The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

Device Description

The Envision Ultrasound pad and Envision Ultrasound cover (Envision) are microbial barriers for use during ultrasound procedures. The Envision device contains a coating that facilitates the acoustic coupling between the patient and ultrasound equipment without the need for traditionally ultrasound gel. This enables the clean transmission of sound waves between the transducer and patient without the mess of gels.

The Envision Ultrasound pad is comprised of four layers. The first layer is a crack and peel release liner that is removed by the customer to expose the adhesive layer (second layer) that sticks to the patient or the transducer within the cover. The third layer is a film carrier layer to hold the adhesive and coating layers together. The final layer is the coating layer, which is the acoustic couplant layer and is activated by using hydrating media, such as saline.

The Envision pad is sold as both a standalone pad and also sold as an integrated ultrasound cover (cover). The cover is a traditional CIVCO ultrasound cover, where one end of the cover is cut out, and the Envision pad, cut down to size, is sealed to the cover at the location of the cut out.

AI/ML Overview

The document describes the Envision™ Ultrasound Cover and Pad, a device intended as a microbial barrier and acoustic coupler for ultrasound procedures. This device is compared to a predicate device (CIVCO General Purpose Transducer Cover K970513) and a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels K181363).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to the predicate or reference device, or through meeting specific standards (e.g., ISO, ASTM). The "Reported Device Performance" column reflects the results of the non-clinical tests.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Envision)	Performance of Predicate/Reference Device (Comparison)
Material	N/A (Composition)	Pad: Polycarbonate, silicone elastomer, polyether polyurethane, coating formulation; Cover: Polyurethane	Predicate Cover: Same (Polyurethane); Predicate Pad: N/A
Material Integrity	Strength and elasticity of the cover sheath component (unspecified standard but "all acceptance criteria met")	All acceptance criteria met related to the strength and elasticity of the cover sheath component.	Equivalent testing and results
Microbial Barrier	ASTM F1671-13 (prevention of blood-borne pathogens)	Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens.	Equivalent testing
Acoustic Impedance	Comparison to reference device (1.68 ± 0.24 x 10^5 g/(cm² sec))	Primary coating: 1.69 ± 0.18 x 10^5 g/(cm² sec); Secondary coating: 1.68 ± 0.29 x 10^5 g/(cm² sec)	1.68 ± 0.24 x 10^5 g/(cm² sec) (Reference Device Data)
Acoustic/Sound Velocity	Comparison to reference device (1398-1750 m/s)	Primary Coating: 1594 ± 170 m/s; Secondary Coating: 1631 ± 282 m/s	1398-1750 m/s (Reference Device Data)
Density of Coating	Comparison to reference device (0.85-1.15 g/mL)	Primary: 1.06 g/mL; Secondary: 1.03 g/mL	0.85-1.15 g/mL (Reference Device Data)
pH of Coating	Comparison to reference device (5.5-7.8)	7.11 (both primary and secondary coatings)	5.5-7.8 (Reference Device Data)
Acoustic Coupling	Ability to facilitate coupling	Hydrated coating used to facilitate coupling.	Uses gel to facilitate coupling
Sterilization	Ethylene Oxide sterilization (met ISO 11135)	Ethylene Oxide (validated per ISO 11135); residuals meet ISO 10993-7 limits.	Ethylene Oxide
Shelf-life	1 year (accelerated aging per ASTM F1980-16)	1 year (supported by accelerated aging per ASTM F1980-16 and packaging validation per ISO 11607-2 and ISTA 2A)	3 years
Biocompatibility	ISO 10993-1 requirements for limited contact duration	Met ISO 10993-1 requirements (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemolysis, Subcutaneous Implantation, Material Mediated Pyrogenicity)	No specific details given for predicate but states "same testing performed"
Water Leak Testing	Demonstrate material strength and elasticity	Performed to demonstrate material strength and elasticity.	No specific details given for predicate but implies "same testing performed"
Rehydration Testing	Withstand multiple rounds of rehydration and perform as intended	Subjected to multiple rounds of rehydration and tested to ensure performance.	Not applicable (predicate uses gel, not rehydration)
Simulated Use Testing	Conformity to user needs and intended use	Performed to ensure design conforms to user needs and intended use.	No specific details given for predicate but implies "same testing performed"

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

The document does not specify exact sample sizes for the test sets in most non-clinical studies. For example, it states "The Envision pad's ability to withstand viral penetration was performed to evaluate the barrier performance... in accordance with ASTM F1671-13," without detailing the number of samples tested under this standard. Similarly, for acoustic properties, specific sample sizes are not provided.

The data provenance is from non-clinical bench testing performed by the manufacturer (CIVCO Medical Instruments Co., Inc.). There is no mention of patient data (prospective or retrospective) or country of origin for such data, as this is a device clearance based on engineering and material performance.

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

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, rather than expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, not on subjective expert consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasound cover and pad, not an AI-powered diagnostic system. Clinical tests were explicitly stated as "not required to demonstrate substantial equivalence."

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical accessory for ultrasound, not an algorithm.

7. The type of ground truth used

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

Established standards and regulations: Such as ISO 10993 for biocompatibility, ASTM F1671-13 for viral penetration, ISO 11135 for sterilization, ASTM F1980-16 for accelerated aging, ISO 11607-2 and ISTA 2A for packaging.
Direct measurement and comparison: For acoustic properties (impedance, sound velocity, density, pH) where the Envision device's physical properties are directly measured and compared against established ranges from a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels).
Functional tests: Water leak testing, rehydration testing, and simulated use testing to ensure the device performs its intended functions.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device. There is no concept of a "training set" for the Envision Ultrasound Cover and Pad.

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

This information is not applicable as this is not an AI/machine learning device.

Summary

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

May 24, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CIVCO Medical Solutions % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K190802

Trade/Device Name: Envision™ Ultrasound Cover and Pad Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: May 21, 2019 Received: May 22, 2019

Dear Mr. Job:

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/cfpmn/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

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

801); 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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

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

Indications for Use

510(k) Number K190802

Device Name

Envision™ Ultrasound cover and pad

Indications for Use (Describe)

The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics.

The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

	Prescription Use (Part 21 CFR 801 Subpart D)		Over-The-Counter Use (21 CFR 801 Subpart C)
--	--------------------------------------------------------------------------------------------------------------	--	--------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Type of Use (Select one or both, as applicable)

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

510(K) SUMMARY

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

The assigned 510(k) numberis: K190802.

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:	319-656-4447
e-mail:	James.Leong@civco.com

2. Date 510(k) Summary Prepared: May 15, 2019

3. Name of the Subject Device and Classification Information:

Trade/Device Name	Envision™ Ultrasound cover and pack
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	General Purpose Transducer Cover
Manufacturer	CIVCO Medical Instruments Co., Inc.
510(k) Number	K970513
Regulation Number	892.1570
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	II
Product Code	ITX

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

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:

1. Intended Use / Indications for Use:
  The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics.

The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile and nonsterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

{5}------------------------------------------------

8. Comparison to Legally Marketed Device

Item		Subject DeviceCIVCO Envision Cover and PadK190802	Predicate DeviceCIVCO General PurposeTransducer CoverK970513
Material		Pad: Polycarbonate, silicone elastomer,polyether polyurethane, coatingformulation	Pad: N/A
		Cover: Polyurethane	Cover: Same
Material Integrity		All acceptance criteria met related tothe strength and elasticity of the coversheath component.	Equivalent testing and results
Microbial Barrier		Meets requirements of ASTM F1671-13 for prevention of blood-bornepathogens	Equivalent testing
AcousticPerformance	AcousticImpedance	Primary coating: $1.69 ± 0.18 x 10^5$g/(cm² sec)Secondary coating: $1.68 ± 0.29 x 10^5$g/(cm² sec)	$1.68 ± 0.24 x 10^5$ g/(cm² sec)
	Acoustic/SoundVelocity	Primary Coating: 1594 ± 170 m/sSecondary Coating: 1631 ± 282 m/s	Reference Device Data:1398-1750 m/s
	Density ofCoating	Primary: 1.06 g/mLSecondary: 1.03 g/mL	Reference Device Data:0.85-1.15g/mL
	pH ofcoating	7.11 (both primary and secondarycoatings)	Reference Device Data:5.5-7.8
Acoustic Coupling		Hydrated coating used to facilitatecoupling	Uses gel to facilitate coupling
Sterilization		Ethylene Oxide	Ethylene Oxide
Shelf-life		1 year	3 years
Accessory		Saline wipe to facilitate coupling	Ultrasound gel packet
Environment of Use		Healthcare facility/hospital	Healthcare facility/hospital

{6}------------------------------------------------

9. Comparison of Indications to the Legally Marketed Device:

The proposed Envision 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 pad and cover is secondary to the ultrasound use. Any questions related to safety and effectiveness of the Envision pad and cover have been addressed using the same testing performed by the legally marketed device, including biocompatibility, viral penetration, and material strength and elasticity studies.

10. Summary of Non-Clinical Tests Performed:

Biocompatibility:
The Envision devices met ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface and external communicating indirect blood path/tissue contact:
-Cytotoxicity - ISO 10993-5
-Sensitization - ISO 10993-10
Irritation ISO 10993-10 -
Acute Systemic Toxicity ISO 10993-11 -
-Hemolysis - ASTM F 756
-Subcutaneous Implantation - ISO 10993-6
-Material Mediated Pyrogenicity - ISO 10993-11
Viral Penetration:

The Envision pad's ability to withstand viral penetration was performed to evaluate the barrier performance of the Envision pad material in accordance with ASTM F1671-13.

Water leak testing: ●
Water leak testing was performed to demonstrate material strength and elasticity of the Envision device.
Acoustic Impedance: ●
The measurement of acoustic impedance was performed to compare the acoustic characteristics of the Envision pad to the predicate cover with ultrasound coupling gel.
Acoustic/Sound Velocity: ●
The measurement of the acoustic velocity was calculated from the acoustic impedance and density to compare the acoustic velocity of the Envision pad to the predicate cover with ultrasound coupling gel.

{7}------------------------------------------------

Physical and Chemical Characteristics:
The density and pH of the Envision pad coating was measured for comparison to the ultrasound coupling gel, which would be used with the predicate device.
Simulated Use Testing
Simulated use testing was performed to ensure the design of the Envision conforms to the user needs and intended use.
Packaging and Shelf-life:
The Envision packaging was validated per ISO 11607-2 and ISTA 2A to ensure the packaging maintains its integrity over the course of the device's shelf-life. Accelerated aging in support of a one-year shelf life was completed in accordance with ASTM F1980-16.
Rehydration Testing
The Envision devices were subjected to multiple rounds of rehydration and tested to ensure the devices would withstand multiple rounds of rehydration and perform as intended.
Ethylene Oxide Sterilization Validation and Residuals Testing
The Envision devices are validated per ISO 11135 to ensure that the devices meet the required sterility assurance level, so the devices remain adequately free from viable microorganisms following sterilization.

The Envision devices are 2x Ethylene Oxide sterilized and tested to ensure that residuals from the Ethylene Oxide cycle do not exceed the limits per ISO 10993-7.

11. Clinical Test Performed:

Clinical tests were not required to demonstrate substantial equivalence.

12. Conclusions

The Envision 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 Envision pad and cover are substantially equivalent to the legally marketed 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.