· Abdominal Diagnostic imaging and minimally invasive puncture procedures.
· Small Parts Diagnostic imaging and minimally invasive puncture procedures.
· Regional Anesthesia Minimally invasive puncture procedures.
· Vascular Access Vessel identification and catheter placement.
· Surgical Diagnostic imaging and puncture procedures.
· Transesophageal Diagnostic imaging and monitoring of heart chamber, valves and vessels.
· Transrectal Diagnostic imaging and minimally invasive puncture procedures.
· Transvaginal Diagnostic imaging and minimally invasive puncture procedures

When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

Device Description

The CIV-Clear cover is a microbial barrier for use during ultrasound procedures. The cover is offered in sterile and non-sterile configurations in a variety of sizes to function with different equipment. The material has been tested and proven to be a viral barrier for microbes 27 nanometers and larger in size.

AI/ML Overview

This FDA 510(k) summary describes the CIV-Clear cover, a microbial barrier for ultrasound procedures. The document aims to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's the breakdown of acceptance criteria and the supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Aspect	Acceptance Criteria (from predicate device standards or established tests)	Reported Device Performance
Material	N/A - Not explicitly stated as a criterion, but a comparison point.	Cover: Ethyl Methyl Acrylate (EMA) and Polyethylene blend
Microbial Barrier	Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens	Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens. Tested to block microbes of size 27 nanometers and larger.
Acoustic Performance (Acoustic Impedance)	Predicate: Primary coating: 1.69 ± 0.18 x 10^5 g/(cm^2 sec); Secondary coating: 1.68 ± 0.29 x 10^5 g/(cm^2 sec)	1.54 ± 0.13 x 10^5 g/(cm^2 sec)
Acoustic Performance (Acoustic Velocity)	Predicate: Primary Coating: 1594 m/s; Secondary Coating: 1631 m/s	1630 m/s
Acoustic Performance (Density of Coating)	Predicate: Primary: 1.06 g/mL; Secondary: 1.03 g/mL	N/A - no coating
Acoustic Performance (pH of coating)	Predicate: 7.11 (both primary and secondary coatings)	N/A - no coating
Acoustic Coupling	Predicate uses hydrated coating to facilitate coupling	Uses gel to facilitate coupling
Sterilization	Ethylene Oxide (validated per ISO 11135, meeting required sterility assurance level)	Ethylene Oxide (validated per ISO 11135, qualified for 2x sterilization, residual levels per ISO 10993-7)
Shelf-life	3 years (validated per ASTM F1980-16)	3 years (accelerated aging per ASTM F1980-16)
Biocompatibility	Meets ISO 10993-1 requirements for limited contact duration for surface devices of breached or compromised surface and external communicating indirect tissue contact.	Met ISO 10993-1 requirements for limited contact duration. Tested for: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogen (ISO 10993-11).
Water Leak Testing	Not explicitly defined as a numerical criterion, but demonstrated material strength and elasticity after sterilization, shipping/conditioning, and aging.	Performed to demonstrate material strength and elasticity.
Packaging Integrity	Validated per ISO 11607-2 and ISTA 3A parameters to maintain integrity over shelf-life.	Uses same packaging as predicate, validated per ISO 11607-2 and ISTA 3A.
Simulated Use Testing	Conforms to user needs and intended use.	Performed to ensure design conforms to user needs and intended use.

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

The document does not specify a separate "test set" in the context of clinical or large-scale performance data in the typical sense of AI/diagnostic device studies. The testing described is primarily non-clinical, involving material science, biological, and engineering tests. For these tests, sample sizes would be determined by the specific ASTM and ISO standards followed, but these are not explicitly stated in the document.

The data provenance is from laboratory testing and engineering evaluations conducted by or for CIVCO Medical Instruments Co., Inc. It is not patient data (retrospective or prospective). The document does not mention any country of origin for the data other than the manufacturer's location (Kalona, IA, USA).

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

This section is not applicable as the described studies are non-clinical, focusing on device properties and safety rather than diagnostic accuracy involving expert interpretation of medical images or patient outcomes. Ground truth in this context refers to the defined parameters of the relevant ISO/ASTM standards.

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

This is not applicable as the described studies are non-clinical and do not involve human interpretation or adjudication of diagnostic outputs.

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 such study was done or reported. The device is a physical barrier (ultrasound cover), not an AI-powered diagnostic tool.

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

This is not applicable as the device is not an algorithm or AI system. It is a physical medical device.

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

The "ground truth" for the non-clinical tests is based on the established parameters and requirements of the referenced industry standards (e.g., ASTM F1671-13 for viral penetration, ISO 10993 for biocompatibility, ISO 11135 for sterilization, ASTM F1980-16 for accelerated aging, ISO 11607-2 and ISTA 3A for packaging). For acoustic performance, the ground truth is the measured physical properties compared against established ranges or predicate device performance.

8. The sample size for the training set

This is not applicable as no AI model or "training set" is mentioned or relevant to this physical device.

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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".

CIVCO Medical Instruments Co., Inc. % Jim Leong Regulatory Affairs Manager 102 First Street South KALONA IA 52247

September 13 , 2021

Re: K211270

Trade/Device Name: CIV-Clear cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: July 20, 2021 Received: July 28, 2021

Dear Jim Leong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211270

Device Name CIV-Clear Cover

Indications for Use (Describe)

The cover is intended as a microbial barrier between the patient and medical imaging equipment.

The transducer covers are used for all body sizes in sterile and non-sterile fields and for the following applications.

· Abdominal Diagnostic imaging and minimally invasive puncture procedures.
· Small Parts Diagnostic imaging and minimally invasive puncture procedures.
· Regional Anesthesia Minimally invasive puncture procedures.
· Vascular Access Vessel identification and catheter placement.
· Surgical Diagnostic imaging and puncture procedures.
· Transesophageal Diagnostic imaging and monitoring of heart chamber, valves and vessels.
· Transrectal Diagnostic imaging and minimally invasive puncture procedures.
· Transvaginal Diagnostic imaging and minimally invasive puncture procedures

When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

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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510(k) Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) numberis: K211270

1. Submitter's Identifications:

Establishment:	CIVCO Medical Instruments Co., Inc
Address:	102 First Street SouthKalona, IA 52247
Registration Number:	1937223
Operations ManufacturerOwner/Operator:	CIVCO Medical Instruments Co., Inc.
Owner/Operator Number:	1937223
Contact Person:	Jim Leong
Phone:	319-248-6502
e-mail:	James.Leong@civco.com

1. Date 510(k) Summary Prepared: April 21, 2021
1. Name of the Subject Device and Classification Information:

Trade/Device Name	CIV-Clear cover
Regulation Number	21 CFR 892.1570
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	Class II
Product Code	ITX

4. Information for the Predicate Device:

Tradename/Device Name	Envision™ Ultrasound Cover and Pad
Manufacturer	CIVCO Medical Instruments Co., Inc.
510(k) Number	K190802
Regulation Number	892.1570
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	II
Product Code	ITX

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5. Information for Reference Device:

Tradename/Device Name	EcoVue® Sterile and Non-Sterile Ultrasound Gels
Manufacturer	HR Pharmaceuticals, Inc.
510(k) Number	K181363
Regulation Number	892.1570
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	II
Product Code	MUI

6. Device Description:

7. Intended Use / Indications for Use:

The cover is intended as a microbial barrier between the patient and medical imaging equipment.

The transducer covers are used for adult of all body sizes in sterile and non-sterile fields and for the following applications.

Abdominal Diagnostic imaging and minimally invasive puncture procedures. .
Small Parts Diagnostic imaging and minimally invasive puncture procedures. ●
Regional Anesthesia Minimally invasive puncture procedures. ●
Vascular Access Vessel identification and catheter placement. ●
Surgical Diagnostic imaging and puncture procedures. ●
Transesophageal Diagnostic imaging and monitoring of heart chamber, valves and ● vessels.
Transrectal Diagnostic imaging and minimally invasive puncture procedures. ●
. Transvaginal - Diagnostic imaging and minimally invasive puncture procedures

When conducting an ultrasound procedure, place an appropriate amount of gel inside cover and/or on transducer face.

8. Clinical Use Envirionment:

The covers are to be used in the healthcare environment where equipment is being utilized.

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9. Comparison to Legally Marketed Device

Item	Subject DeviceCIVCO CIV-Clear CoverK21XXXX	Predicate DeviceCIVCO Envision Cover andPadK190802
Material	N/A	Pad: Polycarbonate, siliconeelastomer, polyetherpolyurethane, coatingformulation
	Cover: Ethyl Methyl Acrylate(EMA) and Polyethylene blend	Cover: Polyurethane
Microbial Barrier	Meets requirements of ASTMF1671-13 for prevention ofblood-borne pathogens	Meets requirements of ASTMF1671-13 for prevention ofblood-borne pathogens
AcousticPerformance	AcousticImpedance	$1.54 ± 0.13 x 10^5 g/(cm^2 sec)$	Primary coating: $1.69 ± 0.18 x 10^5 g/(cm^2 sec)$Secondary coating: $1.68 ± 0.29 x 10^5 g/(cm^2 sec)$
	AcousticVelocity	1630 m/s	Primary Coating: 1594 m/sSecondary Coating: 1631 m/s
	DensityofCoating	N/A - no coating	Primary: 1.06 g/mL)Secondary: 1.03 g/mL
	pH ofcoating	N/A - no coating	7.11 (both primary andsecondary coatings)
Acoustic Coupling		Uses gel to facilitate coupling	Hydrated coating used tofacilitate coupling
Sterilization		Ethylene Oxide	Ethylene Oxide
Shelf-life		3 years	3 years
Accessory		Ultrasound gel packet	Saline wipe to facilitatecoupling

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10. Comparison of Indications to the Legally Marketed Device:

The proposed CIV-Clear devices have the same intended use, of being a microbial barrier, as the legally marketed device. Any differences in the indications for use statement would not affect the safety or effectiveness of the device because the safety and efficacy related to the indicated procedures is dictated by the use of the underlying ultrasound equipment, and the ultrasound cover is secondary to the ultrasound use. Any questions related to safety and effectiveness of the CIV-Clear cover have been addressed using the same testing performed by the legally marketed device, including biocompatibility, viral penetration, and material strength and elasticity studies.

11. Summary of Non-Clinical Tests Performed:

. Biocompatibility:
The CIV-Clear devices met ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface and external communicating indirect tissue contact:
Cytotoxicity ISO 10993-5 -
Sensitization ISO 10993-10 -
Irritation ISO 10993-10 -
Acute Systemic Toxicity ISO 10993-11 -
Material Mediated Pyrogen ISO 10993-11 -
Viral Penetration: ●

The CIV-Clear cover's ability to withstand viral penetration was performed to evaluate the barrier performance of the material in accordance with ASTM F1671-13. Testing has demonstrated the ability to block microbes of size 27 nanometers and larger.

Water leak testing: ●
Water leak testing was performed to demonstrate material strength and elasticity of the CIV-Clear device after sterilization, shipping/conditioning, and aging.
Acoustic Impedance:
The measurement of acoustic impedance was performed to compare the acoustic characteristics of the CIV-Clear cover to the predicate cover with coating.
Simulated Use Testing
Simulated use testing was performed to ensure the design of the CIV-Clear cover conforms to the user needs and intended use.
. Packaging and Shelf-life:
CIV-Clear packing uses the same packaging as the predicate device which has been validated per ISO 11607-2 and ISTA 3A parameters to ensure the packaging

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maintains its integrity over the course of the device's shelf-life. Accelerated aging in support of a three-year shelf life of product was completed in accordance with ASTM F1980-16.

Ethylene Oxide Sterilization Validation and Residual Testing: ● The CIV-Clear devices are processed using sterilization cycle validated per ISO 11135 to ensure that the devise meet the required sterility assurance level, so the devices remain adequately free from viable microorganisms following sterilization.
The sterile CIV-Clear covers qualified for 2x Ethylene Oxide sterilization and tested to ensure that residual levels do not exceed the limits per ISO 10993-7 for contact.

12. Clinical Test Performed:

Clinical tests were not required to demonstrate substantial equivalence.

13. Conclusions:

The CIV-Clear device has the same intended use and its technological characteristics do not raise any different questions of safety or effectiveness, as compared to the legally marketed device. Therefore, the CIV-Clear covers are substantially equivalent to the legally marketed Envision device.

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.