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510(k) Data Aggregation
(139 days)
CIV-Clear cover
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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