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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Instruments. The logo features a stylized globe on the left, with curved lines representing the continents and meridians. To the right of the globe is the company name, "CIVCO MEDICAL INSTRUMENTS," in a bold, sans-serif font. The overall design is clean and professional, conveying a sense of global reach and medical expertise.

Solutions for Ultrasound

B2 of B5

L970514

June 20, 1997

Disposable Endocavity Ultrasound Needle / Biopsy Guide 510(k) Summary -

Date Summary Prepared: 31 January 1997

This summary of the safety and effectiveness information upon which the substantial equivalence determination is based is being submitted in accordance with the requirements of SMDA 1990.

Submitter's Name: Address: Telephone No.: Contact Person:

CIVCO Medical Instruments Company, Inc. 102 First Street South, Kalona, IA 52247 fax: (319) 656-4451 (319) 656-4447 J. William Jones, Manager - Regulatory Affairs

Establishment Registration Number: 1937223

CIVCO Medical Instruments is registered as a medical device manufacturer.

Device Trade / Proprietary Name:
Device Common / Usual Name:
Device Classification Name:

Disposable Endocavity Ultrasound Needle / Biopsy Guide Ultrasound Transducer Needle / Instrument Guide Ultrasonic Diagnostic Transducer Accessories

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

Description of Predicate Device(s): The CIVCO Disposable Endocavity Ultrasound Needle / Biogsv Guide is equivalent to CIVCO's currently, legally marketed Transrectal Needle/Biopsy Guide, 510(k) reference number K875128/A, and Transvaginal Needle/Biopsy Guide, 510(k) reference number K875240/A.

Description of Subject Device Submitted for Premarket Notification: - 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.

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ORIGINALS ARE CODED RED

102 First Street South • Kalona, IA 52247 USA Phone: 319/656-4447 · Fax: 319/656-4451 E-mail: info@civcomedical.com

Image /page/0/Picture/18 description: The image shows two quality assurance logos. The first logo on the left is a circular logo with the text "QUALITY ASSURED FIRM" surrounding "ISO 9001" in the center. There is a checkmark below the text. The second logo on the right has a crown on top of a checkmark. Below the checkmark is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".

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83 of 85 510(k) Summary con't. - Disposable Endocavity Ultrasound Needle / Biopsy Guide

Description of Subject Device Submitted for Premarket Notification con't.

The endocavity guide design integrates the mounting bracket and cannula into a single, disposable The endocavity guloc design mogration the transducer with a clip-on action. The removal process is complished by pulling the needle guide off the transducer in a reverse method from the application.

Typical guide designs are illustrated below.

Image /page/1/Picture/4 description: The image shows four different styles of encased cannulas. The cannulas are all black and white and have a similar shape. The text "Encased Cannula Styles" is in the middle of the image. The cannulas appear to be made of metal or plastic.

Open Cannula Styles

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 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 quide is 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.

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ORIGINALS ARE CODED RED

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B4 of B5 510(k) Summary con't. - Disposable Endocavity Ultrasound Needle / Biopsy Guide

Product categories / models include:

Disposable Endocavity Needle Guide (sterile) Disposable Transrectal Needle Guide (sterile)

Disposable Transvaginal Needle Guide (sterile)

Endocavity needle quides are individually packaged in sterile "procedure kit" form for single patient / procedure, disposable use. "Procedure kits" are also available with Poly and Latex transducer covers combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.

Intended Uses: 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.

Indications for Use: Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.

The intended use and indications for use place the CIVCO Disposable Endocavity Ultrasound Needle / Biopsy Guides in device body contact categories as follows:

a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (< 24 hours)
b) external communicating devices, blood path indirect / tissue communicating, limited contact duration (< 24 hours)

Comparison of Device to Substantially Equivalent, Legally Marketed Device(s):

Intended Use: both subject and predicate devices provide a mechanical means for performing transrectal and/or transvaginal needle / instrument quided procedures with the use of the diagnostic ultrasound endocavity transducer. This device provides a fixed path for the needle or instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures.
Predicate devices utilize a reusable guide bracket (after cleaning / sterilization by user); and a sterile, single use, disposable cannula insert.

The subject device is furnished sterile; and the entire guide is single use patient / procedure, disposable. 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.

Design: Predicate devices are comprised of two components - 1) a reusable guide mount or bracket that securely attaches (wrap-around clamp or slide-on) external to the transducer at a fixed position, and 2) a disposable stainless steel cannula or plastic tube that snap fits into a slot on the reusable component.
The subject device 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.

ORIGINALS ARE CODEL

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Comparison of Device to Substantially Equivalent, Legally Marketed Device(s) con't:

Predicate devices : thermoplastics (polycarbonate, nylon, acetal) and stainless steel Material: (T304 Hypodermic Grade tubing).
Subject devices: thermoplastics ( ABS, polycarbonate) and stainless steel (T304 Hypodermic Grade tubing). These materials have been effectively used in CIVCO ultrasound endocavity needle guide applications for the past seven (7) years.
Predicate devices: machined fabrications from thermoplastic extruded / molded standard Manufacture: shapes and stainless steel tubing.
Subject devices: fabricated from 1) injection molded thermoplastic components, bonded to stainless steel cannula with medical grade adhesive; and 2) injection insert-molded thermoplastic with integral stainless steel cannula.

Subject devices are manufactured in large lots for single use - disposable applications, and are fumished sterile. Procedure kit packaging (in class 10,000 cleanroom) and EtO sterilization are same as for disposables used with the predicate devices.

materials and manufacturing processing (including EtO sterilization) affects to the Safety: healthcare worker and patient via intended use / indications for use contact of this device have been biologically evaluated using biocompatibility tests for cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, and material mediated pyrogen. 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). CIVCO Disposable Ultrasound Endocavity Biopsy / Needle Guide products / materials have been evaluated for safe use under device categories of limited contact duration and body contact for surface devices (skin / mucosal membranes / breached surfaces) and body contact for external communicating devices (blood path indirect / tissue communicating). Biocompatibility testing was conducted using sterilized (where applicable), finished devices. Testing has demonstrated subject materials / devices to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic.
Effectiveness: Both the subject and predicate devices guides are designed for secure and aligned fit to the transducer, while not altering the transducer design integrity or function. Positive registration features of the design assures accurate needle / instrument path and placement in relation to the transducer. Attachment and removal of the subject device is simplified vs. the predicate device. Exterior shapes of the needle quides are contoured for patient comfort with no sharp edges. The integrated one-piece design of the subject device improves effectiveness since the reprocessing (clean, disinfect, sterilize) issues for a reusable device such as the predicate device is eliminated by the sterile, single use. disposable feature. Injection molding manufacturing process assures part-to-part accuracy for repeatable product performance.

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· Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 1997

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

Re: K970514

Disposable Endocavity Ultrasound Needle/Biopsy Guide Dated: June 2, 1997 Received: June 3-1997 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 devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in scordance with the provisions of the Federal Food, Drug, ind 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 produblivousling and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device and be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes complinate with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic Ghar inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fullure 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. This response to your premarket notification 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrt/dsmamain.html". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sincerely yours,

Lillian Yin, Ph.D.

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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510(k) Notification - CIVCO Disposable Endocavity Ultrasound Needle / Biopsy Guide page C3

(

	INDICATIONS FOR USE STATEMENT	Page 1 of 1
510(k) Number (if known):	K970514
Device Name:	Disposable Endocavity Ultrasound Needle / Biopsy Guide
Indications For Use:
	Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.
	(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K970514
Prescription Use (Per 21 CFR 801.109)		OR Over-The-Counter Use (Optional Format 1-2-96)

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.