(139 days)
No
The device description and performance studies focus on the physical properties and barrier function of an ultrasound cover, with no mention of AI or ML technologies.
No.
The device is a microbial barrier for medical imaging equipment and does not directly provide therapeutic benefits to the patient. It facilitates diagnostic imaging procedures by providing a sterile or clean barrier.
No
The device is a microbial barrier (transducer cover) used during diagnostic imaging procedures, not a diagnostic device itself. Its primary function is to provide a sterile barrier, facilitating imaging procedures rather than performing diagnosis.
No
The device is a physical cover intended as a microbial barrier for ultrasound transducers. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is as a "microbial barrier between the patient and medical imaging equipment." This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces its role as a "microbial barrier" and highlights its material properties related to blocking microbes and acoustic characteristics. It doesn't describe any components or processes for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device facilitates ultrasound imaging procedures by providing a sterile barrier, but it does not perform any analysis of biological samples (like blood, urine, tissue) to provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the device's barrier properties, biocompatibility, material strength, and acoustic characteristics – all related to its function as a physical barrier and facilitator of imaging, not as a diagnostic tool. There are no mentions of studies evaluating diagnostic accuracy (sensitivity, specificity, etc.).
In summary, the device is an accessory used during medical imaging procedures to maintain sterility and protect equipment, not a device that performs diagnostic testing on biological samples.
N/A
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 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.
Product codes
ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Small Parts, Regional Anesthesia, Vascular Access, Surgical, Transesophageal, Transrectal, Transvaginal
Indicated Patient Age Range
all body sizes
Intended User / Care Setting
healthcare environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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
-
- Submitter's Identifications:
| Establishment: | CIVCO Medical Instruments Co., Inc |
|---|---|
| Address: | 102 First Street South |
| Kalona, IA 52247 | |
| Registration Number: | 1937223 |
| Operations Manufacturer | |
| Owner/Operator: | CIVCO Medical Instruments Co., Inc. |
| Owner/Operator Number: | 1937223 |
| Contact Person: | Jim Leong |
| Phone: | 319-248-6502 |
| e-mail: | James.Leong@civco.com |
-
- Date 510(k) Summary Prepared: April 21, 2021
-
- 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 |
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 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.
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.
5
9. Comparison to Legally Marketed Device
| Item | Subject Device
CIVCO CIV-Clear Cover
K21XXXX | Predicate Device
CIVCO Envision Cover and
Pad
K190802 | |
|-------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Material | N/A | Pad: Polycarbonate, silicone
elastomer, polyether
polyurethane, coating
formulation | |
| | Cover: Ethyl Methyl Acrylate
(EMA) and Polyethylene blend | Cover: Polyurethane | |
| 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 | |
| Acoustic
Performance | Acoustic
Impedance | $1.54 ± 0.13 x 10^5 g/(cm^2 sec)$ | Primary coating: $1.69 ± 0.18 x 10^5 g/(cm^2 sec)$
Secondary coating: $1.68 ± 0.29 x 10^5 g/(cm^2 sec)$ |
| | Acoustic
Velocity | 1630 m/s | Primary Coating: 1594 m/s
Secondary Coating: 1631 m/s |
| | Density
of
Coating | N/A - no coating | Primary: 1.06 g/mL)
Secondary: 1.03 g/mL |
| | pH of
coating | N/A - no coating | 7.11 (both primary and
secondary coatings) |
| Acoustic Coupling | | Uses gel to facilitate coupling | Hydrated coating used to
facilitate coupling |
| Sterilization | | Ethylene Oxide | Ethylene Oxide |
| Shelf-life | | 3 years | 3 years |
| Accessory | | Ultrasound gel packet | Saline wipe to facilitate
coupling |
6
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
7
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.