The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

Device Description

The ultrasound guidance system is used during diagnostic or therapeutic procedures to assist the clinician in placing an interventional device in a targeted anatomical location. The quidance system consists of a quide, gauge inserts, and may include a bracket. The guide attaches to the OEM ultrasound transducer via a VerzaLink™ locating feature either on the customized bracket (Figure 1) or on the OEM ultrasound transducer housing (Figure 2). The guide is secured to the locating feature using a locking mechanism. The angle of the quide adjusts within a 37° range by moving the angle selector grip proximally or distally on the quide. The angle is secured into place at the desired position using a locking mechanism. The guide receives the gauge inserts. The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. Rotation of a quick-release tab on the gauge insert enables the guide and OEM ultrasound transducer to be removed while leaving the interventional instrument in place. The guide and gauge inserts are provided sterile, and are intended for single-use. The bracket is provided non-sterile and is reusable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Verza™ Guidance System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a clinical study with detailed performance metrics and ground truth establishment for an AI algorithm.

Therefore, many of the requested elements for an AI study (like sample size for test/training sets, ground truth details, expert qualifications, or MRMC studies) are not applicable or extractable from this type of document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing to confirm the safety and effectiveness of design modifications. The acceptance criteria were implicit in demonstrating that these modifications did not diminish safety and effectiveness. The reported performance is a statement of compliance rather than quantitative metrics.

Acceptance Criteria (Implied)	Reported Device Performance
1) Attachment of the guide to the locating feature on the transducer bracket or on the OEM ultrasound transducer housing: The guide must securely attach and function as intended.	"Testing relating to 1) attachment of the guide to the locating feature on the transducer bracket or on the OEM ultrasound transducer housing...met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." Specifically, the guide is secured to the locating feature using a locking mechanism. The proposed guidance system including a bracket was validated with the GE C1-6-D transducer.
2) Expanded range of gauge inserts: The expanded range of gauge inserts (12F to 25G) must function correctly and safely.	"Testing relating to...2) an expanded range of gauge inserts...met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G.
3) Increased guide angle range: The increased guide angle range (37°) must function correctly and safely, allowing precise instrument placement.	"Testing relating to...3) an increased guide angle range met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device." The angle of the guide adjusts within a 37° range and is secured into place with a locking mechanism.
Biocompatibility: Patient-contacting materials must meet established biocompatibility standards.	"Biocompatibility testing was completed for patient-contacting materials according to ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F756." (Conclusion: Met standards)

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

Sample Size: Not specified. The testing described is non-clinical/engineering verification of device function and safety features, not a clinical study on a patient cohort or a dataset for an AI algorithm.
Data Provenance: Not applicable in the context of an AI study. The testing refers to physical device functionality checks in a lab setting. "Clinical images were provided with the submission; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to the test performance data to show that the complete ultrasound guidance system works as intended." This suggests some informal use of clinical images for demonstration, but not as a formal test set for performance evaluation in the AI sense.

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. This is a physical device, not an AI algorithm requiring expert-annotated ground truth.

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

Not applicable. This is a physical device, not an AI algorithm requiring adjudication of ground truth labels.

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 a physical device, not an AI algorithm.

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

Not applicable. This is a physical guidance system, not a standalone AI algorithm.

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

Not applicable. The "ground truth" for this device would be its mechanical and material properties meeting specifications and performing its intended function (guidance of instruments) in simulated or actual usage scenarios.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2016

Civco Medical Instruments Co., Inc. % Ms. Amanda Stahle Sr. Regulatory Affairs Specialist 102 First Street South KALONA IA 52247

Re: K160806

Trade/Device Name: Verza™ Guidance System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 27, 2016 Received: July 29, 2016

Dear Ms. Stahle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160806

Device Name Verza Guidance System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a blue globe-like graphic on the left side. To the right of the graphic is the company name, "CIVCO MEDICAL SOLUTIONS", in blue lettering.

WWW.CIVCO.COM

Section 5 - 510(k) Summary

A. Submitter Information

Submitter Name & Address:	CIVCO Medical Instruments Co., Inc.d/b/a CIVCO Medical Solutions102 First Street SouthKalona, IA 52247
Contact Person:	Amanda Stahle, Sr. Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com
Date Summary Prepared:	March 21, 2016
Trade Name:	Verza™ Guidance System
Common Name:	Ultrasound General Purpose Guidance System
Classification Name & Number:	Diagnostic ultrasonic transducer (892.1570)
Device Class:	Class II
Review Panels:	Radiology
Product Codes:	ITX

B. Predicate Device

The proposed guidance system is substantially equivalent to the following predicate guidance system:

Predicate Device	Manufacturer
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDEFOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODELUA 1337 (K083667)	B-K Medical

The purpose of this 510(k) is to modify the device design to 1) allow the quide to attach to the OEM ultrasound transducer via a customized bracket or directly attach to the OEM ultrasound transducer housing, 2) expand the range of gauge inserts, and 3) increase the quide angle range.

C. Device Description

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	☎ 319.248.6757	✆ 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	☎ 319.248.6757	✆ 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	☎ +31(0) 182.394495	✆ +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	☎ 712.737.8688	✆ 712.737.8654

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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, with curved lines representing the continents and oceans. To the right of the globe is the company name, "CIVCO," in bold, sans-serif font. Below "CIVCO" is the text "MEDICAL SOLUTIONS" in a smaller, sans-serif font.

Image /page/4/Figure/1 description: The image contains two figures, labeled as Figure 1 and Figure 2, which both show the VerzaLink locating feature. Figure 1 shows the locating feature on a bracket, while Figure 2 shows the locating feature on a transducer. The website "WWW.CIVCO.COM" is displayed at the top of the image.

The angle of the quide adjusts within a 37° range by moving the angle selector grip proximally or distally on the quide. The angle is secured into place at the desired position using a locking mechanism.

The guide receives the gauge inserts. The gauge inserts are provided on a gauge insert tree in sizes ranging from 12F to 25G. Rotation of a quick-release tab on the gauge insert enables the guide and OEM ultrasound transducer to be removed while leaving the interventional instrument in place.

The guide and gauge inserts are provided sterile, and are intended for single-use. The bracket is provided non-sterile and is reusable. The device is for use by a medical professional in a physician office, clinic, or hospital environment. The following models are included in this submission:

Part No.	Device Name	Contents
610-1500-24	Verza™ Guidance System	Verza™ guides for use with VerzaLink™enabled transducers and brackets, and CIV-Flex™ covers
642-497	Verza™ Guidance System	Reusable, non-sterile bracket for use withGE C1-6-D transducers, Verza™ guides,and CIV-Flex™ covers

D. Indications for Use/Intended Use

The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	ⓞ 319.248.6757	ⓞ 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	ⓞ 319.248.6757	ⓞ 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	ⓞ +31(0) 182.394495	ⓞ +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	ⓞ 712.737.8688	ⓞ 712.737.8654

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Image /page/5/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, with curved lines representing the continents and oceans. To the right of the globe is the company name, "CIVCO," in a bold, sans-serif font. Below "CIVCO" is the text "MEDICAL SOLUTIONS" in a smaller font size.

WWW.CIVCO.COM

E. Comparison of Technological Characteristics

Both the proposed and predicate guidance systems provide a means for placement of common interventional devices by positioning the interventional device relative to the ultrasound transducer during a diagnostic or therapeutic procedure. Technological characteristics that differ between the proposed and predicate guidance systems include changes in design. Both the proposed and predicate systems consist of a quide and gauge inserts, and may include a bracket or clip. Both guidance systems offer a range of guidance angles, but on the predicate system the angle is created through channels in the gauge inserts whereas on the proposed system the angle is created through angular adjustment of the guide. The gauge inserts for both the predicate and proposed system are placed into the guide and the size is selected to accommodate the size of the interventional instrument. The gauge insert sizes for the predicate system range from 10G to 20G while the proposed system ranges from 12F to 25G. The proposed system may be mounted to the ultrasound transducer via a bracket whereas the predicate system may mount via a wire clip. Alternatively, both the proposed and predicate quidance systems are able to mount directly to the OEM ultrasound transducer. The predicate guidance system snaps onto grooves on the transducer whereas the proposed guidance system is attached to an external locating feature on the transducer and secured using a locking mechanism. Similar plastic and metal materials are used to manufacture the predicate and proposed devices.

F. Non-Clinical Testing

Non-clinical testing was completed to confirm that the proposed guidance system is as safe and effective as the predicate guidance system and that the differences in technological characteristics do not raise any new issues of safety or effectiveness. Testing relating to 1) attachment of the guide to the locating feature on the transducer bracket or on the OEM ultrasound transducer housing, 2) an expanded range of gauge inserts, and 3) an increased quide angle range met the acceptance criteria and confirmed that the new design features have not diminished the safety and effectiveness of the device. The proposed quidance system including a bracket was validated with the GE C1-6-D transducer. Biocompatibility testing was completed for patient-contacting materials according to ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F756. Clinical images were provided with the submission; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to the test performance data to show that the complete ultrasound guidance system works as intended.

G. Conclusion

This premarket submission for the Ultrasound General Purpose Guidance System 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.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	⓮ 319.248.6757	⓿ 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	⓮ 319.248.6757	⓿ 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	⓮ +31(0) 182.394495	⓿ +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	⓮ 712.737.8688	⓿ 712.737.8654

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.