Envision ultrasound pad and cover

{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. 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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. | | <span> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | | <span> <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> | |--|--------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------| |--|--------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 South<br>Kalona, IA 52247 | | Registration Number: | 1937223 | | Operations Manufacturer<br>Owner/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: 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. - 7. 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 Device<br>CIVCO Envision Cover and Pad<br>K190802 | Predicate Device<br>CIVCO General Purpose<br>Transducer Cover<br>K970513 | |-------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Material | | Pad: Polycarbonate, silicone elastomer,<br>polyether polyurethane, coating<br>formulation | Pad: N/A | | | | Cover: Polyurethane | Cover: Same | | Material Integrity | | All acceptance criteria met related to<br>the strength and elasticity of the cover<br>sheath component. | Equivalent testing and results | | Microbial Barrier | | Meets requirements of ASTM F1671-<br>13 for prevention of blood-borne<br>pathogens | Equivalent testing | | Acoustic<br>Performance | Acoustic<br>Impedance | Primary coating: $1.69 ± 0.18 x 10^5$<br>g/(cm² sec)<br>Secondary coating: $1.68 ± 0.29 x 10^5$<br>g/(cm² sec) | $1.68 ± 0.24 x 10^5$ g/(cm² sec) | | | Acoustic/<br>Sound<br>Velocity | Primary Coating: 1594 ± 170 m/s<br>Secondary Coating: 1631 ± 282 m/s | Reference Device Data:<br>1398-1750 m/s | | | Density of<br>Coating | Primary: 1.06 g/mL<br>Secondary: 1.03 g/mL | Reference Device Data:<br>0.85-1.15g/mL | | | pH of<br>coating | 7.11 (both primary and secondary<br>coatings) | Reference Device Data:<br>5.5-7.8 | | Acoustic Coupling | | Hydrated coating used to facilitate<br>coupling | 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.