(435 days)
UltraPhonic® Scanning Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.
Ultra/Phonic® Scanning Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.
Here's a summary of the acceptance criteria and the study details for the Ultra/Phonic® Scanning Gel, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Ultra/Phonic® Scanning Gel Performance |
|---|---|
| Acoustic Properties: |
- Sound velocity
- Density
- Acoustic impedance
- Attenuation coefficient as a function of frequency | - Sound velocity: 1590 ms-1 at 22.5°C
- Density: 1035 kg/m3 at 22.5°C
- Acoustic impedance: 1.65 MRayls at 22.5°C
- Attenuation coefficient (a/f): 0.06 + 0.01116 f^1.3706
Conclusion: "Virtually identical to that of human skin" and "Similar to other coupling gels commonly used in the United States." Acoustic properties of the predicate gel (Sonishield™ 100) are also provided for comparison and are considered "virtually identical." |
| Antimicrobial Effectiveness (USP Category 2) | - Log reductions > 5 for bacterial counts (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa) at 14 and 28 days. - Yeasts and molds (Aspergillus brasiliensis, Candida albicans) did not increase, and "considerably decreased." |
| Biocompatibility (ISO 10993-10): - Skin Irritation
- Skin Sensitization | - Non-sensitizing
- Non-irritating |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | - Meets the requirements of the test and is "not considered cytotoxic." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each specific test (acoustic, antimicrobial, biocompatibility, cytotoxicity). It refers to "evaluations," "tests conducted," and "studies." The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective, though performance testing is generally prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies performed are non-clinical (laboratory and animal) and do not involve human interpretation or subjective expert ground truth establishment in the traditional sense of diagnostic AI studies.
4. Adjudication Method for the Test Set
Not applicable, as this device does not involve subjective diagnostic interpretations requiring adjudication. The performance criteria are based on objective physical, chemical, and biological measurements.
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
Not applicable. This is a medical device (ultrasound scanning gel) and not an AI-powered diagnostic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI model. Its performance is evaluated through direct physical, chemical, and biological testing, not through standalone algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by recognized scientific and regulatory standards and validated laboratory methods.
- Acoustic Properties: Comparative measurements against human skin properties and other commercially available gels.
- Antimicrobial Effectiveness: Defined log reduction criteria established by USP .
- Biocompatibility: Absence of irritation and sensitization as per ISO 10993-10.
- Cytotoxicity: Meeting negative control requirements and absence of cytotoxic effects as per ISO 10993-5:2009.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI model.
§ 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.