these devices have place them in the generally regarded as safe category for their intended use. CIVCO has performed biocompatibility tests [ cytotoxicity, acute systemic toxicity, irritation, and sensitization ] that has demonstrated that the Parker gel pad and B&K silicone devices / materials are: non-toxic. non-irritating. non-sensitizing. Note: The Proxon Standoff [Cone] PVC material is not suitable for use on "infected, inflamed or broken tissue" per the instructions for use.
Parameter	Ultrasound Transducer Standoff	Predicate DevicesUltrasound Standoffs / Gel Pad
Effectiveness	Evaluation testing of the UltrasoundTransducer Standoff has shown thatthe silicone and urethane materials areadequate for the intended use:Mechanical properties of the materialallows for rigid conformal fit to thetransducer, while the elastomericcharacteristics of the material isflexible for conformance to surfacesbeing scanned. Material has been demonstratedcapable, using a quality assurancephantom, of shifting the transducerto improve the visualization of near-field and superficial structures.	Historical marketing / sales andsuccessful user experiences havedemonstrated the effectiveness of thesepredicate standoff devices.

Comparison of Device to Substantially Equivalent, Legally Marketed Device

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Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.

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Comparison of Device to Substantially Equivalent, Legaily Marketed Device cont.

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

F. Conclusions

This premarket submission for the Ultrasound Transducer Standoff has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/7/Picture/16 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 1999

J. William Jones Regulatory Affairs Manager CIVCO Medical Instruments Co., Inc. 102 First Street South Kalona, IA 52247

Re:

K992152 Ultrasound Transducer Standoff Dated: June 24, 1999 Received: June 25, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known):

Ultrasound Transducer Standoff Device Name:

Indications For Use:

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 quided procedures for body surface and endocavity diagnostic ultrasound. 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.

K 992152

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CIVCO Medical Instruments 06/24/99

Ultrasound Transducer Standoff

Regulation Number and Section

§ 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.