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510(k) Data Aggregation
(129 days)
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.
CIVCO Poly Ultrasound Transducer Cover - this device provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. Devices are manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens from one patient to another. Materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required - the sterile or non-sterile Poly Ultrasound Transducer Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:
General Purpose CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) General Purpose Polyethylene Transducer Covers (sterile and non-sterile) Accordion-folded Polyethylene Transducer Covers (sterile) Intraoperative Polyethylene Transducer Covers (sterile) Endocavity CIV-Flex™ (polyurethane) Transducer Covers (sterile and non-sterile) Surgi™ Intraoperative (polvethylene) Transducer Covers (sterile) Intraoperative (polyethylene) Cord and System Drapes (sterile)
Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Poly transducer covers are also combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
The provided document describes the K970513 (CIVCO Poly Ultrasound Transducer Cover) 510(k) summary, which outlines the device's characteristics and its substantial equivalence to a predicate device, K844472 (CIVCO's Scan Drape). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating equivalence in materials, manufacturing, safety (biocompatibility), and effectiveness (barrier properties) to a previously cleared device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics in a table format. Instead, it relies on demonstrating equivalence to the predicate device and satisfactory results from specific tests.
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Both subject and predicate devices provide a thin, conformal protective cover system for ultrasound transducer usage in body surface, endocavity, and intra-operative patient environments. Both help prevent microorganism, body fluid, and particulate material transfer, and maintain a sterile field where applicable. Both are disposable. | The CIVCO Poly Ultrasound Transducer Cover fulfills these intended uses and indications as described. It is equivalent to the predicate device in its application for diagnostic ultrasound across various body contact categories (surface, external communicating) and contact durations (< 24 hours), both sterile and non-sterile. |
| Design | Both are one-piece, open on one end, closed on the other, with various dimensional configurations to accommodate different ultrasound transducer geometries. Externally applied. | The CIVCO Poly Ultrasound Transducer Cover adheres to this design principle, offered in various sizes and shapes to fit specific transducer geometries, confirming its equivalence to the predicate. |
| Material | Cover materials are polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film, with a history of effective use in CIVCO ultrasound transducer cover applications for the past ten (10) years. | The CIVCO Poly Ultrasound Transducer Cover uses polyurethane (CIV-Flex™) and polyethylene extruded thermoplastic film, consistent with the predicate device materials. |
| Manufacturing | Manufacturing processes (impulse heat-seal cover fabrication, packaging in cleanroom, EtO sterilization) are the same as for the predicate device. | The manufacturing processes for the CIVCO Poly Ultrasound Transducer Cover are identical to those of the predicate device, including packaging in a Class 10,000 cleanroom and EtO sterilization (when applicable). |
| Safety | Materials and manufacturing (including EtO sterilization) should not cause adverse effects to healthcare workers or patients. Biocompatibility tests (cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen) should demonstrate non-toxicity, non-sensitization, non-irritation, non-hemolysis, and non-pyrogenicity. | Biocompatibility testing was conducted on sterilized, finished devices according to ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-GLP. Testing demonstrated the subject materials/devices to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic, thus meeting the safety criteria for limited contact duration and body contact for surface and external communicating devices. |
| Effectiveness | Physical/mechanical properties should be the same as the predicate regarding material strength and elasticity to prevent tearing/pinholing during application/removal, scanning, and needle guide attachment. The cover should provide an effective barrier against microbial migration. | Physical/mechanical properties of the finished device are reported as the same as the predicate device, with adequate material strength and elasticity to prevent tearing or pinholing during use. Independent laboratory testing (protocol adapted from evaluating surgeon's glove materials using viral penetration) demonstrated that the polyurethane and polyethylene transducer covers provide an effective barrier to the prevention of microbial migration, thereby meeting the effectiveness criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified in terms of distinct units or number of tests conducted for physical/mechanical properties and barrier effectiveness. The phrases "physical/mechanical properties of the finished device are the same as for that of the predicate device" and "CIVCO Polyurethane and Polyethylene Ultrasound Transducer Covers have been tested by an independent laboratory" indicate testing was performed, but the sample size for these tests is not quantified.
- Data Provenance: Not explicitly stated if the data is retrospective or prospective. Given the context of a 510(k) submission, the testing would generally be conducted prospectively for the purpose of the submission. The country of origin for the data is not specified; the submitter is based in Kalona, IA, USA, but the independent laboratory conducting barrier testing is not named or located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The device is a physical medical instrument (ultrasound transducer cover), and its "ground truth" is established through engineering and biocompatibility testing against defined standards and predicate device performance, not through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established through laboratory testing and engineering comparisons, not subjective assessment requiring adjudication among experts.
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
This is not applicable. The device is an ultrasound transducer cover, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical instrument (ultrasound transducer cover), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Physical and Mechanical Testing: Demonstrating properties like material strength, elasticity, and integrity (no tearing/pinholing) under various use conditions.
- Biocompatibility Testing: Adherence to established standards (ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP) to ensure the device is non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic.
- Barrier Properties Testing: Demonstrated effectiveness in preventing microbial migration, adapted from protocols for similar barrier devices (e.g., surgeon's gloves).
- Comparison to Predicate Device: The ultimate "ground truth" for substantial equivalence is that the new device performs "the same as" a legally marketed predicate device across all critical attributes (intended use, design, material, manufacturing, safety, effectiveness).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no concept of a "training set."
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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