Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

Device Description

Latex Ultrasound Transducer Cover - this device provides an efficient, thin, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Covers are beaded and rolled for easy application to the transducer. Cover materials are dipmolded Natural Rubber Latex similar to that of patient / surgical gloves.

Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required - the sterile or non-sterile Latex Ultrasound Transducer Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary. The removal process is accomplished by pulling or unrolling the cover off the transducer in a reverse method from the application, resulting in the cover being turned inside out.

Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:

General Purpose Latex Transducer Covers (sterile and non-sterile) PROcovers™ Endocavity Latex Transducer Covers (sterile and non-sterile) Endocavity Latex Transducer Covers (sterile and non-sterile) Bulk Packaged Endocavity Latex Transducer Covers (non-sterile) Endocavity Accessories - non-sterile latex fingercots Transesophageal Echocardiography (TEE) Covers (sterile)

Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Latex transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.

AI/ML Overview

The provided text describes the 510(k) summary for the CIVCO Latex Ultrasound Transducer Cover. While it details the device's features, intended use, and comparison to a predicate device, it does not present a typical acceptance criteria table with reported device performance in a quantitative manner as would be found in a clinical study for an AI/ML device.

This document is for a medical device (ultrasound transducer cover), not an AI/ML diagnostic tool, and therefore the types of studies and acceptance criteria are different. The evaluation focuses on physical properties, biocompatibility, and barrier effectiveness rather than diagnostic performance metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the information provided, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table of diagnostic performance metrics, the document describes performance in terms of safety, effectiveness, and material properties.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Study Type/Reference
Biocompatibility	Acute systemic toxicity	Non-toxic	ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP; conducted on sterilized, finished devices
	Irritation	Non-irritating
	Sensitization	Non-sensitizing
	Hemolysis	Non-hemolytic
	Material mediated pyrogen	Non-pyrogenic
Physical/Mechanical Properties	Material strength and elasticity	Adequate to allow use without tearing or pinholing (during application/removal, scanning, attaching/removing needle guide)	Claims based on 7 years of predicate device use; likely internal testing/engineering validation.
Barrier Properties	Resistance to penetration by bloodborne pathogens (viral penetration)	Effective barrier to prevention of microbial migration	Independent laboratory testing, protocol adapted from surgeons' glove evaluation using viral penetration as a test system.
Material Composition	Natural Rubber Latex; conformity to US FDA CFR, Title 21, Section 177.2600	Conforms	Material specifications.
Manufacturing Standards	Manufactured under FDA-CGMP under 21 CFR, Part 820	Compliant	Manufacturing process documentation.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility: The specific sample size for biocompatibility testing is not explicitly stated, but it was conducted on "sterilized (where applicable), finished devices." The provenance would be the manufactured devices themselves.
Barrier Properties: The sample size for the independent laboratory testing of barrier properties is not specified. The provenance would be the manufactured devices.
Given this is a physical device, concepts like "test set" and "data provenance" (e.g., country of origin, retrospective/prospective clinical data) are not directly applicable in the same way they would be for an AI/ML algorithm. The "test set" here refers to the actual manufactured devices undergoing physical and biological evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable for this type of device. "Ground truth" for an ultrasound transducer cover involves objective physical, chemical, and biological measurements, not expert interpretation of diagnostic images. The "experts" involved would be laboratory scientists or engineers conducting the tests, whose qualifications are implied by the nature of the tests (e.g., microbiology, toxicology).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation. The tests described (biocompatibility, barrier properties) yield objective results that do not typically require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is not designed to assist human readers in diagnostic interpretation. Therefore, there's no MRMC study or an effect size for human readers improving with AI vs. without AI assistance. The "effectiveness" here refers to the physical and biological function of the cover itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective, standardized laboratory measurements and compliance with regulatory standards:

Biocompatibility: Results from standardized biological tests (e.g., acute systemic toxicity, irritation, sensitization, hemolysis, pyrogenicity) following ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP.
Barrier Properties: Results from independent laboratory testing using viral penetration as a test system.
Material Composition: Chemical analysis confirming conformity to CFR standards.
Physical Properties: Engineering measurements and functional testing (e.g., resistance to tearing).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

{0}------------------------------------------------

K9 70515

Image /page/0/Picture/1 description: The image contains the text 'B2 of B4'. The text is written in a simple, sans-serif font. The letters and numbers are clearly legible against the white background.

Image /page/0/Picture/2 description: The image shows the logo for CIVCO Medical Instruments. The logo features a stylized globe-like graphic on the left, followed by the word "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL INSTRUMENTS" in a smaller, sans-serif font with wider letter spacing. The logo is black and white.

Solutions for Ultrasound

JUN 20 1997

510 (k) SUMMARY_______________________________________________________________________________________________________________________________________________________________

CIVCO Latex Ultrasound Transducer Cover

Date Summary Prepared: 30 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 (319) 656-4447 fax: (319) 656-4451 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:

Classification: Classification Panel: Classification Procode: CIVCO Latex Ultrasound Transducer Cover Ultrasound Transducer Cover / Sheath / Drape Ultrasonic Diagnostic Transducer Accessories

Class II under 21 CFR 892.1570 90 Radiology ITX

Description of Predicate Device(s): The CIVCO Latex Ultrasound Transducer Cover is equivalent to CIVCO's currently, legally marketed Latex Ultrasound Sheath, 510(k) reference number K895614.

ORIGINALS ARE CODED RED

sheet 1 of 3

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/20 description: The image shows two logos related to quality assurance. The logo on the left is a circular stamp with the text "QUALITY ASSURED FIRM" surrounding "ISO 9001" and the letters "SQS" at the bottom. The logo on the right features a crown above a checkmark, with the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" below the checkmark. These logos indicate that the organization has met certain quality standards and is accredited by a national body.

{1}------------------------------------------------

B3 of B4 510 (k) SUMMARY con't.

Description of Subject Device Submitted for Premarket Notification: Latex Ultrasound Transducer Cover - this device provides an efficient, thin, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Covers are beaded and rolled for easy application to the transducer. Cover materials are dipmolded Natural Rubber Latex similar to that of patient / surgical gloves.

Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:

Intended Uses / Indications for Use: Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Latex Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

The intended use and indications for use place CIVCO Latex Ultrasound Transducer Covers 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)

ORNERS ARE CODED RED

{2}------------------------------------------------

B4 of B4 510 (k) SUMMARY con't.

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

both provide a thin, conformal protective cover system for ultrasound transducer Intended Use: usage in body surface, endocavity, and intra-operative patient environments; both help to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer, and help maintain the sterile field where applicable; both are disposable devices - for single patient / procedure use.
Design: both are one-piece, open on one end, closed on other end with various dimensional configurations necessary to accommodate differences in ultrasound transducer geometries. Covers are externally applied to ultrasound transducer.
both are Natural Rubber Latex; material formulations conform to US Food and Material: Drugs Administration CFR, Title 21, Section 177.2600, and are manufactured under FDA - CGMP under 21 CFR, Part 820.
Manufacturing: manufacturing processes dip-molding, packaging (in class 10,000 cleanroom), and sterilization (when applicable) are same as for predicate device.
Safety: materials and manufacturing processing (including EtO sterilization) affects to the healthcare worker and patient via intended use / indications for use contact of this device have been biologically evaluated using biocompatibility tests for 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 Latex Ultrasound Transducer Cover 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, nonirritating, non-hemolytic, and non-pyrogenic.
physical / mechanical properties of the finished device are the same as for that of Effectiveness: the predicate device; material strength and elasticity is adequate to allow use without tearing or pinholing the cover - a) during application and removal of cover from transducer, b) during scanning under intended uses, and c) attaching / removing a disposable needle guide to the transducer bracket over the cover; natural rubber latex materials have been effectively used in CIVCO ultrasound transducer covers applications for the past seven (7) years; CIVCO latex transducer covers have been tested by an independent laboratory under protocol adapted from that used to evaluate the barrier properties / resistance of surgeons glove materials to penetration by bloodborne pathogens using viral penetration as a test system. This testing has demonstrated that the latex transducer cover is an effective barrier to the prevention of microbial migration.

sheet 3 of 3

ORIGINALS ARE CODED RED

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a circular seal with the words "U.S. Department of Health Services USA" around the edge. In the center of the seal is a stylized symbol that resembles three human figures or profiles facing to the right. The symbol is composed of curved lines and shapes, creating a sense of unity or connection between the figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

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

Re: K970515

CIVCO Latex Ultrasound Transducer Cover Dated: June 2, 1997 Received: June 3, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Jones:

"的

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 commerce prior to May 28, 1976, the enactment date of the Medical 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 II (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 equivalion assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 (2) CFR Part 801 and additionally 809.10 for in vitro disgnostic 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/cdrh/dsmamain.html".

Sincerely yours,

William

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

{4}------------------------------------------------

510(k) Notification - CIVCO Latex Ultrasound Transducer Cover

INDICATIONS FOR USE STATEMENT

Page 1 of 1

K970515 510(k) Number (if known):

CIVCO Latex Ultrasound Transducer Cover Device Name:

Indications For Use:

ﺩ. .:

(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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

CORDER RED

page C3

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.