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510(k) Data Aggregation
(139 days)
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.
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.
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.
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(56 days)
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 transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.
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.
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.
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