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 Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

Device Description

CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, 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. Materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film.

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 Poly 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 the cover off the transducer in a reverse method from the application.

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

General Purpose CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) General Purpose Polyethylene Transducer Covers (sterile and non-sterile) Accordion-folded Polyethylene Transducer Covers (sterile) Intraoperative Polyethylene Transducer Covers (sterile) Endocavity CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) Surgi™ Intraoperative (polvethylene) Transducer Covers (sterile) Intraoperative (polyethylene) Cord and System Drapes (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. Poly transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.

AI/ML Overview

The provided document describes the K970513 (CIVCO Poly Ultrasound Transducer Cover) 510(k) summary, which outlines the device's characteristics and its substantial equivalence to a predicate device, K844472 (CIVCO's Scan Drape). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating equivalence in materials, manufacturing, safety (biocompatibility), and effectiveness (barrier properties) to a previously cleared device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics in a table format. Instead, it relies on demonstrating equivalence to the predicate device and satisfactory results from specific tests.

Acceptance Criteria Category	Description of Criteria (Implied)	Reported Device Performance
Intended Use	Both subject and predicate devices provide a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments. Both help prevent microorganism, body fluid, and particulate material transfer, and maintain a sterile field where applicable. Both are disposable.	The CIVCO Poly Ultrasound Transducer Cover fulfills these intended uses and indications as described. It is equivalent to the predicate device in its application for diagnostic ultrasound across various body contact categories (surface, external communicating) and contact durations (< 24 hours), both sterile and non-sterile.
Design	Both are one-piece, open on one end, closed on the other, with various dimensional configurations to accommodate different ultrasound transducer geometries. Externally applied.	The CIVCO Poly Ultrasound Transducer Cover adheres to this design principle, offered in various sizes and shapes to fit specific transducer geometries, confirming its equivalence to the predicate.
Material	Cover materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film, with a history of effective use in CIVCO ultrasound transducer cover applications for the past ten (10) years.	The CIVCO Poly Ultrasound Transducer Cover uses polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film, consistent with the predicate device materials.
Manufacturing	Manufacturing processes (impulse heat-seal cover fabrication, packaging in cleanroom, EtO sterilization) are the same as for the predicate device.	The manufacturing processes for the CIVCO Poly Ultrasound Transducer Cover are identical to those of the predicate device, including packaging in a Class 10,000 cleanroom and EtO sterilization (when applicable).
Safety	Materials and manufacturing (including EtO sterilization) should not cause adverse effects to healthcare workers or patients. Biocompatibility tests (cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen) should demonstrate non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity.	Biocompatibility testing was conducted on sterilized, finished devices according to ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP. Testing demonstrated the subject materials/devices to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic, thus meeting the safety criteria for limited contact duration and body contact for surface and external communicating devices.
Effectiveness	Physical/mechanical properties should be the same as the predicate regarding material strength and elasticity to prevent tearing/pinholing during application/removal, scanning, and needle guide attachment. The cover should provide an effective barrier against microbial migration.	Physical/mechanical properties of the finished device are reported as the same as the predicate device, with adequate material strength and elasticity to prevent tearing or pinholing during use. Independent laboratory testing (protocol adapted from evaluating surgeon's glove materials using viral penetration) demonstrated that the polyurethane and polyethylene transducer covers provide an effective barrier to the prevention of microbial migration, thereby meeting the effectiveness criteria.

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

Sample Size for Test Set: Not specified in terms of distinct units or number of tests conducted for physical/mechanical properties and barrier effectiveness. The phrases "physical/mechanical properties of the finished device are the same as for that of the predicate device" and "CIVCO Polyurethane and Polyethylene Ultrasound Transducer Covers have been tested by an independent laboratory" indicate testing was performed, but the sample size for these tests is not quantified.
Data Provenance: Not explicitly stated if the data is retrospective or prospective. Given the context of a 510(k) submission, the testing would generally be conducted prospectively for the purpose of the submission. The country of origin for the data is not specified; the submitter is based in Kalona, IA, USA, but the independent laboratory conducting barrier testing is not named or located.

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

This type of information is not applicable to this 510(k) submission. The device is a physical medical instrument (ultrasound transducer cover), and its "ground truth" is established through engineering and biocompatibility testing against defined standards and predicate device performance, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established through laboratory testing and engineering comparisons, not subjective assessment requiring adjudication among experts.

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

This is not applicable. The device is an ultrasound transducer cover, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

This is not applicable. The device is a physical medical instrument (ultrasound transducer cover), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Physical and Mechanical Testing: Demonstrating properties like material strength, elasticity, and integrity (no tearing/pinholing) under various use conditions.
Biocompatibility Testing: Adherence to established standards (ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP) to ensure the device is non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic.
Barrier Properties Testing: Demonstrated effectiveness in preventing microbial migration, adapted from protocols for similar barrier devices (e.g., surgeon's gloves).
Comparison to Predicate Device: The ultimate "ground truth" for substantial equivalence is that the new device performs "the same as" a legally marketed predicate device across all critical attributes (intended use, design, material, manufacturing, safety, effectiveness).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no concept of a "training set."

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

This is not applicable for the same reason as point 8.

Summary

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K970573

Image /page/0/Picture/1 description: The image shows the logo for CIVCO Medical Instruments. The logo features a stylized globe 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 wide letter spacing. The overall design is simple and professional, conveying a sense of global reach and medical expertise.

JUN 2 0 1997

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Solutions for Ultrasound

CIVCO Poly Ultrasound Transducer Cover 510 (k) SUMMARY

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:

CIVCO Poly Ultrasound Transducer Cover Ultrasound Transducer Cover / Sheath / Drape Ultrasonic Diagnostic Transducer Accessories

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

Description of Predicate Device(s): The CIVCO Poly Ultrasound Transducer Cover is equivalent to CIVCO's currently, legally marketed Scan Drape, 510(k) reference number K844472.

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/19 description: The image contains two logos side by side. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. Below the text is the acronym "SQS". The logo on the right features a checkmark above the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" and a crown above the checkmark. The logos appear to represent quality assurance and national accreditation.

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510 (k) SUMMARY con't.

Description of Subject Device Submitted for Premarket Notification: CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, 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. Materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film.

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

Intended Use / 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 material to the patient and healthcare worker during reuse of the transducer (both sterile and nonsterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

The intended use and indications for use place CIVCO Poly 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)

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B4 of B4 510 (k) SUMMARY con't. _______________________________________________________________________________________________________________________________________________________ CIVCO Poly Ultrasound Transducer Cover

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.
both are one-piece, open on one end, closed on other end with various Design: dimensional configurations necessary to accommodate differences in ultrasound transducer geometries. Covers are externally applied to ultrasound transducer.
Cover materials are polyurethane (CIV-Flex™) and polyethylene extruded Material: thermoplastic film; polyurethane and polyethylene materials have been effectively used in CIVCO ultrasound transducer covers applications for the past ten (10) years.
Manufacturing: manufacturing processes impulse heat-seal cover fabrication, packaging (in class 10,000 cleanroom), and EtO sterilization (when applicable) are same as for predicate device.
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 Polyurethane and Polyethylene 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, non-irritating, nonhemolvtic, and non-pvrogenic.

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; CIVCO Polyurethane and Polyethylene Ultrasound 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 polyurethane and polyethylene transducer covers provide an effective barrier to the prevention of microbial migration.

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ORIGINALS ARE CODED RED

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Image /page/3/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, and its head is facing to the left.

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: K970513

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

Dear Mr. Jones:

分

We have reviewed your Secuon 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematice 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 assumply 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 assisted of 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 (21 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/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

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INDICATIONS FOR USE STATEMENT Page 1 of 1

K970513 510(k) Number (if known):

CIVCO Poly Ultrasound Transducer Cover Device Name:

Indications For Use:

(Per 21 CFR 801.109)

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 curing 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 Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K970573

Prescription Use	✓	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

ORIGINATERE CODED RED

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.